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Do Change in Life Style Improve Work Ability?

Primary Purpose

Obesity, Morbid, Sick-leave, Work Related Illnesses

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Occupational rehabilitation
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, Morbid focused on measuring Obesity, Occupational rehabilitation, Sick leave, Life style treatment

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. People who are on sick leave or stands in danger of being sick because of problems related to obesity.
  2. The participants must have a realistic opportunity to return to work.
  3. Body mass index above 30
  4. Age 18-67 years.

Exclusion criteria;

  1. People with a severe eating disorder.
  2. People without a capacity to consent.
  3. People with severe alcohol and/or drug abuse.
  4. People with a major mental illness.
  5. Being pregnant.
  6. People with a health condition that contraindicates physical activity.
  7. People who receive work assessment allowance.
  8. People with or plan to apply for disability benefits.
  9. People with permanently adapted work.

Sites / Locations

  • Anita Dyb Linge

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Occupational rehabilitation

Arm Description

The participants will receive the current occupational rehabilitation program at Muritunet.

Outcomes

Primary Outcome Measures

Work participation
Work participation after a work related rehabilitation program at Muritunet.

Secondary Outcome Measures

Life quality
Quality of life; health - 15D ( Harri Sintonen, http://www.15d-instrument.net)
Work motivation
Return to work self-efficacy, Return-to-work self-efficacy scale (RTWSE-19) (Shaw et al. 2011)
Weight loss
Weight changing

Full Information

First Posted
September 12, 2017
Last Updated
October 22, 2020
Sponsor
Molde University College
Collaborators
Volda University College
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1. Study Identification

Unique Protocol Identification Number
NCT03286374
Brief Title
Do Change in Life Style Improve Work Ability?
Official Title
Do Change in Life Style Improve Work Ability? A Controlled Study of the Effect of Changes in Lifestyle on Work Participation.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Molde University College
Collaborators
Volda University College

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Sick-leave, Work Related Illnesses, Life Style
Keywords
Obesity, Occupational rehabilitation, Sick leave, Life style treatment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study is a Clinical cohort trial with a pseudo prospective, parallel mixed methods design. Questionnaires and register data at baseline, T1, and T2. Focus group interviews at T3, and register data at T4.
Masking
None (Open Label)
Masking Description
Due to the nature of the study intervention, it is not possible to blind the participants. Some of the participants will give a focus group interview and their identity will be known for the other participants in the group. The health care providers will not get information about who will participate or not.
Allocation
N/A
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Occupational rehabilitation
Arm Type
Other
Arm Description
The participants will receive the current occupational rehabilitation program at Muritunet.
Intervention Type
Behavioral
Intervention Name(s)
Occupational rehabilitation
Other Intervention Name(s)
Life style treatment
Intervention Description
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: Four weeks with an institutional stay at Muritunet (BL) Follow-up; Eight weeks, telephone contact between therapist at Muritunet and the participant. 16 weeks, video conference on SKYPE between all the participants and a therapist. Lecture on diets. 28 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T1) 40 weeks, telephone contact between therapist at Muritunet and the participant. 52 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T2)
Primary Outcome Measure Information:
Title
Work participation
Description
Work participation after a work related rehabilitation program at Muritunet.
Time Frame
1-4 years
Secondary Outcome Measure Information:
Title
Life quality
Description
Quality of life; health - 15D ( Harri Sintonen, http://www.15d-instrument.net)
Time Frame
Survey data collected at baseline, six and twelve months after participation in the trial.
Title
Work motivation
Description
Return to work self-efficacy, Return-to-work self-efficacy scale (RTWSE-19) (Shaw et al. 2011)
Time Frame
Survey data collected at baseline, six and twelve months after participation in the trial.
Title
Weight loss
Description
Weight changing
Time Frame
Weight collected at baseline, six and twelve months after participation in the trial.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odd Ragnar Hunnes, Dean
Organizational Affiliation
Volda University Collage
Official's Role
Study Director
Facility Information:
Facility Name
Anita Dyb Linge
City
Valldal
State/Province
Møre Og Romsdal
ZIP/Postal Code
6210
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34992380
Citation
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.
Results Reference
derived
PubMed Identifier
34001067
Citation
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.
Results Reference
derived

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Do Change in Life Style Improve Work Ability?

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