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

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Southern California

Must not be taking: Antipsychotics, Androgen, Estrogen

Disqualifiers: Cardiac disease, Pulmonary disease, T2DM, others

No Placebo Group

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.

Trial 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 (Behavioural Intervention)
• SIT+WALK (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Britni Ryan Belcher, PhD, MPH Los Angeles, CA

Who Is Running the Clinical Trial?

University of Southern California Lead Sponsor

Children's Hospital Los Angeles Collaborator

Dana-Farber Cancer Institute Collaborator

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

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] To examine associations of volumes and bouts of sedentary behavior (SED) and moderate-to-vigorous physical activity (MVPA) with individual and clustered cardio-metabolic outcomes in overweight/obese children.

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

Physical activity interventions in the prevention and treatment of paediatric obesity: systematic review and critical appraisal. [2022] Interventions for prevention and treatment of childhood obesity typically target increases in physical activity and, more recently, reductions in physical inactivity (sedentary behaviour such as television viewing). However, the evidence base for such strategies is extremely limited. The main aim of the present review was to update the systematic review and critical appraisal of evidence in the light of the recent rapid expansion of research in this area. Randomised controlled trials (RCT) that targeted activity or inactivity, that followed up children or adolescents for at least 1 year and that included an objective weight-related outcome measure were included. Trials were appraised using previously published criteria (Harbour & Miller, 2001), and literature search strategies described previously (Reilly et al. 2002) were updated to May 2002. A total of four new RCT, two new systematic reviews and one meta-analysis were identified. The evidence base has increased markedly since the completion of earlier reviews, although high-quality evidence is still lacking. The evidence on childhood obesity prevention is not encouraging, although promising targets for prevention are now clear, notably reduction in sedentary behaviour. There is stronger evidence that targeting activity and/or inactivity might be effective in paediatric obesity treatment, but doubts as to the generalisability of existing interventions, and the clinical relevance of the interventions is unclear. Further research in settings outside the USA is urgently needed, and two ongoing RCT in Scotland are summarised.

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

Insulin secretion and its association with physical activity, fitness and screen time in children. [2018] To determine the independent associations of moderate to vigorous physical activity (MVPA), fitness, screen time, and adiposity with insulin secretion in children.

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] Sedentary children have greater risk of developing abnormalities in glucose homeostasis. We investigated whether interrupting sedentary behavior (sitting) with very short periods of walking would improve glucose metabolism without affecting dietary intake in children with overweight or obesity. We hypothesized that interrupting sitting with short bouts of moderate-intensity walking would decrease insulin area under the curve (AUC) during an oral glucose tolerance test (OGTT) compared with uninterrupted sitting.

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] Uncertainty remains regarding the causal effect of physical activity and sedentary behaviours on the development of type 2 diabetes in children. We aimed to estimate average treatment effects of physical activity and sedentary behaviours on risk of type 2 diabetes in individuals who are at risk during childhood and adolescence.

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] Relationships between movement-related behaviours and metabolic health remain underexplored in adolescents with obesity.

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] Recent evidence suggests that short bouts of uninterrupted sedentary behavior reduce insulin sensitivity and glucose tolerance while increasing triglyceride levels in both healthy and overweight/obese adults. To date no study has examined the acute impact of uninterrupted sitting in children and youth. The objective of the present study was to determine whether 8 h of uninterrupted sitting increases markers of cardiometabolic disease risk in healthy children and youth, in comparison to 8 h of sitting interrupted by light intensity walk breaks or structured physical activity.

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] To examine the association between sedentary time (ST) and light physical activity (LPA), moderate- to vigorous-intensity physical activity (MVPA), and body mass index (BMI), and to track these behaviors over a 3-year follow-up in young schoolchildren.

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] Sedentary behaviour has emerged as a unique determinant of health in adults. Studies in children and adolescents have been less consistent. We reviewed the evidence to determine if the total volume and patterns (i.e. breaks and bouts) of objectively measured sedentary behaviour were associated with adverse health outcomes in young people, independent of moderate-intensity to vigorous-intensity physical activity. Four electronic databases (EMBASE MEDLINE, Ovid EMBASE, PubMed and Scopus) were searched (up to 12 November 2015) to retrieve studies among 2- to 18-year-olds, which used cross-sectional, longitudinal or experimental designs, and examined associations with health outcomes (adiposity, cardio-metabolic, fitness, respiratory, bone/musculoskeletal, psychosocial, cognition/academic achievement, gross motor development and other outcomes). Based on 88 eligible observational studies, level of evidence grading and quantitative meta-analyses indicated that there is limited available evidence that the total volume or patterns of sedentary behaviour are associated with health in children and adolescents when accounting for moderate-intensity to vigorous-intensity physical activity or focusing on studies with low risk of bias. Quality evidence from studies with robust designs and methods, objective measures of sitting, examining associations for various health outcomes, is needed to better understand if the overall volume or patterns of sedentary behaviour are independent determinants of health in children and adolescents.