Program to reduce obesity and diabetes risks in women planning pregnancy
NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
This study tests a special online program to help young women who are overweight or obese lower their diabetes and obesity risks before getting pregnant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 403 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05674799 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) specifically designed for young women aged 18-39 who are overweight or obese and likely to conceive within 24 months. Participants will be randomized into either the NDPP-NextGen group, which involves a 12-month online group class, or a usual care control group that receives general health information. The study aims to assess the program's effects on pre-pregnancy blood sugar levels, weight gain during pregnancy, and the infant's fat tissue percentage at birth. The trial addresses the critical need for early interventions to break the cycle of obesity and diabetes across generations.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-39 with a BMI of 25 or higher who are interested in conceiving within the next 24 months.
Not a fit: Patients who are currently pregnant or have non-gestational diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the risks of obesity and diabetes for both mothers and their future children.
How similar studies have performed: Previous studies have shown that lifestyle interventions like the NDPP can be effective, but this specific approach targeting preconception is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Established patient at Denver Health or Atrium Health Wake Forest Baptist * Biologically female (inclusive of all gender identities) * Aged 18-39 years * English- or Spanish-speaking * BMI ≥25 kg/m2 (≥23 kg/m2 if Asian race) * Activities that lead to pregnancy in past 3 months * Interested in pregnancy within 24 months, including: 1. High interest (actively trying to conceive) 2. General interest (not actively trying but wanting to become pregnant in the foreseeable future) 3. Neutral interest (not planning pregnancy or using contraception for religious reasons) Exclusion Criteria: * Currently pregnant * Non-gestational diabetes (type 1, type 2) * Long-acting contraceptives (intrauterine device, implant, injection) with plans to continue for \>1 year (barrier \& short-acting hormonal contraception permitted given ease of discontinuing to facilitate pregnancy) * Medical procedures (e.g., tubal ligation, hysterectomy) or conditions that impede pregnancy * Documented infertility or unsuccessfully trying to conceive for ≥12 months * Prior participation in the NDPP * History of bariatric surgery * Use of GLP-1s in last year * Currently receiving clinical obesity treatment
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Katherine Sauder, PhD — Wake Forest University Health Sciences
- Study coordinator: Katherine A Sauder, PhD
- Email: Katherine.Sauder@advocatehealth.org
- Phone: 336-716-1280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.