Trial Outcomes & Findings for Health, Aging and Later-Life Outcomes (NCT NCT05424042)

NCT ID: NCT05424042

Last Updated: 2025-10-27

Results Overview

Ability of participants to sustain Caloric Restriction \>10%

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: Month 9
• Results posted on: 2025-10-27

Participant Flow

Recruitment began in July 2022 at one clinical site.

Participants were pre-screened on the phone and then brought in for consent then two screening visits which included a run in period prior to randomization to groups.

Participant milestones

Measure	In-Person Caloric Restriction Arm This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Overall Study STARTED	22	34	34
Overall Study COMPLETED	20	34	29
Overall Study NOT COMPLETED	2	0	5

Reasons for withdrawal

Measure	In-Person Caloric Restriction Arm This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Overall Study Withdrawal by Subject	2	0	4
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Health, Aging and Later-Life Outcomes

Baseline characteristics by cohort

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.	Total n=90 Participants Total of all reporting groups
Age, Continuous	66.6 years STANDARD_DEVIATION 5.0 • n=5 Participants	68.7 years STANDARD_DEVIATION 4.6 • n=7 Participants	66.1 years STANDARD_DEVIATION 5.0 • n=5 Participants	67.2 years STANDARD_DEVIATION 4.9 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	21 Participants n=7 Participants	22 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	29 Participants n=7 Participants	28 Participants n=5 Participants	75 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	34 Participants n=7 Participants	32 Participants n=5 Participants	88 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Screening Weight	90.5 kg STANDARD_DEVIATION 11.9 • n=5 Participants	90.8 kg STANDARD_DEVIATION 14.0 • n=7 Participants	89.7 kg STANDARD_DEVIATION 12.7 • n=5 Participants	90.3 kg STANDARD_DEVIATION 4.9 • n=4 Participants
Body Mass Index	31.0 kg/m2 STANDARD_DEVIATION 2.9 • n=5 Participants	31.7 kg/m2 STANDARD_DEVIATION 2.9 • n=7 Participants	32.0 kg/m2 STANDARD_DEVIATION 2.9 • n=5 Participants	31.7 kg/m2 STANDARD_DEVIATION 2.9 • n=4 Participants
Total MoCA Score	26.0 points STANDARD_DEVIATION 1.9 • n=5 Participants	26.2 points STANDARD_DEVIATION 2.0 • n=7 Participants	26.0 points STANDARD_DEVIATION 2.1 • n=5 Participants	26.1 points STANDARD_DEVIATION 2.0 • n=4 Participants
Grip Strength	32.1 kg STANDARD_DEVIATION 8.8 • n=5 Participants	32.1 kg STANDARD_DEVIATION 11.3 • n=7 Participants	30.3 kg STANDARD_DEVIATION 7.8 • n=5 Participants	31.4 kg STANDARD_DEVIATION 9.4 • n=4 Participants
Step Count per day	7201 steps per day STANDARD_DEVIATION 2536 • n=5 Participants	6411 steps per day STANDARD_DEVIATION 1888 • n=7 Participants	7327 steps per day STANDARD_DEVIATION 2960 • n=5 Participants	6962 steps per day STANDARD_DEVIATION 2514 • n=4 Participants
eSPPB	2.58 score STANDARD_DEVIATION 0.35 • n=5 Participants	2.49 score STANDARD_DEVIATION 0.31 • n=7 Participants	2.59 score STANDARD_DEVIATION 0.36 • n=5 Participants	2.55 score STANDARD_DEVIATION 0.34 • n=4 Participants
400 meter Fast Walk Time	292.4 seconds STANDARD_DEVIATION 42.4 • n=5 Participants	305.2 seconds STANDARD_DEVIATION 42.2 • n=7 Participants	398.7 seconds STANDARD_DEVIATION 36.4 • n=5 Participants	299.8 seconds STANDARD_DEVIATION 40.0 • n=4 Participants

PRIMARY outcome

Timeframe: Month 9

Population: The TRE Arm did not participate in caloric restriction and are not included in the outcome analysis. Only those participants with data from baseline and 9 months Doubly-Labeled water (DLW) are included in the analysis.

Ability of participants to sustain Caloric Restriction >10%

Outcome measures

Measure	In-Person Caloric Restriction Arm n=19 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=30 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Number of Participants That Sustained >10% Caloric Restriction	7 Participants	12 Participants	—

PRIMARY outcome

Timeframe: Month 9

This will measure the sustainability in a 9 month period of time and will be reported as the percentage of day eating within <= 8.5 hour window which is pre-specified for each participant.

