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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03286374
Other study ID # 2017/573
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2017
Est. completion date August 31, 2019

Study information

Verified date October 2020
Source Molde University College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 67 Years
Eligibility 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.

Study Design


Intervention

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)

Locations

Country Name City State
Norway Anita Dyb Linge Valldal Møre Og Romsdal

Sponsors (2)

Lead Sponsor Collaborator
Molde University College Volda University College

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Work participation Work participation after a work related rehabilitation program at Muritunet. 1-4 years
Secondary Life quality 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.
Secondary Work motivation 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.
Secondary Weight loss Weight changing Weight collected at baseline, six and twelve months after participation in the trial.
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