Sedentary Behavior and Health Outcomes Study

NCT03153930 | Completed

• 1 other identifier: 1K01DK113062
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized crossover trial to compare the effectiveness of interrupting SB on glucose homeostasis in the lab and free-living settings. All participants (N=56) will complete one screening visit to determine eligibility, complete at fitness test, and body composition analysis by bioelectrical impedance. After 7-21 days, all participants will complete two 3-hour in-lab oral glucose tolerance tests (spaced 7-21 days apart). Prior to the in-lab OGTT visits, participants will wear an activity monitor for 7 days on the right thigh. The experimental conditions for the OGTTs will be: 1) 3-hour OGTT of continuous sitting; and 2) 3-hour OGTT with sitting interrupted every 30 minutes with 3-minutes of moderate intensity walking on a treadmill. There will be a 7-21 day washout period between the OGTT visits. In addition, a subset of participants (N=12) who meet inclusion criteria and who successfully complete both OGTT visits will complete a second randomized crossover trial in the free-living environment. The experimental conditions for the free-living components will be: 1) 4 days of habitual sedentary behaviors; and 2) 4 days of prompted short exercise breaks during times in which sedentary behaviors have exceeded 30 minutes. Participants in the free-living trial will wear an activity monitor and a continuous glucose monitor.

Conditions

Sedentary Lifestyle; Metabolic Disturbance; Pediatric Obesity; Physical Activity

Keywords

sedentary behavior; youth; moderating factors; metabolic outcomes

Outcome Measures

Primary Outcomes (4)

• In-Lab: Metabolic responses

  glucose, insulin, and c-peptide area under the curve

  3 hours

• Free-living: Glucose responses

  glucose area under the curve

  4 days

• Predictors of in-lab glucose responses

  Independent-sample t-tests will assess if mean in-lab glucose AUC differs within experimental condition by weight status (normal weight or overweight/obese). Independent-sample t-tests will assess if mean AUC values between conditions (delta AUC) differ by weight status. Structural equation models of latent growth curves will be used to assess the relationship between BMI z-score trajectories in the preceding 3 years, in-lab glucose AUC responses by experimental condition. Specifically, models will test if a) the higher the initial BMI z score (year 1), the higher the initial serum value (-10 min); b) the higher the initial BMI z score (year 1), the greater the change in serum AUC between experimental conditions; and c) the greater slope of the BMI z score change, the greater the change in serum AUC between experimental conditions.

  3 years

• Individual variations in glucose responses in-lab

  Mixed-effects location scale models (MIXREGLS) will test how between-subject (BS) and within-subject (WS) variation in SB in the preceding 3 years are associated with glucose responses to in-lab SB interruptions. The predictors are average 3-year SB level and SB level at each year (variation in SB). The Stage 1 mixed-effects location scale model will examine random effects of between-subject variance (i.e., location) and of within-subject variance (i.e., scale), sex, baseline percent body fat, and baseline age. The Stage 2 model will assess how these variance sources from Stage 1 affect the delta AUC between in-lab prolonged SB and SB interruptions with regards to glucose (the WS effects).

  3 years

Secondary Outcomes (1)

• Relationship between in-lab and free-living glucose AUC

  5 days

Study Arms (2)

Sitting Only (SIT)

PLACEBO COMPARATOR

In-Lab (full sample): children will sit continuously for 3 hours during an OGTT Free-living (sub-sample; N=12): children will complete their habitual sedentary behaviors over 4 days; they will also wear a continuous glucose monitor

Behavioral: Sitting only

Walking Breaks (WALK)

EXPERIMENTAL

In-Lab (full sample): children will be asked to walk on a treadmill every 30 minutes for 3 minute bouts during a 3 hour OGTT Free-living (sub-sample; N=12): children will be prompted with an ActivPAL vtap monitor on the right thigh to perform 3-minute walking bouts whenever sedentary time has lasted longer than 30 minutes over 4 days; they will also wear a continuous glucose monitor

Behavioral: Walking breaks

Interventions

Walking breaks BEHAVIORAL

In-Lab (full sample): participants will be asked to walk on a treadmill for 3 minutes every 30 minutes at a moderate pace during a 3-hour OGTT Free-living (sub-sample; N=12): participants will be prompted via an ActivPAL vtap monitor to walk for 3 minutes every time sedentary behavior lasts longer than 30 continuous minutes

Also known as: Interrupting sedentary time

Walking Breaks (WALK)

Sitting only BEHAVIORAL

In-Lab (full sample): participants will remain seated for 3 hours during an OGTT Free-living (sub-sample; N=12): participants will perform their habitual sedentary behaviors

Also known as: Continuous sedentary time

Sitting Only (SIT)

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• current/past participant in the MATCH Study
• good general health
• fasting plasma glucose \<100 mg/dL
• BMI greater than the 5th percentile

You may not qualify if:

• significant cardiac or pulmonary disease likely to or resulting in hypoxia or decreased perfusion
• evidence of impaired glucose tolerance or type 2 diabetes
• presence of other endocrinologic disorders leading to obesity (e.g.: Cushing Syndrome)
• current or past anti-psychotic drugs 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
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Southern California Keck School of Medicine

Los Angeles, California, 90032, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Britni R Belcher, PhD, MPH

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Preventive Medicine

Model Details: Participants will complete a randomized crossover study with 2 conditions: sitting continuously for 3 hours vs. interrupting sitting with 3-minute moderate intensity walking breaks every 30 minutes for 3 hours. A subset will then complete a free-living component wearing a continuous glucose monitor that will consist of habitual activity vs. interrupting periods of 30+ sedentary minutes with short activity breaks.

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 15, 2017
• Study Start: January 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 30, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)