Pilot Social Network Weight Loss Intervention

Not Applicable

Completed

• Conditions: Diet, Healthy; Weight Loss
• Interventions: Behavioral: Mentoring/educational session

• Registration Number: NCT04273503
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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

Study Timeline

• Study Start: 2020-01-28
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-18
• Primary Completion: 2020-06-26
• Study Completion: 2020-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Mentoring/educational session	All participants will receive education on maintaining a healthy diet and improving physical activity.

Primary Outcome Measures

Name	Time	Method
Acceptability	12 weeks	To what extent did was the intervention judged as relevant, satisfying, or helpful to HPs and participants? Interviews with HPs; focus groups and survey with participants.

Secondary Outcome Measures

Name	Time	Method
Weight	12 weeks	Weight will be measured to the nearest 0.1 kg using a portable scale (Seca 880 Digital Floor Scale). BMI is calculated as weight (kg)/height squared (m2).
Glucose	12 weeks	Collected by a single finger prick. Participants will be asked to refrain from eating for at least 6 hours prior to testing. Samples used for testing are whole blood from a fingerstick collected in a lithium heparin coated capillary tube.
Waist circumference	12 weeks	Waist circumference will be measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest. Participants will remove all excess clothing prior to the measurement and smooth the remaining clothing against the skin. Two measurements will be taken; if the difference between the two measures is more than 2.0 cm, a third measurement will be taken. The average of the two closest measures will be used for analyses.
Cholesterol	12 weeks	Collected by a single finger prick. Participants will be asked to refrain from eating for at least 6 hours prior to testing. The portable Whole Blood Lipid Screen Cholestech LDX Analyzer will be used to analyze specimens, which combines enzymatic methodology and solid-phase technology measured by reflectance photometry to measure total cholesterol, HDL cholesterol, triglycerides and glucose in whole blood. LDL cholesterol is a calculated value. Samples used for testing are whole blood from a fingerstick collected in a lithium heparin coated capillary tube. Results will be recorded at the site of collection and samples will be destroyed upon recording of results.
Height	12 weeks	Height will be measured to the nearest 0.1 cm at baseline only using a stadiometer.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States