Appetite and Adiposity Across a Continuum of Activity (AAA)

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 Overview

• Status: Unknown
• Conditions: Physical Activity and Sedentary Behavior
• Intervention / Treatment: Behavioral: Self-monitoing

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sedentary; Individuals will reduce their physical activity level for 14-days	Behavioral: Self-monitoing; Participants will self-monitor their physical activity level via activity monitors
Experimental: Active; Individuals will increase their physical activity level for 14-days	Behavioral: Self-monitoing; Participants will self-monitor their physical activity level via activity monitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite- subjective	Change in appetite will be assessed through subjective ratings of hunger and fullness	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite- objective	Change in appetite will be assessed through objective measures of appetite-related hormones	14 days

Collaborators and Investigators

• Sponsor: Iowa State University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 4, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 3, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: AAA-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided