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

Primary Purpose

Weight Loss, Diet Modification, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Moms
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Loss focused on measuring post-partum women, social media, Facebook, digital health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Connecticut

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Facebook

Traditional

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recruitment
Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.
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.
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.
Retention
Retention is calculated as the percentage of participants who complete the 6-month follow-up study assessment in each condition.
Retention
Retention is calculated as the percentage of participants who complete the 12-month follow-up study assessment in each condition.
Degree of Missingness in Study Measures
Percent of participants missing data on each measure/item included in data collection at baseline.
Degree of Missingness in Study Measures
Percent of participants missing data on each measure/item included in data collection at 6 months.
Degree of Missingness in Study Measures
Percent of participants missing data on each measure/item included in data collection at 12 months.

Secondary Outcome Measures

Weight Change (Exploratory)
Weight will be measured at baseline and 6 months. Percent weight change will be calculated.
Weight Change (Exploratory)
Weight will be measured at baseline and 12 months. Percent weight change will be calculated.

Full Information

First Posted
September 20, 2018
Last Updated
November 19, 2021
Sponsor
University of Connecticut
Collaborators
University of Massachusetts, Worcester, Worcester Polytechnic Institute, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03700736
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
October 26, 2020 (Actual)
Study Completion Date
November 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
Collaborators
University of Massachusetts, Worcester, Worcester Polytechnic Institute, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Diet Modification, Physical Activity
Keywords
post-partum women, social media, Facebook, digital health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facebook
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Traditional
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Moms
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment
Description
Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.
Time Frame
Baseline
Title
Sustained Participation
Description
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.
Time Frame
6 months
Title
Contamination
Description
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.
Time Frame
6 months
Title
Retention
Description
Retention is calculated as the percentage of participants who complete the 6-month follow-up study assessment in each condition.
Time Frame
6 months
Title
Retention
Description
Retention is calculated as the percentage of participants who complete the 12-month follow-up study assessment in each condition.
Time Frame
12 months
Title
Degree of Missingness in Study Measures
Description
Percent of participants missing data on each measure/item included in data collection at baseline.
Time Frame
Baseline
Title
Degree of Missingness in Study Measures
Description
Percent of participants missing data on each measure/item included in data collection at 6 months.
Time Frame
6 months
Title
Degree of Missingness in Study Measures
Description
Percent of participants missing data on each measure/item included in data collection at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Weight Change (Exploratory)
Description
Weight will be measured at baseline and 6 months. Percent weight change will be calculated.
Time Frame
6 months
Title
Weight Change (Exploratory)
Description
Weight will be measured at baseline and 12 months. Percent weight change will be calculated.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molly E. Waring, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31778116
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.
Results Reference
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The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups

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