Healthy Immigrant Community: Mobilizing the Power of Social Networks

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: Community-based mentoring and education sessions

• Study Type: Interventional
• Enrollment (Actual): 481
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Community-Based Mentoring and Education Sessions; Subjects will receive the intervention of community-based mentoring and education sessions immediately after enrollment.	Behavioral: Community-based mentoring and education sessions; 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.
Experimental: Delayed Community-Based Mentoring and Education Sessions; Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment.	Behavioral: Community-based mentoring and education sessions; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Mark Wieland, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2022
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 21-009339; P50MD017342-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No