Time to Move in Pregnancy Hyperglycemia

NCT06125704 | Completed

• 1 other identifier: TtM
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled crossover trial of 36 pregnant individuals with gestational diabetes (GDM) or gestational glucose intolerance (GGI) will:

1. 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. 2.Explore the potential effects of the timing of PA on sleep and mood state.

Conditions

GDM; Hyperglycemia; Physical Activity; Glucose Intolerance; Circadian Rhythm; Exercise

Outcome Measures

Primary Outcomes (1)

• CGM glucose outcomes

  Glucose outcome measures include: 24-hour glucose and coefficient of variation, daytime glucose, nighttime glucose, pre-breakfast area under the glucose curve (AUC; calculated for the 120 minutes prior to the start of breakfast), and all post-meal AUCs (calculated for the 120 minutes after the start of the breakfast, lunch and dinner).

  Throughout the 11-day study period

Secondary Outcomes (4)

• Duration of sleep

  Throughout the 11-day study period

• Sleep efficiency

  Throughout the 11-day study period

• Sleep quality

  Throughout the 11-day study period

• Mood

  Throughout the 11-day study period (i.e., on days assigned to physical activity)

Study Arms (2)

Morning physical activity first

OTHER

Randomized to complete 30 minute of moderate intensity walking or stepping in the morning (i.e., between 5am-9am, within 30-40 minutes of starting breakfast) on days 4 and 5, and 30 minute of moderate intensity walking or stepping in the late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on days 9 and 10.

Behavioral: Moderate intensity walking or stepping

Afternoon/evening physical activity first

OTHER

Randomized to complete 30 minute of moderate intensity walking or stepping in the late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on days 4 and 5, and 30 minute of moderate intensity walking or stepping in the morning (i.e., between 5am-9am, within 30-40 minutes of starting breakfast) on days 9 and 10.

Behavioral: Moderate intensity walking or stepping

Interventions

Moderate intensity walking or stepping BEHAVIORAL

30 minutes of moderate intensity walking or stepping (i.e., at a pace of approximately 100 steps per minute), varied by time of day it is performed: morning (i.e., between 5am-9am, within 30-40 minutes of starting breakfast) versus late afternoon/evening (i.e., between 4pm-8pm, within 30-40 minutes of dinner).

Afternoon/evening physical activity first; Morning physical activity first

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Indication that physical activity is or should be limited in the current pregnancy
• Previously diagnosed with diabetes (i.e., Type I or Type II diabetes) outside of pregnancy
• Current use of daily medications known to alter insulin resistance and/or metabolic profiles (e.g., metformin, corticosteroids, anti-psychotics)
• Current use of medication for polycystic ovarian syndrome (PCOS) (i.e., history of PCOS okay as long as she is not currently taking medication for PCOS)
• Condition or circumstance that would preclude their ability to follow a strict, time-based study protocol (e.g., psychiatric illness).

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• University of Tennessee Graduate School of Medicine: collaborator

Study Sites (1)

The University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Related Publications (2)

• Ehrlich SF, Hallenbeck BR, Lewis J, Yousefi F, Miller JI, Zite NB, Fortner KB, Schoutko WW, Crouter SE, Raynor H, Maples JM. Rationale and protocol for the Time to Move Randomized Crossover Trial: morning versus evening time physical activity and CGM-assessed glucose levels in individuals with pregnancy hyperglycemia. Front Clin Diabetes Healthc. 2026 Jan 13;6:1709683. doi: 10.3389/fcdhc.2025.1709683. eCollection 2025.

  PMID: 41607684 DERIVED

• Ehrlich SF, Hallenbeck BR, Zite NB, Fortner KB, Paudel A, Raynor HA, Crouter SE, Maples JM. A Randomized Controlled Pilot Trial of a Behavioral Physical Activity Intervention for Pregnancy Hyperglycemia. J Pregnancy. 2025 Nov 20;2025:7485092. doi: 10.1155/jp/7485092. eCollection 2025.

  PMID: 41321483 DERIVED

MeSH Terms

Conditions

Motor Activity; Hyperglycemia; Glucose Intolerance

Condition Hierarchy (Ancestors)

Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Samantha Ehrlich, PhD

  The University of Tennessee, Knoxville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocaite Professor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 9, 2023
• Study Start: December 6, 2023
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available starting 6 months after publication and be available for 3 years.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact Dr. Samantha Ehrlich at sehrlic1@utk.edu

Locations

US (1)