Clinical trial NCT04273503: Pilot Social Network Weight Loss Intervention
Official title: Healthy Immigrant Community: Pilot Social Network Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Weight Loss
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Behavioral intervention
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: Glucose
timeFrame: 12 weeks
measure: Cholesterol
timeFrame: 12 weeks
measure: Height
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Wieland, MD
role: PRINCIPAL_INVESTIGATOR
References: