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

Primary Purpose

Physical Capacity, Leg Strength, Eating Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lifestyle
Sponsored by
Sykehuset i Vestfold HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Capacity

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jarle BergeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lifestyle treatment

Arm Description

Patients will be included in the Lifestyle treatment that is a existing treatment program at Vestfold Hospital Trust.

Outcomes

Primary Outcome Measures

Weight change 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.

Secondary Outcome Measures

Maximal leg strength change 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
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
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
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
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
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
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
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)
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.

Full Information

First Posted
April 30, 2018
Last Updated
August 31, 2021
Sponsor
Sykehuset i Vestfold HF
Collaborators
University college of south-east Norway
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1. Study Identification

Unique Protocol Identification Number
NCT03593148
Brief Title
The Effect of Lifestyle Treatment in Patients With Morbid Obesity
Acronym
LIFETIME
Official Title
The Effect of Lifestyle Treatment on Physical Capacity, Maximal Strength, Eating Behavior and Quality of Life in Patients With Morbid Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 23, 2025 (Anticipated)
Study Completion Date
December 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset i Vestfold HF
Collaborators
University college of south-east Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Capacity, Leg Strength, Eating Behavior, Life of Quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle treatment
Arm Type
Other
Arm Description
Patients will be included in the Lifestyle treatment that is a existing treatment program at Vestfold Hospital Trust.
Intervention Type
Other
Intervention Name(s)
Lifestyle
Intervention Description
Lifestyle treatment
Primary Outcome Measure Information:
Title
Weight change at 2-year follow up
Description
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.
Time Frame
Changes from baseline body weight at 2-year follow up.
Secondary Outcome Measure Information:
Title
Maximal leg strength change at 2-year follow up
Description
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.
Time Frame
Changes from baseline maximal leg strenght at 2-year follow up.
Title
Physical capacity change at 2-year follow up
Description
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.
Time Frame
Changes from baseline physical capacity at 2-year follow up.
Title
Health-related quality of life (HRQoL) - Short Form Health Survey (RAND-36), change at 2-year follow up
Description
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.
Time Frame
Changes from baseline RAND-36 at 2-year follow up.
Title
Health-related quality of life (HRQoL) - Impact on Weight Questionnaire (IWQOL-Lite), change at 2-year follow up
Description
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.
Time Frame
Changes from baseline IWQOL-Lite at 2-year follow up.
Title
Health-related quality of life (HRQoL) - Weight-Related Symptom Measure (WRSM), change at 2-year follow up
Description
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.
Time Frame
Changes from baseline WRSM at 2-year follow up.
Title
Binge Eating Scale (BES), change at 2-year follow up
Description
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.
Time Frame
Changes from baseline BES at 2-year follow up.
Title
The Power of Food scale (PFS) change at 2-year follow up
Description
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.
Time Frame
Changes from baseline PES at 2-year follow up.
Title
Weight change at 1-year follow up
Description
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.
Time Frame
Changes from baseline body weight at 1-year follow up.
Title
Three Factor Eating Questionnaire (TFEQ - R21)
Description
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.
Time Frame
Changes from baseline TFEQ-R21 at 2-year follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jarle Berge
Phone
+47 33134111
Email
jarle.berge@siv.no
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Hertel, PhD
Phone
+4733342000
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Hertel, PhD
Organizational Affiliation
The Hospital of Vestfold
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jarle Berge
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarle Berge
Phone
33134111
Email
jarle.berge@siv.no

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Effect of Lifestyle Treatment in Patients With Morbid Obesity

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