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

  • STATUS
    Recruiting
  • End date
    May 31, 2025
  • participants needed
    235
  • sponsor
    University of Southern California
Updated on 26 November 2021
Accepts healthy volunteers

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, and affective 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.

Description

Rationale: Sedentary behavior (SB) contributes to increased risk for obesity and metabolic disease, cognitive deficits, and affect disorders 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. 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, and mood 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 7-11-year-old children with overweight/obesity. Participants (N=150 (50 per group); ages 7-11) will be recruited from the community and the Children's Hospital Los Angeles (CHLA) pediatric obesity clinic. 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; and (3) determine the multi-day efficacy of interrupting sitting on affect and anxiety improvements.

Study Population: The study population will consist of children with overweight/obesity recruited from the greater Los Angeles area and the CHLA pediatric obesity clinic. 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 for 7 days on the right thigh to determine baseline activity levels. 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 and continuous glucose 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, and executive cognitive function.

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.

Details
Condition Mood, anxiety disorder, Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Disorders, Anxiety Disorders (Pediatric), Sedentary Behavior, anxious, Metabolic Disturbance, ANXIETY NEUROSIS, Anxiety Symptoms, Anxiety, Generalized Anxiety Disorder (GAD)
Treatment EX, SIT+WALK
Clinical Study IdentifierNCT04469790
SponsorUniversity of Southern California
Last Modified on26 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 7-11 years-old
Good general health
Fasting plasma glucose < 100 mg/dL
BMI85th percentile
Pre- or peri-puberty

Exclusion Criteria

Significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion
Evidence of impaired glucose tolerance or T2DM, 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
Clear my responses

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