Obesity, Lifestyle and Work Intervention
Primary Purpose
Obesity, Morbid Obesity, Sick-leave
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle and work intervention
Lifestyle intervention
Sponsored by
About this trial
This is an interventional health services research trial for Obesity focused on measuring Obesity, Work Focus, Workability, Life-style treatment
Eligibility Criteria
Inclusion Criteria:
- Participants with a Body Mass Index (BMI) > 30 with or without comorbidity
Exclusion Criteria:
- People without a capacity to consent.
- People with severe alcohol and/or drug abuse.
- People with a major mental illness.
- Being pregnant.
- People with a health condition that contraindicates physical activity.
- People with or plan to apply for disability benefits.
- People with permanently adapted work.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lifestyle and work intervention
Lifestyle intervention
Arm Description
Lifestyle intervention with work focus.
Lifestyle intervention without work focus.
Outcomes
Primary Outcome Measures
Full or partial return to work.
Mapping changes in work employability and work related factors with survey data from the ARR form (http://www.arbeidoghelse.no).
Secondary Outcome Measures
Weight loss (kilograms)
Measured changes with Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer.
Return to work self-efficacy
Mapping changes with the Return-to-work-efficacy scale (RTWSE-19). The 19-item RTWSE-19 scale is a new self-report measure intended to assess workers' beliefs of their current ability to resume normal job responsibilities following pain onset. Response range (1-10). 1 is "not sure at all" and 10 is "very sure". The 19 subscales are divided into three main categories, and the total score is the sum of these catagories. Higher value indicate better outcome. (Shaw et.al 2011).
Quality of Life (15D), health-related quality of life
Mapping changes in 15D. The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL. 5 ordinal levels on each dimension, by which more or less of the attribute is distinguished. A set of utility or preference weights is used to generate the 15D score (single index number) on a 0-1 scale. The valuation system of the 15D is based on an application of the multiattribute utility theory. The single index (15D score) on a 0 1 scale, representing the overall HRQoL (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL) is calculated from the health state descriptive system by using a set of population based preference or utility weights. (Harri Sintonen, http://www.15d-instrument.net).
Subjective somatic and psychological complaints
Mapping changes with the scoring system subjective health complaints (SHC). The SHC consists of 29 questions concerning severity and duration of subjective somatic and psychological complaints. Intensity of each complaint is scored on a four-point scale from 0-3, where 0 is no complaints and three is severe complaints. The SHC inventory yields scores on single items and a total number of health complaints categorized into five factors: musculoskeletal pain (alpha=0.74), pseudoneurology (alpha=0.73), gastrointestinal problems (alpha=0.62), allergy (alpha=0.58) and flu (alpha=0.67). Eriksen HR, Ihlebæk C, Ursin H. A scoring system for subjective Health complaints (SHC). Scand J Public Health. 1999;27:63-72.
Vo2 peak
Measured changes in the maximum amount of oxygen the participant can utilize during intense exercise. Measured in litres of oxygen per minute (L/min) or as a relative rate in (for example) millilitres of oxygen per kilogram of body mass per minute (e.g., mL/(kg·min). Physical test on a treadmill.
Body Mass Index
Height will be added in Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer. BMI will be reported in kg/m².
Waist circumstance (cm).
Measured changes with Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer.
Hight (centimetmeters)
The distance from the bottom of the feet to the top of the head, standing erect, measured with a stadiometer, in centimetres.
Promoting and hindering factors for Return to work.
