Recruiting

Physical Activity

Sponsor:

Baylor College of Medicine

Code:

NCT06782906

Conditions

Prediabetes

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

≥10,000 daily steps (≥5 days/week) and stopping evening snacking

Study Details

Brief summary:

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.

Conditions

Prediabetes

Study ID

NCT06782906

Start date

May 13, 2025

Status verified date

Jun, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 12-18 years of age
2. Having a diagnosis of prediabetes
3. Engaging in frequent evening snacking
4. Inadequate physical activity

Exclusion Criteria:

1. Diagnosis of diabetes
2. Significant history of chronic disease
3. Evidence of significant liver or kidney disease;
4. Any hormone replacement therapy; and
5. Pregnancy.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

≥10,000 daily steps (≥5 days/week) and stopping evening snacking

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.

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 and Locations

Central contacts

Mustafa Tosur, MD

832-822-3780mustafa.tosur@bcm.edu

Lori Malone

713-798-1070lmalone@bcm.edu

Locations

Texas Children's Hospital / Children's Nutrition Research Center / Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Mustafa Tosur, MD

832-822-3780mustafa.tosur@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-06-02.