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OpenTrials
Completed

NCT Number: NCT05136339

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Community-based mentoring and education sessions

Behavioral

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.

Primary outcomes

  1. Change in Weight

    Time frame: Baseline, 6 months, 12 months

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

  2. Change in Waist Circumference From Baseline to 6 Months and From Baseline to 12 Months

    Time frame: Baseline, 6 months, 12 months

    Measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest.

  3. Change in "Life's Simple 6" Composite Score From Baseline to 6 Months and From Baseline to 12 Months

    Time frame: Baseline, 6 months, 12 months

    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 (0-12 points).

  4. Lost >5% of Body Weight

    Time frame: 6 months, 12 months

    Number of participants in each arm who lost a clinically significant amount of weight (>5%).

Secondary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: Baseline, 6 months, 12 months

    Measured three times and the average of the second and third readings will be used in analyses, reported in mmHg. Change from baseline to 6 months and from baseline to 12 months.

  2. Change in Fasting Glucose Level

    Time frame: Baseline, 6 months, 12 months

    6 hours fasting glucose blood serum level, reported in mg/dL. Baseline to 6 months and baseline to 12 months.

  3. Change in Low-density Lipoprotein (LDL)

    Time frame: Baseline, 6 months, 12 months

    Change in LDL cholesterol blood serum level, reported in mg/dL. Baseline to 6 months and baseline to 12 months

  4. Change in Dietary Quality

    Time frame: Baseline, 6 months, 12 months

    24-hour dietary recall collected using the Nutrition Data System for Research (NDSR) used to calculate the Healthy Eating index (HEI-2015). The HEI range is 0-100 with higher scores indicating healthier dietary quality. Scores can be further categorized as HEI≥69.3 optimal, HEI 56.9-69.2 intermediate, HEI<56.9 poor. Change from baseline to 6 months and baseline to 12 months.

  5. Change in Physical Activity

    Time frame: Baseline, 6 months, 12 months

    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 to 6 months and baseline to 12 months. For this study, we present IPAQ results as a continuous variable of MET minutes per week, which refers to the total amount of physical activity measured in Metabolic Equivalent of Task (MET) units over a week. Physical Activity Guidelines recommend achieving 500 to 1,000 MET minutes per week for significant health benefits.

  6. Change in Diastolic Blood Pressure

    Time frame: Baseline, 6 months, 12 months

    Chage from baseline to 6 months and from baseline to 12 months (mmHg)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2021
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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