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Healthy Immigrant Community: Mobilizing the Power of Social Networks

Primary Purpose

Weight Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community-based mentoring and education sessions
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate Community-Based Mentoring and Education Sessions

Delayed Community-Based Mentoring and Education Sessions

Arm Description

Subjects will receive the intervention of community-based mentoring and education sessions immediately after enrollment.

Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment.

Outcomes

Primary Outcome Measures

Change in Body Mass Index (BMI)
BMI is calculated as weight (kg)/height squared (m2)
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.

Secondary Outcome Measures

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).
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.
Change in fasting glucose level
6 hours fasting glucose blood serum level, reported in mg/dL
Change in low-density lipoprotein (LDL)
Change in LDL cholesterol blood serum level, reported in mg/dL
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
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

Full Information

First Posted
November 16, 2021
Last Updated
July 10, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05136339
Brief Title
Healthy Immigrant Community: Mobilizing the Power of Social Networks
Official Title
Healthy Immigrant Community: Mobilizing the Power of Social Networks
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 23, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
481 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Community-Based Mentoring and Education Sessions
Arm Type
Experimental
Arm Description
Subjects will receive the intervention of community-based mentoring and education sessions immediately after enrollment.
Arm Title
Delayed Community-Based Mentoring and Education Sessions
Arm Type
Experimental
Arm Description
Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment.
Intervention Type
Behavioral
Intervention Name(s)
Community-based mentoring and education sessions
Intervention Description
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 Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Description
BMI is calculated as weight (kg)/height squared (m2)
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Change in waist circumference
Description
Measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest.
Time Frame
Baseline, 6 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Change in "Life's Simple 7" Composite Score
Description
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).
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Change in blood pressure (systolic and diastolic)
Description
Measured three times and the average of the second and third readings will be used in analyses, reported in mmHg.
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Change in fasting glucose level
Description
6 hours fasting glucose blood serum level, reported in mg/dL
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Change in low-density lipoprotein (LDL)
Description
Change in LDL cholesterol blood serum level, reported in mg/dL
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Change in Dietary Quality
Description
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
Time Frame
Baseline, 6 months, 12 months, 24 months
Title
Change in physical activity
Description
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
Time Frame
Baseline, 6 months, 12 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Wieland, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Healthy Immigrant Community: Mobilizing the Power of Social Networks

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