The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03700736 |
|
Recruitment Status :
Completed
First Posted : October 9, 2018
Last Update Posted : January 15, 2021
|
Sponsor:
University of Connecticut
Collaborators:
University of Massachusetts, Worcester
Worcester Polytechnic Institute
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Molly Waring, University of Connecticut
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Weight Loss Diet Modification Physical Activity | Behavioral: Healthy Moms | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 62 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Delivering a Post-Partum Weight Loss Intervention Via Facebook vs In-Person Groups: a Feasibility Trial |
| Actual Study Start Date : | September 5, 2018 |
| Actual Primary Completion Date : | October 26, 2020 |
| Actual Study Completion Date : | November 23, 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Facebook
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
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. |
|
Active Comparator: Traditional
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
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 Measures :
- Recruitment [ Time Frame: Baseline ]Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.
- Sustained participation [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]Retention is calculated as the proportion of participants who complete the 6-month follow-up study visit in each condition.
- Retention [ Time Frame: 12 months ]Retention is calculated as the proportion of participants who complete the 12-month follow-up study visit in each condition.
- Degree of missingness in study measures [ Time Frame: Baseline ]Percent of participants missing data on each measure/item included in data collection at baseline.
- Degree of missingness in study measures [ Time Frame: 6 months ]Percent of participants missing data on each measure/item included in data collection at 6 months.
- Degree of missingness in study measures [ Time Frame: 12 months ]Percent of participants missing data on each measure/item included in data collection at 12 months.
Secondary Outcome Measures :
- Weight change (exploratory) [ Time Frame: 6 months ]Weight will be measured at baseline and 6 months. Percent weight change will be calculated.
- Weight change (exploratory) [ Time Frame: 12 months ]Weight will be measured at baseline and 12 months. Percent weight change will be calculated.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700736
Locations
| United States, Connecticut | |
| University of Connecticut | |
| Storrs, Connecticut, United States, 06269 | |
Sponsors and Collaborators
University of Connecticut
University of Massachusetts, Worcester
Worcester Polytechnic Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Molly E. Waring, PhD | University of Connecticut |
| Responsible Party: | Molly Waring, Associate Professor, University of Connecticut |
| ClinicalTrials.gov Identifier: | NCT03700736 |
| Other Study ID Numbers: |
H17-206 R34HL136979 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 9, 2018 Key Record Dates |
| Last Update Posted: | January 15, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Molly Waring, University of Connecticut:
|
post-partum women social media digital health |
Additional relevant MeSH terms:
|
Body Weight Weight Loss Body Weight Changes |