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NCT05674799 · ClinicalTrials.gov registry record · NA
NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
A NA study of Overweight or Obesity, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- NA
- Development phase
- 403
- Enrollment target
- 1
- Study location
NCT05674799: Recruiting NA study of Overweight or Obesity, sponsored by Wake Forest University Health Sciences.
NCT05674799 is a NA study of Overweight or Obesity that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 403 participants, below the 31,700-participant average among 32 other Overweight or Obesity trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05674799, a NA study of Overweight or Obesity, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 403 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
Height and weight will be measured and combined to report BMI at the post-conception research visit occurring at 6-8 weeks gestation.
Conditions Studied
Interventions
- BEHAVIORAL NDPP-NextGen
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 403 participants |
| Start Date | 2023-04-08 |
| Est. Completion | 2028-05-31 |
| Phase | NA |
What NCT05674799 shows while recruiting
NCT05674799 is an interventional study that assigns participants to a tested intervention. The registered 403 participants enrollment target is mid-sized for trials with a published cap, below the 31,700-participant average among 32 other Overweight or Obesity trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Overweight or Obesity appearing as the primary indexed condition, and to 1 intervention - of which NDPP-NextGen is the first listed.
NCT05674799 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05674799 about?
NCT05674799 is a clinical study titled "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 likel...
What is the current status of trial NCT05674799?
This trial is currently recruiting. It is a NA study. The enrollment target is 403 participants. The study started on 2023-04-08. Estimated completion is 2028-05-31.
What conditions does trial NCT05674799 study?
This clinical trial studies the following conditions: Overweight or Obesity.
What interventions are being tested in trial NCT05674799?
The interventions under investigation include: NDPP-NextGen (BEHAVIORAL).
Who is sponsoring clinical trial NCT05674799?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05674799 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05674799's enrollment target sits among peer trials
403 11th of 32 higher than 22 of 32 other Overweight or Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overweight or Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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