NCT01973686

Brief Summary

The aim of the present study is to investigate the changes in body composition and the degree of compensation to exercise induced energy expenditure after 1 year of physical activity with either moderate or vigorous intensity in overweight and class 1 obese men and women. The present study is a sub study to main study "Active Commuting To Improve Well-being and Health in Everyday Life" (NCT 01962259)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

2.6 years

First QC Date

October 21, 2013

Last Update Submit

July 31, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Total body fat

    Changes in total body fat (kg) measured by dual x-ray absorptiometry

    Change from baseline in body fat at 3 months

  • Total body fat

    Changes in total body fat (kg) measured by dual x-ray absorptiometry

    Change from baseline in body fat at 6 months

Secondary Outcomes (4)

  • Net energy balance and degree of compensation

    3 and 6 months

  • Compensatory mechanisms

    Baseline, 3 and 6 months

  • Appetite control

    Baseline, 3 and 6 months

  • Anthropometry

    Baseline, 3 and 6 months

Other Outcomes (1)

  • Exercise compliance and energy expenditure

    Baseline, 3 and 6 month

Study Arms (3)

Vigorous intensity LTPA

EXPERIMENTAL

Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week

Behavioral: Physical activity

Moderate intensity LTPA

EXPERIMENTAL

Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week

Behavioral: Physical activity

Control

NO INTERVENTION

Receives no intervention

Interventions

Moderate intensity LTPAVigorous intensity LTPA

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participation in main study (NCT 01962259)

You may not qualify if:

  • No participation in main study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Department of Biomedical Sciences

Copenhagen, 2200, Denmark

Location

Related Publications (1)

  • Quist JS, Rosenkilde M, Petersen MB, Gram AS, Sjodin A, Stallknecht B. Effects of active commuting and leisure-time exercise on fat loss in women and men with overweight and obesity: a randomized controlled trial. Int J Obes (Lond). 2018 Mar;42(3):469-478. doi: 10.1038/ijo.2017.253. Epub 2017 Oct 10.

MeSH Terms

Conditions

OverweightObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bente M Stallknecht, MD PhD DMSc

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2013

First Posted

October 31, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2016

Study Completion

July 1, 2017

Last Updated

August 2, 2018

Record last verified: 2018-07

Locations