GO-ACTIWE Energy Metabolism

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973686
• Other study ID #: ACTIWE-2
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: July 2017

Study information

• Verified date: July 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Participation in main study (NCT 01962259)

Exclusion Criteria:

• No participation in main study

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Physical activity

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Department of Biomedical Sciences	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Total body fat	Changes in total body fat (kg) measured by dual x-ray absorptiometry	Change from baseline in body fat at 3 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	Anthropometry	Body composition measured by dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height	Baseline, 3 and 6 months

External Links

•   Project homepage