ClockWork Postpartum Weight Management Study (NCT04992637) | Clinical Trial Compass
CompletedNot Applicable
ClockWork Postpartum Weight Management Study
United States17 participantsStarted 2021-07-30
Plain-language summary
The ClockWork Postpartum Weight Management Pilot Study is an intervention study that will assess the feasibility, acceptability, and initial efficacy of the ClockWork intervention among women with prepregnancy overweight/obesity during the first 4 months postpartum.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years of age
* Prenatal BMI greater than or equal to 25
* At least 28 weeks gestation
* English speaking
* Singleton pregnancy
Exclusion Criteria:
* Preexisting diabetes
* Use of medications known to affect weight (example, second generation antipsychotics)
* Enrolled in current weight management programming
* Recent weight loss surgery (within the past 3 years)
* Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate treatment will be excluded and referred for care.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of sessions attended among women randomized to receive the ClockWork Intervention
Timeframe: First 4 months postpartum
2
The percentage of days with completed monitoring among women randomized to receive the ClockWork Intervention
Timeframe: First 4 months postpartum
3
Participant liking of ClockWork (sessions, content, digital monitoring interface)
Timeframe: First 4 months postpartum
4
Perceived utility ratings of ClockWork (sessions, content, digital monitoring interface)
Timeframe: First 4 months postpartum
5
Changes in the "ART" (amount, regularity, and timing of targeted intervention behaviors) from baseline to 4 months postpartum
Timeframe: First 4 months postpartum
6
Weight change from delivery to 4 months postpartum
Timeframe: First 4 months postpartum
7
Weight change from prepregnancy to 4 months postpartum