- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03286374
Do Change in Life Style Improve Work Ability?
October 22, 2020 updated by: Anita Dyb Linge, Molde University College
Do Change in Life Style Improve Work Ability? A Controlled Study of the Effect of Changes in Lifestyle on Work Participation.
The main aim of this Cohort trial is to get more information about how life style changes affect work participation for people with BMI above 30.
The information can contribute to improving the quality of occupational rehabilitation programs in the specialized health care services and for others who work with weight loss programs and work related rehabilitation programs.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The goal of rehabilitation, in general, is to help people to reach and maintain their optimal function and copying capabilities and to promote independence and participation in society.
For occupational rehabilitation is the goal also to increase function and work ability to prevent the individuals permanent to fall out of working life.
People with high BMI needs beside work rehabilitation also focus on life style changes to reduce consequences of obesity.
The Central Norway Regional Health Authority (HMN RHF) has initiated action to reduce work absence and consequence of obesity by introducing a work related rehabilitation program for people with BMI above 30.
This program combines work participation and life style changes and exists only in two institutions in Norway.
The goal of the program is to increase function and work ability and weight loss.
The program is new, and few documents exist on the effect and the correlation between life style changes and work ability.
There is also need to question whether obesity is the reason for work absence or is there other factors that affect work ability.
This trial wants to follow-up a group of people who have been participating occupational rehabilitation at Muritunet.
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Møre Og Romsdal
-
Valldal, Møre Og Romsdal, Norway, 6210
- Anita Dyb Linge
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- People who are on sick leave or stands in danger of being sick because of problems related to obesity.
- The participants must have a realistic opportunity to return to work.
- Body mass index above 30
- Age 18-67 years.
Exclusion criteria;
- People with a severe eating disorder.
- 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 who receive work assessment allowance.
- People with or plan to apply for disability benefits.
- People with permanently adapted work.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Occupational rehabilitation
The participants will receive the current occupational rehabilitation program at Muritunet.
|
The participants in the occupational rehabilitation program get both practical and theoretical intervention in groups. Four main interventions; cognitive therapy, physical activity, diets and training in work-oriented approach. The rehabilitation stay is as followed:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Work participation
Time Frame: 1-4 years
|
Work participation after a work related rehabilitation program at Muritunet.
|
1-4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Life quality
Time Frame: Survey data collected at baseline, six and twelve months after participation in the trial.
|
Quality of life; health - 15D ( Harri Sintonen, http://www.15d-instrument.net)
|
Survey data collected at baseline, six and twelve months after participation in the trial.
|
|
Work motivation
Time Frame: Survey data collected at baseline, six and twelve months after participation in the trial.
|
Return to work self-efficacy, Return-to-work self-efficacy scale (RTWSE-19) (Shaw et al. 2011)
|
Survey data collected at baseline, six and twelve months after participation in the trial.
|
|
Weight loss
Time Frame: Weight collected at baseline, six and twelve months after participation in the trial.
|
Weight changing
|
Weight collected at baseline, six and twelve months after participation in the trial.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Odd Ragnar Hunnes, Dean, Volda University Collage
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Linge AD, Bjorkly SK, Jensen C, Hasle B. Bandura's Self-Efficacy Model Used to Explore Participants' Experiences of Health, Lifestyle, and Work After Attending a Vocational Rehabilitation Program with Lifestyle Intervention - A Focus Group Study. J Multidiscip Healthc. 2021 Dec 24;14:3533-3548. doi: 10.2147/JMDH.S334620. eCollection 2021.
- Linge AD, Jensen C, Laake P, Bjorkly SK. Changes to body mass index, work self-efficacy, health-related quality of life, and work participation in people with obesity after vocational rehabilitation: a prospective observational study. BMC Public Health. 2021 May 17;21(1):936. doi: 10.1186/s12889-021-10954-y.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 30, 2017
Primary Completion (Actual)
August 31, 2019
Study Completion (Actual)
August 31, 2019
Study Registration Dates
First Submitted
September 12, 2017
First Submitted That Met QC Criteria
September 13, 2017
First Posted (Actual)
September 18, 2017
Study Record Updates
Last Update Posted (Actual)
October 23, 2020
Last Update Submitted That Met QC Criteria
October 22, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/573
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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