PREPARE: A Randomized Trial of a Pre-pregnancy Weight Loss Intervention
Completed · Not applicable
Conditions studied: Overweight, Obese
In brief
The US obesity epidemic is being transmitted to the next generation. Growing evidence suggests that both a mothers' weight at pregnancy onset, and excessive weight gain during pregnancy, are associated with increased risk of pregnancy-related complications such as gestational diabetes and pre-eclampsia, and an increased risk that her child will become obese and face obesity-related health issues in later life. Currently, over one-third of reproductive-aged women in the U.S. are obese \[body mass index (BMI) ≥ 30\]. Our research team has shown that we can improve birth weight outcomes in babies of obese women who start a weight-management intervention program at 14 to 15 weeks of their pregnancy (soon after their first prenatal visit). However, organogenesis and metabolic programming begin early in the first trimester, well before the first prenatal visit. Therefore, waiting to address mothers' weight, physical activity, and diet quality until the first prenatal visit is not optimal. Given the need to reach overweight and obese women prior to pregnancy, and the Institute of Medicine's (IOM's) recent recommendation, based on observational studies, that women should reach a healthy weight before conceiving, this randomized clinical trial will evaluate a comprehensive preconception weight loss program.
Key facts
- Study ID
- NCT02346162
- Run by
- Kaiser Permanente
- People needed
- 326
- Starts
- 2015-06-01
- Expected to finish
- 2019-06-21
- Last updated by the study team
- 2022-04-05
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Current Kaiser Permanente Northwest (KPNW) member
- Expects to be KPNW member for at least 2 more years
- Body Mass Index (BMI) ≥ 27
- Not currently pregnant
- Access to computer with Internet
- Completion of screening diet assessment
- English speaking
You may not qualify if…
- Taking medication (insulin or pills) for treatment of diabetes
- Gastrointestinal disease requiring special diet or medications (for example, ulcerative colitis, celiac sprue, phenylketonuria)
- Currently receiving treatment for cancer
- Renal disease (kidney disease requiring special diet or medication)
- History of bariatric surgery
- Use of prescription weight loss medications in the last three months
- Another household member already participating in the Prepare study
Where it is running
- Anna Edelmann — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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