Trial Outcomes & Findings for Healthy Immigrant Community: Mobilizing the Power of Social Networks (NCT NCT05136339)

NCT ID: NCT05136339

Last Updated: 2026-01-27

Results Overview

Difference in weight (measured in kilograms) from baseline to 6 months and from baseline to 12 months

Recruitment status

COMPLETED

Study phase

Target enrollment

475 participants

Primary outcome timeframe

Baseline, 6 months, 12 months

Results posted on

2026-01-27

Participant Flow

The social networks (units of randomization) were defined as the Health Promoter (HP) and their friend/family social network members. At 0-5 months, this included 29 Hispanic and 22 Somali social networks. At 6-11 months, this included 23 Hispanic and 22 Somali social networks. At 12-24 months, this included 23 Hispanic and 22 Somali social networks.

The units of randomization were social networks defined by a Health Promoter and their network members. Randomization occurred after all participants were enrolled and baseline measures completed. Constrained randomization was used with the assignment selected from a set of allocations balanced on ethnicity, age, network size, and sex of the HPs. The period titles are referring to the time after starting intervention.

Participant milestones

Participant milestones
Measure	Immediate Community-Based Mentoring and Education Sessions Subjects received the intervention of community-based mentoring and education sessions immediately after enrollment. In the first 6 months (months 0-5) health promoters facilitated 12 face-to-face or virtual group visits. Each visit targeted a specific health promotion behavior for weight loss and/or reduction of cardiovascular risk. Each group session included goal setting, review of food and/or activity tracking, and positive reflections. Strategies for weight loss included regular weigh-ins, completion of food and physical activity records, reducing portion sizes, planning meals, use of MyPlate for dietary proportions, removing problem foods from the home, increasing physical activity level, and reducing sedentary behavior. HPs supported and monitored progress of their group via six evidence-based strategies: tracking, goal setting, mindfulness, social support, problem solving, and motivation. Over the subsequent 6 months (months 6-11), health promoters facilitated an additional 12 virtual or face-to-face weight maintenance sessions to focus on goal setting, social support, motivation for lifestyle changes, review of food and/or activity tracking, and reflections. No new education material was provided.	Delayed Community-Based Mentoring and Education Sessions Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment. In the first 6 months (months 12-17 from baseline) health promoters facilitated 12 face-to-face or virtual group visits. Each visit targeted a specific health promotion behavior for weight loss and/or reduction of cardiovascular risk. Each group session included goal setting, review of food and/or activity tracking, and positive reflections. Strategies for weight loss included regular weigh-ins, completion of food and physical activity records, reducing portion sizes, planning meals, use of MyPlate for dietary proportions, removing problem foods from the home, increasing physical activity level, and reducing sedentary behavior. HPs supported and monitored progress of their group via six evidence-based strategies: tracking, goal setting, mindfulness, social support, problem solving, and motivation. Over the subsequent 6 months (months 18-24 from baseline), health promoters facilitated an additional 12 virtual or face-to-face weight maintenance sessions to focus on goal setting, social support, motivation for lifestyle changes, review of food and/or activity tracking, and reflections. No new education material was provided.
0-5 Months STARTED	246	229
0-5 Months Hispanic HP	15	14
0-5 Months Somali HP	11	11
0-5 Months Hispanic Participants	131	115
0-5 Months Somali Participants	89	89
0-5 Months COMPLETED	213	208
0-5 Months NOT COMPLETED	33	21
6-11 Months STARTED	213	208
6-11 Months Hispanic HP	14	9
6-11 Months Somali HP	11	11
6-11 Months Hispanic Participants	118	110
6-11 Months Somali Participants	70	78
6-11 Months COMPLETED	213	193
6-11 Months NOT COMPLETED	0	15
12-24 Months STARTED	213	193
12-24 Months Hispanic HP	14	9
12-24 Months Somali HP	11	11
12-24 Months Hispanic Participants	116	103
12-24 Months Somali Participants	72	70
12-24 Months COMPLETED	195	180
12-24 Months NOT COMPLETED	18	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Healthy Immigrant Community: Mobilizing the Power of Social Networks