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Active Class Space Metabolic Benefits Study (ACS)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light-Intensity Condition
Moderate-Intensity Condition
High-Intensity Condition
Sedentary Condition
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring physical activity

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children ages 7-11 years old from the greater Ann Arbor and Ypsilanti areas were recruited to participate in this study.

Exclusion Criteria:

  • Participants were excluded based on the following criteria: (1) were taking medications or were diagnosed with diseases that could influence exercise ability or cognitive function and (2) were previously diagnosed with any major illness/health condition since birth.

Sites / Locations

  • Childhood Disparities Research Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Sedentary Condition

Light-Intensity Condition

Moderate-Intensity Condition

High-Intensity Condition

Arm Description

Forty minutes of screen time. Standardized meals provided.

Forty minutes of light-intensity activity. Standardized meals provided.

Forty minutes of moderate-intensity activity. Standardized meals provided.

Forty minutes of high-intensity activity. Standardized meals provided.

Outcomes

Primary Outcome Measures

Physical activity energy expenditure
Physical activity energy expenditure throughout the condition day and over the next three days. Participants wore an accelerometer for four days. Energy expenditure was calculated from accelerometer data.

Secondary Outcome Measures

40-item immediate mental performance math test
Number of math questions answered correctly within 90 seconds in the morning (800hr), midday (1200hr) and afternoon (1600hr). Scores were marked as number correct out of 40.
Dietary intake
Standardized meals were provided in the morning, midday and evening and 3-day dietary records were collected three days post-condition day. Total daily dietary intake was calculated from food consumed in the lab and at home.
Physical activity minutes
Physical activity minutes throughout the condition day and over the next three days. Participants wore an accelerometer for four days. Minutes participating in physical activity was calculated using accelerometer data.
4-item hunger and satiety visual analog scale
Self reported hunger and satiety in the morning (800hr), midday (1200hr) and afternoon (1600hr). Scores were calculated from a visual analog scale ranging from 0-100 (0= hungry; 0=full), yielding a total between 0- 400
Single-item ratings of perceived exertion
Perceived exertion during 20, 2-minute activity or sedentary breaks. This single item questionnaire is scored 6-20 (6 = light exertion; 20 maximal exertion).
Single-item feeling scale
Participants self-reported how they felt during each 20, 2-minute activity or sedentary breaks. This single item questionnaire is scored -5 to +5 (-5 = very bad; +5 = very good).
16-item exercise enjoyment measure
Self-reported mood in the morning (800hr), midday (1200hr) and afternoon (1600hr). The scale is a combination of 16 positive and negative statements. The responses were scored on a 5-point Likert like scale (1= disagree a lot, 5 = agree a lot). Seven of the 16 statements were reverse scored.
12-item psychological mood measure
Self-reported mood at midday (1200hr) and afternoon (1600hr). A 3 dimensional, 12-item scale designed to measure changes in 3 categories; positive well-being (e.g., i feel terrific), psychological distress (e.g., i feel miserable), and fatigue (e.g., i feel exhausted). For each item participants will be asked to indicate how strongly they are experiencing the feeling state at that time. Items will be scored on a 7-point Likert scale (1 = "not at all," 7 = "very much so"). Each subscale ranges from 4 to 28 with higher scores representing greater fatigue, positive well-being or psychological distress.

