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Completed

NCT Number: NCT03593798

Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity

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

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Key information

Conditions

Physical Capacity

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Telemark University College, Bø, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle

Other

Lifestyle intervention an effect on weight and physical capacity

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Physical capacity changes after 12 weeks as assessed by the maximal oxygen uptake test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sykehuset i Vestfold HF

Other

Collaborators

  • University of South-Eastern Norway

Registry information

Acronym: LEICO

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2018
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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