Outcome measures

Measure	In-Person Caloric Restriction Arm n=34 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Ability to Maintain Time Restricted Eating (TRE) Intervention	83.5 % of days Interval 68.4 to 94.6	—	—

PRIMARY outcome

Timeframe: Month 9

Retention > 85%

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Number of Participants Who Were Retained	20 participants	34 participants	29 participants

SECONDARY outcome

Timeframe: From Baseline to Month 6, and From Baseline to 9 Months

Assessed using home scales.

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Body Weight Change Change in Body Weight at 6 months	-4.47 kg 95% Confidence Interval 6.44 • Interval -6.6 to -2.34	-6.09 kg 95% Confidence Interval 5.58 • Interval -7.76 to -4.41	-1.35 kg 95% Confidence Interval 4.37 • Interval -3.13 to 0.43
Body Weight Change Change in Body Weight at 9 months	-4.44 kg Interval -6.76 to -2.1	-6.66 kg Interval -8.49 to -4.83	-0.94 kg Interval -2.89 to 1.02

SECONDARY outcome

Timeframe: From Baseline to Month 9

Assessed by (Dual-Energy X-Ray Absorptiometry) DXA.

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Changes in Fat Mass	-2.92 kg 95% Confidence Interval 2.79 • Interval -4.73 to -1.11	-4.46 kg 95% Confidence Interval 2.46 • Interval -5.85 to -3.07	0.02 kg 95% Confidence Interval 1.53 • Interval -1.48 to 1.53

SECONDARY outcome

Timeframe: From Baseline to Month 9

As assessed by DXA for the total lean body mass.

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Changes in Lean Body Mass	-1.73 kg 95% Confidence Interval 1.47 • Interval -2.51 to -0.94	-2.21 kg 95% Confidence Interval 2.03 • Interval -2.82 to -1.6	-0.59 kg 95% Confidence Interval 1.63 • Interval -1.26 to 0.07

SECONDARY outcome

Timeframe: From Baseline to Month 9

As assessed by DXA using the Hip BMD

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Bone Mineral Density	-0.01 g/cm2 95% Confidence Interval 0.02 • Interval -0.02 to 0.0	-0.01 g/cm2 95% Confidence Interval 0.03 • Interval -0.02 to 0.0	-0.00 g/cm2 95% Confidence Interval 0.02 • Interval -0.01 to 0.01

SECONDARY outcome

Timeframe: From Baseline to Month 9

As assessed by Indirect Calorimetry between baseline and 9 months follow-up

Outcome measures

Measure	In-Person Caloric Restriction Arm n=20 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=33 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=29 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Resting Energy Expenditure	-35.3 Kcal Standard Deviation 221.4	-74.1 Kcal Standard Deviation 217.3	-94.8 Kcal Standard Deviation 182.8

SECONDARY outcome

Timeframe: From Baseline to Month 9

Assessed by ActivPAL

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Physical Activity Energy Expenditure	0.42 kcals per day Standard Deviation 1.26	0.68 kcals per day Standard Deviation 1.19	0.29 kcals per day Standard Deviation 0.59

SECONDARY outcome

Timeframe: From Baseline to Month 9

Using doubly-labeled water (DLW). Energy intake will be calculated from Total Energy Expenditure (TEE) assessed by DLW and change in body energy stores (measured by body weight and/or DXA) according to the equation: Energy Intake = TEE + Change in body energy stores

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Energy Intake	-129.5 kcals per day Standard Deviation 237.3	-133.6 kcals per day Standard Deviation 228.7	-45.6 kcals per day Standard Deviation 171.8

SECONDARY outcome

Timeframe: From Baseline to Month 9

The D3-Creatine (D3Cr) method used to assess total muscle mass is completed after the participant ingests a known amount of D3-creatine (creatine with deuterium atoms replacing hydrogens) and the labeled creatine is distributed throughout the body, with approximately 98% ending up in skeletal muscle. By measuring the ratio of labeled (D3-creatinine) to unlabeled creatinine in a urine sample the total body creatine pool can be determined and total muscle mass can be calculated.

