NCT04273503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

February 12, 2020

Last Update Submit

July 28, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Weight

    12 weeks

  • Waist circumference

    12 weeks

  • Glucose

    12 weeks

  • Cholesterol

    12 weeks

  • Height

    12 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Mentoring/educational session

Interventions

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

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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, but they will be excluded from the measurements and analyses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Wieland, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Behavioral intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 18, 2020

Study Start

January 28, 2020

Primary Completion

June 26, 2020

Study Completion

June 30, 2020

Last Updated

July 30, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations