Trial Outcomes & Findings for Peer Support for Weight Loss Maintenance (NCT NCT03396653)

Last Updated: 2024-06-12

Results Overview

Weight change (measured on a digital scale to the nearest 0.1-kilogram) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months).

Recruitment status

COMPLETED

Study phase

Target enrollment

849 participants

Primary outcome timeframe

Baseline to 18-months

Results posted on

2024-06-12

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 I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). Peer-delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).	Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. Professionally-Delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.	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	153	134	562
Phase I (Weight Loss): 16 Weeks COMPLETED	153	134	0
Phase I (Weight Loss): 16 Weeks NOT COMPLETED	0	0	562
Phase II (Weight Maintenance): 18 Months STARTED	153	134	0
Phase II (Weight Maintenance): 18 Months 6 Month Assessment	145	131	0
Phase II (Weight Maintenance): 18 Months 12 Month Assessment	139	122	0
Phase II (Weight Maintenance): 18 Months COMPLETED	144	123	0
Phase II (Weight Maintenance): 18 Months NOT COMPLETED	9	11	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	Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance n=153 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). Peer-delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).	Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance n=134 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. Professionally-Delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.	Phase I Only (Weight Loss Phase): 16 Weeks n=562 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=849 Participants Total of all reporting groups
Age, Continuous	52.6 Years STANDARD_DEVIATION 11.7 • n=153 Participants	54.8 Years STANDARD_DEVIATION 11.7 • n=134 Participants	48.9 Years STANDARD_DEVIATION 12.2 • n=562 Participants	50.5 Years STANDARD_DEVIATION 12.3 • n=849 Participants
Sex: Female, Male Female	129 Participants n=153 Participants	111 Participants n=134 Participants	464 Participants n=562 Participants	704 Participants n=849 Participants
Sex: Female, Male Male	24 Participants n=153 Participants	23 Participants n=134 Participants	98 Participants n=562 Participants	145 Participants n=849 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=153 Participants	18 Participants n=134 Participants	94 Participants n=562 Participants	125 Participants n=849 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	140 Participants n=153 Participants	116 Participants n=134 Participants	434 Participants n=562 Participants	690 Participants n=849 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=153 Participants	0 Participants n=134 Participants	34 Participants n=562 Participants	34 Participants n=849 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=153 Participants	1 Participants n=134 Participants	2 Participants n=562 Participants	3 Participants n=849 Participants
Race (NIH/OMB) Asian	6 Participants n=153 Participants	5 Participants n=134 Participants	15 Participants n=562 Participants	26 Participants n=849 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=153 Participants	1 Participants n=134 Participants	0 Participants n=562 Participants	1 Participants n=849 Participants
Race (NIH/OMB) Black or African American	15 Participants n=153 Participants	19 Participants n=134 Participants	87 Participants n=562 Participants	121 Participants n=849 Participants
Race (NIH/OMB) White	125 Participants n=153 Participants	101 Participants n=134 Participants	395 Participants n=562 Participants	621 Participants n=849 Participants
Race (NIH/OMB) More than one race	7 Participants n=153 Participants	5 Participants n=134 Participants	16 Participants n=562 Participants	28 Participants n=849 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=153 Participants	2 Participants n=134 Participants	47 Participants n=562 Participants	49 Participants n=849 Participants
Region of Enrollment United States	153 participants n=153 Participants	134 participants n=134 Participants	562 participants n=562 Participants	849 participants n=849 Participants
Weight (kg)	82.9 kilograms STANDARD_DEVIATION 15.3 • n=153 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	85.4 kilograms STANDARD_DEVIATION 17.4 • n=134 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	—	84.0 kilograms STANDARD_DEVIATION 16.3 • n=287 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.
Blood pressure (mmHg) Systolic Blood Pressure	118.6 mm Hg STANDARD_DEVIATION 15.6 • n=153 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	118.4 mm Hg STANDARD_DEVIATION 13.2 • n=134 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	—	118.5 mm Hg STANDARD_DEVIATION 14.5 • n=287 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.
Blood pressure (mmHg) Diastolic Blood Pressure	76.4 mm Hg STANDARD_DEVIATION 8.3 • n=153 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	76.8 mm Hg STANDARD_DEVIATION 9.3 • n=134 Participants • This study specific measure was first collected at Phase II baseline and data were analyzed only from randomized Phase II participants.	—	76.6 mm Hg STANDARD_DEVIATION 8.7 • n=287 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: Baseline to 18-months

Population: The number of participants analyzed in this outcome measure reflects the number that completed this measure at the 18 month assessment (primary outcome assessment). All missing participant data indicates that the participant did not complete this assessment procedure.

Weight change (measured on a digital scale to the nearest 0.1-kilogram) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months).

