Effect of Increased Physical Activity and Stopping Evening Snacking in Metabolic Health in Youth With Prediabetes

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06782906
Status
Recruiting
Apply to this trial

Conditions

  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • ≥10,000 daily steps (≥5 days/week) and stopping evening snacking — BEHAVIORAL
    Participants in the intervention arm will be asked to perform ≥10,000 daily steps (≥5 days/week) and omit evening snacking after 8:00 p.m.

Study Details

Non-healthy eating habits and a lack of exercise contribute to prediabetes and type 2 diabetes (T2D). Evening snacking is linked to abnormal weight gain in adults and healthy adolescents. Most adolescents do not get enough exercise. This study aims to look at the benefits of more exercise and stopping evening snacking in youth with prediabetes. The study lasts 8 weeks, and participants will be randomly assigned to either an intervention group or a standard of care group.

Key Dates

Start date
May 13, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Arm
    Participants in the intervention arm will be asked to perform ≥10,000 daily steps (≥5 days/week) and omit evening snacking after 8:00 p.m.
  • No Intervention: Standard of Care Arm
    Participants in the standard of care arm will be asked to follow recommendations of their physician.

Primary Outcome Measure

Insulin sensitivity index for glucose disposal (ISI [Gly]) during oral glucose tolerance test [ Time Frame: At week 9-10 following completion of 8 weeks of intervention period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's Hospital / Children's Nutrition Research Center / Baylor College of MedicineHoustonTexas77030
Mustafa Tosur, MD
[email protected]
832-822-3780

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By research site
Texas Children's Hospital / Children's Nutrition Research Center / Baylor College of Medicine· Houston, TX

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