Trial Outcomes & Findings for Using Partners to Enhance Long-Term Weight Loss (NCT NCT03801174)

Last Updated: 2024-06-06

Results Overview

Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint

Recruitment status

COMPLETED

Study phase

Target enrollment

346 participants

Primary outcome timeframe

24 months

Results posted on

2024-06-06

Participant Flow

Enrollment numbers reflect only patients, not dyads, as this is how the study analysis was powered.

Enrollment numbers reflect only patients, not dyads. Partners were not assessed and therefore are not their own arm. Partners were not considered as enrolled, and are not included in the reported enrollment number. Partners did not have Baseline, pre-specified Primary and/or Secondary Outcome Measure, and Adverse Event data collected.

Participant milestones

Participant milestones
Measure	Partner-assisted Intervention: Patient Patients and partners will receive intervention Partner-assisted intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.	Patient-only Intervention Patients will receive intervention Patient-only intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Overall Study STARTED	115	116
Overall Study COMPLETED	63	80
Overall Study NOT COMPLETED	52	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Partner-assisted Intervention: Patient Patients and partners will receive intervention Partner-assisted intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.	Patient-only Intervention Patients will receive intervention Patient-only intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Overall Study Withdrawal by Subject	14	15
Overall Study Death	1	0
Overall Study Pregnancy	2	2
Overall Study Lost to Follow-up	19	10
Overall Study Other	4	3
Overall Study Lack of Efficacy	4	0
Overall Study Unwilling to complete activities	5	6
Overall Study Moved out of area	3	0

Baseline Characteristics

Using Partners to Enhance Long-Term Weight Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Partner-assisted Intervention: Patient n=115 Participants Patients and partners will receive intervention Partner-assisted intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.	Patient-only Intervention n=116 Participants Patients will receive intervention Patient-only intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.	Total n=231 Participants Total of all reporting groups
Age, Continuous Participant	47.3 years STANDARD_DEVIATION 11.31 • n=5 Participants	47.24 years STANDARD_DEVIATION 11.76 • n=7 Participants	47.27 years STANDARD_DEVIATION 11.51 • n=5 Participants
Sex/Gender, Customized Identify as Female	76 participants n=5 Participants	79 participants n=7 Participants	155 participants n=5 Participants
Sex/Gender, Customized Identify as Male	37 participants n=5 Participants	37 participants n=7 Participants	74 participants n=5 Participants
Sex/Gender, Customized Genderqueer	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Sex/Gender, Customized Multi-gender	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Sex/Gender, Customized Birth sex - Female	78 participants n=5 Participants	79 participants n=7 Participants	157 participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants	112 Participants n=7 Participants	220 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 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
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	97 Participants n=5 Participants	101 Participants n=7 Participants	198 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	115 participants n=5 Participants	116 participants n=7 Participants	231 participants n=5 Participants
Body weight	106.20 kilograms STANDARD_DEVIATION 19.03 • n=5 Participants	106.90 kilograms STANDARD_DEVIATION 19.84 • n=7 Participants	106.55 kilograms STANDARD_DEVIATION 19.41 • n=5 Participants
Daily caloric intake	2182.66 kcal/day STANDARD_DEVIATION 730.00 • n=5 Participants	2103.10 kcal/day STANDARD_DEVIATION 737.88 • n=7 Participants	2142.88 kcal/day STANDARD_DEVIATION 733.43 • n=5 Participants
Steps per day	8023.37 steps/day STANDARD_DEVIATION 3412.32 • n=5 Participants	8203.70 steps/day STANDARD_DEVIATION 3622.56 • n=7 Participants	8114.40 steps/day STANDARD_DEVIATION 3512.68 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint

Outcome measures

Outcome measures
Measure	Partner-assisted Intervention n=115 Participants Patients and partners will receive intervention Partner-assisted intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.	Patient-only Intervention n=116 Participants Patients will receive intervention Patient-only intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Body Weight (kg)	104.46 kilograms Interval 101.73 to 107.18	104.23 kilograms Interval 101.54 to 106.92

SECONDARY outcome

Timeframe: 24 months

average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint

Outcome measures

Outcome measures
Measure	Partner-assisted Intervention n=115 Participants Patients and partners will receive intervention Partner-assisted intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.	Patient-only Intervention n=116 Participants Patients will receive intervention Patient-only intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Caloric Intake (kcal)	1835 KCALs/day Interval 1689.0 to 1980.0	1885 KCALs/day Interval 1746.0 to 2024.0

SECONDARY outcome

Timeframe: 24 months

average daily steps over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint

Outcome measures

Outcome measures
Measure	Partner-assisted Intervention n=115 Participants Patients and partners will receive intervention Partner-assisted intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.	Patient-only Intervention n=116 Participants Patients will receive intervention Patient-only intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Physical Activity	7400 steps/day Interval 6615.0 to 8186.0	8206 steps/day Interval 7475.0 to 8936.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Score based on 12-item Unidimensional Relationship Closeness Scale (1-7, strongly disagree to strongly agree) and single-item Inclusion of Other in Self scale (7 Venn diagrams)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

5 items assessed on 11-point scale ranging from 0 (not at all effective) to 10 (very effective)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

5 items assessed on 11-point scale ranging from 0 (not at all confident) to 10 (very confident)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

9 items assessed on 5-point scale (never, rarely, sometimes, often, almost always)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

5 items assessed on 5-point frequency scale (never, sometimes, frequently, often, very often)

Outcome measures

Outcome data not reported

Adverse Events

Partner-assisted Intervention

Serious events: 3 serious events

Other events: 55 other events

Deaths: 1 deaths

Patient-only Intervention

Serious events: 3 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Partner-assisted Intervention n=115 participants at risk Patients and partners will receive intervention Partner-assisted intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.	Patient-only Intervention n=116 participants at risk Patients will receive intervention Patient-only intervention: All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
Cardiac disorders Atrial fibrillation	0.00% 0/115 • 24 months Partners were not assessed for adverse events.	0.86% 1/116 • Number of events 1 • 24 months Partners were not assessed for adverse events.
Cardiac disorders Cardiac ablation	0.00% 0/115 • 24 months Partners were not assessed for adverse events.	0.86% 1/116 • Number of events 1 • 24 months Partners were not assessed for adverse events.
Cardiac disorders Death	0.87% 1/115 • Number of events 1 • 24 months Partners were not assessed for adverse events.	0.00% 0/116 • 24 months Partners were not assessed for adverse events.
Gastrointestinal disorders Ulcerative colitis	0.87% 1/115 • Number of events 1 • 24 months Partners were not assessed for adverse events.	0.00% 0/116 • 24 months Partners were not assessed for adverse events.
General disorders Adverse medication interaction	0.87% 1/115 • Number of events 1 • 24 months Partners were not assessed for adverse events.	0.00% 0/116 • 24 months Partners were not assessed for adverse events.
Infections and infestations Covid-19	0.00% 0/115 • 24 months Partners were not assessed for adverse events.	0.86% 1/116 • Number of events 1 • 24 months Partners were not assessed for adverse events.
Surgical and medical procedures Hip replacement	0.00% 0/115 • 24 months Partners were not assessed for adverse events.	0.86% 1/116 • Number of events 1 • 24 months Partners were not assessed for adverse events.

Other adverse events

Additional Information

Corrine Voils, PhD

University of Wisconsin - Madison

Phone: 608-262-9636

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place