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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Childhood Obesity
- 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 group | Role | What they receive |
|---|---|---|
| Sedentary Condition | Sham comparator | Forty minutes of screen time. Standardized meals provided. Receives: Behavioral: Sedentary Condition |
| Light-Intensity Condition | Active comparator | Forty minutes of light-intensity activity. Standardized meals provided. Receives: Behavioral: Light-Intensity Condition |
| Moderate-Intensity Condition | Active comparator | Forty minutes of moderate-intensity activity. Standardized meals provided. Receives: Behavioral: Moderate-Intensity Condition |
| High-Intensity Condition | Active comparator | Forty 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.
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)
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
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
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-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
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
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
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
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.
- First posted13 Jul 2016 (estimated)
- Study startJun 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Hasson, University of Michigan
- Investigators
- Rebecca E Hasson, PhD, Principal investigator, University of Michigan
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 30849931Block 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 29485933Nagy 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 28682697O'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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Class Space Metabolic Benefits Study
- ClinicalTrials.gov ID
- NCT02831309
- Acronym / sponsor ID
- ACS / HUM00084540
- Conditions
- Childhood Obesity
- Keywords
- physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sedentary Condition | Sham comparator | Behavioral: Sedentary ConditionForty minutes of screen time. Standardized meals provided. |
| Light-Intensity Condition | Active comparator | Behavioral: Light-Intensity ConditionForty minutes of light-intensity activity. Standardized meals provided. |
| Moderate-Intensity Condition | Active comparator | Behavioral: Moderate-Intensity ConditionForty minutes of moderate-intensity activity. Standardized meals provided. |
| High-Intensity Condition | Active comparator | Behavioral: High-Intensity ConditionForty minutes of high-intensity activity. Standardized meals provided. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children ages 7-11 years old from the greater Ann Arbor and Ypsilanti areas were recruited to participate in this study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light-Intensity ConditionThe 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. | Behavioural | Light-Intensity Condition |
| Moderate-Intensity ConditionThe 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. | Behavioural | Moderate-Intensity Condition |
| High-Intensity ConditionThe 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. | Behavioural | High-Intensity Condition |
| Sedentary ConditionThe sedentary condition consisted of 8 hours of sitting interrupted with 2-minutes of screen time every 18 minutes. Standardized meals were provided. | Behavioural | Sedentary Condition |
Primary outcome
Physical activity energy expenditure
Time frame: 4 days
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.
8 secondary outcomes
40-item immediate mental performance math test
Time frame: 1 day
Dietary intake
Time frame: 4 days
Physical activity minutes
Time frame: 4 days
4-item hunger and satiety visual analog scale
Time frame: 1 day
Single-item ratings of perceived exertion
Time frame: 1 day
Single-item feeling scale
Time frame: 1 day
16-item exercise enjoyment measure
Time frame: 1 day
12-item psychological mood measure
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Derived from this study: PubMed 30849931Weston 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.
- Derived from this study: PubMed 29485933Block 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.
- Derived from this study: PubMed 28682697Nagy 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.
- Derived from this study: PubMed 28605263O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca E Hasson, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
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.