Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity

Completed

• Conditions: Physical Capacity

• Registration Number: NCT03593798
• Lead Sponsor: Sykehuset i Vestfold HF

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.

Study Timeline

• Study Start: 2013-11-01
• Primary Completion: 2016-05-30
• Study Completion: 2016-05-30
• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-20
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight change at 12-weeks follow up	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	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 Outcome Measures

Name	Time	Method
Physical capacity changes after 12 weeks as assessed by the maximal oxygen uptake test	Changes from baseline physical capacity at 12-weeks follow up.	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.

Trial Locations

Locations (2)

Vestfold Hospital Trust; 🇳🇴 Tønsberg, Norway

Telemark University College; 🇳🇴 Bø, Norway