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Completed

NCT Number: NCT01973686

GO-ACTIWE Energy Metabolism

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)

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen, Department of Biomedical Sciences

Copenhagen, 2200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in main study (NCT 01962259)

Exclusion criteria

  • No participation in main study

Treatment and study plan

Physical activity

Behavioral

Primary outcomes

  1. Total body fat

    Time frame: Change from baseline in body fat at 3 months

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

  2. Total body fat

    Time frame: Change from baseline in body fat at 6 months

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

Secondary outcomes

  1. Net energy balance and degree of compensation

    Time frame: 3 and 6 months

    • 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

  2. Compensatory mechanisms

    Time frame: Baseline, 3 and 6 months

    • 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

  3. Appetite control

    Time frame: Baseline, 3 and 6 months

    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

  4. Anthropometry

    Time frame: Baseline, 3 and 6 months

    Body composition measured by dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height

Other outcomes

  1. Exercise compliance and energy expenditure

    Time frame: Baseline, 3 and 6 month

    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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 31, 2013
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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