RECRUITING

Effects of Multi-day Interruptions in Sitting on Type 2 Diabetes-relevant Outcomes in Children

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Testing the Efficacy of Multi-day Interruptions in Sedentary Behaviors on Metabolic, Cognitive, and Affective Outcomes in Youth at Risk for Type 2 Diabetes

Quick Facts

Study Start:2022-03-01
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04469790

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Age 8-11 years-old
  2. 2. Good general health
  3. 3. Fasting plasma glucose \< 100 mg/dL
  4. 4. BMI≥85th percentile
  5. 5. Pre- or peri-puberty
  1. 1. Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion
  2. 2. Evidence of impaired glucose tolerance or T2DM, presence of other endocrinologic disorders leading to obesity (e.g., Cushing Syndrome)
  3. 3. Current or past anti-psychotic drug use that would affect metabolism
  4. 4. Non-diet treatment for hypertension or dyslipidemia
  5. 5. Precocious puberty and/or receiving androgen and estrogen therapy
  6. 6. Medication use known to affect body composition/weight

Contacts and Locations

Study Locations (Sites)

Britni Ryan Belcher, PhD, MPH
Los Angeles, California, 90032
United States

Collaborators and Investigators

Sponsor: University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • exercise
  • cognitive functions
  • continuous glucose monitoring

Additional Relevant MeSH Terms

  • Sedentary Behavior
  • Affect
  • Metabolic Disturbance
  • Anxiety
  • Cardiac Autonomic Nervous System Function