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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 is a NA study that has completed, run by The University of Tennessee, Knoxville. The registered enrollment target is 20 participants.

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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.

Interventions

  • BEHAVIORAL Physical Activity Intervention
  • OTHER Wellness Education

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-08-21
Est. Completion 2022-10-15
Phase NA

What the Registry Record Tells You About NCT04209348

The ClinicalTrials.gov registry entry for NCT04209348 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Tennessee, Knoxville, which has 81 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Physical Activity Intervention is the first listed.

NCT04209348 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.