Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Intensive Lifestyle Intervention

• Registration Number: NCT01997060
• Lead Sponsor: University of Copenhagen

Brief Summary

In Denmark and the western world, there is an increasing prevalence of obesity probably due to a combination of inadequate daily physical activity and a high energy intake. One approach to achieve weight loss and change life style is to participate in an intensive supervised prolonged life style modification course. The immediate effect is often positive, but over time the overall effect is limited as the majority will not maintain weight loss and a changed life style.

The purpose of this study is therefore to characterize the physiological factors that determine/influence the capacity to maintain weight loss and a healthy lifestyle after a prolonged lifestyle intervention.

We have the following research questions:

1. Are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss?

2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict success in maintaining weight loss and lifestyle changes 3, 12 and 39 months after intervention?

3. How does gender and age influence the capacity to maintain the lifestyle induced adaptation in muscle and adipose tissue and maintaining weight loss?

The study design is a longitudinal intervention and will be based on a lifestyle intervention, as it is practiced in a real life setting at Ubberup folk high school.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Participants at Ubberup Folk High School

Exclusion Criteria

• Previous Gastric Bypass Surgery or Gastric Banding
• BMI<25

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intensive Lifestyle Intervention	Intensive Lifestyle Intervention	Intensive Lifestyle Intervention at Ubberup Folk High School for 10-14 weeks. Daily exercise for 1-3hrs. Calorie restriction (\~-700KCal/day). Education within nutrition, exercise and healthy living in general.

Primary Outcome Measures

Name	Time	Method
Total body weight	Changes from baseline at 3, 6, 15 and 39 months

Secondary Outcome Measures

Name	Time	Method
Anthropometry	Changes from baseline at 3, 6, 15 and 39 months	Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.
Maximal Oxygen Consumption	Changes from baseline at 3, 6, 15 and 39 months
Maximal fat oxidation during exercise	Changes from baseline at 3, 6, 15 and 39 months	Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.

Trial Locations

Locations (1)

University of Copenhagen, Department of Biomedical Sciences; 🇩🇰 Copenhagen, Denmark