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ObesityNCT01997060

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

A study testing Intensive Lifestyle Intervention in people with Obesity and Overweight, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
Intensive Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteDenmark
Study dates
Jan 2014to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants at Ubberup Folk High School

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • University of Copenhagen, Department of Biomedical Sciences

    Copenhagen, 2200

Other trials in Denmark

About this 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.

Read more

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.

Conditions
Obesity, Overweight
Being tested
Intensive Lifestyle Intervention
Keywords
Lifestyle intervention, Body weight, Body composition, Weight loss maintenance, Physical activity
Medical subject headings
Obesity, Overweight, Body Weight, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Lifestyle InterventionBehavioural

Study groups in NCT01997060
Study groupRoleWhat they receive
Intensive Lifestyle InterventionExperimentalIntensive 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.
Receives: Behavioral: Intensive Lifestyle Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total body weight

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

Secondary outcomes (3)

  1. Maximal fat oxidation during exercise

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

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

  2. Anthropometry

    Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.

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

  3. Maximal Oxygen Consumption

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01997060
Sponsor's protocol ID
UBBERUP2
Status last verified
Jan 2016
First submitted
21 Nov 2013
Last updated
1 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Karlsen TI, Sohagen M, Hjelmesaeth J. Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Health Qual Life Outcomes. 2013 Oct 3;11:165. doi: 10.1186/1477-7525-11-165.

    PubMed 24090083

  • McCormack SE, McCarthy MA, Harrington SG, Farilla L, Hrovat MI, Systrom DM, Thomas BJ, Torriani M, McInnis K, Grinspoon SK, Fleischman A. Effects of exercise and lifestyle modification on fitness, insulin resistance, skeletal muscle oxidative phosphorylation and intramyocellular lipid content in obese children and adolescents. Pediatr Obes. 2014 Aug;9(4):281-91. doi: 10.1111/j.2047-6310.2013.00180.x. Epub 2013 Jun 25.

    PubMed 23801526

  • Danielsen KK, Svendsen M, Maehlum S, Sundgot-Borgen J. Changes in body composition, cardiovascular disease risk factors, and eating behavior after an intensive lifestyle intervention with high volume of physical activity in severely obese subjects: a prospective clinical controlled trial. J Obes. 2013;2013:325464. doi: 10.1155/2013/325464. Epub 2013 Apr 22.

    PubMed 23710347

  • Bruun JM, Helge JW, Richelsen B, Stallknecht B. Diet and exercise reduce low-grade inflammation and macrophage infiltration in adipose tissue but not in skeletal muscle in severely obese subjects. Am J Physiol Endocrinol Metab. 2006 May;290(5):E961-7. doi: 10.1152/ajpendo.00506.2005. Epub 2005 Dec 13.

    PubMed 16352667

  • Pedersen JO, Zimmermann E, Stallknecht BM, Bruun JM, Kroustrup JP, Larsen JF, Helge JW. [Lifestyle intervention in the treatment of severe obesity]. Ugeskr Laeger. 2006 Jan 9;168(2):167-72. Danish.

    PubMed 16403343

  • Bruun JM, Stallknecht B, Helge JW, Richelsen B. Interleukin-18 in plasma and adipose tissue: effects of obesity, insulin resistance, and weight loss. Eur J Endocrinol. 2007 Oct;157(4):465-71. doi: 10.1530/EJE-07-0206.

    PubMed 17893261

  • Christiansen T, Bruun JM, Madsen EL, Richelsen B. Weight loss maintenance in severely obese adults after an intensive lifestyle intervention: 2- to 4-year follow-up. Obesity (Silver Spring). 2007 Feb;15(2):413-20. doi: 10.1038/oby.2007.530.

    PubMed 17299115

  • Elsborg P, Elbe AM. Exercise-specific volition and motivation for weight loss maintenance following an intensive lifestyle intervention. Health Psychol. 2018 Aug;37(8):759-766. doi: 10.1037/hea0000636.

    PubMed 30024231

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Lifestyle Intervention in people with Obesity and Overweight, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total body weight (time frame: Changes from baseline at 3, 6, 15 and 39 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01997060, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.

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