N/A
Completed N=62
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
Weight Loss · Diet Modification · Physical Activity
Source: ClinicalTrials.gov NCT03700736 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Recruitment — 163; 105; 195; 65 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment |
163; 105; 195; 65; 16; 62 | — |
| PRIMARY Sustained Participation |
20; 18 | — |
| PRIMARY Contamination |
1; 1; 3; 0; 8; 15 | — |
| PRIMARY Retention |
28; 30; 2; 2 | — |
| PRIMARY Retention |
28; 30; 2; 2 | — |
| PRIMARY Degree of Missingness in Study Measures |
2; 2; 0; 1; 28; 29 | — |
| PRIMARY Degree of Missingness in Study Measures |
2; 2; 0; 1; 28; 29 | — |
| PRIMARY Degree of Missingness in Study Measures |
2; 2; 0; 1; 28; 29 | — |
| SECONDARY Weight Change (Exploratory) |
-2.8; -4.8 | — |
| SECONDARY Weight Change (Exploratory) |
-2.8; -4.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT03700736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.