Weight LossEMPOWER-MomNCT04914819
Postpartum Weight Loss for Women at Elevated Cardiovascular Risk
A study testing Online Behavioral Weight Loss Program and Virtual weigh-in in people with Weight Loss and Postpartum Weight Retention, run by University of Pennsylvania at 1 site in United States.
Trial summary
The aim of this study is to test the feasibility and effectiveness of a 16-week online behavioral weight loss program compared to usual care to promote weight loss in the postpartum period among women with cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Weight Loss, Postpartum Weight Retention, Hypertension in Pregnancy
- What is being tested?
- Online Behavioral Weight Loss Program and Virtual weigh-in
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2021to 31 Dec 2021
- 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
- Age ≥18 years;
- Delivered a baby at HUP or PAH within 3-12 months prior to study start;
- BMI ≥ 27 kg/m2
- Diagnosis of one of the following medical conditions: chronic hypertension, gestational hypertension, preeclampsia, eclampsia, gestational diabetes, or diabetes mellitus (type 1 or 2) based on diagnosis codes in the EMR
- Has online access through smartphone or computer and has email address
- Ability to read and provide informed consent to participate in the study
Who cannot join
- Delivered prior to 32 weeks gestation in the EMR
- Documentation of fetal demise or neonatal demise in the EMR
- Currently pregnant or planning to get pregnant within the next 5 months
- Does not speak English
- Answers yes to any of the following questions:
- Are you currently participating in any other weight loss or physical activity studies?
- Do you have any medical conditions or other reasons why you could not participate in a 16-week weight loss or physical activity program?
- Participants will be excluded after completing the run-in period if they do not complete the daily food log or their baseline BMI is < 27 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EmPOWER-Mom Study)
The aim of this study is to test the feasibility and effectiveness of a 16-week online behavioral weight loss program compared to usual care to promote weight loss in the postpartum period among women with cardiovascular risk factors. The investigators will also be testing different behavioral strategies to recruit postpartum women to the study, including 2 email recruitment strategies and 2 mailer recruitment strategies, informed by behavioral design.
- Conditions
- Weight Loss, Postpartum Weight Retention, Hypertension in Pregnancy, Diabetes Mellitus in Pregnancy, Preeclampsia, Recruitment
- Being tested
- Online Behavioral Weight Loss Program, Virtual weigh-in
- Keywords
- weight loss, postpartum period, hypertension in pregnancy, cardiovascular risk reduction, diabetes prevention program
- Medical subject headings
- Weight Loss, Gestational Weight Gain, Hypertension, Pregnancy-Induced, Diabetes, Gestational, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Behavioral Weight Loss ProgramBehavioural
Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
Virtual weigh-inBehavioural
Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Online Behavioral Weight Loss | Active comparator | Participants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study. Receives: Behavioral: Online Behavioral Weight Loss Program; Behavioral: Virtual weigh-in |
| Usual Care | Active comparator | Participants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided. Receives: Behavioral: Virtual weigh-in |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight in Pounds From Baseline to 16-week Follow-up
Mean change in weight in pounds from baseline to 16-week follow-up between study arms.
Measured: Baseline and 16 weeks
Enrollment Rate Between Email Recruitment Strategies
We will compare enrollment rates between two behaviorally-framed email strategies
Measured: 8 weeks
Sign-up Rate Between Mailer Recruitment Strategies
We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift
Measured: 8 weeks
Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up
Proportion of participants who lost 5 percent or more of their weight from baseline to 16-week follow-up between study groups.
Measured: Baseline and 16 weeks
Secondary outcomes (3)
Study Completion Rate Between 2 Arms
Proportion of participants that completed all follow-up procedures between both study arms.
