What this study is
The goal of this clinical trial is to test an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) that is tailored to young women in childbearing years. The investigators will recruit 360 women aged 18-39 years with overweight/obesity who are not currently pregnant, but likely to conceive within 24 months. Women will be randomized to NDPP-NextGen or a usual care control group. The NDPP-NextGen group will participate in the adapted NDPP online group class across 12 months, and the control group will get a packet of information about how to be healthy before, during and after pregnancy.
The main goals of the study are:
1. to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMI 2. to assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancy 3. to explore effects of NDPP-NextGen on infant's percentage of fat tissue at birth
All participants will complete up to 4 research visits: baseline, conception, mid-pregnancy, and delivery. These visits will include:
1. Questionnaires about health, diet, activity, smoking, self-confidence, and depression 2. Body size measurements 3. Fasted blood draws
Participants will also be asked to weigh themselves weekly using home scales that are connected to the research database. At the delivery visit, investigators will measure the baby's body size and collect a cord blood sample.
What's being tested
- NDPP-NextGen
Intervention · BEHAVIORAL
NDPP-NextGen will incorporate content on preconception/prenatal health into standard NDPP. Participants will be encouraged to make sustainable improvements in diet and activity, but without pre-set goals to better accommodate diverse, low-income populations. Upon pregnancy, recommendations will adjust to support appropriate GWG, breastfeeding, and postpartum weight loss. We will provide education on diet and activity during pregnancy/postpartum, including sufficient energy intake and exercise safety to support the growing fetus. NDPP-NextGen will include 3 strategies to better engage young women. (1) "Pre-sessions" to increase knowledge of diabetes risks, self-efficacy, and readiness to change using motivational interviewing techniques. (2) Delivering classes remotely (via phone- and video-conference) to facilitate participation regardless of inclement weather, dependent care, illness, transportation, etc. (3) Offering classes specially for young women to increase personal relevance.
Study details
- Sponsor
- Wake Forest University Health Sciences
- Conditions
- Overweight or Obesity
- Enrolling
- 403 people
- Starts
- 2023-04-08
- Est. completion
- 2028-05-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 39 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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:; High interest (actively trying to conceive); General interest (not actively trying but wanting to become pregnant in the foreseeable future); Neutral interest (not planning pregnancy or using contraception for religious reasons)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWake Forest University Health Sciences
Winston-Salem, North Carolina, United States
- Katherine A Sauder, PhD · Contact336-716-1280ksauder@wakehealth.edu
- Katherine A Sauder, PhD · Principal investigator
Recruiting
Study team
Sponsor
Wake Forest University Health Sciences
Study ID IRB00108429
Principal investigator
Katherine Sauder, PhD
Wake Forest University Health Sciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.