Full Information

First Posted
June 29, 2016
Last Updated
July 12, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02831309
Brief Title
Active Class Space Metabolic Benefits Study
Acronym
ACS
Official Title
Active Class Space Metabolic Benefits Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
ACS examined the potential influence of intermittent physical activity breaks of various intensities (control, light, moderate, vigorous) on measures of immediate mental performance, mood, hunger and several metabolic outcomes in children aged 7-11 years. We build upon previous work to hypothesize that higher-intensity intermittent physical activity breaks throughout an 8-hour day will improve immediate mental performance, mood, and post-exercise physical activity levels, while reducing hunger and post-exercise food intake.
Detailed Description
Background: A range of metabolic, behavioral, mental and physical health benefits of regular physical activity have been documented in adults and children in the long-term. Yet, relatively little is known about how children's usual daily physical activity patterns (i.e. small bursts throughout the day) affect acute (immediately post-activity) and short-term (72 hours post-activity) metabolic and psychosocial outcomes. Additionally, little is known how this specific pattern of physical activity affects subsequent physical activity levels (i.e. compensatory behavior) and subsequent dietary intake, over the short-term- information critical to designing effective interventions involving the physical environment of the school classroom. Overall Goal: Active Class Space (ACS) will examine the potential influence of intermittent physical activity breaks of various intensities (control, light, moderate, vigorous) on measures of immediate mental performance, mood, hunger and several metabolic outcomes in children aged 7-11 years. We build upon previous work to hypothesize that higher-intensity intermittent physical activity breaks throughout an 8-hour day will improve immediate mental performance, mood, and post-exercise physical activity levels, while reducing hunger and post-exercise food intake. Specific Aims: (1) To determine the effects of intermittent physical activity breaks of varying intensities on immediate mental performance, hunger and satiety; (2) To determine the effects of intermittent activity breaks of varying intensities on ratings of perceived exertion (RPE), perceived exercise enjoyment, in-task mood, post-exercise food intake and post-exercise physical activity levels; and (3) To examine gender differences in the preceding variables in response to low-, moderate, and high-intensity intermittent physical activity. Design: Eighteen healthy males and twenty-one healthy females between the ages of 7-11 years completed completed four experimental conditions in random order: (1) 8 hours of sitting interrupted with 2--minute, light--intensity activity breaks performed at 25% of heart rate reserve (HRR) every 18 minutes; (2) 8 hours of sitting interrupted with 2--minute, moderate--intensity activity breaks (50% HRR); (3) 8 hours of sitting interrupted with 2--minute, high--intensity activity breaks (75% HRR); and (4) 8 hours of sitting interrupted with 2 minutes of sedentary screen time. Standardized meals will be provided during each experimental condition. Dietary intake and physical activity levels were monitored for the remainder of the experimental day and over the subsequent three days for each condition. Dependent Variables: Major outcome variables include: Energy expenditure measured by indirect calorimetry and heart rate; dietary intake measured using a 3-day dietary record; physical activity measured by accelerometry; immediate mental performance assessed using a 90-sec mathematical computation test; hunger and satiety assessed using a visual analog scale; RPE assessed using the Borg scale; perceived exercise enjoyment assessed using the physical activity enjoyment scale (PACES); in-task mood assessed using the Feeling Scale (FS) and Subjective Exercise Experiences Scale (SEES). Data Analysis: A linear mixed model will be fitted for each outcome variable with effects for condition, sex, BMI, and baseline physical activity level. A Bonferroni correction will be used to adjust for multiple comparisons in post hoc tests following the mixed-effect model. A similar linear mixed-model for raw levels of each outcome variable over time will also be fitted to assess temporal differences between conditions. This model will include effects for condition, time, time-by-condition interaction, sex, BMI, and baseline physical activity levels. Significance: ACS will shed new light on the short-term metabolic, behavioral, mental and physical health benefits of intermittent physical activity breaks in children. The results from this study will inform the design of behavioral and environmental interventions to promote physical activity and cognitive development in pediatric populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sedentary Condition
Arm Type
Sham Comparator
Arm Description
Forty minutes of screen time. Standardized meals provided.
Arm Title
Light-Intensity Condition
Arm Type
Active Comparator
Arm Description
Forty minutes of light-intensity activity. Standardized meals provided.
Arm Title
Moderate-Intensity Condition
Arm Type
Active Comparator
Arm Description
Forty minutes of moderate-intensity activity. Standardized meals provided.
Arm Title
High-Intensity Condition
Arm Type
Active Comparator
Arm Description
Forty minutes of high-intensity activity. Standardized meals provided.
Intervention Type
Behavioral
Intervention Name(s)
Light-Intensity Condition
Intervention Description
The light-intensity condition consisted of 8 hours of sitting interrupted with 2--minute, light--intensity activity breaks performed at 25% of heart rate reserve (HRR) every 18 minutes. Standardized meals were provided.
Intervention Type
Behavioral
Intervention Name(s)
