NCT02763449

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

April 4, 2016

Last Update Submit

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

EXPERIMENTAL

Individuals will reduce their physical activity level for 14-days

Behavioral: Self-monitoing

Active

EXPERIMENTAL

Individuals will increase their physical activity level for 14-days

Behavioral: Self-monitoing

Interventions

Self-monitoingBEHAVIORAL

Participants will self-monitor their physical activity level via activity monitors

ActiveSedentary

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

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