PrediabetesNCT06782906
Effect of Increased Physical Activity and Stopping Evening Snacking in Metabolic Health in Youth With Prediabetes
A study testing ≥10,000 daily steps (≥5 days/week) and stopping evening snacking in people with Prediabetes, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- ≥10,000 daily steps (≥5 days/week) and stopping evening snacking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12-18 years of age
- Having a diagnosis of prediabetes
- Engaging in frequent evening snacking
- Inadequate physical activity
Who cannot join
- Diagnosis of diabetes
- Significant history of chronic disease
- Evidence of significant liver or kidney disease;
- Any hormone replacement therapy; and
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Children's Hospital / Children's Nutrition Research Center / Baylor College of Medicine
Houston, Texas, 77030
Mustafa Tosur, MD, 832-822-3780, mustafa.tosur@bcm.edu
About this study
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.
Read the detailed description
Poor nutrition in addition to a lack of physical activity play significant roles in childhood T2D development, primarily by negatively affecting adiposity and insulin action in concert with other T2D risk factors. Many aspects of nutrition, including frequency of eating, were examined in relation to obesity/increased adiposity and T2D risk. Previous studies suggest increased snacking may cause overeating, and potentially lead to weight gain.
Findings from adolescents in the 2005-2016 National Health and Nutrition Examination Survey (NHANES), showed those with overweight/obesity consume more snacks per day (1.85 and 1.97 snacks per day, respectively) and more calories per snack (305 and 340 kcal/snack, respectively) than their normal-weight peers (1.69 and 262 kcal/snack).Snack consumption in adolescents is also correlated with higher daily energy intake, lower fruit/vegetable intake, along with more frequent fast-food and sugar-sweetened beverage consumptions. The timing of snacking occasions has also emerged as a potential confounder. Among adults, greater evening snacking was associated with higher BMI and higher obesogenic dietary index (e.g., intake of fast food, etc.) while greater morning snacking was associated with increased fruit and vegetable consumption. Having a bedtime snack was associated with increased odds of overweight/obesity (1.47, 95% CI: 1.34-1.62) in Japanese women. Evening snacking was also shown to be independently correlated with overweight/obesity in Italian adolescents (RR 3.12, 95% CI: 1.17-8.34). In the Healthy Growth Study, children who had high-energy intake at dinner and evening snacking were more likely to skip breakfast - a metabolically unhealthy habit.
Also, despite the known metabolic benefits of physical activity, only 1 in 4 adolescents achieve recommended daily physical activity goals (60-min, moderate-to-vigorous physical activity (MVPA)/day).Both snacking and exercise may also affect metabolic health by independently modulating gene expression levels of critical metabolic pathways and subsequently intracellular signaling. Metabolic dysregulation resulting in altered plasma concentrations of several amino acids (e.g., higher branch-chain amino acid and lower glycine concentrations, etc.) was associated with insulin resistance.
Therefore, targeted interventions towards evening snacking and increased physical activity may prove beneficial in adolescents with prediabetes by preventing progression to T2D.
- Conditions
- Prediabetes
- Being tested
- ≥10,000 daily steps (≥5 days/week) and stopping evening snacking
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
≥10,000 daily steps (≥5 days/week) and stopping evening snackingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: ≥10,000 daily steps (≥5 days/week) and stopping evening snacking |
| Standard of Care Arm | No intervention | Participants in the standard of care arm will be asked to follow recommendations of their physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity index for glucose disposal (ISI [Gly]) during oral glucose tolerance test
Insulin sensitivity index for glycemia (ISI [Gly]) will be calculated with a formula using insulin and glucose area under the curves during oral glucose tolerance tests (OGTT) as described previously (Belfiore et al., Metabolism, 2001):
ISI (Gly) = 2 / [INSp x GLYp) + 1]
INSp: insulinemic area during OGTT with 3 (0, 1h and 2h) or 5 sampling (0, 30, 60, 90 and 120 min) GLYp: glycemic area during OGTT (0, 1h and 2h) or 5 sampling (0, 30, 60, 90 and 120 min)
INSp and GLYp are expressed by taking the mean normal value as 1, i.e., by dividing the value observed in the person under study by the mean normal value so that, if INSp (or GLYp) is 1.5-fold the mean normal values, it will be considered as equal to 1.5, and so on. We will use appropriate "mean normal values," which will be derived from data obtained in our laboratory.
