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Do Change in Life Style Improve Work Ability?

Sponsor
Molde University College (Other)
Overall Status
Completed
CT.gov ID
NCT03286374
Collaborator
Volda University College (Other)
95
Enrollment
1
Location
1
Arm
24
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Occupational rehabilitation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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.
Primary Purpose:
Health Services Research
Official Title:
Do Change in Life Style Improve Work Ability? A Controlled Study of the Effect of Changes in Lifestyle on Work Participation.
Actual Study Start Date :
Aug 30, 2017
Actual Primary Completion Date :
Aug 31, 2019
Actual Study Completion Date :
Aug 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Occupational rehabilitation

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

Behavioral: Occupational rehabilitation
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)
Other Names:
  • Life style treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Work participation [1-4 years]

      Work participation after a work related rehabilitation program at Muritunet.

    Secondary Outcome Measures

    1. Life quality [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)

    2. Work motivation [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)

    3. Weight loss [Weight collected at baseline, six and twelve months after participation in the trial.]

      Weight changing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 67 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anita Dyb Linge Valldal Møre Og Romsdal Norway 6210

    Sponsors and Collaborators

    • Molde University College
    • Volda University College

    Investigators

    • Study Director: Odd Ragnar Hunnes, Dean, Volda University Collage

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Anita Dyb Linge, Ph.D Student, Molde University College
    ClinicalTrials.gov Identifier:
    NCT03286374
    Other Study ID Numbers:
    • 2017/573
    First Posted:
    Sep 18, 2017
    Last Update Posted:
    Oct 23, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Anita Dyb Linge, Ph.D Student, Molde University College
    Obesity
    Occupational rehabilitation
    Sick leave
    Life style treatment
    Additional relevant MeSH terms:
    Obesity, Morbid

    Study Results

    No Results Posted as of Oct 23, 2020