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NCT Number: NCT05674799

NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks

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.

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Key information

Conditions

Overweight or Obesity Body Weight Body Weight Changes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Weight Gain Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases Weight Gain

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Katherine A Sauder, PhD

CONTACT

[email protected]

336-716-1280

Katherine A Sauder, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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)

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

Treatment and study plan

NDPP-NextGen

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.

Primary outcomes

  1. BMI in early pregnancy

    Time frame: 6-8 weeks gestation

    Height and weight will be measured and combined to report BMI at the post-conception research visit occurring at 6-8 weeks gestation.

Secondary outcomes

  1. Glycemia in early pregnancy

    Time frame: 6-8 weeks gestation

    Fasting glucose

Other outcomes

  1. Peri-conceptional BMI

    Time frame: Scale data will be pulled at 6-8 weeks gestation

    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.

  2. Rate and timing of gestational weight gain (GWG)

    Time frame: Scale data will be pulled weekly from time of conception up to delivery

    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.

  3. A1C in early pregnancy

    Time frame: 6-8 weeks gestation

    Fasted blood draw

  4. Glycemic status in early pregnancy

    Time frame: 6-8 weeks gestation

    Fasted blood draw to classify as normoglycemia, pre-diabetes, or type 2 diabetes at conception per American Diabetes Association definitions

  5. Rate of gestational diabetes (GDM) in mid-pregnancy

    Time frame: 28-32 weeks gestation

    Abstracted from medical records

  6. Diet quality

    Time frame: Baseline

    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).

  7. Diet quality

    Time frame: 6-8 weeks gestation

    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).

  8. Diet quality

    Time frame: 28-32 weeks gestation

    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).

  9. Physical Activity

    Time frame: Baseline

    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.

  10. Physical Activity

    Time frame: 6-8 weeks gestation

    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.

  11. Physical Activity

    Time frame: 28-32 weeks gestation

    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.

  12. Smoking frequency

    Time frame: Baseline

    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).

  13. Smoking frequency

    Time frame: 6-8 weeks gestation

    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).

  14. Smoking frequency

    Time frame: 28-32 weeks gestation

    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).

  15. Weight management self-efficacy

    Time frame: Baseline

    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).

  16. Weight management self-efficacy

    Time frame: 6-8 weeks gestation

    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).

  17. Weight management self-efficacy

    Time frame: 28-32 weeks gestation

    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).

  18. Rate of miscarriages

    Time frame: Through study completion, an average of 2 years

    Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.

  19. Rate of stillbirths

    Time frame: Through study completion, an average of 2 years

    Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.

  20. Rate of fetal deaths

    Time frame: Through study completion, an average of 2 years

    Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.

  21. Rate of pre-term births

    Time frame: Through study completion, an average of 2 years

    Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.

  22. Rate of pregnancy-induced hypertension

    Time frame: Through study completion, an average of 2 years

    Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.

  23. Rate of pre-eclampsia

    Time frame: Through study completion, an average of 2 years

    Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.

  24. Rate of eclampsia

    Time frame: Through study completion, an average of 2 years

    Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.

  25. Rate of cesarean delivery

    Time frame: Through study completion, an average of 2 years

    Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.

  26. Neonatal adiposity

    Time frame: At birth

    Percent of total mass that is fat mass, as measured by air displacement plethysmography using the PEA POD device

  27. Maternal adiposity

    Time frame: Baseline

    Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device

  28. Maternal adiposity

    Time frame: 6-8 weeks gestation

    Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device

  29. Infant birthweight

    Time frame: At birth

    Medical records

  30. Rate of macrosomia

    Time frame: At birth

    Infant birthweight >4000g. Abstracted from medical records

  31. Rate of infants classified as large for gestational age (LGA)

    Time frame: At birth

    Infant birthweight >90th percentile. Abstracted from medical records

  32. Rate of infants classified as small for gestational age

    Time frame: At birth

    Infant birthweight <10th percentile. Abstracted from medical records

  33. Rate of infants with low birthweight

    Time frame: At birth

    Infant birthweight <2500g. Abstracted from medical records

  34. Instances of fetal growth restriction

    Time frame: At birth

    Abstracted from medical records

  35. Rate of infant birth trauma

    Time frame: At birth

    Abstracted from medical records

  36. Rate of infant shoulder dystocia

    Time frame: At birth

    Abstracted from medical records

  37. Rate of infant intensive care admission

    Time frame: At birth

    Abstracted from medical records

  38. Rate of infants with a major congenital anomaly

    Time frame: At birth

    Abstracted from medical records

  39. Rate of neonatal hypoglycemia requiring treatment

    Time frame: At birth

    Abstracted from medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine A Sauder, PhD

CONTACT

[email protected]

336-716-1280

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jan 6, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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