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NCT04209348 · ClinicalTrials.gov registry record · NA
The Project Wellness Pilot Feasibility Randomized Controlled Trial
A NA study, sponsored by The University of Tennessee, Knoxville.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT04209348: Completed NA study, sponsored by The University of Tennessee, Knoxville.
NCT04209348 is a NA study that has completed, run by The University of Tennessee, Knoxville. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04209348, a NA study, has completed, sponsored by The University of Tennessee, Knoxville.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
This pilot feasibility randomized controlled trial will be conducted among women at risk for or diagnosed with gestational diabetes (GDM) at the University of Tennessee Medical Center Knoxville (UTMC). The trial will be called Project Wellness. It will compare a physical activity (behavior change) intervention (i.e., walking/stepping in place) versus a general wellness intervention (e.g., health education focusing on immunizations, contraceptive options following delivery, etc.) on physical activity levels, maternal glycemic profile in the third trimester, and infant size and anthropometric measurements soon after birth (i.e., weight, length, circumference, skinfolds). It is hypothesized that the physical activity intervention will increase physical activity levels, and improve maternal glycemic profile and infant anthropometric measures at birth. It is also hypothesized that maternal glycemic profile in the third trimester will be associated with infant anthropometric measurements at birth.
Primary Outcome
Change in self-reported moderate to vigorous intensity walking or running activity within the sports \& exercise domain, as assessed by Pregnancy Physical Activity Questionnaire (i.e., measure at follow-up study visit minus the measure at baseline study visit). Reference: Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and Validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sports Exerc. 2004;36(10):1750-1760.
Interventions
- BEHAVIORAL Physical Activity Intervention
- OTHER Wellness Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-08-21 |
| Est. Completion | 2022-10-15 |
| Phase | NA |
What the finished NCT04209348 record still lists
NCT04209348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Physical Activity Intervention is the first listed.
NCT04209348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04209348 about?
NCT04209348 is a clinical study titled "The Project Wellness Pilot Feasibility Randomized Controlled Trial". This pilot feasibility randomized controlled trial will be conducted among women at risk for or diagnosed with gestational diabetes (GDM) at the University of Tennessee Medical Center Knoxville (UTMC). The trial will be called Project Wellness. It will compare a physical activity (behavior change) i...
What is the current status of trial NCT04209348?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2020-08-21. Estimated completion is 2022-10-15.
What interventions are being tested in trial NCT04209348?
The interventions under investigation include: Physical Activity Intervention (BEHAVIORAL), Wellness Education (OTHER).
Who is sponsoring clinical trial NCT04209348?
This trial is sponsored by The University of Tennessee, Knoxville, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04209348's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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