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

• Sponsor: University of Connecticut (Other)
• Overall Status: Completed
• CT.gov ID: NCT03700736
• Collaborator: University of Massachusetts, Worcester (Other), Worcester Polytechnic Institute (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 62
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.6
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Diet Modification; Physical Activity	Behavioral: Healthy Moms	N/A

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.

Study Design

• Study Type: Interventional
• 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: Sep 5, 2018
• Actual Primary Completion Date: Oct 26, 2020
• Actual Study Completion Date: Nov 23, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Recruitment [Baseline]

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

2. Sustained Participation [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.

3. Contamination [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.

4. Retention [6 months]

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

5. Retention [12 months]

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

6. Degree of Missingness in Study Measures [Baseline]

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

7. Degree of Missingness in Study Measures [6 months]

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

8. Degree of Missingness in Study Measures [12 months]

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

Secondary Outcome Measures

1. Weight Change (Exploratory) [6 months]

   Weight will be measured at baseline and 6 months. Percent weight change will be calculated.

2. Weight Change (Exploratory) [12 months]

   Weight will be measured at baseline and 12 months. Percent weight change will be calculated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

• Study Protocol - Mar 9, 2020
• Statistical Analysis Plan - Oct 20, 2021
• Informed Consent Form - Aug 20, 2018

More Information

Publications

• 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.

• Responsible Party: Molly Waring, Associate Professor, University of Connecticut
• ClinicalTrials.gov Identifier: NCT03700736
• Other Study ID Numbers: H17-206; R34HL136979
• First Posted: Oct 9, 2018
• Last Update Posted: Nov 23, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Associate Professor, University of Connecticut: post-partum women; social media; Facebook; digital health
• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

Participant Flow

Arm/Group Title	Facebook	Traditional
Arm/Group Description	6-month post-partum weight loss intervention delivered via a private Facebook group	6-month post-partum weight loss intervention delivered via in-person group meetings
Period Title: Overall Study
STARTED	30	32
COMPLETED	27	25
NOT COMPLETED	3	7

Baseline Characteristics

Arm/Group Title	Facebook	Traditional	Total
Arm/Group Description	6-month post-partum weight loss intervention delivered via a private Facebook group	6-month post-partum weight loss intervention delivered via in-person group meetings	Total of all reporting groups
Overall Participants	30	32	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.3 (3.5)	32.3 (4.4)	32.8 (4.0)
Sex: Female, Male (Count of Participants)
Female	30 100%	32 100%	62 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 16.7%	4 12.5%	9 14.5%
Not Hispanic or Latino	25 83.3%	28 87.5%	53 85.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 3.3%	2 6.3%	3 4.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 3.3%	3 9.4%	4 6.5%
White	26 86.7%	26 81.3%	52 83.9%
More than one race	1 3.3%	0 0%	1 1.6%
Unknown or Not Reported	1 3.3%	1 3.1%	2 3.2%
Region of Enrollment (participants) [Number]
United States	30 100%	32 100%	62 100%
Weight (pounds) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [pounds]	188.9	180.6	186.0

Outcome Measures

1. Primary Outcome

Title	Recruitment
Description	Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individuals Contacted
Arm/Group Description	Individuals who expressed interest in study participation
Measure Participants	606
Could not reach to screen	163 543.3%
Not interested in participating	105 350%
Ineligible at initial eligibility screening	195 650%
Eligible but did not complete baseline visit	65 216.7%
Eligible at screening but met additional exclusion criteria or did not complete baseline procedures	16 53.3%
Randomized	62 206.7%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Latest treatment module participated in based on last intervention meeting attended (Traditional) or last treatment module engaged in based on original posts, replies/comments, reactions, and poll votes (Facebook)

Arm/Group Title	Facebook	Traditional
Arm/Group Description	6-month post-partum weight loss intervention delivered via a private Facebook group	6-month post-partum weight loss intervention delivered via in-person group meetings
Measure Participants	30	32
Median (Inter-Quartile Range) [latest treatment module participated in]	20	18

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants reported use of other weight loss programs and seeking weight loss info/support on social media on the 6-month survey. We report the number and percentage of participants in each condition that reported use of other weight loss programs, sought weight loss info/support on social media, both, or neither. These data are available only for participants who completed the 6-month survey. Note that we encouraged participants in both groups to reference online resources (e.g., recipes).

Arm/Group Title	Facebook	Traditional
Arm/Group Description	6-month post-partum weight loss intervention delivered via a private Facebook group	6-month post-partum weight loss intervention delivered via in-person group meetings
Measure Participants	26	28
Used other weight loss programs & sought weight loss info/support on social media	1 3.3%	1 3.1%
Used other weight loss programs	3 10%	0 0%
Sought weight loss info or support on social media	8 26.7%	15 46.9%
Neither	14 46.7%	12 37.5%

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Retention is defined as completing 6-month follow-up study assessment (providing weight and/or completing the follow-up survey)

Arm/Group Title	Facebook	Traditional
Arm/Group Description	6-month post-partum weight loss intervention delivered via a private Facebook group	6-month post-partum weight loss intervention delivered via in-person group meetings
Measure Participants	30	32
Retained	27 90%	30 93.8%
Lost to follow-up	3 10%	2 6.3%

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Retention is defined as completing 12-month follow-up study assessment (providing weight and/or completing the follow-up survey)

Arm/Group Title	Facebook	Traditional
Arm/Group Description	6-month post-partum weight loss intervention delivered via a private Facebook group	6-month post-partum weight loss intervention delivered via in-person group meetings
Measure Participants	30	32
Retained	28 93.3%	30 93.8%
Lost to follow-up	2 6.7%	2 6.3%

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Missing (or incomplete) measures needed for cost-effectiveness aim of subsequent efficacy trial: weight and/or quality of life measure.

