Preventing Weight Gain in African American Reproductive-Aged Women

Obesity Clinical Trial

— FB--Pilot  

Official title:

Preventing Weight Gain in African American Reproductive-Aged Women: Pilot Program

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

• Body Weight
• Obesity
• Weight Gain
• Women's Health

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