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

June 3, 2025 updated by: Britni Ryan Belcher, PhD, MPH, University of Southern California

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rationale: Sedentary behavior (SB) contributes to increased risk for obesity and metabolic disease, cognitive deficits, affect disorders, and cardiovascular disease over the lifespan. These are critical outcomes because children with these risk factors are more likely to develop type 2 diabetes mellitus (T2DM). SB increases T2DM risk by promoting hyperglycemia and greater postprandial glycemic variability as well as via cognitive detriments and depressive symptoms that lead to poor energy balance behaviors, obesity, and worsening insulin resistance. Additionally, prolonged SB may contribute to dominance of the sympathetic nervous system and lead to poor cardiovascular disease outcomes. Physical activity can reduce these risk factors, however less than half of US youth meet guideline recommendations, and physical activity continues to decline throughout adolescence. Thus, there is a critical need to test alternative intervention approaches to sustained bouts of exercise for the prevention of T2DM in children. The investigators were the first to show that interrupting SB with short, 3-minute, bouts of moderate exercise improved glucose tolerance and negative mood in a single 3-hour session. However, it is unknown whether these short-term improvements translate to sustained multi-day benefits to metabolic, cognitive, mood, and cardiac autonomic nervous system outcomes.

Intervention: This phase II randomized controlled trial (RCT) will compare the effects of SB interruptions vs. sustained bouts of exercise to prolonged sitting in 8-11-year-old children with overweight/obesity. Participants (N=150 (50 per group)) will be recruited from the community. The participants will wear continuous glucose monitors for one week and complete pre- and post- experiment 3-hour oral glucose tolerance tests (OGTT). Children will be randomized to 7 consecutive days of one of the following 3-hour experimental conditions: a) continuous sitting (SIT); b) sitting interrupted by 3-minute bouts of moderate-intensity walking every 30 minutes (SIT+WALK); or c) a single 18-minute bout of moderate-intensity walking followed by continuous sitting (EX).

Objectives/Purpose: The overall goal of this study is to test the efficacy of multi-day effects of interrupting SB as a T2DM prevention strategy in youth with overweight/obesity. This proposal will address the following aims: (1) determine the multi-day efficacy of interrupting sitting on glucose homeostasis measured by continuous glucose monitor and oral glucose tolerance tests; (2) determine the multi-day efficacy of interrupting sitting on cognitive function improvements; (3) determine the multi-day efficacy of interrupting sitting on affect and anxiety improvements; and (4) determine the multi-day efficacy of interrupting sitting on cardiac autonomic nervous system improvements measured by heart rate variability.

Study Population: The study population will consist of children with overweight/obesity recruited from the greater Los Angeles area. Children will be screened for eligibility (no evidence of type 2 diabetes, have overweight/obesity, be in good health, and be in early pubertal stages).

Study Methodology: This study is a phase II RCT with 3 study arms. Participants (N=150) will complete one screening visit to determine eligibility, complete a fitness test, and body composition analysis via dual x-ray absorptiometry (DEXA). All participants will complete two 3-hour in-lab oral glucose tolerance tests (spaced 6 days apart). Participants will wear an activity monitor on the right thigh and an electrocardiogram (ECG) monitor on the chest 7 days to determine baseline activity levels and heart rate variability, respectively. Then, participants will complete 7 consecutive in-lab sessions (SIT, SIT+WALK, or EX), with a 3-hour OGTT on Days 1 and 7. Participants will wear activity monitors, continuous glucose monitors, and ECG monitors during these 7 days of experimental sessions. Questionnaires will assess dietary intake, affect, anxiety, and mood, and the NIH Toolbox will assess executive cognitive function.

Study Arms: Participants will be randomized to 7 consecutive days of one of the following 3-hour experimental conditions in the lab: a) continuous sitting (SIT); b) sitting interrupted by 3-minute bouts of moderate-intensity walking every 30 minutes (SIT+WALK); or c) a single 18-minute bout of moderate-intensity walking followed by continuous sitting (EX).

Endpoints/Outcomes: The primary endpoints are: insulin, C-peptide, and glucose area under the curve (AUC) in the in-lab experiments, and glucose AUC from the continuous glucose monitor. Secondary endpoints are positive and negative affect, anxiety, executive cognitive function, and heart rate variability metrics.

Follow-up: Study duration is estimated as 14 days minimum and 30 days maximum, to allow for a 7-21 day period between the screening and experimental visits.

Statistical Analyses: The populations for analyses include the full analytical dataset which consists of all randomized study participants; the investigators will employ per protocol and intent to treat analyses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90032
        • Recruiting
        • Britni Ryan Belcher, PhD, MPH
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 8-11 years-old
  2. Good general health
  3. BMI≥85th percentile

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: SIT+WALK
Participants will interrupt their sitting for one week
Other Names:
  • Interrupted sitting
Experimental: EX
Perform 18 consecutive minutes of moderate-intensity walking, then sit for the remaining time
Behavioral: EX
Participants will perform a single bout of exercise and then sit for the remaining time for one week
Other Names:
  • Sustained exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7
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)
Time Frame: 3 hours (-10, 0, 30, 60, 90, 120, 150, 180 minutes) AUC change from Day 1 to Day 7
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
Time Frame: 7 days
mean daily 24-hr glucose area under the curve (AUC)
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive function measures
Time Frame: change from Day 1 to Day 7
attention, inhibition, working and episodic memory tasks from NIH Toolbox
change from Day 1 to Day 7
Positive and Negative Affect Scale for Children
Time Frame: change from Day 1 to Day 7
10-item positive and negative affect scale with scores for each ranging from 0 to 5, higher scores indicating worse outcome for negative affect and better outcome for positive affect
change from Day 1 to Day 7
State-Trait Anxiety Inventory for Children (STAIC)
Time Frame: change from Day 1 to Day 7
state anxiety will be measured using the STAIC, with a range from 20 to 80 with higher scores indicating more anxiety
change from Day 1 to Day 7
Cardiac autonomic nervous system measures
Time Frame: 7 days
mean daily heart rate variability metrics, including standard deviation of R-R intervals, root mean square of RR interval differences, high frequency, low frequency, and high to low frequency ratio
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DK123333 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on SIT+WALK

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings