Program to reduce obesity and diabetes risks in women planning pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.