Arm/Group Title	Facebook	Traditional
Arm/Group Description	6-month behavioral weight loss intervention delivered via a private Facebook group	6-month behavioral weight loss intervention delivered via in-person group meetings
Measure Participants	30	32
Missing (or incomplete) quality of life	4 13.3%	2 6.3%
Available information on both weight and quality of life	26 86.7%	30 93.8%

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Missing (or incomplete) measures needed for cost-effectiveness aim of subsequent efficacy trial: weight and/or quality of life measure. Note that as quality of measure was assessed as part of 6-month survey, participants who did not complete the survey are missing this measure.

Arm/Group Title	Facebook	Traditional
Arm/Group Description	6-month post-partum weight loss intervention delivered via a private Facebook group	6-month post-partum weight loss intervention delivered via in-person group meetings
Measure Participants	30	32
Missing weight and quality of life	3 10%	2 6.3%
Missing quality of life	1 3.3%	3 9.4%
Available information on both weight and quality of life	26 86.7%	27 84.4%

8. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Missing (or incomplete) measures needed for cost-effectiveness aim of subsequent efficacy trial: weight and/or quality of life measure. Note that as quality of measure was assessed as part of 12-month survey, participants who did not complete the survey are missing this measure.

Arm/Group Title	Facebook	Traditional
Arm/Group Description	6-month post-partum weight loss intervention delivered via a private Facebook group	6-month post-partum weight loss intervention delivered via in-person group meetings
Measure Participants	30	32
Missing weight and quality of life	2 6.7%	2 6.3%
Missing quality of life	0 0%	1 3.1%
Available information for both weight and quality of life	28 93.3%	29 90.6%

9. Secondary Outcome

Title	Weight Change (Exploratory)
Description	Weight will be measured at baseline and 6 months. Percent weight change will be calculated.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Percent weight change from baseline to 6 months. All baseline weights were measured at a study visit. At 6 months, weight was measured at a study visit or participants self-reported current or pre-pregnancy weight (if pregnant). Note that due to COVID19, all follow-up weights for wave 2 were self-reported. Complete case weight change is reported.

Arm/Group Title	Facebook	Traditional
Arm/Group Description	6-month post-partum weight loss intervention delivered via a private Facebook group	6-month post-partum weight loss intervention delivered via in-person group meetings
Measure Participants	27	30
Mean (Standard Deviation) [percent weight loss from baseline]	-3.0 (7.2)	-5.4 (6.8)

10. Secondary Outcome

Title	Weight Change (Exploratory)
Description	Weight will be measured at baseline and 12 months. Percent weight change will be calculated.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Percent weight change from baseline to 12 months. All baseline weights were measured at study visit. At 12 months, weight was measured at study visit or participants self-reported current or pre-pregnancy weight (if pregnant). Note that due to COVID19, all follow-up weights for wave 2 were self-reported. Complete case weight change is reported.

Arm/Group Title	Facebook	Traditional
Arm/Group Description	6-month post-partum weight loss intervention delivered via a private Facebook group	6-month post-partum weight loss intervention delivered via in-person group meetings
Measure Participants	28	30
Mean (Standard Deviation) [percent weight loss from baseline]	-2.8 (7.4)	-4.8 (7.6)

Adverse Events

Time Frame	Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments
Adverse Event Reporting Description	Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.
Arm/Group Title	Facebook		Traditional
Arm/Group Description	6-month behavioral weight loss intervention delivered via a private Facebook group		6-month behavioral weight loss intervention delivered via in-person group meetings
All Cause Mortality
	Facebook		Traditional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/32 (0%)
Serious Adverse Events
	Facebook		Traditional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Facebook		Traditional
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/30 (83.3%)		23/32 (71.9%)
General disorders
Communicable disease (e.g., cold, flu)	15/30 (50%)	17	15/32 (46.9%)	17
5% or greater weight gain	2/30 (6.7%)	2	3/32 (9.4%)	3
Injury, poisoning and procedural complications
Musculoskeletal pain or injury (not related to exercise)	5/30 (16.7%)	5	4/32 (12.5%)	5
Pregnancy, puerperium and perinatal conditions
Pregnancy during intervention or follow-up	2/30 (6.7%)	2	3/32 (9.4%)	3
Psychiatric disorders
Depressive symptoms	12/30 (40%)	13	5/32 (15.6%)	6

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.