Outcome measures

Outcome measures
Measure	Peer-Delivered Weight Maintenance n=144 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). Peer-delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).	Professionally-Delivered Weight Maintenance n=124 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. Professionally-Delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.
Weight Change (kg)	1.2 kilograms Standard Deviation 7.0	2.5 kilograms Standard Deviation 6.0

SECONDARY outcome

Timeframe: Baseline to 18-months

Blood pressure (mmHg) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months).

Outcome measures

Outcome measures
Measure	Peer-Delivered Weight Maintenance n=141 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). Peer-delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).	Professionally-Delivered Weight Maintenance n=122 Participants Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. Professionally-Delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.
Blood Pressure (mmHg) Systolic Blood Pressure	2.5 mmHg Standard Deviation 13.4	4.0 mmHg Standard Deviation 14.2
Blood Pressure (mmHg) Diastolic Blood Pressure	3.3 mmHg Standard Deviation 8.2	4.6 mmHg Standard Deviation 9.4

Adverse Events

Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance

Serious events: 36 serious events

Other events: 103 other events

Deaths: 0 deaths

Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance

Serious events: 22 serious events

Other events: 89 other events

Deaths: 0 deaths

Phase I Only (Weight Loss Phase): 16 Weeks

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance n=153 participants at risk Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). Peer-delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).	Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance n=134 participants at risk Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. Professionally-Delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.	Phase I Only (Weight Loss Phase): 16 Weeks n=562 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).
Cardiac disorders Heart Trouble	0.00% 0/153 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	2.2% 3/134 • Number of events 3 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Injury, poisoning and procedural complications Muscle or bone injury (e.g., broken bone, torn ligament, sprain)	4.6% 7/153 • Number of events 8 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	6.0% 8/134 • Number of events 8 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
General disorders Other	12.4% 19/153 • Number of events 19 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	9.7% 13/134 • Number of events 13 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Nervous system disorders Stroke, ministroke (TIA), or other neurological problems	3.3% 5/153 • Number of events 5 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/134 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Gastrointestinal disorders Gall bladder attack or surgery	1.3% 2/153 • Number of events 2 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/134 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Psychiatric disorders New diagnosis, started treatment, or hospitalized for depression	0.65% 1/153 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/134 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Respiratory, thoracic and mediastinal disorders Asthma attack: leading to hospitalization or visit to ER / urgent care	0.65% 1/153 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/134 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.65% 1/153 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/134 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Nervous system disorders Fainting	0.65% 1/153 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/134 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.

Other adverse events

Other adverse events
Measure	Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance n=153 participants at risk Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group). Peer-delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).	Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance n=134 participants at risk Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions. Professionally-Delivered Weight Maintenance: Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.	Phase I Only (Weight Loss Phase): 16 Weeks n=562 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).
Cardiac disorders Heart Trouble	6.5% 10/153 • Number of events 13 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	7.5% 10/134 • Number of events 13 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.18% 1/562 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Nervous system disorders Fainting	5.9% 9/153 • Number of events 11 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	2.2% 3/134 • Number of events 3 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Nervous system disorders Stroke, ministroke (TIA), or other neurological problems	2.0% 3/153 • Number of events 3 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.75% 1/134 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Injury, poisoning and procedural complications Muscle or bone injury (e.g., broken bone, torn ligament, sprain)	25.5% 39/153 • Number of events 55 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	31.3% 42/134 • Number of events 65 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	1.6% 9/562 • Number of events 10 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Metabolism and nutrition disorders New diagnosis or hospitalization for diabetes	1.3% 2/153 • Number of events 2 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	1.5% 2/134 • Number of events 2 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Psychiatric disorders New diagnosis, started treatment, or hospitalized for depression	2.0% 3/153 • Number of events 3 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	1.5% 2/134 • Number of events 2 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.18% 1/562 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Psychiatric disorders Eating disorder	0.65% 1/153 • Number of events 2 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/134 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.18% 1/562 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Psychiatric disorders New diagnosis, started treatment or hospitalized for any other mental health problem	1.3% 2/153 • Number of events 2 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	2.2% 3/134 • Number of events 3 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Respiratory, thoracic and mediastinal disorders Asthma attack: leading to hospitalization or visit to ER / urgent care	1.3% 2/153 • Number of events 2 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.75% 1/134 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.18% 1/562 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.65% 1/153 • Number of events 2 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/134 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Surgical and medical procedures Weight loss medication (including herbal remedies)	2.6% 4/153 • Number of events 4 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	2.2% 3/134 • Number of events 3 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.00% 0/562 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
Injury, poisoning and procedural complications Motor vehicle accident	7.2% 11/153 • Number of events 11 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	6.0% 8/134 • Number of events 8 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.18% 1/562 • Number of events 1 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.
General disorders Other	49.0% 75/153 • Number of events 105 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	50.7% 68/134 • Number of events 104 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.	0.89% 5/562 • Number of events 5 • 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, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.

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