Healthy Immigrant Community: Mobilizing the Power of Social Networks

Weight Loss Clinical Trial

Official title:

Healthy Immigrant Community: Mobilizing the Power of Social Networks

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05136339
• Other study ID #: 21-009339
• Secondary ID: P50MD017342-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 23, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 481
• Est. completion date: June 30, 2025
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index (BMI)	BMI is calculated as weight (kg)/height squared (m2)	Baseline, 6 months, 12 months, 24 months
Primary	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	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
Secondary	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
Secondary	Change in fasting glucose level	6 hours fasting glucose blood serum level, reported in mg/dL	Baseline, 6 months, 12 months, 24 months
Secondary	Change in low-density lipoprotein (LDL)	Change in LDL cholesterol blood serum level, reported in mg/dL	Baseline, 6 months, 12 months, 24 months
Secondary	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
Secondary	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