Measured: 16 weeks
Intervention Arm: Number of Weeks With One or More Logins
Engagement with BWL platform measured by mean number of weeks with one or more logins
Measured: 16 weeks
Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days
Mean number of weeks that calories, physical activity minutes, and body weight were reported at least 5 of 7 days
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start18 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jennifer Lewey, MD, MPH, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914819
- Sponsor's protocol ID
- 844694
- Other IDs
- 5K23HL153667-03
- Acronym
- EMPOWER-Mom
- Status last verified
- Jun 2023
- First submitted
- 20 May 2021
- Last updated
- 6 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Weight Loss for Women at Elevated Cardiovascular Risk (EmPOWER-Mom Study)
- ClinicalTrials.gov ID
- NCT04914819
- Acronym / sponsor ID
- EMPOWER-Mom / 844694
- Conditions
- Weight Loss, Postpartum Weight Retention, Hypertension in Pregnancy, Diabetes Mellitus in Pregnancy, Preeclampsia, Recruitment
- Keywords
- weight loss, postpartum period, hypertension in pregnancy, cardiovascular risk reduction, diabetes prevention program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Posted 6 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to test the feasibility and effectiveness of a 16-week online behavioral weight loss program compared to usual care to promote weight loss in the postpartum period among women with cardiovascular risk factors. The investigators will also be testing different behavioral strategies to recruit postpartum women to the study, including 2 email recruitment strategies and 2 mailer recruitment strategies, informed by behavioral design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Behavioral Weight Loss | Active comparator | Behavioral: Online Behavioral Weight Loss Program, Behavioral: Virtual weigh-inParticipants will attend a virtual introduction to weight loss session and be enrolled in a 16-week online behavioral weight loss program. Participants will complete a virtual weigh-in at the start and end of the study. |
| Usual Care | Active comparator | Behavioral: Virtual weigh-inParticipants will complete a virtual weigh-in at the start and end of the study. No additional intervention will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years;
- Delivered a baby at HUP or PAH within 3-12 months prior to study start;
- BMI ≥ 27 kg/m2
- Diagnosis of one of the following medical conditions: chronic hypertension, gestational hypertension, preeclampsia, eclampsia, gestational diabetes, or diabetes mellitus (type 1 or 2) based on diagnosis codes in the EMR
- Has online access through smartphone or computer and has email address
Key exclusion criteria (8 listed)
- Delivered prior to 32 weeks gestation in the EMR
- Documentation of fetal demise or neonatal demise in the EMR
- Currently pregnant or planning to get pregnant within the next 5 months
- Does not speak English
- Answers yes to any of the following questions:
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 |
|---|---|---|
| Online Behavioral Weight Loss ProgramParticipants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach. | Behavioural | Online Behavioral Weight Loss |
| Virtual weigh-inParticipants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks. | Behavioural | Online Behavioral Weight Loss, Usual Care |
Primary outcome
Change in Weight in Pounds From Baseline to 16-week Follow-up
Time frame: Baseline and 16 weeks
Mean change in weight in pounds from baseline to 16-week follow-up between study arms.
Enrollment Rate Between Email Recruitment Strategies
Time frame: 8 weeks
We will compare enrollment rates between two behaviorally-framed email strategies
Sign-up Rate Between Mailer Recruitment Strategies
Time frame: 8 weeks
We will compare enrollment rates between the group receiving a mailer versus mailer plus baby gift
Number of Participants Losing 5 Percent or More of Weight From Baseline to 16-week Follow-up
Time frame: Baseline and 16 weeks
Proportion of participants who lost 5 percent or more of their weight from baseline to 16-week follow-up between study groups.
3 secondary outcomes
Study Completion Rate Between 2 Arms
Time frame: 16 weeks
Intervention Arm: Number of Weeks With One or More Logins
Time frame: 16 weeks
Intervention Arm: Number of Weeks With Daily Data Reporting for at Least 5 of 7 Days
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Behavioral Weight Loss Program and Virtual weigh-in in people with Weight Loss and Postpartum Weight Retention, run by University of Pennsylvania 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 6 inclusion and 8 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 6 Jul 2023. 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 6 Jul 2023). 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?
Change in Weight in Pounds From Baseline to 16-week Follow-up (time frame: Baseline and 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2023.