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

NCT05674799 | Recruiting DMC

• 2 other identifiers: IRB001084291R01DK130900-01A1
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMI
2. 2.to assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancy
3. 3.to explore effects of NDPP-NextGen on infant's percentage of fat tissue at birth
4. 4.Questionnaires about health, diet, activity, smoking, self-confidence, and depression
5. 5.Body size measurements
6. 6.Fasted blood draws

Conditions

Overweight or Obesity

Keywords

Body mass index; Pre-conception; Diabetes Mellitus; Diet; Gestational diabetes; Neonatal adiposity; Maternal and Child Health; Overweight; Obese; Pregnancy; Randomized Control Trial; Weight; adverse maternal outcomes; Diabetes Prevention Program; glucose; gestational weight gain; lifestyle intervention; usual care; remote delivery; young women

Outcome Measures

Primary Outcomes (1)

• 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.

  6-8 weeks gestation

Secondary Outcomes (1)

• Glycemia in early pregnancy

  6-8 weeks gestation

Other Outcomes (39)

• Peri-conceptional BMI

  Scale data will be pulled at 6-8 weeks gestation

• Rate and timing of gestational weight gain (GWG)

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

• A1C in early pregnancy

  6-8 weeks gestation

Study Arms (2)

Healthy Lifestyle

EXPERIMENTAL

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

Healthy Women

NO INTERVENTION

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.

Interventions

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.

Healthy Lifestyle

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You 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 may not qualify 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus; Diabetes, Gestational; Body Weight; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Weight Gain; Body Weight Changes

Study Officials

• Katherine Sauder, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine A Sauder, PhD

CONTACT

336-716-1280; Katherine.Sauder@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Professional research assistants who will be collecting data and conducting the research visits will not be told if participants are in the treatment or control group, although this may be disclosed by the participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to a 12-month lifestyle intervention promoting healthy diet and activity to reduce body weight (NDPP-NextGen), or usual care

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: January 6, 2023
• Study Start: April 8, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)