Trial Outcomes & Findings for Physical Activity Choices Everyday (NCT NCT03824769)

Last Updated: 2023-12-11

Results Overview

Change in weekly minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during the Phase II maintenance program. At each assessment time point, participants were instructed to wear the accelerometer on their right waist during all waking hours for 7 days. Participants with a minimum of 600 min of valid daily wear time for at least 4 days were included in reported outcomes.

Recruitment status

COMPLETED

Study phase

Target enrollment

160 participants

Primary outcome timeframe

Phase II baseline to 1 month, 2 months and 4 months (end of treatment)

Results posted on

2023-12-11

Participant Flow

Following enrollment, participants began Phase I, a 16-week weight loss program aiming to induce clinically significant weight loss (5% of starting body weight). After Phase I, eligibility to continue to Phase II (weight maintenance) was evaluated. Those who lost at least 5% of their body weight remained eligible. Given that Phase II was the primary focus of the study, primary outcome data were analyzed only from randomized, Phase II participants (eligible subset of Phase I participants).

Participant milestones

Participant milestones
Measure	Phase II (RCT): Behavioral Weight Loss Maintenance + Healthy Thinking Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. All participants randomized to this treatment arm completed Phase I (Weight Loss Phase) and were eligible for Phase II (Weight Maintenance Phase).	Phase II (RCT): Behavioral Weight Loss Maintenance Treatment + Future Thinking Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. Weight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.	Phase I Only (Weight Loss Phase): 16 Weeks This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase).
Phase I (Weight Loss): 16 Weeks STARTED	24	28	108
Phase I (Weight Loss): 16 Weeks COMPLETED	24	28	0
Phase I (Weight Loss): 16 Weeks NOT COMPLETED	0	0	108
Phase II (Weight Maintenance): 4 Months STARTED	24	28	0
Phase II (Weight Maintenance): 4 Months 1 Month Assessment	22	27	0
Phase II (Weight Maintenance): 4 Months 2 Month Assessment	21	26	0
Phase II (Weight Maintenance): 4 Months COMPLETED	22	28	0
Phase II (Weight Maintenance): 4 Months NOT COMPLETED	2	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Weight Loss Maintenance + Healthy Thinking n=24 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. Weight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.	Behavioral Weight Loss Maintenance Treatment + Future Thinking n=28 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. Weight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.	Phase I Only (Weight Loss Phase): 16 Weeks n=108 Participants This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase).	Total n=160 Participants Total of all reporting groups
Age, Continuous	45.83 years STANDARD_DEVIATION 10.26 • n=24 Participants	48.11 years STANDARD_DEVIATION 13.02 • n=28 Participants	46.80 years STANDARD_DEVIATION 12.03 • n=108 Participants	46.88 years STANDARD_DEVIATION 11.91 • n=160 Participants
Sex: Female, Male Female	21 Participants n=24 Participants	21 Participants n=28 Participants	96 Participants n=108 Participants	138 Participants n=160 Participants
Sex: Female, Male Male	3 Participants n=24 Participants	7 Participants n=28 Participants	12 Participants n=108 Participants	22 Participants n=160 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=24 Participants	0 Participants n=28 Participants	14 Participants n=108 Participants	17 Participants n=160 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=24 Participants	28 Participants n=28 Participants	94 Participants n=108 Participants	143 Participants n=160 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=28 Participants	0 Participants n=108 Participants	0 Participants n=160 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=24 Participants	0 Participants n=28 Participants	0 Participants n=108 Participants	0 Participants n=160 Participants
Race/Ethnicity, Customized Asian	0 Participants n=24 Participants	1 Participants n=28 Participants	3 Participants n=108 Participants	4 Participants n=160 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=24 Participants	0 Participants n=28 Participants	24 Participants n=108 Participants	27 Participants n=160 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=24 Participants	0 Participants n=28 Participants	0 Participants n=108 Participants	0 Participants n=160 Participants
Race/Ethnicity, Customized White	19 Participants n=24 Participants	24 Participants n=28 Participants	73 Participants n=108 Participants	116 Participants n=160 Participants
Race/Ethnicity, Customized More than One Race	2 Participants n=24 Participants	0 Participants n=28 Participants	4 Participants n=108 Participants	6 Participants n=160 Participants
Race/Ethnicity, Customized Other	0 Participants n=24 Participants	1 Participants n=28 Participants	1 Participants n=108 Participants	2 Participants n=160 Participants
Race/Ethnicity, Customized Prefer not to answer	0 Participants n=24 Participants	2 Participants n=28 Participants	3 Participants n=108 Participants	5 Participants n=160 Participants
Region of Enrollment United States	24 participants n=24 Participants	28 participants n=28 Participants	108 participants n=108 Participants	160 participants n=160 Participants
Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry	194.29 minutes STANDARD_DEVIATION 119.595 • n=24 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	229.82 minutes STANDARD_DEVIATION 162.393 • n=28 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	—	213.42 minutes STANDARD_DEVIATION 143.985 • n=52 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.
Delay Discounting (Adjusting Amount Task)	0.002589348 k-value STANDARD_DEVIATION 0.003302 • n=24 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	0.021894643 k-value STANDARD_DEVIATION 0.108428 • n=28 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	—	0.012984507 k-value STANDARD_DEVIATION 0.079520 • n=52 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.
Delay Discounting (Monetary Choice Questionnaire)	0.017834 k-value STANDARD_DEVIATION 0.019678 • n=24 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	0.025506 k-value STANDARD_DEVIATION 0.047832 • n=28 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	—	0.021965 k-value STANDARD_DEVIATION 0.037427 • n=52 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.
Weight	94.89 kilograms STANDARD_DEVIATION 17.09 • n=24 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	92.00 kilograms STANDARD_DEVIATION 16.38 • n=28 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	—	93.33 kilograms STANDARD_DEVIATION 16.61 • n=52 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.

