GDM Clinical Trial - Time to Move in Pregnancy Hyperglycemia

Status Recruiting

Clinical Trial Summary

This randomized controlled crossover trial of 36 pregnant individuals with gestational diabetes (GDM) or gestational glucose intolerance (GGI) will: 1. Determine the effects of physical activity (PA) timing, specifically 30 minutes of moderate intensity walking or stepping in the morning (between 5am-9am, within 30-40 minutes of starting breakfast), versus late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on glucose across the 24-hour cycle. 2. Explore the potential effects of the timing of PA on sleep and mood state.

Clinical Trial Description

Research participants will: 1. Exercise according to a schedule provided by the study for an 11-day period. They will complete either no exercise or 30 minutes of walking/stepping (e.g., stepping in place or around the house when walking outside is not an option or not an attractive option) on specifically assigned days, at specifically assigned times of day. 2. Wear a masked Dexcom G6 continuous glucose monitor (CGM) for the 11-day study period. 3. Wear a masked physical activity (PA) monitor watch (ActiGraph CentrePoint Insight Watch) on the non-dominant wrist for the 11-day study period (all day and all night). 4. Take pictures of all of food and drinks consumed, at the start and end (showing food and drink not eaten) of all eating occasions. Participants will use their phones to upload photos to a study website for the entire 11-day study period. Participants will also complete 24-hour dietary recall phone calls for 3 of the 11 study days (i.e., for 1 morning PA day, 1 late afternoon/evening PA day, and 1 no PA day, with the days randomly selected). 5. Complete electronic REDCap surveys, including daily surveys that assess: when (i.e., the exact times) they started eating breakfast, lunch, and dinner that day; when (e.g., the exact times) they went to bed and fell asleep for the night and woke up and got out of bed the next morning, and questions on the quality of their sleep; adverse events and issues with the study equipment (e.g., CGM); and mood state following PA (on days assigned 30 minutes of walking/stepping). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06125704
Study type	Interventional
Source	The University of Tennessee, Knoxville
Contact	Samantha Ehrlich, PhD
Phone	?(865) 315-7880?
Email	sehrlic1@utk.edu
Status	Recruiting
Phase	N/A
Start date	December 6, 2023
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05661799` - Persistence of Physical Activity in People With Type 2 Diabetes Over Time.	N/A
Recruiting	`NCT03903874` - Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt	N/A
Recruiting	`NCT03662438` - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)	N/A
Withdrawn	`NCT04540523` - Home-Based Exergaming Intervention	N/A
Recruiting	`NCT03250000` - Changes in Microcirculation and Functional Status During Exacerbation of COPD	N/A
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT03430648` - Is Tau Protein Linked to Mobility Function?
Completed	`NCT05019482` - Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time	N/A
Completed	`NCT03253406` - Health Wearables and College Student Health	N/A
Not yet recruiting	`NCT05985460` - A Very Brief Intervention to Increase the Intention to Practice Physical Activity	N/A
Completed	`NCT03700736` - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups	N/A
Completed	`NCT03380143` - Whole-of-Community Youth Population Physical Activity	N/A
Completed	`NCT03170921` - Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals	N/A
Completed	`NCT04973813` - Active Choice Intervention About Physical Activity for Physically Inactive Adults	N/A
Completed	`NCT03982095` - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Completed	`NCT03271112` - Frailty Prevention in Elders From Reunion Island	N/A
Completed	`NCT05670223` - Healthy Activities Improve Lives	N/A
Completed	`NCT04894929` - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement	N/A
Recruiting	`NCT04578067` - Empowering Immigrant Women for Active and Healthy Lifestyle	N/A
Completed	`NCT03297567` - Physical Therapy Guidelines For Hospitalized Elderly	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Time to Move in Pregnancy Hyperglycemia — TtM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms