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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01997060
Enrollment
80
Registered
2013-11-27
Start date
2014-01-31
Completion date
2015-06-30
Last updated
2016-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Lifestyle intervention, Body weight, Body composition, Weight loss maintenance, Physical activity

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.

Interventions

BEHAVIORALIntensive Lifestyle Intervention

Sponsors

Ubberup Folk High School
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Participants at Ubberup Folk High School

Exclusion criteria

* Previous Gastric Bypass Surgery or Gastric Banding * BMI\<25

Design outcomes

Primary

MeasureTime frame
Total body weightChanges from baseline at 3, 6, 15 and 39 months

Secondary

MeasureTime frameDescription
AnthropometryChanges from baseline at 3, 6, 15 and 39 monthsBody composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.
Maximal Oxygen ConsumptionChanges from baseline at 3, 6, 15 and 39 months
Maximal fat oxidation during exerciseChanges from baseline at 3, 6, 15 and 39 monthsRespiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.

Other

MeasureTime frameDescription
Mitochondria respiration and efficiencyChanges from baseline at 3, 6, 15 and 39 monthsMitochondria respiration and efficiency is measured by Oreboros Oxygraph.
Blood and plasma substrates, hormones and metabolitesChanges from baseline at 3, 6, 15 and 39 monthsHbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), ghrelin
Muscle lipid compositionChanges from baseline at 3, 6, 15 and 39 monthsMuscle lipid composition will be analysed using a lipidomics approach.
Expression of muscle lipasesChanges from baseline at 3, 6, 15 and 39 monthsWestern 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)
Intramuscular lipid droplet content and size, glycogen content and ceramide content and locationChanges from baseline at 3, 6, 15 and 39 monthsIntramuscular 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
Adipose tissue macrophage inflammation and cytokine productionChanges from baseline at 3, 6, 15 and 39 months
Motivation for lifestyle changes and sociological factors involvedChanges from baseline at 3, 6, 15 and 39 monthsQuestionnaires
Adherence to physical activityChanges from baseline at 3, 6, 15 and 39 monthsInternational Physical Activity Questionaire (IPAQ) to determine adherence to physical activity. Furthermore we will use diary and ActiHeart (accelerometer).
Adherence to healthy dietChanges from baseline at 3, 6, 15 and 39 monthsQuestionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026