Pilot Social Network Weight Loss Intervention

NCT ID: NCT04273503

Last Updated: 2021-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2020-06-30

Brief Summary

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Specific Aim #1: Pilot test a social network-informed CBPR-derived health promotion program for feasibility outcomes with overweight or obese adults from two immigrant communities.

Specific Aim #2: Assess the preliminary impact of embedding a social network-informed CBPR-derived intervention within a regional health promotion resource hub on sustainability and uptake outcomes.

Detailed Description

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The intervention will consist of 12 community-based mentoring and education sessions, group activities and application of a community toolkit for healthy weight loss delivered by trained interventionists from Hispanic and Somali communities to their social networks. Using a pre-post study design, 4 social networks of adults with approximately 32 network participants will receive the intervention. Primary outcomes, measured 3 months after implementation, will include feasibility measures of acceptability, implementation, and practicality. Secondary outcomes will include BMI, waist circumference, blood pressure, fasting blood glucose, total cholesterol, physical activity level, dietary change, and health-related quality of life.

Eligibility criteria include (1) self-identification as Hispanic or Somali, (2) member of an HPs social network, (3) age≥18 and \<65 (4) willingness to participate in all aspects of the study; and (5) provision of informed consent. Exclusion criteria include (1) pregnancy at the time of enrollment and (2) serious medical conditions or disabilities that would make physical activity difficult.

We will test how best to integrate a social network intervention within an existing evidence-based regional health promotion infrastructure (WellConnect) that will enhance its potential dissemination and community-wide uptake

Conditions

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Diet, Healthy Weight Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Behavioral intervention
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention

All participants will receive education on maintaining a healthy diet and improving physical activity.

Group Type EXPERIMENTAL

Mentoring/educational session

Intervention Type BEHAVIORAL

12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.

Interventions

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Mentoring/educational session

12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. self-identification as Hispanic or Somali
2. member of an HPs social network
3. age≥18 and \<65
4. willingness to participate in all aspects of the study
5. provision of informed consent.

Exclusion Criteria

1. pregnancy at the time of enrollment
2. 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, but they will be excluded from the measurements and analyses.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mark L Wieland

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Wieland, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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19-011574

Identifier Type: -

Identifier Source: org_study_id

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