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Total Muscle Mass	-1.46 kg Interval -3.51 to 0.59	0.64 kg Interval -0.92 to 2.2	1.88 kg Interval 0.1 to 3.67

SECONDARY outcome

Timeframe: From Baseline to Month 9

Data will be collected and nutrients and food groups analyzed using the publicly available National Cancer Institute's Automated Self-Administered 24-Hour (ASA24) dietary assessment tool.

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Self-Reported Energy Intake	-371.4 kcals/day Interval -612.2 to -130.6	-244.1 kcals/day Interval -433.0 to -55.3	-255.6 kcals/day Interval -452.9 to -58.3

SECONDARY outcome

Timeframe: From Baseline to Month 9

400m walk - assessed in number of seconds (unlimited time)

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Physical Function--Change in Walk Time	-7.05 seconds 95% Confidence Interval 40.23 • Interval -20.02 to 5.92	-19.76 seconds 95% Confidence Interval 26.81 • Interval -29.28 to -10.25	-19.18 seconds 95% Confidence Interval 17.58 • Interval -29.8 to -8.56

SECONDARY outcome

Timeframe: From Baseline to Month 9

measured in kg (0-90kg)

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Physical Function--Change in Grip Strength	-1.47 kg Standard Deviation 4.34	-0.48 kg Standard Deviation 4.67	-0.38 kg Standard Deviation 5.65

SECONDARY outcome

Timeframe: From Baseline to Month 9

Change in overall physical performance with total score ranging from 0 to 4 with a higher score denoting better physical function.

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Physical Function--Change in eSPPB	-0.10 score Standard Deviation 0.34	0.08 score Standard Deviation 0.26	-0.00 score Standard Deviation 0.22

SECONDARY outcome

Timeframe: From baseline to Month 9

Total score ranges from 0-30 with a higher score denoting better cognitive function.

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Cognitive Function--MoCA	1.20 score Standard Deviation 2.28	0.68 score Standard Deviation 2.42	1.17 score Standard Deviation 2.07

SECONDARY outcome

Timeframe: From Baseline to 9 Months

Fasting insulin, an age-related biomarker

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Age-Related Biomarkers--Fasting Insulin	-5.60 pmol/L Standard Deviation 23.97	-12.41 pmol/L Standard Deviation 19.91	-2.06 pmol/L Standard Deviation 24.26

SECONDARY outcome

Timeframe: From Baseline to 9 Months

Interleukin-6 (IL-6) is an Age-related biomarker, cytokine, and key mediator of inflammation

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Age-Related Biomarkers--interleukin-6 (IL-6)	1.20 pg/mL Standard Deviation 3.84	-0.22 pg/mL Standard Deviation 1.79	0.30 pg/mL Standard Deviation 2.12

SECONDARY outcome

Timeframe: From Baseline to 9 Months

Tumor Necrosis Factor Receptor 1 (TNRFI), an Age-Related Biomarker, is a protein that acts as a receptor for TNF-alpha, a cytokin involved in inflammation.

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI)	-3.80 pg/mL Standard Deviation 204.73	-55.12 pg/mL Standard Deviation 281.33	-15.52 pg/mL Standard Deviation 151.12

SECONDARY outcome

Timeframe: From Baseline to 9 Months

Change in cystatin C - An Age-Related Biomarker used to assess kidney function

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Age-Related Biomarkers--cystatin C	-0.10 mg/L Standard Deviation 0.21	-0.04 mg/L Standard Deviation 0.14	-0.24 mg/L Standard Deviation 1.12

SECONDARY outcome

Timeframe: From Baseline to 9 Months

Change in C-reactive Protein, an Age-Related Biomarker that is used to detect inflammation in the body

Outcome measures

Measure	In-Person Caloric Restriction Arm n=22 Participants This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 Participants This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 Participants This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Change in Age-Related Biomarkers-- CRP From Serum	1.12 mg/L Standard Deviation 4.47	0.60 mg/L Standard Deviation 4.95	1.20 mg/L Standard Deviation 6.26

Adverse Events

In-Person Caloric Restriction Arm

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Remote Caloric Restriction Arm

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Time-Restricted Eating Arm

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	In-Person Caloric Restriction Arm n=22 participants at risk This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 participants at risk This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 participants at risk This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Cardiac disorders Cardiac disorders - Other	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Cardiac disorders Myocardial infarction	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Nervous system disorders Transient ischemic attacks	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Surgical and medical procedures Surgical and medical procedures - Other	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).

