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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700736
• Other study ID #: H17-206
• Secondary ID: R34HL136979
• Status: Completed
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: November 23, 2020

Study information

• Verified date: November 2021
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 23, 2020
• Est. primary completion date: October 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diet Modification
• Physical Activity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (4)

Lead Sponsor	Collaborator
University of Connecticut	National Heart, Lung, and Blood Institute (NHLBI), University of Massachusetts, Worcester, Worcester Polytechnic Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.	Baseline
Primary	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
Primary	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
Primary	Retention	Retention is calculated as the percentage of participants who complete the 6-month follow-up study assessment in each condition.	6 months
Primary	Retention	Retention is calculated as the percentage of participants who complete the 12-month follow-up study assessment in each condition.	12 months
Primary	Degree of Missingness in Study Measures	Percent of participants missing data on each measure/item included in data collection at baseline.	Baseline
Primary	Degree of Missingness in Study Measures	Percent of participants missing data on each measure/item included in data collection at 6 months.	6 months
Primary	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	Weight Change (Exploratory)	Weight will be measured at baseline and 6 months. Percent weight change will be calculated.	6 months
Secondary	Weight Change (Exploratory)	Weight will be measured at baseline and 12 months. Percent weight change will be calculated.	12 months