Sedentary Interruptions + Exercise for Reducing Type 2 Diabetes Risk in Children

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Antipsychotics, Androgen, Estrogen

Disqualifiers: Cardiac disease, Pulmonary disease, T2DM, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 7 days

188 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall objective of this in-lab randomized controlled trial is to test the efficacy of multi-day interruptions in sedentary behavior vs. single bouts of sustained exercise on metabolic, cognitive, affective, and cardiac autonomic nervous system responses in children with overweight and obesity who are at risk for type 2 diabetes. The use of continuous glucose monitoring will provide insight into the daily and cumulative metabolic effects of each condition that have thus far not been studied. In-lab studies demonstrating sustained efficacy of this approach in ameliorating negative effects of sedentary behaviors in children are necessary for the optimization of field-based interventions. Given the lack of success of interventions to prevent obesity-related diseases and increasing rates of type 2 diabetes in children and its related healthcare costs, this study addresses a critical public health need by testing of novel intervention strategies to reduce obesity-related diseases in children with overweight and obesity.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications that affect body weight or composition.

What data supports the effectiveness of the treatment for reducing type 2 diabetes risk in children?

Research shows that interrupting sitting with short periods of walking can improve how the body handles sugar in children who are overweight, which may help reduce the risk of developing type 2 diabetes. ^{1 2 3 4 5}

Is interrupting sitting with walking safe for children?

Research suggests that interrupting sitting with short periods of walking is generally safe for children, as it involves moderate physical activity similar to everyday movements. ^{3 4 5 6 7}

How does the SIT+WALK treatment for reducing Type 2 diabetes risk in children differ from other treatments?

The SIT+WALK treatment is unique because it focuses on breaking up long periods of sitting with short bouts of walking, which can improve glucose metabolism in children without changing their diet. This approach is different from traditional treatments that might focus solely on medication or dietary changes. ^{1 4 7 8 9}

Eligibility Criteria

This trial is for children aged 7-11 who are overweight or obese, with a BMI in the top 15% for their age. They must have normal fasting blood sugar levels and be generally healthy without any significant heart or lung diseases, endocrine disorders like Cushing Syndrome, or treatments affecting body weight.

Inclusion Criteria

I have not gone through puberty yet.

Fasting plasma glucose < 100 mg/dL

I am between 7 and 11 years old.

Exclusion Criteria

I have serious heart or lung conditions that affect my breathing or blood flow.

I have diabetes or a condition like Cushing Syndrome that causes obesity.

I am taking medication that can change my weight or body shape.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline Assessment

Participants complete a fitness test, body composition analysis, and baseline activity and heart rate variability monitoring

7 days

1 visit (in-person) for initial assessment, continuous monitoring for 7 days

Treatment

Participants undergo 7 consecutive days of experimental conditions (SIT, SIT+WALK, or EX) with continuous glucose monitoring and ECG monitoring

7 days

7 visits (in-person)

Follow-up

Participants are monitored for changes in metabolic, cognitive, affective, and cardiac autonomic nervous system outcomes

7-21 days

Treatment Details

Interventions

• EX
• SIT+WALK

Trial Overview The study compares two ways to reduce sedentary behavior's negative effects on kids at risk for type 2 diabetes: breaking up sitting time over several days versus single sessions of exercise. It measures how these methods affect metabolism, mood, cognitive function, and heart rate variability using continuous glucose monitoring.

Participant Groups

Group I: SIT+WALK Experimental Treatment 1 Intervention

Interrupt sitting with 3-minutes of moderate-intensity walking every 30 minutes for 3 hours

Group II: EX Experimental Treatment 1 Intervention

Perform 18 consecutive minutes of moderate-intensity walking, then sit for the remaining time

Group III: SIT Active Control 1 Intervention

Continuous sitting for 3 hours

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

In a study of 120 overweight/obese children, higher volumes of sedentary behavior (SED) were linked to lower levels of HDL cholesterol, suggesting that reducing sedentary time could improve heart health.

Engaging in moderate-to-vigorous physical activity (MVPA) was associated with lower diastolic blood pressure and reduced cardio-metabolic risk, highlighting the importance of physical activity in managing health outcomes in overweight/obese children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumes and bouts of sedentary behavior and physical activity: associations with cardiometabolic health in obese children. Cliff, DP., Jones, RA., Burrows, TL., et al.[2022]

The review identified a total of four new randomized controlled trials and two systematic reviews, indicating a significant increase in research on childhood obesity prevention and treatment since previous reviews, but high-quality evidence remains limited.

While there is some promise in targeting reductions in sedentary behavior and increasing physical activity for treating pediatric obesity, the effectiveness of these interventions is still uncertain, and more research is needed, especially outside the USA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity interventions in the prevention and treatment of paediatric obesity: systematic review and critical appraisal. Reilly, JJ., McDowell, ZC.[2022]

In children aged 8-10 with at least one obese parent, higher levels of body fat (measured as percent fat mass) were linked to increased insulin secretion, indicating that adiposity plays a significant role in insulin regulation.

