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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT04469790
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
8 Years - 11 Years
Healthy Volunteers
Accepted

Interventions

  • SIT+WALK — BEHAVIORAL
    Participants will interrupt their sitting for one week
  • EX — BEHAVIORAL
    Participants will perform a single bout of exercise and then sit for the remaining time for one week

Study Details

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.

Key Dates

Start date
Mar 1, 2022
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: SIT
    Continuous sitting for 3 hours
  • Experimental: SIT+WALK
    Interrupt sitting with 3-minutes of moderate-intensity walking every 30 minutes for 3 hours
  • Experimental: EX
    Perform 18 consecutive minutes of moderate-intensity walking, then sit for the remaining time

Primary Outcome Measure

In-Lab glucose area under the curve (AUC) [ Time Frame: 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Britni Ryan Belcher, PhD, MPHLos AngelesCalifornia90032-

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Britni Ryan Belcher, PhD, MPH· Los Angeles, CA

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