NCT04623008Completed
Using Mental Imagination to Prevent Excessive Gestational Weight Gain in Overweight and Obese Pregnant Women
Source: ClinicalTrials.gov · Last updated 3 Jan 2025
Brief summary (registry, in English)
Moms Are Worth It is a lifestyle behavior intervention study aims to prevent excessive gestational weight gain in overweight or obese pregnant women through promotion of the stress management, healthy eating, and physical activity. Eligible women will be randomly assigned to a usual care or an intervention plus usual care group. The intervention will last 20 weeks and will be delivered via weekly web and individual health coaching session (10 of them)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 19 Oct 2020
- Start date
- 1 Feb 2021
- Primary completion date
- 30 Jan 2023
- Lead sponsor
- Ohio State University
- Diseases
- Obesity
- NCT number
- NCT04623008
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 1 Feb 2021 to the primary completion date, 30 Jan 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Past bariatric surgery,
Other illness
- Self-reported history of ≥ 3 miscarriages,
- Diagnosed hypertension and/or type 1 or 2 diabetes,
- History of or current diagnosis of an eating disorder,
- Serious current physical disease (e.g., renal disease or cancer),
- Current or history of substance abuse in the past 6 months,
- Current treatment for a serious psychological disorder (e.g., schizophrenia and bipolar disorder),
Other
- Planned termination of the pregnancy,
- Contraindications to walking,
- Consented women will become not eligible to participate in the study if they are not randomized by 16-week 6 days gestation. This is because the study intervention starts ≤ 17 weeks gestation.
- Women will become not ineligible for participation if they did not complete the baseline data.
Who the study is looking for
- Participants must be pregnant women ≤ 13 week-gestation with a single fetus as assessed by ultrasound.
- Participants must also have self-reported pre-pregnancy body mass index (BMI) of 25.0-45.0 kg/m2 and height (height and weight to compute body mass index).
- Ability to read and speak English,
- Age of 18-45 years,
- Access to a working smart phone with unlimited text messaging,
- Access to internet,
- Receipt of prenatal care from our collaborating clinics and plan to deliver the baby at The Ohio State University (OSU) Wexner Medical Center,
- Resident of Franklin Count,
- Committed to the 20-week intervention.
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.