Healthy Immigrant Community: Mobilizing the Power of Social Networks

January 23, 2026 updated by: Mark L Wieland, Mayo Clinic
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
475

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 months, 12 months
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.
Baseline, 6 months, 12 months
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).
Baseline, 6 months, 12 months
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%).
6 months, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months, 12 months
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.
Baseline, 6 months, 12 months
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
Baseline, 6 months, 12 months
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.
Baseline, 6 months, 12 months
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.
Baseline, 6 months, 12 months
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)
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Wieland, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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