Pilot Social Network Weight Loss Intervention

Weight Loss Clinical Trial

— HIC  

Official title:

Healthy Immigrant Community: Pilot Social Network Weight Loss Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273503
• Other study ID #: 19-011574
• Status: Completed
• Phase: N/A
• Start date: January 28, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 30, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Diet, Healthy
• Weight Loss

Intervention

Behavioral:
• Mentoring/educational session
12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	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.	12 weeks
Secondary	Weight	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).	12 weeks
Secondary	Waist circumference	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.	12 weeks
Secondary	Glucose	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.	12 weeks
Secondary	Cholesterol	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.	12 weeks
Secondary	Height	Height will be measured to the nearest 0.1 cm at baseline only using a stadiometer.	12 weeks

External Links

•   Mayo Clinic Clinical Trials