Other adverse events

Measure	In-Person Caloric Restriction Arm n=22 participants at risk This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count.	Remote Caloric Restriction Arm n=34 participants at risk This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing.	Time-Restricted Eating Arm n=34 participants at risk This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period.
Ear and labyrinth disorders Vertigo	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Eye disorders Cataract	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Gastrointestinal disorders Diarrhea	13.6% 3/22 • Number of events 3 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	20.6% 7/34 • Number of events 9 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	11.8% 4/34 • Number of events 4 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Gastrointestinal disorders Vomiting	9.1% 2/22 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
General disorders Flu like symptoms	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
General disorders Non-cardiac chest pain	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Immune system disorders Allergic reaction	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Bronchial infection	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Conjunctivitis	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Eye infection	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Gum infection	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Kidney infection	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Lung infection	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Shingles	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Sinusitis	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Upper respiratory infection	13.6% 3/22 • Number of events 3 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	8.8% 3/34 • Number of events 3 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Urinary tract infection	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Injury, poisoning and procedural complications Bruising	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Injury, poisoning and procedural complications Fall	9.1% 2/22 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 4 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Injury, poisoning and procedural complications Fracture	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Metabolism and nutrition disorders Hyperlipidemia	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Musculoskeletal and connective tissue disorders Back pain	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Musculoskeletal and connective tissue disorders Myalgia	18.2% 4/22 • Number of events 6 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	23.5% 8/34 • Number of events 11 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	20.6% 7/34 • Number of events 8 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Musculoskeletal and connective tissue disorders Pain in extremity	27.3% 6/22 • Number of events 7 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	52.9% 18/34 • Number of events 31 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	26.5% 9/34 • Number of events 9 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Nervous system disorders Dizziness	13.6% 3/22 • Number of events 4 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 5 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Nervous system disorders Headache	13.6% 3/22 • Number of events 3 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	11.8% 4/34 • Number of events 5 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	26.5% 9/34 • Number of events 9 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Psychiatric disorders Anxiety	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Psychiatric disorders Insomnia	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Renal and urinary disorders Renal calculi	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Renal and urinary disorders Urinary frequency	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Renal and urinary disorders Urinary retention	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Reproductive system and breast disorders Pelvic floor muscle weakness	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Respiratory, thoracic and mediastinal disorders Sore throat	9.1% 2/22 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Skin and subcutaneous tissue disorders Dermatitis	9.1% 2/22 • Number of events 3 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	11.8% 4/34 • Number of events 4 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Surgical and medical procedures Surgical and medical procedures - Other	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Vascular disorders Vascular disorders - Other	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Cardiac disorders Atrial fibrillation	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Eye disorders Eye disorders - Other	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Gastrointestinal disorders Constipation	9.1% 2/22 • Number of events 4 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	23.5% 8/34 • Number of events 11 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	11.8% 4/34 • Number of events 4 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Gastrointestinal disorders Nausea	18.2% 4/22 • Number of events 4 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	23.5% 8/34 • Number of events 8 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	11.8% 4/34 • Number of events 4 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
General disorders Fatigue	27.3% 6/22 • Number of events 8 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	32.4% 11/34 • Number of events 13 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	23.5% 8/34 • Number of events 10 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Skin infection	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Vaginal infection	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Infections and infestations Wound infection	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Metabolism and nutrition disorders Hypoglycemia	9.1% 2/22 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	8.8% 3/34 • Number of events 6 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Nervous system disorders Nervous system disorders - other	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	8.8% 3/34 • Number of events 3 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	8.8% 3/34 • Number of events 3 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Nervous system disorders Presyncope	18.2% 4/22 • Number of events 6 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	8.8% 3/34 • Number of events 3 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	8.8% 3/34 • Number of events 5 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Nervous system disorders Syncope	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Psychiatric disorders Depression	9.1% 2/22 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	8.8% 3/34 • Number of events 3 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Psychiatric disorders Irritability	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	5.9% 2/34 • Number of events 2 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Renal and urinary disorders Dysuria	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Skin and subcutaneous tissue disorders Rash maculo-papular	4.5% 1/22 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).
Vascular disorders Hypertension	0.00% 0/22 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	2.9% 1/34 • Number of events 1 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).	0.00% 0/34 • AEs were collected between consent/screening and ended at study completion (approximately 9 months following start of intervention).

Additional Information

Cynthia Stowe

Wake Forest University School of Medicine

Phone: 336-716-0686

Email: cynthia.stowe@advocatehealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place