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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
Molde University College
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 14, 2019
    Last Updated
    March 21, 2019
    Sponsor
    Molde University College
    Collaborators
    Norwegian Labour and Welfare Administration
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    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

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    Obesity, Lifestyle and Work Intervention

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