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GO-ACTIWE Energy Metabolism

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ClinicalTrials.gov Identifier: NCT01973686
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Bente Merete Stallknecht, University of Copenhagen

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)

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Active Commuting To Improve Well-being and Health in Everyday Life (ACTIWE)
Actual Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2017

Arm Intervention/treatment
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
No Intervention: Control
Receives no intervention



Primary Outcome Measures :
  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 Outcome Measures :
  1. Net energy balance and degree of compensation [ Time Frame: 3 and 6 months ]
    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

  2. Compensatory mechanisms [ Time Frame: Baseline, 3 and 6 months ]
    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

  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 Outcome Measures:
  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



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participation in main study (NCT 01962259)

Exclusion Criteria:

  • No participation in main study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973686


Locations
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Denmark
University of Copenhagen, Department of Biomedical Sciences
Copenhagen, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Bente M Stallknecht, MD PhD DMSc Professor

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bente Merete Stallknecht, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01973686     History of Changes
Other Study ID Numbers: ACTIWE-2
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms