Physical Activity and Sedentary BehaviorAAANCT02763449
Appetite and Adiposity Across a Continuum of Activity
A study testing Self-monitoing in people with Physical Activity and Sedentary Behavior, run by Iowa State University.
Trial summary
The purpose of this study is to understand what happens when someone either becomes more active or more inactive. This study will measure your energy intake, energy expenditure, and body composition under normal conditions, when you become active, and when you become inactive. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity and Sedentary Behavior
- What is being tested?
- Self-monitoing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2018
- 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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women
- Age 25-35 yrs
- BMI ≥25.0 to <35.0 kg/m2
- Subjective physical activity (pre run-in): Sedentary for the previous 3 months (< 20min, 3 times/week of structured exercise)
- Objective physical activity (run-in): daily steps/day >4500 yet <7,000 during 7 day run-in period
- Weight-stable (± 5%) within the previous 3 months
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- Non-smoking for last year
- Able to provide own transportation to study visits and intervention
- Not currently involved in any other research study
- Willing and able to participate in all aspects of the trial including research testing
- Willing to give informed consent to participate
- Able to participate in a moderate physical exercise program
Who cannot join
- Self-reported significant cardiovascular disease including but not limited to serious arrhythmias, cardiomyopathy, congestive heart failure, myocardial infarction, stroke
- Other self-reported medical conditions including but not limited to metabolic disorders such as diabetes, chronic or recurrent respiratory conditions, active cancer, musculoskeletal disease interfering with exercise, or any serious medical condition that may affect adherence to the protocol or exercising safely, or be aggravated by exercise
- Medications known to affect exercise performance or metabolism (e.g. thyroid medication, beta-blockers, or stimulants)
- Excess caffeine use (> 500mg/day)
- Restrained eater (>13) on the restraint section of the three-factor eating questionnaire
- Current or past diagnosis of an eating disorder
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- Any self-reported contraindications to exercise according to the American College of Sports Medicine criteria
- Pregnant or actively trying to become pregnant
- Gave birth in the past 12 months or <6 months post-lactation
- Other medical, psychiatric or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol.
- Known allergy to the metal nickel
- Known allergies to pasta or tomato sauce
About this study
The purpose of this study is to understand what happens when someone either becomes more active or more inactive. This study will measure your energy intake, energy expenditure, and body composition under normal conditions, when you become active, and when you become inactive.
- Conditions
- Physical Activity and Sedentary Behavior
- Being tested
- Self-monitoing
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoingBehavioural
Participants will self-monitor their physical activity level via activity monitors
| Study group | Role | What they receive |
|---|---|---|
| Sedentary | Experimental | Individuals will reduce their physical activity level for 14-days Receives: Behavioral: Self-monitoing |
| Active | Experimental | Individuals will increase their physical activity level for 14-days Receives: Behavioral: Self-monitoing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite- subjective
Change in appetite will be assessed through subjective ratings of hunger and fullness
Measured: 14 days
Secondary outcomes (1)
Appetite- objective
Change in appetite will be assessed through objective measures of appetite-related hormones
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Activity and Sedentary BehaviorStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Shook, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763449
- Sponsor's protocol ID
- AAA-1
- Acronym
- AAA
- Status last verified
- May 2016
- First submitted
- 4 Apr 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite and Adiposity Across a Continuum of Activity
- ClinicalTrials.gov ID
- NCT02763449
- Acronym / sponsor ID
- AAA / AAA-1
- Conditions
- Physical Activity and Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 May 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.
The purpose of this study is to understand what happens when someone either becomes more active or more inactive. This study will measure your energy intake, energy expenditure, and body composition under normal conditions, when you become active, and when you become inactive.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary | Experimental | Behavioral: Self-monitoingIndividuals will reduce their physical activity level for 14-days |
| Active | Experimental | Behavioral: Self-monitoingIndividuals will increase their physical activity level for 14-days |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Men and women
Key exclusion criteria (12 listed)
- Self-reported significant cardiovascular disease including but not limited to serious arrhythmias, cardiomyopathy, congestive heart failure, myocardial infarction, stroke
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 |
|---|---|---|
| Self-monitoingParticipants will self-monitor their physical activity level via activity monitors | Behavioural | Active, Sedentary |
Primary outcome
Appetite- subjective
Time frame: 14 days
Change in appetite will be assessed through subjective ratings of hunger and fullness
1 secondary outcome
Appetite- objective
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Self-monitoing in people with Physical Activity and Sedentary Behavior, run by Iowa State University.
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 12 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Appetite- subjective (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2016.