NCT04209348

The Project Wellness Pilot Feasibility Randomized Controlled Trial

Project Wellness: A Pilot Feasibility Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The University of Tennessee, Knoxville · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will also be followed through 12 months postpartum: Maternal weight and device-based and self-reported measures of physical activity will be assessed at 3, 6, 9 and 12 months postpartum, as well as the same infant size and anthropometric measurements assessed soon after delivery.

Conditions

• Diabetes, Gestational

Interventions

Type	Name	Description
BEHAVIORAL	Physical Activity Intervention	Motivational interviewing techniques helped participants set reasonable, specific, and achievable individual goals at each session: a duration (i.e., minutes) and frequency (i.e., days of the week) of walking or stepping, and potentially, a step count (i.e., a proxy for intensity). Individual goals often differed from the program goal in an effort to meet the participants 'where they are'.
OTHER	Wellness Education	The following topics were addressed: postpartum contraception, maternal immunizations, infant immunizations, car seat safety and planning for your hospital stay, and safe sleep and skin to skin. No information on PA was provided to the control group (i.e., neither encouragement for PA nor instructions to limit PA).

Timeline

• Start date: 2020-08-21
• Primary completion: 2021-09-21
• Completion: 2022-10-15
• First posted: 2019-12-24
• Last updated: 2024-02-12
• Results posted: 2024-02-12

Locations

1 site across 1 country: United States