Weight GainFB--PilotNCT02416921
Preventing Weight Gain in African American Reproductive-Aged Women
A study testing Weight-gain Prevention and Women's Health in people with Weight Gain and Women's Health, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Women's Health, Obesity
- What is being tested?
- Weight-gain Prevention and Women's Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Preventing Weight Gain in African American Reproductive-Aged Women: Pilot Program
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.
Read the 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.
- Conditions
- Weight Gain, Women's Health, Obesity
- Being tested
- Weight-gain Prevention, Women's Health
- Keywords
- Facebook, Weight Gain Prevention, Women's Health, Online, Weight Gain, Weight Loss, Female Contraception, Obesity, Body Weight, Internet
- Medical subject headings
- Weight Gain, Obesity, Weight Loss, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-gain PreventionBehavioural
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 HealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight-gain Prevention | Experimental | Subjects in this group will engage in a 4-week weight-gain prevention curriculum delivered via Facebook Receives: Behavioral: Weight-gain Prevention |
| Women's Health | Active comparator | Subjects in this group will engage in a 4-week women's health curriculum delivered via Facebook Receives: Behavioral: Women's Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program satisfaction, as measured by the OWN Program Satisfaction Survey
Measured: 9 weeks, beginning with start of cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Missouri, Kansas City, University of Massachusetts, Worcester
- Responsible party
- Sponsor
- Investigators
- Rick Stein, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416921
- Sponsor's protocol ID
- 201412141
- Other IDs
- 1P30DK092950
- Acronym
- FB--Pilot
- Status last verified
- May 2016
- First submitted
- 18 Mar 2015
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Weight Gain in African American Reproductive-Aged Women: Pilot Program
- ClinicalTrials.gov ID
- NCT02416921
- Acronym / sponsor ID
- FB--Pilot / 201412141
- Conditions
- Weight Gain, Women's Health, Obesity
- Keywords
- Facebook, Weight Gain Prevention, Women's Health, Online, Weight Gain, Weight Loss, Female Contraception, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Missouri, Kansas City, University of Massachusetts, Worcester
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-gain Prevention | Experimental | Behavioral: Weight-gain PreventionSubjects in this group will engage in a 4-week weight-gain prevention curriculum delivered via Facebook |
| Women's Health | Active comparator | Behavioral: Women's HealthSubjects in this group will engage in a 4-week women's health curriculum delivered via Facebook |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight-gain PreventionA 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. | Behavioural | Weight-gain Prevention |
| Women's HealthA 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. | Behavioural | Women's Health |
Primary outcome
Program satisfaction, as measured by the OWN Program Satisfaction Survey
Time frame: 9 weeks, beginning with start of cohort
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick Stein, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-gain Prevention and Women's Health in people with Weight Gain and Women's Health, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program satisfaction, as measured by the OWN Program Satisfaction Survey (time frame: 9 weeks, beginning with start of cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.