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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02416921
Other study ID # 201412141
Secondary ID 1P30DK092950
Status Completed
Phase N/A
First received March 18, 2015
Last updated May 20, 2016
Start date April 2015
Est. completion date September 2015

Study information

Verified date May 2016
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate the effect of a Facebook-delivered weight-gain prevention program versus a Facebook-delivered program with general women's health information.


Description:

Weight gain is an important health concern, and disparities in the prevalence of obesity between African American and White women increase throughout the reproductive period. This study is a randomized, controlled trial testing the feasibility and acceptability of a peer-coach-administered, Facebook-delivered intervention to prevent weight gain in overweight and obese African American women. Study visits lasting approximately 1 hour will occur at baseline, post-intervention, and 1-month follow-up, to assess effectiveness and acceptability. The core intervention will occur over a 4-week period. Educational content in both the weight-gain prevention program and women's health program will be delivered via Facebook, with new content posted each weekday related to that week's topics. The peer coaches may contact participants via private messaging, when needed, to provide support and encourage engagement. If successful, this intervention could be easily disseminated to populations in under-served and community settings.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- African American

- Has Facebook account and uses it, on average, at least once a day

- Body Mass Index (BMI) of 25-45

- Has access to the internet

- Able to consent in English

Exclusion Criteria:

- Currently pregnant or breastfeeding, recently postpartum (within 6 weeks)

- Diagnosis of Diabetes Mellitus

- History of contraindicated medical conditions or conditions that can affect weight

- Current use of certain medications

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Weight-gain Prevention
A 4-week weight-gain prevention curriculum will be delivered via Facebook. Participants will be provided tips to prevent weight-gain and will be given the opportunity to engage with the peer coaches and other participants in the group.
Women's Health
A 4-week women's health curriculum will be delivered via Facebook. Participants will be provided tips for staying healthy and will be given the opportunity to engage with the peer coaches and other participants in the group.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (4)

Lead Sponsor Collaborator
Washington University School of Medicine National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Massachusetts, Worcester, University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Program satisfaction, as measured by the OWN Program Satisfaction Survey 9 weeks, beginning with start of cohort No
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