PRIMARY outcome

Timeframe: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)

Population: The number of participants analyzed in this outcome measure generally reflects the number that completed accelerometry assessment procedures at each timepoint. At the 2 month assessment, one Healthy Thinking participant's data was excluded due to insufficient device wear time. All other missing participant data indicates that the participant did not complete this assessment procedure.

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Maintenance + Healthy Thinking n=24 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. Weight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.	Behavioral Weight Loss Maintenance Treatment + Future Thinking n=28 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. Weight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.
Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry Phase II baseline to 1-month	-21.4286 Minutes Standard Deviation 61.52851	-53.9600 Minutes Standard Deviation 149.60712
Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry Phase II baseline to 2-month	19.6000 Minutes Standard Deviation 100.36900	-38.6800 Minutes Standard Deviation 108.40846
Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry Phase II baseline to 4-month	-12.7143 Minutes Standard Deviation 96.02403	-65.7308 Minutes Standard Deviation 126.15627

PRIMARY outcome

Timeframe: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)

Population: The number of participants analyzed in each group reflects the number of randomized participants that completed the delay discounting measure at each timepoint.

Change in delay discounting measured using the Adjusting Amount task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The Adjusting Amount task identifies an individual's discount rate, which reflects how much they devalue future rewards. In the task, participants are presented with a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) monetary reward. Then, using a titration procedure, the delayed reward amount is adjusted based on the participant's choices to find the point at which they are indifferent between the two options (i.e., discounting rate). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Maintenance + Healthy Thinking n=24 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. Weight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.	Behavioral Weight Loss Maintenance Treatment + Future Thinking n=28 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. Weight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.
Delay Discounting (Adjusting Amount Task) Baseline to 2-month	0.000165 k-value Standard Deviation 0.003824	0.108922 k-value Standard Deviation 0.558786
Delay Discounting (Adjusting Amount Task) Baseline to 1-month	0.001280 k-value Standard Deviation 0.003962	0.107264 k-value Standard Deviation 0.547971
Delay Discounting (Adjusting Amount Task) Baseline to 4-month	-0.000071 k-value Standard Deviation 0.003989	0.101414 k-value Standard Deviation 0.538400

PRIMARY outcome

Timeframe: Phase II baseline to 2 months and 4 months (end of treatment)

Population: The number of participants analyzed at each timepoint reflects the number of randomized participants who completed this measure.

