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

NCT04469790 | Recruiting DMC

• 1 other identifier: R01DK123333
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

exercise; cognitive functions; continuous glucose monitoring

Outcome Measures

Primary Outcomes (4)

• In-Lab glucose area under the curve (AUC)

  change in glucose AUC from oral glucose tolerance tests

  3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7

• In-Lab insulin area under the curve (AUC)

  change in insulin AUC from oral glucose tolerance tests

  3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7

• In-Lab c-peptide area under the curve (AUC)

  change in c-peptide AUC from oral glucose tolerance tests

  3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7

• Continuous glucose monitor measures

  mean daily 24-hr glucose area under the curve (AUC)

  7 days

Secondary Outcomes (4)

• Cognitive function measures

  change from Day 1 to Day 7

• Positive and Negative Affect Scale for Children

  change from Day 1 to Day 7

• State-Trait Anxiety Inventory for Children (STAIC)

  change from Day 1 to Day 7

• Cardiac autonomic nervous system measures

  7 days

Study Arms (3)

SIT

NO INTERVENTION

Continuous sitting for 3 hours

SIT+WALK

EXPERIMENTAL

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

Behavioral: SIT+WALK

EX

EXPERIMENTAL

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

Behavioral: EX

Interventions

SIT+WALK BEHAVIORAL

Participants will interrupt their sitting for one week

Also known as: Interrupted sitting

SIT+WALK

EX BEHAVIORAL

Participants will perform a single bout of exercise and then sit for the remaining time for one week

Also known as: Sustained exercise

EX

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-11 years-old
• Good general health
• BMI≥85th percentile

You may not qualify if:

• Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion
• Diagnosis of T2DM and/or presence of other endocrinologic disorders leading to obesity (e.g., Cushing Syndrome)
• Current or past anti-psychotic drug use that would affect metabolism
• Non-diet treatment for hypertension or dyslipidemia
• Precocious puberty and/or receiving androgen and estrogen therapy
• Medication use known to affect body composition/weight

Sponsors & Collaborators

• University of Southern California: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Britni Ryan Belcher, PhD, MPH

Los Angeles, California, 90032, United States

RECRUITING

Related Publications (3)

• Belcher BR, Berrigan D, Papachristopoulou A, Brady SM, Bernstein SB, Brychta RJ, Hattenbach JD, Tigner IL Jr, Courville AB, Drinkard BE, Smith KP, Rosing DR, Wolters PL, Chen KY, Yanovski JA. Effects of Interrupting Children's Sedentary Behaviors With Activity on Metabolic Function: A Randomized Trial. J Clin Endocrinol Metab. 2015 Oct;100(10):3735-43. doi: 10.1210/jc.2015-2803. Epub 2015 Aug 27.

  PMID: 26312582 BACKGROUND

• Broadney MM, Belcher BR, Berrigan DA, Brychta RJ, Tigner IL Jr, Shareef F, Papachristopoulou A, Hattenbach JD, Davis EK, Brady SM, Bernstein SB, Courville AB, Drinkard BE, Smith KP, Rosing DR, Wolters PL, Chen KY, Yanovski JA. 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. Diabetes Care. 2018 Oct;41(10):2220-2228. doi: 10.2337/dc18-0774. Epub 2018 Aug 6.

  PMID: 30082324 BACKGROUND

• Belcher BR, McAlister KL, Zink J, Chapman TM, Moore KN, Castillo S, Hewus M, Kaslander JN, Dieli-Conwright CM, Huh J, Page KA. Design of a randomized controlled trial to test the efficacy of interrupting sitting on type 2 diabetes risk factors in children with overweight/obesity: The sedentary behavior study 3 protocol. Contemp Clin Trials. 2025 May;152:107862. doi: 10.1016/j.cct.2025.107862. Epub 2025 Feb 21.

  PMID: 39987963 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Anxiety Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized parallel-arm clinical trial

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: July 14, 2020
• Study Start: March 1, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)