Mapping contextual conditions and mechanisms that might be important in the process back to work through In-Depth interviews
Full Information
NCT ID
NCT03886870
First Posted
March 14, 2019
Last Updated
March 21, 2019
Sponsor
Molde University College
Collaborators
Norwegian Labour and Welfare Administration
1. Study Identification
Unique Protocol Identification Number
NCT03886870
Brief Title
Obesity, Lifestyle and Work Intervention
Official Title
Does Adding A Work Intervention Into An Already Existing Life Style Intervention Improve Work Ability? A Randomized Controlled Trial Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 3, 2014 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molde University College
Collaborators
Norwegian Labour and Welfare Administration
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main aim of this study was to examine whether introducing a work intervention into a traditional lifestyle rehabilitation program for persons with BMI above 30, would affect the participants' ability to work and their lifestyle change. The investigators wanted to find out how the participants experienced their health, workability and work capacity, quality of life, diet and self-efficacy before and during the intervention
Detailed Description
The background for this study was insights about obesity and sick leave. Obesity is related to lower labor force participation, increased sickness absence and reduced productivity. A Danish study from 2006 reported a yearly 1, 8 million extra days of work absence and close to 1.100 cases of disability pension related to obesity. A 2016-report from OECD show that persons with obesity between the ages 50-59 have three times as much work absence as those who do not struggle with obesity. This indicates that persons with obesity are a group where the need for work rehabilitation is important. Despite this connection, work focus has not been a part of lifestyle interventions for persons with morbid obesity until the last two years.
By introducing a work intervention into a traditional lifestyle rehabilitation program for persons with BMI over 30, the investigators wanted to examine whether this would affect the participants' ability to work and their lifestyle change. The study was designed as a randomized controlled study with an exploring prospective design. The intervention lasted 12 months and each patient had three visits (baseline, 6 and 12 months) at Muritunet, each lasting 4-2-2 weeks. The participants were randomized into two intervention, one with work intervention and one without.
Data material gathered at each stay consisting of self-reported forms, test, journal and individual interviews. These were all collected at baseline, and at six and twelve months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid Obesity, Sick-leave, Work Related Illnesses, Life Style
Keywords
Obesity, Work Focus, Workability, Life-style treatment
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was designed as a randomized controlled study with an exploring prospective design. The intervention lasted 12 months and each patient had three visits (baseline, 6 and 12 month) at Muritunet, each lasting 4-2-2 weeks. The participants was randomized either into a lifestyle and work intervention or into a lifestyle intervention.
Data material gathered at each stay consisting of self-reported forms, test, journal and individual interviews. These were all collected at baseline, and at six and twelve months.
Masking
Participant
Masking Description
Single blind masking
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle and work intervention
Arm Type
Experimental
Arm Description
Lifestyle intervention with work focus.
Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
Lifestyle intervention without work focus.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle and work intervention
Intervention Description
The intervention period lasted for a year with three institution-based stays, 4 weeks at baseline and 2 weeks at 6 and 12 months. At baseline, participants got a functional assessment and an individual adjusted rehabilitation plan. At all three stages: The intervention contains activity training with a focus on the joy of movement, strength- and cardio-training. There were lectures and cognitive therapy to promote self-care and lifestyle change. The intervention contained lectures on diet, nutrition and cooking-classes. Participants set goals at baseline and adjusting these during the progress. Exercise programs was designed to use at home. The Cognitive Information Processing model of career guidance was the mainframe for the work dimension. All participants had talks with the work consultant at baseline, 6 and 12 months. Two work lectures, "Duties and rights as employees" and "Work as medicine". When needed the work consultant contacted the employer in order to facilitate changes.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
The intervention period lasted for a year with three institution-based stay, 4 weeks at baseline and 2 weeks at 6 and 12 months. At baseline, participants got a functional assessment and an individual adjusted rehabilitation plan.
At all three stages: The intervention contains activity training with focus on joy of movement, strength- and cardio-training. There was lectures and cognitive therapy to promote self-care and lifestyle change. The intervention contained lectures on diet, nutrition and cooking-classes. Participants set goals at baseline and adjusting these during the progress. They developed exercise programs designed to use at home.
Primary Outcome Measure Information:
Title
Full or partial return to work.
Description
Mapping changes in work employability and work related factors with survey data from the ARR form (http://www.arbeidoghelse.no).
Time Frame
Data collected during the interventions, baseline, 6 and 12 months.
