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The Effect of Lifestyle Treatment in Patients With Morbid Obesity (LIFETIME)

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ClinicalTrials.gov Identifier: NCT03593148
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
University college of south-east Norway
Information provided by (Responsible Party):
Jarle Berge, Sykehuset i Vestfold HF

Tracking Information
First Submitted Date  ICMJE April 30, 2018
First Posted Date  ICMJE July 19, 2018
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date December 23, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
Weight change at 2-year follow up [ Time Frame: Changes from baseline body weight at 2-year follow up. ]
Effect of intensive treatment on weight loss changes at 2- year follow up. Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and at 2-year follow up.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
  • Maximal leg strength change at 2-year follow up [ Time Frame: Changes from baseline maximal leg strenght at 2-year follow up. ]
    Maximum leg strength will be measure with a bone press device (OPS161 Interchangeable Leg Press) at baseline, after 3-6 month and 1-2 years. The test will be conduct as an individual adapted protocol with gradual loading until voluntary maximum bone strength is achieve.
  • Physical capacity change at 2-year follow up [ Time Frame: Changes from baseline physical capacity at 2-year follow up. ]
    Physical capacity will be measure as maximum oxygen uptake (VO2max) by indirect calorimetry (Jaeger Oxycone Pro) at baseline, after 3-6 month and 1-2 years. Indirect calorimetry is to be regard as a gold standard for measurement of maximum oxygen uptake.
  • Health-related quality of life (HRQoL) - Short Form Health Survey (RAND-36), change at 2-year follow up [ Time Frame: Changes from baseline RAND-36 at 2-year follow up. ]
    The patient reported outcome measurements (PROMS) comprise three elements; generic and obesity specific health related quality of life (HRQoL) and obesity specific symptoms measured at baseline, 3 months, 6 months, 1 year and 2 years. The RAND-36 is a 36-item measure of generic HRQOL consisting of eight additive subscales (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health) and two summary scores each based on four subscales (Physical Component Summary and Mental Component Summary). Scores on all subscales range from 0 to 100. Summary-scores will be norm-based, with mean (SD) 50 (10). Higher scores on all scales represent better HRQOL.
  • Health-related quality of life (HRQoL) - Impact on Weight Questionnaire (IWQOL-Lite), change at 2-year follow up [ Time Frame: Changes from baseline IWQOL-Lite at 2-year follow up. ]
    The patient reported outcome measurements (PROMS) comprise three elements; generic and obesity specific health related quality of life (HRQoL) and obesity specific symptoms measured at baseline, 3 months, 6 months, 1 year and 2 years. The IWQOL-Lite is a 31-item measure of weight-related quality of life. There are five domain scores (Physical Function, Self-Esteem, Sexual Life, Public Distress and Work) and a total score. Scores for all domains and total score range from 0-100, with lower scores indicating greater impairment.
  • Health-related quality of life (HRQoL) - Weight-Related Symptom Measure (WRSM), change at 2-year follow up [ Time Frame: Changes from baseline WRSM at 2-year follow up. ]
    The patient reported outcome measurements (PROMS) comprise three elements; generic and obesity specific health related quality of life (HRQoL) and obesity specific symptoms measured at baseline, 3 months, 6 months, 1 year and 2 years. The WRSM is a 20-item measure for the presence and distress of 20 weight-related symptoms. The distress scores of the symptoms are reported on a six-point likert scale. Two summary scores are calculated; an additive score of presence of symptoms ranging from 1 to 20 and a symptom distress score for all symptoms. Symptom distress scores range from 0 to 100, with higher scores indicating a higher or worse total symptom distress.
  • Binge Eating Scale (BES), change at 2-year follow up [ Time Frame: Changes from baseline BES at 2-year follow up. ]
    The patient reported outcome measurements (PROMS) eating behavior at baseline, 3 months, 6 months, 1 year and 2 years. The Binge Eating Scale comprise 16 items assessing binge eating problems. Additive scores range between 0-46, with higher scores indicating greater problems. Cut-off scores have been established to determine binge severity, with "severe" represented by scores > 27, "moderate" by scores 18-26, and "mild-none" by scores < 17.
  • The Power of Food scale (PFS) change at 2-year follow up [ Time Frame: Changes from baseline PES at 2-year follow up. ]
    The patient reported outcome measurements (PROMS) eating behavior at baseline, 3 months, 6 months, 1 year and 2 years. The Power of Food scale assess both the psychological impact and respondent's responsiveness to a food-abundant environment. This is a 15-item scale whose items pertain to three situations: food being readily available in the environment but not physically present, food is physically present, but not tasted, and food is first tasted but not already consumed. The three subscales is scored 0-100 with higher scores indicating greater eating problems.
  • Weight change at 1-year follow up [ Time Frame: Changes from baseline body weight at 1-year follow up. ]
    Effect of intensive treatment on weight loss changes after 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 at 1-year follow up.
  • Three Factor Eating Questionnaire (TFEQ - R21) [ Time Frame: Changes from baseline TFEQ-R21 at 2-year follow up. ]
    The patient reported outcome measurements (PROMS) eating behavior at baseline, 3 months, 6 months, 1 year and 2 years. TFEQ-R21 consists of 21 questions that measure cognitive and emotional conditions related to food intake, as well as degree of control over food intake. Each item scores either 0 or 1 point.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Lifestyle Treatment in Patients With Morbid Obesity
Official Title  ICMJE The Effect of Lifestyle Treatment on Physical Capacity, Maximal Strength, Eating Behavior and Quality of Life in Patients With Morbid Obesity
Brief Summary The effect of lifestyle treatment on physical capacity, maximal strength, eating behavior and quality of life in patients with morbid obesity (LIFETIME)
Detailed Description In this study, the investigators will investigate whether more intensive day-based lifestyle treatment process have a better effect on weight loss and health-related quality of life than a previous treatment. Investigators also want to investigate whether patients with good physical capacity (maximal oxygen uptake) and bone strength (maximum bone strength) before initiating treatment and / or after 3 and 6 months intensive training may have greater weight loss 1 and 2 years after treatment than patients with lower physical capacity and bone strength.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Physical Capacity
  • Leg Strength
  • Eating Behavior
  • Life of Quality
Intervention  ICMJE Other: Lifestyle
Lifestyle treatment
Study Arms  ICMJE Lifestyle treatment
Patients will be included in the Lifestyle treatment that is a existing treatment program at Vestfold Hospital Trust.
Intervention: Other: Lifestyle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 23, 2025
Estimated Primary Completion Date December 23, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Treatment seeking 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
  • Pregnancy
  • Severe eating disorders
  • Active substance abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jarle Berge +47 33134111 jarle.berge@siv.no
Contact: Jens Hertel, PhD +4733342000
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03593148
Other Study ID Numbers  ICMJE LIFETIME
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jarle Berge, Sykehuset i Vestfold HF
Study Sponsor  ICMJE Sykehuset i Vestfold HF
Collaborators  ICMJE University college of south-east Norway
Investigators  ICMJE
Principal Investigator: Jens Hertel, PhD The Hospital of Vestfold
PRS Account Sykehuset i Vestfold HF
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP