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Completed

NCT Number: NCT01997060

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

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.

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Key information

Conditions

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

Age range

18 year–65 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

  • Participants at Ubberup Folk High School

Exclusion criteria

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

Treatment and study plan

Intensive lifestyle intervention

Behavioral

Primary outcomes

  1. Total body weight

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

Secondary outcomes

  1. Maximal fat oxidation during exercise

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

    Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.

  2. Anthropometry

    Time frame: 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.

  3. Maximal Oxygen Consumption

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

Other outcomes

  1. Adherence to physical activity

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

    International Physical Activity Questionaire (IPAQ) to determine adherence to physical activity. Furthermore we will use diary and ActiHeart (accelerometer).

  2. Adherence to healthy diet

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

    Questionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet.

  3. Mitochondria respiration and efficiency

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

    Mitochondria respiration and efficiency is measured by Oreboros Oxygraph.

  4. Blood and plasma substrates, hormones and metabolites

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

    HbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), ghrelin

  5. Muscle lipid composition

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

    Muscle lipid composition will be analysed using a lipidomics approach.

  6. Expression of muscle lipases

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

    Western blot analysis will be applied to analyse expression of muscle lipases; hormone sensitive lipase (HSL), adipose triglyceride lipase (ATGL) and lipoprotein lipase (LPL) as well as muscle PAT proteins; PLIN 2 (ADRP), PLIN 3 (TIP47) and PLIN 5 (OXPAT)

  7. Intramuscular lipid droplet content and size, glycogen content and ceramide content and location

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

    Intramuscular lipid droplet content and size, glycogen content and ceramide content and location will be quantified by immunohistochemical staining of serial cryo-sections of muscle tissue samples that are visualized by confocal microscopy

  8. Adipose tissue macrophage inflammation and cytokine production

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

  9. Motivation for lifestyle changes and sociological factors involved

    Time frame: Changes from baseline at 3, 6, 15 and 39 months

    Questionnaires

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Ubberup Folk High School

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2013
Registry last updated
Feb 1, 2016

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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