Secondary Outcome Measure Information:
Title
Weight loss (kilograms)
Description
Measured changes with Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer.
Time Frame
Data collected during the interventions, baseline, 6 and 12 months.
Title
Return to work self-efficacy
Description
Mapping changes with the Return-to-work-efficacy scale (RTWSE-19). The 19-item RTWSE-19 scale is a new self-report measure intended to assess workers' beliefs of their current ability to resume normal job responsibilities following pain onset. Response range (1-10). 1 is "not sure at all" and 10 is "very sure". The 19 subscales are divided into three main categories, and the total score is the sum of these catagories. Higher value indicate better outcome. (Shaw et.al 2011).
Time Frame
Data collected during the interventions, baseline, 6 and 12 months.
Title
Quality of Life (15D), health-related quality of life
Description
Mapping changes in 15D. The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL. 5 ordinal levels on each dimension, by which more or less of the attribute is distinguished. A set of utility or preference weights is used to generate the 15D score (single index number) on a 0-1 scale. The valuation system of the 15D is based on an application of the multiattribute utility theory. The single index (15D score) on a 0 1 scale, representing the overall HRQoL (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL) is calculated from the health state descriptive system by using a set of population based preference or utility weights. (Harri Sintonen, http://www.15d-instrument.net).
Time Frame
Data collected during the interventions, baseline, 6 and 12 months.
Title
Subjective somatic and psychological complaints
Description
Mapping changes with the scoring system subjective health complaints (SHC). The SHC consists of 29 questions concerning severity and duration of subjective somatic and psychological complaints. Intensity of each complaint is scored on a four-point scale from 0-3, where 0 is no complaints and three is severe complaints. The SHC inventory yields scores on single items and a total number of health complaints categorized into five factors: musculoskeletal pain (alpha=0.74), pseudoneurology (alpha=0.73), gastrointestinal problems (alpha=0.62), allergy (alpha=0.58) and flu (alpha=0.67). Eriksen HR, Ihlebæk C, Ursin H. A scoring system for subjective Health complaints (SHC). Scand J Public Health. 1999;27:63-72.
Time Frame
Data collected during the interventions, baseline, 6 and 12 months.
Title
Vo2 peak
Description
Measured changes in the maximum amount of oxygen the participant can utilize during intense exercise. Measured in litres of oxygen per minute (L/min) or as a relative rate in (for example) millilitres of oxygen per kilogram of body mass per minute (e.g., mL/(kg·min). Physical test on a treadmill.
Time Frame
Data collected during the interventions, baseline and 12 months.
Title
Body Mass Index
Description
Height will be added in Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer. BMI will be reported in kg/m².
Time Frame
Data collected during the interventions, baseline, 6 and 12 months.
Title
Waist circumstance (cm).
Description
Measured changes with Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer.
Time Frame
Data collected during the interventions, baseline, 6 and 12 months.
Title
Hight (centimetmeters)
Description
The distance from the bottom of the feet to the top of the head, standing erect, measured with a stadiometer, in centimetres.
Time Frame
Data collected during the interventions, baseline.
Title
Promoting and hindering factors for Return to work.
Description
Mapping contextual conditions and mechanisms that might be important in the process back to work through In-Depth interviews
Time Frame
Data collected during the interventions, baseline, 6 and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with a Body Mass Index (BMI) > 30 with or without comorbidity
Exclusion Criteria:
People without a capacity to consent.
People with severe alcohol and/or drug abuse.
People with a major mental illness.
Being pregnant.
People with a health condition that contraindicates physical activity.
People with or plan to apply for disability benefits.
People with permanently adapted work.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir Ove Vegsund
Organizational Affiliation
Muritunet
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Abstract and lecture: Nordic Conference in Work and Rehabilitation. Abstract and lecture: Work Disability Prevention and Integration Conference 2019 An article in BMC Public Health, 2019, qualitative results. An article, mixed methods results, 2019
Learn more about this trial
Obesity, Lifestyle and Work Intervention
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