Moderate to vigorous physical activity (MVPA) and better fitness levels were associated with lower insulin secretion, suggesting that increased physical activity may help improve insulin sensitivity in children at risk of obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin secretion and its association with physical activity, fitness and screen time in children. Henderson, M., Gray-Donald, K., Rabasa-Lhoret, R., et al.[2018]

Interrupting prolonged sitting with short bouts of moderate-intensity walking significantly improved glucose metabolism in overweight or obese children, reducing insulin and C-peptide levels during an oral glucose tolerance test.

The intervention led to a 21% reduction in insulin area under the curve (AUC) and an 18% reduction in C-peptide AUC, without increasing overall energy intake from a subsequent meal, suggesting it is a safe and effective strategy to reduce metabolic risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Interrupting Sedentary Behavior With Short Bouts of Moderate Physical Activity on Glucose Tolerance in Children With Overweight and Obesity: A Randomized Crossover Trial. Broadney, MM., Belcher, BR., Berrigan, DA., et al.[2019]

In a study of 630 children with a parental history of obesity, increased moderate-to-vigorous physical activity (MVPA) was associated with improved insulin sensitivity, while higher sedentary time and screen time were linked to reduced insulin sensitivity and increased insulin secretion, indicating their roles in type 2 diabetes risk.

The research highlights that for every additional hour of sedentary behavior or screen time, there was a significant negative impact on insulin sensitivity and a slight increase in fasting blood sugar levels, suggesting that reducing sedentary activities could be crucial for diabetes prevention in at-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating causal effects of physical activity and sedentary behaviours on the development of type 2 diabetes in at-risk children from childhood to late adolescence: an analysis of the QUALITY cohort. Harnois-Leblanc, S., Sylvestre, MP., Van Hulst, A., et al.[2023]

In a study of 134 adolescents with obesity, those who were less sedentary (SED-) showed significantly better metabolic health, including lower fat mass, blood pressure, and insulin resistance compared to those who were more sedentary (SED+).

Engaging in moderate to vigorous physical activity (MVPA+) also improved metabolic health, with lower triglycerides and insulin resistance, highlighting that both reducing sedentary time and increasing physical activity are important for managing obesity in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedentary time has a stronger impact on metabolic health than moderate to vigorous physical activity in adolescents with obesity: a cross-sectional analysis of the Beta-JUDO study. Julian, V., Bergsten, P., Forslund, A., et al.[2022]

In a study involving 19 healthy children aged 10 to 14, 8 hours of uninterrupted sitting did not significantly affect markers of cardiometabolic disease risk, such as insulin, glucose, or lipid levels, compared to sitting with breaks or physical activity.

The findings suggest that short bouts of uninterrupted sitting may not pose immediate cardiometabolic risks in healthy youth, indicating that the effects seen in adults may not directly apply to children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged sitting and markers of cardiometabolic disease risk in children and youth: a randomized crossover study. Saunders, TJ., Chaput, JP., Goldfield, GS., et al.[2022]

In a study of 64 young schoolchildren over 3 years, sedentary time (ST) increased while light physical activity (LPA) decreased, indicating a concerning trend in children's activity levels.

The study found that as LPA and moderate-to-vigorous physical activity (MVPA) decreased, ST increased, suggesting that interventions are needed to promote more active lifestyles among children to combat rising sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Among Changes in Sedentary Time, Physical Activity, and Body Mass Index in Young Schoolchildren: A 3-Year Longitudinal Study. Santos, A., Silva-Santos, S., Duncan, M., et al.[2018]

A review of 88 studies found limited evidence that sedentary behavior is linked to negative health outcomes in children and adolescents when considering their levels of moderate to vigorous physical activity.

The research highlights a need for higher-quality studies with objective measures of sedentary behavior to clarify its role as an independent health determinant in young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objectively measured sedentary behaviour and health and development in children and adolescents: systematic review and meta-analysis. Cliff, DP., Hesketh, KD., Vella, SA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Volumes and bouts of sedentary behavior and physical activity: associations with cardiometabolic health in obese children. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Physical activity interventions in the prevention and treatment of paediatric obesity: systematic review and critical appraisal. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Insulin secretion and its association with physical activity, fitness and screen time in children. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Interrupting Sedentary Behavior With Short Bouts of Moderate Physical Activity on Glucose Tolerance in Children With Overweight and Obesity: A Randomized Crossover Trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Estimating causal effects of physical activity and sedentary behaviours on the development of type 2 diabetes in at-risk children from childhood to late adolescence: an analysis of the QUALITY cohort. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Sedentary time has a stronger impact on metabolic health than moderate to vigorous physical activity in adolescents with obesity: a cross-sectional analysis of the Beta-JUDO study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Prolonged sitting and markers of cardiometabolic disease risk in children and youth: a randomized crossover study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Relationship Among Changes in Sedentary Time, Physical Activity, and Body Mass Index in Young Schoolchildren: A 3-Year Longitudinal Study. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Objectively measured sedentary behaviour and health and development in children and adolescents: systematic review and meta-analysis. [2022]