An interventional study of NDPP-NextGen in Overweight or Obesity, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Prevention
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:
All participants will complete up to 4 research visits: baseline, conception, mid-pregnancy, and delivery. These visits will include:
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.
Intrauterine exposure to maternal overweight/obesity and diabetes transmits risks to offspring, triggering a disease cycle across generations. Over half of US women have overweight or obesity at conception and \~10% of pregnancies are affected by diabetes, exposing nearly 2 million infants each year. Prenatal lifestyle interventions are well-studied, yet begin too late to impact the critical period of conception and early pregnancy. Starting interventions before conception may be key to halting the disease cycle. However, prior research is limited, often lacks offspring outcomes (especially sensitive measures), includes mostly white and affluent participants, and has been challenged to identify women likely to conceive soon. Further research is needed on scalable strategies to improve maternal-child health during preconception and early pregnancy, especially for racial and ethnic minority or low-income women with disparately high prevalence of obesity and diabetes. The National Diabetes Prevention Program (NDPP) is a widely-disseminated lifestyle intervention to reduce weight and glycemia that has untapped potential to improve maternal-child health. From an implementation science perspective, the NDPP has greater potential impact than new interventions that are unlikely to be scaled up, even if efficacious. Denver Health has delivered the NDPP to >1600 adults since 2013, including >350 young women. Preliminary data shows that the NDPP may reduce peri-conceptional risks in diverse, low-income women. While limited engagement by younger women in the NDPP is a concern, strategies to increase engagement (motivational "pre-sessions", remote delivery, and classes specially for young women) are promising. For example, young women attended the 12-month NDPP for 64 days longer after receiving a pre-session, with 2.0 kg/m2 lower preconception BMI and 0.4% lower A1c in early pregnancy, than controls. To plan a preconception trial, the investigators developed a 2-step screening protocol to 1) use electronic health record data (e.g., contraceptive use) to identify women who are more likely to conceive by 24 months (36% vs. 13% for all young women), and 2) outreach to confirm current family planning to expect ≥60% conception, based on preliminary data showing that 73% conceived by 24 months if they endorsed intention to conceive or being sexual active without highly effective contraception. The investigators propose a randomized controlled trial of an enhanced NDPP (NDPP-NextGen) initiated before pregnancy to evaluate effects on maternal-child health. They will recruit 360 women aged 18-39 years with overweight/obesity who are likely to conceive within 24 months. Women will be randomized to NDPP- NextGen or a usual care control group. The specific aims are 1) to assess effects of NDPP-NextGen on peri- conceptional BMI and prenatal glycemia; 2) to assess effects of NDPP-NextGen on gestational weight gain and behavioral outcomes in pregnancy; and 3) to explore effects of NDPP-NextGen on neonatal adiposity and explanatory mechanisms.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 403 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Interested in pregnancy within 24 months, including:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women in the Healthy Lifestyle group will be invited to attend the online NDPP-NextGen class which will cover how to eat healthy, be active, and lose weight before getting pregnant. The classes will be led by a trained Lifestyle Coach. Each class lasts about 1 hour. Classes initially meet about once a week (for the first 6 months), then twice a month (for the next 3 months), and then once a month (for the last 3 months). Classes will meet virtually through video-conference. Lifestyle coaches will also call participants in between classes to discuss how participants are doing, answer questions, and provide reminders for upcoming classes. Prior to the first class, women will also participate in a "pre-session" designed to increase NDPP engagement via discussion of diabetes risks and treatment options (i.e., clarify relevance) and motivational interviewing to resolve barriers.
Behavioral: NDPP-NextGen
Women in the Healthy Women group get a packet of information standardly given in OB clinics about how to be healthy before, during and after pregnancy.
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.
BMI in early pregnancy
Height and weight will be measured and combined to report BMI at the post-conception research visit occurring at 6-8 weeks gestation.
Time frame: 6-8 weeks gestation
Glycemia in early pregnancy
Fasting glucose
Time frame: 6-8 weeks gestation
Peri-conceptional BMI
BMI at conception will be collected with cellular-enabled scales (BodyTrace®) that facilitate weekly at-home measurement to obtain weight closer to conception. Scales automatically transfer weights to a HIPAA-compliant database that is accessible only by the research team. Research staff will monitor for ≥1 transmitted weight each week, and provide prompts and assistance as needed. Investigators will average the two weights from before/after estimated date of conception to calculate approximate peri-conceptional BMI.
Time frame: Scale data will be pulled at 6-8 weeks gestation
Rate and timing of gestational weight gain (GWG)
Primary method of collection will be through the use of home cellular scale weights. We will also abstract all weights from prenatal medical records as a secondary method to assess GWG. GWG will be analyzed as the difference from conception to delivery and gain within each trimester, adjusting for BMI at conception. We will also analyze GWG trajectories using linear mixed models with repeated measures drawn from the home scales and/or prenatal clinical weights. We will then classify women as having inadequate, appropriate, or excessive GWG based on BMI category, and analyze using logistic regression, again adjusting for BMI at conception.
Time frame: Scale data will be pulled weekly from time of conception up to delivery
A1C in early pregnancy
Fasted blood draw
Time frame: 6-8 weeks gestation
Glycemic status in early pregnancy
Fasted blood draw to classify as normoglycemia, pre-diabetes, or type 2 diabetes at conception per American Diabetes Association definitions
Time frame: 6-8 weeks gestation
Rate of gestational diabetes (GDM) in mid-pregnancy
Abstracted from medical records
Time frame: 28-32 weeks gestation
Diet quality
Diet will be assessed with 24-hour dietary recalls using the Automated Self-Administered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars).
