Healthy Immigrant Community: Mobilizing the Power of Social Networks

Study Overview
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Brief Summary
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The objective of this study is to leverage existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast, Minnesota.

Official Title
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Healthy Immigrant Community: Mobilizing the Power of Social Networks

Conditions
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Weight Loss

Intervention / Treatment
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* Behavioral: Community-based mentoring and education sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identification as Hispanic or Somali. Member of a social network identified in the social network analysis. Willingness to participate in all aspects of the study. Provision of informed consent. Exclusion Criteria: Pregnancy at the time of enrollment. Serious medical conditions or disabilities that would make physical activity difficult. To avoid stigmatization, a normal weight (BMI<25) will not exclude individuals from participating in the intervention, but they will be excluded from the measurements and analyses.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Community-Based Mentoring and Education Sessions<br>Subjects will receive the intervention of community-based mentoring and education sessions immediately after enrollment. | Behavioral: Community-based mentoring and education sessions<br>* Community-based mentoring and education sessions, group activities, and application of a community toolkit for healthy weight loss delivered by trained Health Promoters from Hispanic and Somali communities to their social networks.<br>|
| Experimental: Delayed Community-Based Mentoring and Education Sessions<br>Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment. | Behavioral: Community-based mentoring and education sessions<br>* Community-based mentoring and education sessions, group activities, and application of a community toolkit for healthy weight loss delivered by trained Health Promoters from Hispanic and Somali communities to their social networks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Mass Index (BMI) | BMI is calculated as weight (kg)/height squared (m2) | Baseline, 6 months, 12 months, 24 months | 
| Change in waist circumference | Measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest. | Baseline, 6 months, 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Life's Simple 7 Composite Score | Adapted from the American Heart Association standards based on health assessment data. Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-14 points). The final score will be categorized as 0-6 (poor), 7-8 (intermediate), 9-14 (ideal). | Baseline, 6 months, 12 months, 24 months | 
| Change in blood pressure (systolic and diastolic) | Measured three times and the average of the second and third readings will be used in analyses, reported in mmHg. | Baseline, 6 months, 12 months, 24 months | 
| Change in fasting glucose level | 6 hours fasting glucose blood serum level, reported in mg/dL | Baseline, 6 months, 12 months, 24 months | 
| Change in low-density lipoprotein (LDL) | Change in LDL cholesterol blood serum level, reported in mg/dL | Baseline, 6 months, 12 months, 24 months | 
| Change in Dietary Quality | 24-hour dietary recall collected using the Nutrition Data System for Research (NDSR) used to calculate the Healthy Eating index (HEI-2015), scores categorized as HEI≥69.3 optimal, HEI 56.9-69.2 intermediate, HEI<56.9 poor | Baseline, 6 months, 12 months, 24 months | 
| Change in physical activity | Measured using the International Physical Activity Questionnaire (IPAQ) that assesses the number of minutes of mild, moderate, and vigorous physical activity over the previous 7 days, scores categorized as ≥150 min/wk moderate or ≥75 min/wk vigorous or ≥150 min/wk moderate+vigorous = optimal; 1-149 min/wk moderate or 1-74 min/wk vigorous or 1-149 min/wk moderate+vigorous = intermediate; no physical activity = poor | Baseline, 6 months, 12 months, 24 months |