Appetite and Adiposity Across a Continuum of Activity
AAA
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 5, 2016
May 1, 2016
1.4 years
April 4, 2016
May 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Appetite- subjective
Change in appetite will be assessed through subjective ratings of hunger and fullness
14 days
Secondary Outcomes (1)
Appetite- objective
14 days
Study Arms (2)
Sedentary
EXPERIMENTALIndividuals will reduce their physical activity level for 14-days
Active
EXPERIMENTALIndividuals will increase their physical activity level for 14-days
Interventions
Participants will self-monitor their physical activity level via activity monitors
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 4, 2016
First Posted
May 5, 2016
Study Start
May 1, 2016
Primary Completion
October 1, 2017
Study Completion
December 1, 2018
Last Updated
May 5, 2016
Record last verified: 2016-05