Time frame: Baseline
Diet quality
Diet will be assessed with 24-hour dietary recalls using the Automated Self-Administered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars).
Time frame: 6-8 weeks gestation
Diet quality
Diet will be assessed with 24-hour dietary recalls using the Automated Self-Administered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars).
Time frame: 28-32 weeks gestation
Physical Activity
Assessed using the Pregnancy Physical Activity Questionnaire (PPAQ), while adjusting metabolic task equivalents for pregnancy. Investigators will calculate average activity intensity (sedentary to vigorous) and type (household, occupational, exercise, transportation) over the past 3 months at each collection point. Physical activity outcomes include daily minutes of sedentary, light, moderate, vigorous, household, occupational, exercise, transportation activity.
Time frame: Baseline
Physical Activity
Assessed using the Pregnancy Physical Activity Questionnaire (PPAQ), while adjusting metabolic task equivalents for pregnancy. Investigators will calculate average activity intensity (sedentary to vigorous) and type (household, occupational, exercise, transportation) over the past 3 months at each collection point. Physical activity outcomes include daily minutes of sedentary, light, moderate, vigorous, household, occupational, exercise, transportation activity.
Time frame: 6-8 weeks gestation
Physical Activity
Assessed using the Pregnancy Physical Activity Questionnaire (PPAQ), while adjusting metabolic task equivalents for pregnancy. Investigators will calculate average activity intensity (sedentary to vigorous) and type (household, occupational, exercise, transportation) over the past 3 months at each collection point. Physical activity outcomes include daily minutes of sedentary, light, moderate, vigorous, household, occupational, exercise, transportation activity.
Time frame: 28-32 weeks gestation
Smoking frequency
Participants will be asked about lifetime and recent (past 6 months) usage of cigarette and marijuana. Smoking outcomes include any smoking in pregnancy (binary) and number of cigarettes (total, trimester-specific).
Time frame: Baseline
Smoking frequency
Participants will be asked about lifetime and recent (past 6 months) usage of cigarette and marijuana. Smoking outcomes include any smoking in pregnancy (binary) and number of cigarettes (total, trimester-specific).
Time frame: 6-8 weeks gestation
Smoking frequency
Participants will be asked about lifetime and recent (past 6 months) usage of cigarette and marijuana. Smoking outcomes include any smoking in pregnancy (binary) and number of cigarettes (total, trimester-specific).
Time frame: 28-32 weeks gestation
Weight management self-efficacy
Assessed with the Weight Efficacy Lifestyle Questionnaire-Short Form (WEL-SF) on current confidence with weight management around negative emotions, availability, social pressure, physical discomfort, and positive activities. Weight management self-efficacy is a single score derived from the 8-item short form (range 0-72).
Time frame: Baseline
Weight management self-efficacy
Assessed with the Weight Efficacy Lifestyle Questionnaire-Short Form (WEL-SF) on current confidence with weight management around negative emotions, availability, social pressure, physical discomfort, and positive activities. Weight management self-efficacy is a single score derived from the 8-item short form (range 0-72).
Time frame: 6-8 weeks gestation
Weight management self-efficacy
Assessed with the Weight Efficacy Lifestyle Questionnaire-Short Form (WEL-SF) on current confidence with weight management around negative emotions, availability, social pressure, physical discomfort, and positive activities. Weight management self-efficacy is a single score derived from the 8-item short form (range 0-72).
Time frame: 28-32 weeks gestation
Rate of miscarriages
Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.
Time frame: Through study completion, an average of 2 years
Rate of stillbirths
Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.
Time frame: Through study completion, an average of 2 years
Rate of fetal deaths
Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.
Time frame: Through study completion, an average of 2 years
Rate of pre-term births
Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.
Time frame: Through study completion, an average of 2 years
Rate of pregnancy-induced hypertension
Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.
Time frame: Through study completion, an average of 2 years
Rate of pre-eclampsia
Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.
Time frame: Through study completion, an average of 2 years
Rate of eclampsia
Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.
Time frame: Through study completion, an average of 2 years
Rate of cesarean delivery
Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.
Time frame: Through study completion, an average of 2 years
Neonatal adiposity
Percent of total mass that is fat mass, as measured by air displacement plethysmography using the PEA POD device
Time frame: At birth
Maternal adiposity
Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device
Time frame: Baseline
Maternal adiposity
Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device
Time frame: 6-8 weeks gestation
Infant birthweight
Medical records
Time frame: At birth
Rate of macrosomia
Infant birthweight \>4000g. Abstracted from medical records
Time frame: At birth
Rate of infants classified as large for gestational age (LGA)
Infant birthweight \>90th percentile. Abstracted from medical records
Time frame: At birth
Rate of infants classified as small for gestational age
Infant birthweight \<10th percentile. Abstracted from medical records
Time frame: At birth
Rate of infants with low birthweight
Infant birthweight \<2500g. Abstracted from medical records
Time frame: At birth
Instances of fetal growth restriction
Abstracted from medical records
Time frame: At birth
Rate of infant birth trauma
Abstracted from medical records
Time frame: At birth
Rate of infant shoulder dystocia
Abstracted from medical records
Time frame: At birth
Rate of infant intensive care admission
Abstracted from medical records
Time frame: At birth
Rate of infants with a major congenital anomaly
Abstracted from medical records
Time frame: At birth
Rate of neonatal hypoglycemia requiring treatment
Abstracted from medical records
Time frame: At birth
Plan to share: No
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