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Clinical Trials/NCT03593798
NCT03593798
Completed
Not Applicable

Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity

Sykehuset i Vestfold HF2 sites in 1 country200 target enrollmentNovember 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Capacity
Sponsor
Sykehuset i Vestfold HF
Enrollment
200
Locations
2
Primary Endpoint
Weight change at 12-weeks follow up
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2013
End Date
May 30, 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jarle Berge

Principal investigator

Sykehuset i Vestfold HF

Eligibility Criteria

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

Outcomes

Primary Outcomes

Weight change at 12-weeks follow up

Time Frame: Changes from baseline body weight 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.

Weight change at 1-year follow up

Time Frame: Changes from baseline body weight 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.

Secondary Outcomes

  • Physical capacity changes after 12 weeks as assessed by the maximal oxygen uptake test(Changes from baseline physical capacity at 12-weeks follow up.)

Study Sites (2)

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