Skip to main content
Clinical Trials/NCT03700736
NCT03700736
Completed
Not Applicable

Delivering a Post-Partum Weight Loss Intervention Via Facebook vs In-Person Groups: a Feasibility Trial

University of Connecticut1 site in 1 country62 target enrollmentSeptember 5, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Weight Loss
Sponsor
University of Connecticut
Enrollment
62
Locations
1
Primary Endpoint
Sustained Participation
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 5, 2018
End Date
November 23, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Molly Waring

Associate Professor

University of Connecticut

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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.

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.

Recruitment

Time Frame: Baseline

Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.

Retention

Time Frame: 12 months

Retention is calculated as the percentage of participants who complete the 12-month follow-up study assessment in each condition.

Secondary Outcomes

  • Weight Change (Exploratory)(12 months)

Study Sites (1)

Loading locations...

Similar Trials