Weight LossNCT03700736

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

A study testing Healthy Moms in people with Weight Loss and Diet Modification, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Weight Loss, Diet Modification, Physical Activity
What is being tested?: Healthy Moms
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: 5 Sep 2018to 23 Nov 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Connecticut
Storrs, Connecticut, 06269

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Weight Loss, Diet Modification, Physical Activity
Being tested: Healthy Moms
Keywords: post-partum women, social media, Facebook, digital health
Medical subject headings: Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Healthy MomsBehavioural
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.

Study groups in NCT03700736
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Healthy Moms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 201823 Nov 2020

First posted9 Oct 2018
Study start5 Sep 2018
Primary completion26 Oct 2020
Study completion23 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Weight LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03700736
Sponsor's protocol ID: H17-206
Other IDs: R34HL136979
Status last verified: Nov 2021
First submitted: 20 Sep 2018
Last updated: 23 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 31778116
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.
PubMed 37103991

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Delivering a Post-Partum Weight Loss Intervention Via Facebook vs In-Person Groups: a Feasibility Trial
ClinicalTrials.gov ID: NCT03700736
Acronym / sponsor ID: H17-206
Conditions: Weight Loss, Diet Modification, Physical Activity
Keywords: post-partum women, social media, Facebook, digital health
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: University of ConnecticutUniversity, hospital or other
Collaborators: University of Massachusetts, Worcester, Worcester Polytechnic Institute, National Heart, Lung, and Blood Institute (NHLBI)
Study start: 5 Sep 2018 (actual)
Primary completion: 26 Oct 2020 (actual)
Study completion: 23 Nov 2020 (actual)
First posted: 9 Oct 2018 (actual)
Results: Posted 22 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Facebook	Active comparator	Behavioral: Healthy MomsWomen 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.
Traditional	Active comparator	Behavioral: Healthy MomsWomen 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Healthy MomsThe 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.	Behavioural	Facebook, Traditional

Primary outcome

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 percentage of participants who complete the 6-month follow-up study assessment in each condition.
Retention
Time frame: 12 months
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
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.

2 secondary outcomes

Weight Change (Exploratory)
Time frame: 6 months
Weight Change (Exploratory)
Time frame: 12 months

Results and safety

Results posted to the registry on 22 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Facebook	30	27
Traditional	32	25

Primary outcome: Recruitment

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Individuals Contacted n = 606
Could not reach to screen	163
Not interested in participating	105
Ineligible at initial eligibility screening	195
Eligible but did not complete baseline visit	65
Eligible at screening but met additional exclusion criteria or did not complete baseline procedures	16
Randomized	62

Primary outcome: Sustained Participation

Time frame: 6 months. Median (Inter-Quartile Range). Unit: latest treatment module participated in

Measure	Facebook n = 30	Traditional n = 32
Value	20 (19 to 20)	18 (2 to 20)

Population analysed: 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)

Primary outcome: Contamination

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Facebook n = 26	Traditional n = 28
Used other weight loss programs & sought weight loss info/support on social media	1	1
Used other weight loss programs	3	0
Sought weight loss info or support on social media	8	15
Neither	14	12

Population analysed: 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).

Primary outcome: Retention

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Facebook n = 30	Traditional n = 32
Retained	27	30
Lost to follow-up	3	2

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Facebook	0 of 30 (0%)	25 of 30 (83.3%)	0 of 30
Traditional	0 of 32 (0%)	23 of 32 (71.9%)	0 of 32

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31778116Waring 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.
Derived from this study: PubMed 37103991Waring 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.
Individual participant dataSharing planned: No

Related trials for Weight Loss

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Molly E. Waring, PhD principal investigator

University of Connecticut

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Moms in people with Weight Loss and Diet Modification, run by University of Connecticut at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03700736, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.