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

NCT01997060 | Completed DMC

• 1 other identifier: UBBERUP2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.Are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss?
2. 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. 3.How does gender and age influence the capacity to maintain the lifestyle induced adaptation in muscle and adipose tissue and maintaining weight loss?

Conditions

Obesity; Overweight

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total body weight

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

Secondary Outcomes (3)

• Maximal fat oxidation during exercise

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

• Anthropometry

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

• Maximal Oxygen Consumption

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

Other Outcomes (9)

• Adherence to physical activity

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

• Adherence to healthy diet

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

• Mitochondria respiration and efficiency

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

Study Arms (1)

Intensive Lifestyle Intervention

EXPERIMENTAL

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.

Behavioral: Intensive Lifestyle Intervention

Interventions

Intensive Lifestyle Intervention BEHAVIORAL

Intensive Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants at Ubberup Folk High School

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead
• Ubberup Folk High School: collaborator

Study Sites (1)

University of Copenhagen, Department of Biomedical Sciences

Copenhagen, 2200, Denmark

Location

Related Publications (8)

• 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.

  PMID: 24090083 BACKGROUND

• 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.

  PMID: 23801526 BACKGROUND

• 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.

  PMID: 23710347 BACKGROUND

• 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.

  PMID: 16352667 BACKGROUND

• 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.

  PMID: 16403343 BACKGROUND

• 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.

  PMID: 17893261 BACKGROUND

• 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.

  PMID: 17299115 BACKGROUND

• 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.

  PMID: 30024231 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Body Weight; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jørn W Helge, PhD

  University of Copenhagen, Department of Biomedical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 27, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

DK (1)