New study aims to break the cycle of obesity and diabetes in young women and their babies
NCT ID NCT05674799
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) designed for young women aged 18-39 with overweight or obesity who may become pregnant within two years. Participants will either join online group classes for 12 months or receive standard health information. Researchers will measure blood sugar, weight gain during pregnancy, and the baby's body fat at birth to see if the program improves health for both mother and child.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 403 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 39 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Wake Forest University Health Sciences
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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