Lifestyle Intervention and Physical Capacity in Patients With Morbid Obesity

NCT03593798 | Completed

• 1 other identifier: LEICO
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Physical Capacity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  Changes from baseline physical capacity at 12-weeks follow up.

Interventions

Lifestyle OTHER

Lifestyle intervention an effect on weight and physical capacity

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Obese patient seeking lifestyle intervention program

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sykehuset i Vestfold HF: lead
• University college of south-east Norway: collaborator

Study Sites (2)

Telemark University College

Bø, 3800, Norway

Location

Vestfold Hospital Trust

Tønsberg, 3103, Norway

Location

Related Publications (1)

• 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.

  PMID: 31262301 DERIVED

Study Officials

• Jens Hertel, PhD

  The Hospital of Vestfold

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: July 20, 2018
• Study Start: November 1, 2013
• Primary Completion: May 30, 2016
• Study Completion: May 30, 2016
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

NO (2)