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Recruiting NCT06782906

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

No phase Interventional Prediabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ≥10,000 daily steps (≥5 days/week) and stopping evening snacking.
Who it may be relevant to
Registry conditions: Prediabetes. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral ≥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 measures

  • 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]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

Inclusion criteria

  • 12-18 years of age
  • Having a diagnosis of prediabetes
  • Engaging in frequent evening snacking
  • Inadequate physical activity

Exclusion criteria

  • Diagnosis of diabetes
  • Significant history of chronic disease
  • Evidence of significant liver or kidney disease;
  • Any hormone replacement therapy; and
  • Pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Texas Children's Hospital / Children's Nutrition Research Center / Baylor College of Medic — Houston

Identifiers

NCT: NCT06782906 · H-56321 · 58-3092-5-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