Time to Move in Pregnancy Hyperglycemia (TtM)

April 28, 2026 updated by: Samantha Ehrlich, The University of Tennessee, Knoxville

The Time to Move Randomized Crossover Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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) or unmasked Dexcom G7 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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • The University of Tennessee Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Eligibility Criteria

  • Singleton, viable pregnancy with low suspicion for clinically significant abnormality or aneuploidy
  • Age 18-40 years (at recruitment)
  • Comfortable communicating with study staff in English and completing study surveys in English (i.e., no translator needed)
  • Identified as Gestational Glucose Intolerance (GGI) and a 3-hr 100g OGTT for Gestational Diabetes Mellitus (GDM) performed ≥ 24 weeks (i.e., GGI or GDM), or GDM by the one step procedure or a 1-hr 50-g glucose challenge test (GCT) ≥ 180 mg/dl performed ≥ 24 weeks

Identification of GGI 1-hr 50-g GCT (non-fasting), with plasma glucose at 1-hr ≥ 130 mg/dL

Identification of GDM by the two-step procedure

Identified as GGI, followed by a 3-hr 100g OGTT at ≥ 24 weeks after an overnight fast, with at least two of four plasma glucose values meeting or exceeding:

  • Fasting: 95 mg/dL
  • 1-hr: 180 mg/dL
  • 2-hr: 155 mg/dL
  • 3-hr: 140 mg/dl

Identification of GDM by the one-step procedure 75-g OGTT at ≥ 24 weeks after an overnight fast, with at least one plasma glucose value meeting or exceeding:

  • Fasting: 92 mg/dL
  • 1-hr: 180 mg/dL
  • 2-hr: 153 mg/dL

Identification of GDM by 1-hr 50-g GCT

1-hr 50-g GLT (non-fasting), with plasma glucose at 1-hr ≥ 180 mg/dL at ≥ 24 weeks

Exclusion Criteria

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Morning physical activity first
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
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).
Other: Afternoon/evening physical activity first
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGM glucose outcomes
Time Frame: Throughout the 11-day study period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of sleep
Time Frame: Throughout the 11-day study period
Self-reported length of each sleep period (in hours: minutes)
Throughout the 11-day study period
Sleep efficiency
Time Frame: Throughout the 11-day study period
Self-reported percentage of time spent asleep while in bed (0-100%), for each sleep period
Throughout the 11-day study period
Sleep quality
Time Frame: Throughout the 11-day study period
Self-reported quality of sleep (i.e., very poor, poor, fair, good, or very good), for each sleep period
Throughout the 11-day study period
Mood
Time Frame: Throughout the 11-day study period (i.e., on days assigned to physical activity)
Mood following physical activity, using the short version of the Multi-Dimensional Mood Questionnaire (MDMQ, with 15 items) which measures self-reported mood states (i.e., scores range from 15-90, with higher scores indicating better mood state).
Throughout the 11-day study period (i.e., on days assigned to physical activity)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Tennessee, Knoxville

Collaborators

University of Tennessee Graduate School of Medicine

Investigators

  • Principal Investigator: Samantha Ehrlich, PhD, The University of Tennessee, Knoxville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2023

Primary Completion (Actual)

November 24, 2025

Study Completion (Actual)

November 24, 2025

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TtM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes: all IPD that underlie published results and related data dictionaries available.

IPD Sharing Time Frame

Data will become available starting 6 months after publication and be available for 3 years.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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