Measured: At week 9-10 following completion of 8 weeks of intervention period
Secondary outcomes (10)
index for fat disposal (ISI [FFA]) during oral glucose tolerance test
Insulin sensitivity index for fat disposal (ISI [FFA]) will be calculated with a formula using insulin and free fatty acid area under the curves during oral glucose tolerance tests (OGTT) as described previously (Belfiore et al., Metabolism, 2001):
ISI (FFA) = 2 / [INSp x FFAp) + 1]
INSp: insulinemic area during OGTT with 3 (0, 1h and 2h) or 5 sampling (0, 30, 60, 90 and 120 min) FFAp: glycemic area during OGTT (0, 1h and 2h) or 5 sampling (0, 30, 60, 90 and 120 min)
INSp and FFAp are expressed by taking the mean normal value as 1, i.e., by dividing the value observed in the person under study by the mean normal value so that, if INSp or FFAp) is 1.5-fold the mean normal values, it will be considered as equal to 1.5, and so on. We will use appropriate "mean normal values," which will be derived from data obtained in our laboratory.
Measured: At week 9-10 following completion of 8 weeks of intervention period
HbA1c
Hemoglobin A1c (HbA1c) as measured in the plasma.
Measured: At week 9-10 following completion of 8 weeks of intervention period
Percentage of adiposity (percent body fat)
Percent body fat as measured by DXA scan
Measured: At week 9-10 following completion of 8 weeks of intervention period
Amino acid concentrations
Fasting amino acid concentrations as measured in the plasma
Measured: At week 9-10 following completion of 8 weeks of intervention period
Adiponectin
Fasting adiponectin concentration as measured in the plasma
Measured: At week 9-10 following completion of 8 weeks of intervention period
C-reactive protein (CRP)
CRP concentration as measured in the plasma
Measured: At week 9-10 following completion of 8 weeks of intervention period
TNF-alpha
TNF-alpha concentrations as measured in the plasma
Measured: At week 9-10 following completion of 8 weeks of intervention period
Interleukin 6 (IL-6)
IL-6 level as measured in the plasma
Measured: At week 9-10 following completion of 8 weeks of intervention period
Gene expression levels of critical pathways
RNA sequencing for gene expression levels of critical metabolic pathways
Measured: At week 9-10 following completion of 8 weeks of intervention period
Total energy expenditure
In a subset of cohort (n=20), free-living total energy expenditure (TEE) will be measured by the doubly labeled water (DLW) over a 14-d period using multiple urine collections at different time points. This optional part will be offered to all participants, and similar number of participants will be selected randomly from both arms (intervention and standard of care arm) by balancing gender and age categories.
Measured: At week 9-10 following completion of 8 weeks of intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start13 May 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Tosur, Baylor College of Medicine
- Investigators
- Mustafa Tosur, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782906
- Sponsor's protocol ID
- H-56321
- Other IDs
- 58-3092-5-008
- Status last verified
- Jun 2026
- First submitted
- 7 Jan 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Physical Activity and Stopping Evening Snacking in Metabolic Health in Youth With Prediabetes
- ClinicalTrials.gov ID
- NCT06782906
- Acronym / sponsor ID
- H-56321
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 20 Jan 2025 (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.
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.
Detailed description
Poor nutrition in addition to a lack of physical activity play significant roles in childhood T2D development, primarily by negatively affecting adiposity and insulin action in concert with other T2D risk factors. Many aspects of nutrition, including frequency of eating, were examined in relation to obesity/increased adiposity and T2D risk. Previous studies suggest increased snacking may cause overeating, and potentially lead to weight gain.
Findings from adolescents in the 2005-2016 National Health and Nutrition Examination Survey (NHANES), showed those with overweight/obesity consume more snacks per day (1.85 and 1.97 snacks per day, respectively) and more calories per snack (305 and 340 kcal/snack, respectively) than their normal-weight peers (1.69 and 262 kcal/snack).Snack consumption in adolescents is also correlated with higher daily energy intake, lower fruit/vegetable intake, along with more frequent fast-food and sugar-sweetened beverage consumptions. The timing of snacking occasions has also emerged as a potential confounder. Among adults, greater evening snacking was associated with higher BMI and higher obesogenic dietary index (e.g., intake of fast food, etc.) while greater morning snacking was associated with increased fruit and vegetable consumption. Having a bedtime snack was associated with increased odds of overweight/obesity (1.47, 95% CI: 1.34-1.62) in Japanese women. Evening snacking was also shown to be independently correlated with overweight/obesity in Italian adolescents (RR 3.12, 95% CI: 1.17-8.34). In the Healthy Growth Study, children who had high-energy intake at dinner and evening snacking were more likely to skip breakfast - a metabolically unhealthy habit.
Also, despite the known metabolic benefits of physical activity, only 1 in 4 adolescents achieve recommended daily physical activity goals (60-min, moderate-to-vigorous physical activity (MVPA)/day).Both snacking and exercise may also affect metabolic health by independently modulating gene expression levels of critical metabolic pathways and subsequently intracellular signaling. Metabolic dysregulation resulting in altered plasma concentrations of several amino acids (e.g., higher branch-chain amino acid and lower glycine concentrations, etc.) was associated with insulin resistance.
Therefore, targeted interventions towards evening snacking and increased physical activity may prove beneficial in adolescents with prediabetes by preventing progression to T2D.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: ≥10,000 daily steps (≥5 days/week) and stopping evening snackingParticipants 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. |
| Standard of Care Arm | No intervention | –Participants in the standard of care arm will be asked to follow recommendations of their physician. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 12-18 years of age
- Having a diagnosis of prediabetes
- Engaging in frequent evening snacking
- Inadequate physical activity
Key exclusion criteria (5 listed)
- Diagnosis of diabetes
- Significant history of chronic disease
- Evidence of significant liver or kidney disease;
- Any hormone replacement therapy; and
- Pregnancy.
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 |
|---|---|---|
| ≥10,000 daily steps (≥5 days/week) and stopping evening snackingParticipants 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. | Behavioural | Intervention Arm |
Primary outcome
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
Insulin sensitivity index for glycemia (ISI [Gly]) will be calculated with a formula using insulin and glucose area under the curves during oral glucose tolerance tests (OGTT) as described previously (Belfiore et al., Metabolism, 2001): ISI (Gly) = 2 / [INSp x GLYp) + 1] INSp: insulinemic area during OGTT with 3 (0, 1h and 2h) or 5 sampling (0, 30, 60, 90 and 120 min) GLYp: glycemic area during OGTT (0, 1h and 2h) or 5 sampling (0, 30, 60, 90 and 120 min) INSp and GLYp are expressed by taking the mean normal value as 1, i.e., by dividing the value observed in the person under study by the mean normal value so that, if INSp (or GLYp) is 1.5-fold the mean normal values, it will be considered as equal to 1.5, and so on. We will use appropriate "mean normal values," which will be derived from data obtained in our laboratory.
10 secondary outcomes
index for fat disposal (ISI [FFA]) during oral glucose tolerance test
Time frame: At week 9-10 following completion of 8 weeks of intervention period
HbA1c
Time frame: At week 9-10 following completion of 8 weeks of intervention period
Percentage of adiposity (percent body fat)
Time frame: At week 9-10 following completion of 8 weeks of intervention period
Amino acid concentrations
Time frame: At week 9-10 following completion of 8 weeks of intervention period
Adiponectin
Time frame: At week 9-10 following completion of 8 weeks of intervention period
C-reactive protein (CRP)
Time frame: At week 9-10 following completion of 8 weeks of intervention period
TNF-alpha
Time frame: At week 9-10 following completion of 8 weeks of intervention period
Interleukin 6 (IL-6)
Time frame: At week 9-10 following completion of 8 weeks of intervention period
Gene expression levels of critical pathways
Time frame: At week 9-10 following completion of 8 weeks of intervention period
Total energy expenditure
Time frame: At week 9-10 following completion of 8 weeks of intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Mustafa Tosur, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ≥10,000 daily steps (≥5 days/week) and stopping evening snacking in people with Prediabetes, run by Baylor College of Medicine 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 4 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: looking for participants now, as of the sponsor's last update on 2 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Tosur, MD (832-822-3780, mustafa.tosur@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.