GO-ACTIWE Energy Metabolism

Study Overview
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Brief Summary
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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)

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in main study (NCT 01962259) Exclusion Criteria: No participation in main study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |