NCT02158130

Brief Summary

The proposed study seeks to better understand the role of body weight, energy expenditure, and energy intake as mechanisms of body weight gain during detraining following aerobic exercise. It is hypothesized that participants in the higher dose exercise group will have greater body weight gain compared to the lower exercise dose and control group from wk 24 to wk 76 follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

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

June 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

June 4, 2014

Last Update Submit

March 21, 2016

Conditions

Keywords

Physical InactivityAerobic Exercise DetrainingBody WeightEnergy ExpenditureMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Body Weight

    Fasting body weight

    Week 64 - 88 post study randomization

Secondary Outcomes (2)

  • Energy Expenditure

    Week 64 - 90 since study randomization

  • Energy Intake

    Week 64 - 90 post study randomization

Other Outcomes (5)

  • Circumferences

    Week 64-88 post study randomization

  • Blood Pressure

    Week 64-88 post study randomization

  • Body Composition

    Week 64 - 88 post study randomization

  • +2 more other outcomes

Study Arms (3)

Healthy Living

non exercise healthy living control group

General Health

Exercise Group (8 KKW) One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per week, which will result in each session lasting approximately 30 minutes. We will recruit 1 year post study intervention.

Weight Loss

Exercise Group (20 KKW) Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session. We will recruit 1 year post study intervention.

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants that successfully enrolled and completed the E-Mechanic study and are not past 88 weeks study randomization.

You may qualify if:

  • Completed the E-Mechanic study
  • Be willing to archive blood samples
  • Not participating in a study that would alter body weight, energy intake, or energy expenditure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma

MeSH Terms

Conditions

Motor ActivityBody WeightObesitySedentary BehaviorMetabolic Syndrome

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • John W Apolzan, PhD

    PBRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 6, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations