GDMTtMNCT06125704
Time to Move in Pregnancy Hyperglycemia
A study testing Moderate intensity walking or stepping in people with GDM and Physical Activity, run by The University of Tennessee, Knoxville at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- GDM, Physical Activity, Hyperglycemia
- What is being tested?
- Moderate intensity walking or stepping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2023to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920
About this study
Official title: 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:
- 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.
- Explore the potential effects of the timing of PA on sleep and mood state.
Read the detailed description
Research participants will:
- 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.
- Wear a masked Dexcom G6 continuous glucose monitor (CGM) or unmasked Dexcom G7 CGM for the 11-day study period.
- 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).
- 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).
- 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).
- Conditions
- GDM, Physical Activity, Hyperglycemia, Glucose Intolerance, Circadian Rhythm, Exercise
- Being tested
- Moderate intensity walking or stepping
- Medical subject headings
- Motor Activity, Hyperglycemia, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity walking or steppingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Moderate intensity walking or stepping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Throughout the 11-day study period
Secondary outcomes (4)
Duration of sleep
Self-reported length of each sleep period (in hours: minutes)
Measured: Throughout the 11-day study period
Sleep efficiency
Self-reported percentage of time spent asleep while in bed (0-100%), for each sleep period
Measured: Throughout the 11-day study period
Sleep quality
Self-reported quality of sleep (i.e., very poor, poor, fair, good, or very good), for each sleep period
Measured: Throughout the 11-day study period
Mood
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).
Measured: Throughout the 11-day study period (i.e., on days assigned to physical activity)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start6 Dec 2023
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GDMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee Graduate School of Medicine
- Responsible party
- Principal investigator, Samantha Ehrlich, The University of Tennessee, Knoxville
- Investigators
- Samantha Ehrlich, PhD, Principal investigator, The University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125704
- Sponsor's protocol ID
- TtM
- Acronym
- TtM
- Status last verified
- Apr 2026
- First submitted
- 30 Oct 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: all IPD that underlie published results and related data dictionaries available.
Publications
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.
PubMed 41607684Ehrlich 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.
PubMed 41321483
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Time to Move Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06125704
- Acronym / sponsor ID
- TtM / TtM
- Conditions
- GDM, Physical Activity, Hyperglycemia, Glucose Intolerance, Circadian Rhythm, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- University of Tennessee Graduate School of Medicine
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled crossover trial of 36 pregnant individuals with gestational diabetes (GDM) or gestational glucose intolerance (GGI) will:
- 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.
- Explore the potential effects of the timing of PA on sleep and mood state.
Detailed description
Research participants will:
- 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.
- Wear a masked Dexcom G6 continuous glucose monitor (CGM) or unmasked Dexcom G7 CGM for the 11-day study period.
- 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).
- 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).
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning physical activity first | Other | Behavioral: Moderate intensity walking or steppingRandomized 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. |
| Afternoon/evening physical activity first | Other | Behavioral: Moderate intensity walking or steppingRandomized 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity walking or stepping30 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). | Behavioural | Afternoon/evening physical activity first, Morning physical activity first |
Primary outcome
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).
4 secondary outcomes
Duration of sleep
Time frame: Throughout the 11-day study period
Sleep efficiency
Time frame: Throughout the 11-day study period
Sleep quality
Time frame: Throughout the 11-day study period
Mood
Time frame: Throughout the 11-day study period (i.e., on days assigned to physical activity)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 41607684Ehrlich 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.
- Derived from this study: PubMed 41321483Ehrlich 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.
- Individual participant dataSharing planned: Yes. Yes: all IPD that underlie published results and related data dictionaries available.
Related trials for GDM
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Gestational Diabetes
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Ehrlich, PhD principal investigator
The University of Tennessee, Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity walking or stepping in people with GDM and Physical Activity, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CGM glucose outcomes (time frame: Throughout the 11-day study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06125704, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.