Change in delay discounting measured using the Monetary Choice Questionnaire (MCQ) task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The MCQ identifies an individual's discount rate, which reflects how much they devalue future rewards. In the task, each question asks participants to make a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) reward. Unlike the Adjusting Amount task, each MCQ question includes different combinations of delay periods and reward amounts that are not influenced by previous responses (i.e., delay periods and reward amounts are static and the same for each participant). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Maintenance + Healthy Thinking n=24 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. Weight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.	Behavioral Weight Loss Maintenance Treatment + Future Thinking n=28 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. Weight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.
Delay Discounting (Monetary Choice Questionnaire) Baseline to 2-months	0.002863 k-value Standard Deviation 0.029509	-0.007161 k-value Standard Deviation 0.017930
Delay Discounting (Monetary Choice Questionnaire) Baseline to 4-months	-0.001625 k-value Standard Deviation 0.022689	-0.004049 k-value Standard Deviation 0.015750

SECONDARY outcome

Timeframe: 4 months

Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Maintenance + Healthy Thinking n=22 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. Weight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.	Behavioral Weight Loss Maintenance Treatment + Future Thinking n=28 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. Weight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.
Weight	-11.87 kilograms Standard Deviation 7.66	-9.28 kilograms Standard Deviation 6.63

Adverse Events

Phase II (RCT): Behavioral Weight Loss Maintenance + Healthy Thinking

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Phase II (RCT) Behavioral Weight Loss Maintenance Treatment + Future Thinking

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Phase I Only (Weight Loss Phase): 16 Weeks

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase II (RCT): Behavioral Weight Loss Maintenance + Healthy Thinking n=24 participants at risk Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. Weight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.	Phase II (RCT) Behavioral Weight Loss Maintenance Treatment + Future Thinking n=28 participants at risk Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. Weight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.	Phase I Only (Weight Loss Phase): 16 Weeks n=108 participants at risk This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase).
General disorders Other	0.00% 0/24 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	0.00% 0/28 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	0.93% 1/108 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).
Injury, poisoning and procedural complications Motor vehicle accident	0.00% 0/24 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	0.00% 0/28 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	0.93% 1/108 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).

Other adverse events

Other adverse events
Measure	Phase II (RCT): Behavioral Weight Loss Maintenance + Healthy Thinking n=24 participants at risk Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment. Weight Loss Maintenance + Healthy Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.	Phase II (RCT) Behavioral Weight Loss Maintenance Treatment + Future Thinking n=28 participants at risk Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment. Weight Loss Maintenance Treatment + Future Thinking: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.	Phase I Only (Weight Loss Phase): 16 Weeks n=108 participants at risk This group consists of the participants who enrolled in Phase I (Weight Loss Phase) but were not randomized to Phase I because they dropped out or were not eligible for Phase II (Weight Maintenance Phase).
Injury, poisoning and procedural complications Muscle or bone injury (e.g., broken bone, torn ligament, sprain)	12.5% 3/24 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	10.7% 3/28 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	0.93% 1/108 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).
General disorders Other	16.7% 4/24 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	10.7% 3/28 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	2.8% 3/108 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).
Gastrointestinal disorders Gall bladder attack or surgery	4.2% 1/24 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	0.00% 0/28 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	0.00% 0/108 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).
Psychiatric disorders New diagnosis, started treatment, or hospitalized for depression	0.00% 0/24 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	3.6% 1/28 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	0.00% 0/108 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).
Nervous system disorders Stroke, ministroke (TIA), or other neurological problems	4.2% 1/24 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	0.00% 0/28 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).	0.00% 0/108 • Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 2-month and 4-month assessment visits (a total of 32 weeks).

Additional Information

Zeely Denmat

University of Connecticut

Phone: 860-455-3842

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place