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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 below

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I am between 18 and 40 years old.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the 11-day study period for reporting.

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 more

TtM 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Tennessee, KnoxvilleLead Sponsor

83 Previous Clinical Trials

18,523 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this research study?

"Indeed, as per the details provided on clinicaltrials.gov, this research study is actively seeking eligible participants. The trial was initially posted on December 6th, 2023, and recently updated on December 23rd, 2023. It aims to recruit a total of 36 patients from one designated site."

Answered by AI

Are there any available openings for participants in this ongoing research study?

"Indeed, according to the information provided by clinicaltrials.gov, this trial is currently in search of eligible participants. The initial posting for this study occurred on December 6th, 2023 and the most recent update was made on December 23rd, 2023."

Answered by AI