Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity (LEICO)

Lifestyle intervention and physical capacity in patients with morbid Obesity (LEICO)

Study Overview

• Status: Completed
• Conditions: Physical Capacity
• Intervention / Treatment: Other: Lifestyle

Detailed Description

It is still uncertainty about which is the most effective lifestyle treatment to reducing body weight and increased quality of life. Increased physical capacity and muscle mass lead to increased energy expenditure, thus explaining parts of the difference in weight loss achieved after lifestyle treatment. However, literature in this area is limited and need better documentation of how, and to what extent increased physical capacity can affect the effect of lifestyle treatment offered to patients in the health service.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Norway
  • Bø, Norway, 3800
    • Telemark University College
  • Tønsberg, Norway, 3103
    • Vestfold Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Obese patient seeking lifestyle intervention program

Description

Inclusion Criteria:

• Treatment morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the Vestfold Hospital Trust.

Exclusion Criteria:

• Uncompensated heart failure
• Recent myocardial infarction or stroke (<½ years)
• Severe arrhythmia or heart failure
• Unstable angina pectoris
• Renal failure
• Severe eating disorders
• Active substance abuse

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change at 1-year follow up	Can physical capacity before start of a routine medical care have a impact on weight loss at 1-year follow-up. Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and after 1-year follow up. Changes from baseline body weight at 1-year follow up. Participants receive interventions as part of routine medical care, and studie the effect of the intervention.	Changes from baseline body weight at 1-year follow up.
Weight change at 12-weeks follow up	Can physical capacity before start of a routine medical care have a impact on weight loss at 12-weeks follow-up. Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and after 12-weeks follow up. Changes from baseline body weight at 12-weeks follow up. Participants receive interventions as part of routine medical care, and studie the effect of the intervention.	Changes from baseline body weight at 12-weeks follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical capacity changes after 12 weeks as assessed by the maximal oxygen uptake test	Can the mean twelve-week change in physical capacity be associated with weight loss. The maximal oxygen uptake test was performed as an incremental treadmill test on Woodway ELG 55 (Waukesha, Germany) or, for patients with walking restrictions, on an incremental bicycle test (Lode Corival V3, Lode BV, Groningen, Netherlands). Oxygen uptake was registered using the Jaeger oxycon pro ergospirometry test system (Jaeger Oxycon Pro JLAB 5.x, Hoechberg, Germany). Changes from baseline physical capacity at 12-weeks follow up.	Changes from baseline physical capacity at 12-weeks follow up.

Collaborators and Investigators

• Sponsor: Sykehuset i Vestfold HF
• Collaborators: University college of south-east Norway
• Investigators: Study Director: Jens Hertel, PhD, The Hospital of Vestfold

Publications and helpful links

General Publications

• Berge J, Storen O, Hertel JK, Gjevestad E, Smastuen MC, Hjelmesaeth J. Associations between cardiorespiratory fitness and weight loss in patients with severe obesity undergoing an intensive lifestyle intervention program: retrospective cohort study. BMC Endocr Disord. 2019 Jul 1;19(1):69. doi: 10.1186/s12902-019-0394-z.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): May 30, 2016
• Study Completion (Actual): May 30, 2016

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: LEICO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No