Back to resultsAppetite and Adiposity Across a Continuum of Activity (AAA)
Primary Purpose
Physical Activity and Sedentary Behavior
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-monitoing
Sponsored by
About this trial
This is an interventional basic science trial for Physical Activity and Sedentary Behavior
Eligibility Criteria
Inclusion Criteria:
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
- 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
Exclusion Criteria:
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sedentary
Active
Arm Description
Individuals will reduce their physical activity level for 14-days
Individuals will increase their physical activity level for 14-days
Outcomes
Primary Outcome Measures
Appetite- subjective
Change in appetite will be assessed through subjective ratings of hunger and fullness
Secondary Outcome Measures
Appetite- objective
Change in appetite will be assessed through objective measures of appetite-related hormones
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02763449
Brief Title
Appetite and Adiposity Across a Continuum of Activity
Acronym
AAA
Official Title
Appetite and Adiposity Across a Continuum of Activity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iowa State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity and Sedentary Behavior
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sedentary
Arm Type
Experimental
Arm Description
Individuals will reduce their physical activity level for 14-days
Arm Title
Active
Arm Type
Experimental
Arm Description
Individuals will increase their physical activity level for 14-days
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoing
Intervention Description
Participants will self-monitor their physical activity level via activity monitors
Primary Outcome Measure Information:
Title
Appetite- subjective
Description
Change in appetite will be assessed through subjective ratings of hunger and fullness
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Appetite- objective
Description
Change in appetite will be assessed through objective measures of appetite-related hormones
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Appetite and Adiposity Across a Continuum of Activity
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