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Morning physical activity first for High Blood Sugar (TtM Trial)
N/A
Recruiting
Led By Samantha Ehrlich, PhD
Research Sponsored by The University of Tennessee, Knoxville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-40 years (at recruitment)
Eligibility Criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the 11-day study period
Awards & highlights
TtM Trial Summary
This trial will study the effects of different times of physical activity on glucose levels in pregnant people with gestational diabetes or gestational glucose intolerance. It will also investigate if the timing of physical activity affects sleep
Who is the study for?
This trial is for pregnant individuals aged 18-40 with gestational diabetes or glucose intolerance, carrying a single baby without significant abnormalities. Participants must have been diagnosed after 24 weeks of pregnancy and be comfortable communicating in English without a translator.Check my eligibility
What is being tested?
The study tests the effects of timing on physical activity—specifically, whether walking or stepping for 30 minutes in the morning versus late afternoon/evening has different impacts on blood sugar levels, sleep quality, and mood during pregnancy.See study design
What are the potential side effects?
Since the intervention involves moderate intensity walking or stepping, potential side effects may include typical exercise-related discomforts such as muscle soreness or fatigue but are generally minimal.
TtM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old.
Select...
I meet the specific requirements needed to participate.
TtM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the 11-day study period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the 11-day study period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CGM glucose outcomes
Secondary outcome measures
Duration of sleep
Mood
Sleep efficiency
+1 moreTtM Trial Design
2Treatment groups
Experimental Treatment
Group I: Morning physical activity firstExperimental Treatment1 Intervention
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.
Group II: Afternoon/evening physical activity firstExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
The University of Tennessee, KnoxvilleLead Sponsor
83 Previous Clinical Trials
18,493 Total Patients Enrolled
University of Tennessee Graduate School of MedicineOTHER
12 Previous Clinical Trials
1,088 Total Patients Enrolled
Samantha Ehrlich, PhDPrincipal InvestigatorThe University of Tennessee, Knoxville
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