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

NCT03700736 | Completed Results DMC

• 2 other identifiers: H17-206R34HL136979
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Diet Modification; Physical Activity

Keywords

post-partum women; social media; Facebook; digital health

Outcome Measures

Primary Outcomes (8)

• Recruitment

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

  Baseline

• Sustained Participation

  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.

  6 months

• Contamination

  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.

  6 months

• Retention

  Retention is calculated as the percentage of participants who complete the 6-month follow-up study assessment in each condition.

  6 months

• Retention

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

  12 months

• Degree of Missingness in Study Measures

  Percent of participants missing data on each measure/item included in data collection at baseline.

  Baseline

• Degree of Missingness in Study Measures

  Percent of participants missing data on each measure/item included in data collection at 6 months.

  6 months

• Degree of Missingness in Study Measures

  Percent of participants missing data on each measure/item included in data collection at 12 months.

  12 months

Secondary Outcomes (2)

• Weight Change (Exploratory)

  6 months

• Weight Change (Exploratory)

  12 months

Study Arms (2)

Facebook

ACTIVE COMPARATOR

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.

Behavioral: Healthy Moms

Traditional

ACTIVE COMPARATOR

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.

Behavioral: Healthy Moms

Interventions

Healthy Moms BEHAVIORAL

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.

Facebook; Traditional

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women 18 years or older
• 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
• minutes or less to travel to intervention meetings
• willing and able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead
• University of Massachusetts, Worcester: collaborator
• Worcester Polytechnic Institute: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (2)

• 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.

  PMID: 31778116 BACKGROUND

• Waring ME, Pagoto SL, Moore Simas TA, Blackman Carr LT, Eamiello ML, Libby BA, Rudin LR, Heersping GE. Delivering a Postpartum Weight Loss Intervention via Facebook or In-Person Groups: Results From a Randomized Pilot Feasibility Trial. JMIR Mhealth Uhealth. 2023 Apr 27;11:e41545. doi: 10.2196/41545.

  PMID: 37103991 DERIVED

MeSH Terms

Conditions

Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

In wave 2, due to safety concerns related to COVID-19, the last two intervention meetings for the Traditional condition were held via WebEx (vs in-person meetings) and 6-month and 12-month assessments for participants in both conditions were held remotely (vs in-person study visits). Thus in wave 2, all follow-up weights are self-reported.

Results Point of Contact

• Title: Dr. Molly Waring
• Organization: University of Connecticut

molly.waring@uconn.edu

860-486-1446

Study Officials

• Molly E. Waring, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 9, 2018
• Study Start: September 5, 2018
• Primary Completion: October 26, 2020
• Study Completion: November 23, 2020
• Last Updated: November 23, 2021
• Results First Posted: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)