GO-ACTIWE Energy Metabolism

Active Commuting To Improve Well-being and Health in Everyday Life (ACTIWE)

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)

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Physical activity

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • University of Copenhagen, Department of Biomedical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participation in main study (NCT 01962259)

Exclusion Criteria:

• No participation in main study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Receives no intervention
Experimental: Vigorous intensity LTPA; 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
Experimental: Moderate intensity LTPA; Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week	Behavioral: Physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 and 6 months
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	Baseline, 3 and 6 months
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	Baseline, 3 and 6 months
Anthropometry	Body composition measured by dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height	Baseline, 3 and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise compliance and energy expenditure	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	Baseline, 3 and 6 month

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Bente M Stallknecht, MD PhD DMSc, Professor

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimate): October 31, 2013

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: ACTIWE-2