Clinical trial NCT03700736: The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
Official title: Delivering a Post-Partum Weight Loss Intervention Via Facebook vs In-Person Groups: a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Diet Modification
Physical Activity
Keywords: post-partum women
social media
Facebook
digital health
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
name: Worcester Polytechnic Institute
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-10-09
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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
* 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

Primary outcomes:
measure: Recruitment
timeFrame: Baseline
measure: Sustained Participation
timeFrame: 6 months
measure: Contamination
timeFrame: 6 months
measure: Retention
timeFrame: 6 months
measure: Retention
timeFrame: 12 months
measure: Degree of Missingness in Study Measures
timeFrame: Baseline
measure: Degree of Missingness in Study Measures
timeFrame: 6 months
measure: Degree of Missingness in Study Measures
timeFrame: 12 months
Secondary outcomes:
measure: Weight Change (Exploratory)
timeFrame: 6 months
measure: Weight Change (Exploratory)
timeFrame: 12 months
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Molly E. Waring, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waring ME, Libby BA, Moore Simas TA, Bracken ML, Bibeau JL, Herrera V, Wang J, Pagoto SL. Delivering a Post-Partum Weight Loss Intervention via Facebook or In-Person Groups: Protocol for a Randomized Feasibility Pilot Trial. JMIR Res Protoc. 2019 Nov 28;8(11):e15530. doi: 10.2196/15530.