Obesity, MorbidNCT03286374
Do Change in Life Style Improve Work Ability?
A study testing Occupational rehabilitation in people with Obesity, Morbid and Sick-leave, run by Molde University College at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Obesity, Morbid, Sick-leave, Work Related Illnesses
- What is being tested?
- Occupational rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteNorway
- Study dates
- 30 Aug 2017to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- People who receive work assessment allowance.
- People with or plan to apply for disability benefits.
- People with permanently adapted work.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Morbid, Sick-leave, Work Related Illnesses, Life Style
- Being tested
- Occupational rehabilitation
- Keywords
- Obesity, Occupational rehabilitation, Sick leave, Life style treatment
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational rehabilitationBehavioural
Also called Life style treatment
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)
| Study group | Role | What they receive |
|---|---|---|
| Occupational rehabilitation | Other | The participants will receive the current occupational rehabilitation program at Muritunet. Receives: Behavioral: Occupational rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work participation
Work participation after a work related rehabilitation program at Muritunet.
Measured: 1-4 years
Secondary outcomes (3)
Life quality
Quality of life; health - 15D ( Harri Sintonen, http://www.15d-instrument.net)
Measured: Survey data collected at baseline, six and twelve months after participation in the trial.
Work motivation
Return to work self-efficacy, Return-to-work self-efficacy scale (RTWSE-19) (Shaw et al. 2011)
Measured: Survey data collected at baseline, six and twelve months after participation in the trial.
Weight loss
Weight changing
Measured: Weight collected at baseline, six and twelve months after participation in the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start30 Aug 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molde University College
- Sponsor type
- University, hospital or other
- Collaborators
- Volda University College
- Responsible party
- Principal investigator, Anita Dyb Linge, Molde University College
- Investigators
- Odd Ragnar Hunnes, Dean, Study director, Volda University Collage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286374
- Sponsor's protocol ID
- 2017/573
- Status last verified
- Oct 2020
- First submitted
- 12 Sep 2017
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34992380Linge 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.
PubMed 34001067
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Change in Life Style Improve Work Ability? A Controlled Study of the Effect of Changes in Lifestyle on Work Participation.
- ClinicalTrials.gov ID
- NCT03286374
- Acronym / sponsor ID
- 2017/573
- Conditions
- Obesity, Morbid, Sick-leave, Work Related Illnesses, Life Style
- Keywords
- Obesity, Occupational rehabilitation, Sick leave, Life style treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Molde University CollegeUniversity, hospital or other
- Collaborators
- Volda University College
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Occupational rehabilitation | Other | Behavioral: Occupational rehabilitationThe participants will receive the current occupational rehabilitation program at Muritunet. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational rehabilitationAlso: Life style treatmentThe 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: 1. Four weeks with an institutional stay at Muritunet (BL) 2. Follow-up; 1. Eight weeks, telephone contact between therapist at Muritunet and the participant. 2. 16 weeks, video conference on SKYPE between all the participants and a therapist. Lecture on diets. 3. 28 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T1) 4. 40 weeks, telephone contact between therapist at Muritunet and the participant. 5. 52 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T2) | Behavioural | Occupational rehabilitation |
Primary outcome
Work participation
Time frame: 1-4 years
Work participation after a work related rehabilitation program at Muritunet.
3 secondary outcomes
Life quality
Time frame: 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.
Weight loss
Time frame: Weight collected at baseline, six and twelve months after participation in the trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 34992380Linge 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.
- Derived from this study: PubMed 34001067Linge 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odd Ragnar Hunnes, Dean study director
Volda University Collage
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational rehabilitation in people with Obesity, Morbid and Sick-leave, run by Molde University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work participation (time frame: 1-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03286374, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.