search
Back to results

GO-ACTIWE Energy Metabolism

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical activity
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participation in main study (NCT 01962259)

Exclusion Criteria:

  • No participation in main study

Sites / Locations

  • University of Copenhagen, Department of Biomedical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Vigorous intensity LTPA

Moderate intensity LTPA

Control

Arm Description

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

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

Receives no intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Net energy balance and degree of compensation
1. Net energy balance calculated from changes in body composition, and 2. the degree of compensation as the difference between energy spent during exercise and net energy balance
Compensatory mechanisms
1. Resting metabolic rate determined by indirect calorimetry, 2. Total physical activity (TPA) measured using accelerometry, 3. Non-exercise activity determined as the difference between TPA and exercise activity, and 4. Energy intake determined by food records and during meal tests
Appetite control
Appetite control determined via 1. blood samples (peptides and metabolites) and 2. self rated sensations (visual analogue scales) in relation with standardized meals and exercise, as well as 3. ad libitum energy intake and 4. Eating behaviours determined via three-factor eating questionaire
Anthropometry
Body composition measured by dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height

Full Information

First Posted
October 21, 2013
Last Updated
July 31, 2018
Sponsor
University of Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT01973686
Brief Title
GO-ACTIWE Energy Metabolism
Official Title
Active Commuting To Improve Well-being and Health in Everyday Life (ACTIWE)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vigorous intensity LTPA
Arm Type
Experimental
Arm Description
Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
Arm Title
Moderate intensity LTPA
Arm Type
Experimental
Arm Description
Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
Arm Title
Control
Arm Type
No Intervention
Arm Description
Receives no intervention
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Primary Outcome Measure Information:
Title
Total body fat
Description
Changes in total body fat (kg) measured by dual x-ray absorptiometry
Time Frame
Change from baseline in body fat at 3 months
Title
Total body fat
Description
Changes in total body fat (kg) measured by dual x-ray absorptiometry
Time Frame
Change from baseline in body fat at 6 months
Secondary Outcome Measure Information:
Title
Net energy balance and degree of compensation
Description
1. Net energy balance calculated from changes in body composition, and 2. the degree of compensation as the difference between energy spent during exercise and net energy balance
Time Frame
3 and 6 months
Title
Compensatory mechanisms
Description
1. Resting metabolic rate determined by indirect calorimetry, 2. Total physical activity (TPA) measured using accelerometry, 3. Non-exercise activity determined as the difference between TPA and exercise activity, and 4. Energy intake determined by food records and during meal tests
Time Frame
Baseline, 3 and 6 months
Title
Appetite control
Description
Appetite control determined via 1. blood samples (peptides and metabolites) and 2. self rated sensations (visual analogue scales) in relation with standardized meals and exercise, as well as 3. ad libitum energy intake and 4. Eating behaviours determined via three-factor eating questionaire
Time Frame
Baseline, 3 and 6 months
Title
Anthropometry
Description
Body composition measured by dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Time Frame
Baseline, 3 and 6 months
Other Pre-specified Outcome Measures:
Title
Exercise compliance and energy expenditure
Description
Exercise compliance and energy expenditure will be measured and adjusted continuously with the use of heart rate monitors over the course of the 1 year intervention
Time Frame
Baseline, 3 and 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participation in main study (NCT 01962259) Exclusion Criteria: No participation in main study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente M Stallknecht, MD PhD DMSc
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen, Department of Biomedical Sciences
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28993707
Citation
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.
Results Reference
derived

Learn more about this trial

GO-ACTIWE Energy Metabolism

We'll reach out to this number within 24 hrs