Moderate-Intensity Condition
Intervention Description
The moderate-intensity condition consisted of 8 hours of sitting interrupted with 2--minute, moderate-intensity activity breaks performed at 50% of heart rate reserve (HRR) every 18 minutes. Standardized meals were provided.
Intervention Type
Behavioral
Intervention Name(s)
High-Intensity Condition
Intervention Description
The high-intensity condition consisted of 8 hours of sitting interrupted with 2--minute, vigorous-intensity activity breaks performed at 75% of heart rate reserve (HRR) every 18 minutes. Standardized meals were provided.
Intervention Type
Behavioral
Intervention Name(s)
Sedentary Condition
Intervention Description
The sedentary condition consisted of 8 hours of sitting interrupted with 2-minutes of screen time every 18 minutes. Standardized meals were provided.
Primary Outcome Measure Information:
Title
Physical activity energy expenditure
Description
Physical activity energy expenditure throughout the condition day and over the next three days. Participants wore an accelerometer for four days. Energy expenditure was calculated from accelerometer data.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
40-item immediate mental performance math test
Description
Number of math questions answered correctly within 90 seconds in the morning (800hr), midday (1200hr) and afternoon (1600hr). Scores were marked as number correct out of 40.
Time Frame
1 day
Title
Dietary intake
Description
Standardized meals were provided in the morning, midday and evening and 3-day dietary records were collected three days post-condition day. Total daily dietary intake was calculated from food consumed in the lab and at home.
Time Frame
4 days
Title
Physical activity minutes
Description
Physical activity minutes throughout the condition day and over the next three days. Participants wore an accelerometer for four days. Minutes participating in physical activity was calculated using accelerometer data.
Time Frame
4 days
Title
4-item hunger and satiety visual analog scale
Description
Self reported hunger and satiety in the morning (800hr), midday (1200hr) and afternoon (1600hr). Scores were calculated from a visual analog scale ranging from 0-100 (0= hungry; 0=full), yielding a total between 0- 400
Time Frame
1 day
Title
Single-item ratings of perceived exertion
Description
Perceived exertion during 20, 2-minute activity or sedentary breaks. This single item questionnaire is scored 6-20 (6 = light exertion; 20 maximal exertion).
Time Frame
1 day
Title
Single-item feeling scale
Description
Participants self-reported how they felt during each 20, 2-minute activity or sedentary breaks. This single item questionnaire is scored -5 to +5 (-5 = very bad; +5 = very good).
Time Frame
1 day
Title
16-item exercise enjoyment measure
Description
Self-reported mood in the morning (800hr), midday (1200hr) and afternoon (1600hr). The scale is a combination of 16 positive and negative statements. The responses were scored on a 5-point Likert like scale (1= disagree a lot, 5 = agree a lot). Seven of the 16 statements were reverse scored.
Time Frame
1 day
Title
12-item psychological mood measure
Description
Self-reported mood at midday (1200hr) and afternoon (1600hr). A 3 dimensional, 12-item scale designed to measure changes in 3 categories; positive well-being (e.g., i feel terrific), psychological distress (e.g., i feel miserable), and fatigue (e.g., i feel exhausted). For each item participants will be asked to indicate how strongly they are experiencing the feeling state at that time. Items will be scored on a 7-point Likert scale (1 = "not at all," 7 = "very much so"). Each subscale ranges from 4 to 28 with higher scores representing greater fatigue, positive well-being or psychological distress.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children ages 7-11 years old from the greater Ann Arbor and Ypsilanti areas were recruited to participate in this study. Exclusion Criteria: Participants were excluded based on the following criteria: (1) were taking medications or were diagnosed with diseases that could influence exercise ability or cognitive function and (2) were previously diagnosed with any major illness/health condition since birth.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca E Hasson, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childhood Disparities Research Laboratory
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30849931
Citation
Weston E, Nagy M, Ajibewa TA, O'Sullivan M, Block S, Hasson RE. Acute Effects of Interrupting Prolonged Sitting With Intermittent Physical Activity on Blood Pressure in Preadolescent Children. Pediatr Exerc Sci. 2019 Nov 1;31(4):408-415. doi: 10.1123/pes.2018-0224. Epub 2019 Jun 27.
Results Reference
derived
PubMed Identifier
29485933
Citation
Block SS, Tooley TR, Nagy MR, O'Sullivan MP, Robinson LE, Colabianchi N, Hasson RE. Acute Effect of Intermittent Exercise and Action-Based Video Game Breaks on Math Performance in Preadolescent Children. Pediatr Exerc Sci. 2018 Aug 1;30(3):326-334. doi: 10.1123/pes.2017-0183. Epub 2018 Feb 27.
Results Reference
derived
PubMed Identifier
28682697
Citation
Nagy MR, O'Sullivan MP, Block SS, Tooley TR, Robinson LE, Colabianchi N, Hasson RE. Affective Responses to Intermittent Physical Activity in Healthy Weight and Overweight/Obese Elementary School-Age Children. J Phys Act Health. 2017 Nov 1;14(11):845-851. doi: 10.1123/jpah.2016-0552. Epub 2017 Oct 6.
Results Reference
derived
PubMed Identifier
28605263
Citation
O'Sullivan MP, Nagy MR, Block SS, Tooley TR, Robinson LE, Colabianchi N, Hasson RE. Acute Compensatory Responses to Interrupting Prolonged Sitting With Intermittent Activity in Preadolescent Children. Pediatr Exerc Sci. 2018 May 1;30(2):259-265. doi: 10.1123/pes.2017-0078. Epub 2017 Oct 12.
Results Reference
derived

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Active Class Space Metabolic Benefits Study

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