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The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups

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ClinicalTrials.gov Identifier: NCT03700736
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : January 15, 2021
Sponsor:
Collaborators:
University of Massachusetts, Worcester
Worcester Polytechnic Institute
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Molly Waring, University of Connecticut

Tracking Information
First Submitted Date  ICMJE September 20, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date January 15, 2021
Actual Study Start Date  ICMJE September 5, 2018
Actual Primary Completion Date October 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
  • Recruitment [ Time Frame: Baseline ]
    Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.
  • Sustained participation [ Time Frame: 6 months ]
    We will calculate sustained participation as time to last intervention session attended in the in-person condition and as time to last post, comment, or reaction (based on date of last post or comment reacted to) in the Facebook condition.
  • Contamination [ Time Frame: 6 months ]
    Participants in both treatment conditions will report if they have participated in other weight loss programs (online or in-person), and whether they have searched for weight loss support on Facebook or other online social networks.
  • Retention [ Time Frame: 6 months ]
    Retention is calculated as the proportion of participants who complete the 6-month follow-up study visit in each condition.
  • Retention [ Time Frame: 12 months ]
    Retention is calculated as the proportion of participants who complete the 12-month follow-up study visit in each condition.
  • Degree of missingness in study measures [ Time Frame: Baseline ]
    Percent of participants missing data on each measure/item included in data collection at baseline.
  • Degree of missingness in study measures [ Time Frame: 6 months ]
    Percent of participants missing data on each measure/item included in data collection at 6 months.
  • Degree of missingness in study measures [ Time Frame: 12 months ]
    Percent of participants missing data on each measure/item included in data collection at 12 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
  • Weight change (exploratory) [ Time Frame: 6 months ]
    Weight will be measured at baseline and 6 months. Percent weight change will be calculated.
  • Weight change (exploratory) [ Time Frame: 12 months ]
    Weight will be measured at baseline and 12 months. Percent weight change will be calculated.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
Official Title  ICMJE Delivering a Post-Partum Weight Loss Intervention Via Facebook vs In-Person Groups: a Feasibility Trial
Brief Summary The goal of the project is to conduct a feasibility pilot randomized trial comparing delivery of a post-partum weight loss intervention via Facebook versus via in-person group sessions. The project will provide preliminary data needed to finalize the design of a large randomized trial to compare the non-inferiority and cost-effectiveness of the post-partum weight loss intervention delivered via Facebook versus in-person group sessions. If efficacious and cost-effective, the Facebook-delivered intervention leads naturally to strategies for scaling up for widespread impact.
Detailed Description Post-partum weight retention contributes to obesity for many women, increasing risk for cardiovascular disease and other chronic diseases and complicating future pregnancies. Lifestyle interventions have shown to be modestly efficacious for post-partum weight loss in randomized controlled trials, yet interventions with numerous visits are logistically challenging for many post-partum women. Innovative and efficacious treatment models for post-partum weight loss that fit into the busy lives of new moms are needed, and cost-effectiveness is critical for adoption. Facebook may be an efficient platform for delivering evidence-based weight loss programming to post-partum women. Delivering interventions via Facebook allows us to connect with post-partum women where they are, more fully integrating into their lives and daily routines. Investigators have developed a post-partum weight loss intervention based on the Diabetes Prevention Program, tailored to needs of post-partum women and for delivery via Facebook. Investigators will conduct a feasibility pilot randomized trial comparing delivery of a post-partum weight loss intervention via Facebook to in-person group sessions. Primary outcomes are the feasibility of recruitment, sustained participation, contamination, retention, and feasibility of assessment procedures in both treatment conditions. Weight loss will be described as an exploratory outcome. The project will provide preliminary data needed to finalize the design of a large randomized trial to compare the non-inferiority and cost-effectiveness of the post-partum weight loss intervention delivered via Facebook versus in-person group sessions. Demonstrating cost-effectiveness in addition to efficacy of our Facebook-delivered post-partum weight loss intervention is critical to support widespread implementation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Weight Loss
  • Diet Modification
  • Physical Activity
Intervention  ICMJE Behavioral: Healthy Moms
The 6-month intervention will include dietary and exercise counseling and tips to help participants meet their healthy lifestyle goals. Participants will receive personalized calorie and physical activity goals to help them achieve a healthy weight loss of 1-2 pounds per week. Participants will be encouraged to increase physical activity to 150 minutes per week of moderate intensity activity. Counselors will encourage and support participants to make a plan for incorporating regular physical activity into their lives in a way (i.e., duration per session, frequency per week) that works for that individual woman. We will encourage participants to track their diet and exercise daily. We will encourage participants to use My Fitness Pal to track their diet and activity.
Study Arms  ICMJE
  • Active Comparator: Facebook
    Women will receive the Healthy Moms intervention, a 6-month behavioral weight loss intervention, via a private ("secret") Facebook group. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based lifestyle intervention. A study counselor will facilitate discussions about the topics posted in the Facebook group. Each participant will get an individualized calorie and physical activity goal to help them achieve a healthy weight loss of 1-2 pounds per week. Participants will be encouraged to increase physical activity to 150 minutes per week of moderate intensity activity. Participants will also be encouraged to download the MyFitnessPal app to track daily diet.
    Intervention: Behavioral: Healthy Moms
  • Active Comparator: Traditional
    Women will receive the Healthy Moms intervention, a 6-month behavioral weight loss intervention, via in-person 90-minute group sessions (weekly in months 1-4, every other week in months 5-6). The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based lifestyle intervention. Intervention components will be introduced in the format of handouts, group discussions, and lists of existing resources. Each participant will get an individualized calorie and physical activity goal to help them achieve a healthy weight loss of 1-2 pounds per week. Participants will be encouraged to increase physical activity to 150 minutes per week of moderate intensity activity. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.
    Intervention: Behavioral: Healthy Moms
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2020)
62
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2018)
72
Actual Study Completion Date  ICMJE November 23, 2020
Actual Primary Completion Date October 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • women 18 years or older
  • 8 weeks to 12 months post-partum at enrollment
  • overweight or obese (BMI ≥ 25 kg/m2) per measured height and weight at the baseline visit
  • owns a scale
  • comfortable reading and speaking in English
  • owns an iPhone or Android smartphone
  • active Facebook user
  • medical clearance (e.g., from primary care provider or obstetrician/gynecologist)
  • willing and able to participate in either treatment condition (Facebook or in-person)
  • available to attend in-person meetings over the 6-month study period
  • 45 minutes or less to travel to intervention meetings
  • willing and able to provide informed consent

Exclusion Criteria:

  • UConn employee or student who is key personnel on the study, UConn employee or student who is a spouse, dependent, or relative of any key personnel, or UConn student who key personnel on this study teaches
  • women who are currently pregnant or plan to conceive during study period
  • current participation in clinical weight loss program
  • Type 1 or Type 2 diabetes
  • medical conditions affecting weight
  • medications affecting weight
  • incapable of walking 1/4 of a mile without stopping
  • pain that prevents engagement in exercise
  • previous bariatric surgery
  • planned surgery during study period
  • plans to move out of the area during the study period
  • high depressive symptoms or suicidal ideation
  • positive screen for binge eating disorder
  • failure to complete the baseline survey
  • failure to complete the orientation webinar
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03700736
Other Study ID Numbers  ICMJE H17-206
R34HL136979 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Molly Waring, University of Connecticut
Study Sponsor  ICMJE University of Connecticut
Collaborators  ICMJE
  • University of Massachusetts, Worcester
  • Worcester Polytechnic Institute
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Molly E. Waring, PhD University of Connecticut
PRS Account University of Connecticut
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP