RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-08
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05674799

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 39 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Established patient at Denver Health or Atrium Health Wake Forest Baptist
  2. * Biologically female (inclusive of all gender identities)
  3. * Aged 18-39 years
  4. * English- or Spanish-speaking
  5. * BMI ≥25 kg/m2 (≥23 kg/m2 if Asian race)
  6. * Activities that lead to pregnancy in past 3 months
  7. * Interested in pregnancy within 24 months, including:
  8. 1. High interest (actively trying to conceive)
  9. 2. General interest (not actively trying but wanting to become pregnant in the foreseeable future)
  10. 3. Neutral interest (not planning pregnancy or using contraception for religious reasons)
  1. * Currently pregnant
  2. * Non-gestational diabetes (type 1, type 2)
  3. * 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)
  4. * Medical procedures (e.g., tubal ligation, hysterectomy) or conditions that impede pregnancy (e.g., polycystic ovarian syndrome)
  5. * Documented infertility or unsuccessfully trying to conceive for ≥12 months
  6. * Prior participation in the NDPP

Contacts and Locations

Study Contact

Katherine A Sauder, PhD
CONTACT
336-716-1280
ksauder@wakehealth.edu

Principal Investigator

Katherine Sauder, PhD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Katherine Sauder, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-08
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2023-04-08
Study Completion Date2028-05-31

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Overweight or Obesity