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Preventing Weight Gain in African American Reproductive-Aged Women (FB--Pilot)

Primary Purpose

Weight Gain, Women's Health, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight-gain Prevention
Women's Health
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Gain focused on measuring Facebook, Weight Gain Prevention, Women's Health, Online, Weight Gain, Weight Loss, Female Contraception, Obesity, Body Weight, Internet

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Weight-gain Prevention

Women's Health

Arm Description

Subjects in this group will engage in a 4-week weight-gain prevention curriculum delivered via Facebook

Subjects in this group will engage in a 4-week women's health curriculum delivered via Facebook

Outcomes

Primary Outcome Measures

Program satisfaction, as measured by the OWN Program Satisfaction Survey

Secondary Outcome Measures

Full Information

First Posted
March 18, 2015
Last Updated
May 20, 2016
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Missouri, Kansas City, University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT02416921
Brief Title
Preventing Weight Gain in African American Reproductive-Aged Women
Acronym
FB--Pilot
Official Title
Preventing Weight Gain in African American Reproductive-Aged Women: Pilot Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Missouri, Kansas City, University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain, Women's Health, Obesity
Keywords
Facebook, Weight Gain Prevention, Women's Health, Online, Weight Gain, Weight Loss, Female Contraception, Obesity, Body Weight, Internet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight-gain Prevention
Arm Type
Experimental
Arm Description
Subjects in this group will engage in a 4-week weight-gain prevention curriculum delivered via Facebook
Arm Title
Women's Health
Arm Type
Active Comparator
Arm Description
Subjects in this group will engage in a 4-week women's health curriculum delivered via Facebook
Intervention Type
Behavioral
Intervention Name(s)
Weight-gain Prevention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Women's Health
Intervention Description
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.
Primary Outcome Measure Information:
Title
Program satisfaction, as measured by the OWN Program Satisfaction Survey
Time Frame
9 weeks, beginning with start of cohort

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Stein, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Preventing Weight Gain in African American Reproductive-Aged Women

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