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Childhood ObesityACSNCT02831309

Active Class Space Metabolic Benefits Study

A study testing Light-Intensity Condition, Moderate-Intensity Condition and High-Intensity Condition in people with Childhood Obesity, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Obesity
What is being tested?
Light-Intensity Condition, Moderate-Intensity Condition and High-Intensity Condition
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteUnited States
Study dates
Jun 2014to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Childhood Disparities Research Laboratory

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Read the 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.

Being tested
Light-Intensity Condition, Moderate-Intensity Condition, High-Intensity Condition, Sedentary Condition
Keywords
physical activity
Medical subject headings
Pediatric Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Light-Intensity ConditionBehavioural

    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.

  • Moderate-Intensity ConditionBehavioural

    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.

  • High-Intensity ConditionBehavioural

    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.

  • Sedentary ConditionBehavioural

    The sedentary condition consisted of 8 hours of sitting interrupted with 2-minutes of screen time every 18 minutes. Standardized meals were provided.

Study groups in NCT02831309
Study groupRoleWhat they receive
Sedentary ConditionSham comparatorForty minutes of screen time. Standardized meals provided.
Receives: Behavioral: Sedentary Condition
Light-Intensity ConditionActive comparatorForty minutes of light-intensity activity. Standardized meals provided.
Receives: Behavioral: Light-Intensity Condition
Moderate-Intensity ConditionActive comparatorForty minutes of moderate-intensity activity. Standardized meals provided.
Receives: Behavioral: Moderate-Intensity Condition
High-Intensity ConditionActive comparatorForty minutes of high-intensity activity. Standardized meals provided.
Receives: Behavioral: High-Intensity Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 days

Secondary outcomes (8)
  1. 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.

    Measured: 1 day

  2. 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.

    Measured: 4 days

  3. 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.

    Measured: 4 days

  4. 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

    Measured: 1 day

  5. 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).

    Measured: 1 day

  6. 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).

    Measured: 1 day

  7. 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.

    Measured: 1 day

  8. 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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2016 (estimated)
  2. Study startJun 2014
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02831309
Sponsor's protocol ID
HUM00084540
Acronym
ACS
Status last verified
Jul 2016
First submitted
29 Jun 2016
Last updated
13 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30849931
  • 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.

    PubMed 29485933
  • 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.

    PubMed 28682697
  • 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.

    PubMed 28605263

Questions about this trial

What is this clinical trial studying?

A study testing Light-Intensity Condition, Moderate-Intensity Condition and High-Intensity Condition in people with Childhood Obesity, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity energy expenditure (time frame: 4 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02831309, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.

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