Clinical trial NCT03886870: Obesity, Lifestyle and Work Intervention
Official title: Does Adding A Work Intervention Into An Already Existing Life Style Intervention Improve Work Ability? A Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Morbid Obesity
Sick-leave
Work Related Illnesses
Life Style
Keywords: Obesity
Work Focus
Workability
Life-style treatment
Lead sponsor: Molde University College
Sponsor class: OTHER
Collaborators: name: Norwegian Labour and Welfare Administration
First posted: 2019-03-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as a randomized controlled study with an exploring prospective design. The intervention lasted 12 months and each patient had three visits (baseline, 6 and 12 month) at Muritunet, each lasting 4-2-2 weeks. The participants was randomized either into a lifestyle and work intervention or into a lifestyle intervention.

Data material gathered at each stay consisting of self-reported forms, test, journal and individual interviews. These were all collected at baseline, and at six and twelve months.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main aim of this study was to examine whether introducing a work intervention into a traditional lifestyle rehabilitation program for persons with BMI above 30, would affect the participants' ability to work and their lifestyle change. The investigators wanted to find out how the participants experienced their health, workability and work capacity, quality of life, diet and self-efficacy before and during the intervention

Detailed description: The background for this study was insights about obesity and sick leave. Obesity is related to lower labor force participation, increased sickness absence and reduced productivity. A Danish study from 2006 reported a yearly 1, 8 million extra days of work absence and close to 1.100 cases of disability pension related to obesity. A 2016-report from OECD show that persons with obesity between the ages 50-59 have three times as much work absence as those who do not struggle with obesity. This indicates that persons with obesity are a group where the need for work rehabilitation is important. Despite this connection, work focus has not been a part of lifestyle interventions for persons with morbid obesity until the last two years.

By introducing a work intervention into a traditional lifestyle rehabilitation program for persons with BMI over 30, the investigators wanted to examine whether this would affect the participants' ability to work and their lifestyle change. The study was designed as a randomized controlled study with an exploring prospective design. The intervention lasted 12 months and each patient had three visits (baseline, 6 and 12 months) at Muritunet, each lasting 4-2-2 weeks. The participants were randomized into two intervention, one with work intervention and one without.

Data material gathered at each stay consisting of self-reported forms, test, journal and individual interviews. These were all collected at baseline, and at six and twelve months.

Eligibility criteria: Inclusion Criteria:

* Participants with a Body Mass Index (BMI) \> 30 with or without comorbidity

Exclusion Criteria:

* 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 with or plan to apply for disability benefits.
* People with permanently adapted work.

Primary outcomes:
measure: Full or partial return to work.
timeFrame: Data collected during the interventions, baseline, 6 and 12 months.
Secondary outcomes:
measure: Weight loss (kilograms)
timeFrame: Data collected during the interventions, baseline, 6 and 12 months.
measure: Return to work self-efficacy
timeFrame: Data collected during the interventions, baseline, 6 and 12 months.
measure: Quality of Life (15D), health-related quality of life
timeFrame: Data collected during the interventions, baseline, 6 and 12 months.
measure: Subjective somatic and psychological complaints
timeFrame: Data collected during the interventions, baseline, 6 and 12 months.
measure: Vo2 peak
timeFrame: Data collected during the interventions, baseline and 12 months.
measure: Body Mass Index
timeFrame: Data collected during the interventions, baseline, 6 and 12 months.
measure: Waist circumstance (cm).
timeFrame: Data collected during the interventions, baseline, 6 and 12 months.
measure: Hight (centimetmeters)
timeFrame: Data collected during the interventions, baseline.
measure: Promoting and hindering factors for Return to work.
timeFrame: Data collected during the interventions, baseline, 6 and 12 months.
Other outcomes:
Locations:
Study officials:
affiliation: Muritunet
name: Geir Ove Vegsund
role: STUDY_DIRECTOR
References: