Obesity, Lifestyle and Work Intervention

NCT ID: NCT03886870

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-03
• Study Completion Date: 2018-02-01

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.

Conditions

Obesity; Morbid Obesity; Sick-leave; Work Related Illnesses; Life Style

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Lifestyle and work intervention

Lifestyle intervention with work focus.

Group Type: EXPERIMENTAL

Lifestyle intervention

Intervention Type: BEHAVIORAL

The intervention period lasted for a year with three institution-based stay, 4 weeks at baseline and 2 weeks at 6 and 12 months. At baseline, participants got a functional assessment and an individual adjusted rehabilitation plan.

At all three stages: The intervention contains activity training with focus on joy of movement, strength- and cardio-training. There was lectures and cognitive therapy to promote self-care and lifestyle change. The intervention contained lectures on diet, nutrition and cooking-classes. Participants set goals at baseline and adjusting these during the progress. They developed exercise programs designed to use at home.

Lifestyle intervention

Lifestyle intervention without work focus.

Group Type: EXPERIMENTAL

Lifestyle and work intervention

Intervention Type: BEHAVIORAL

The intervention period lasted for a year with three institution-based stays, 4 weeks at baseline and 2 weeks at 6 and 12 months. At baseline, participants got a functional assessment and an individual adjusted rehabilitation plan. At all three stages: The intervention contains activity training with a focus on the joy of movement, strength- and cardio-training. There were lectures and cognitive therapy to promote self-care and lifestyle change. The intervention contained lectures on diet, nutrition and cooking-classes. Participants set goals at baseline and adjusting these during the progress. Exercise programs was designed to use at home. The Cognitive Information Processing model of career guidance was the mainframe for the work dimension. All participants had talks with the work consultant at baseline, 6 and 12 months. Two work lectures, "Duties and rights as employees" and "Work as medicine". When needed the work consultant contacted the employer in order to facilitate changes.

Interventions

Lifestyle and work intervention

The intervention period lasted for a year with three institution-based stays, 4 weeks at baseline and 2 weeks at 6 and 12 months. At baseline, participants got a functional assessment and an individual adjusted rehabilitation plan. At all three stages: The intervention contains activity training with a focus on the joy of movement, strength- and cardio-training. There were lectures and cognitive therapy to promote self-care and lifestyle change. The intervention contained lectures on diet, nutrition and cooking-classes. Participants set goals at baseline and adjusting these during the progress. Exercise programs was designed to use at home. The Cognitive Information Processing model of career guidance was the mainframe for the work dimension. All participants had talks with the work consultant at baseline, 6 and 12 months. Two work lectures, "Duties and rights as employees" and "Work as medicine". When needed the work consultant contacted the employer in order to facilitate changes.

Intervention Type: BEHAVIORAL

Lifestyle intervention

The intervention period lasted for a year with three institution-based stay, 4 weeks at baseline and 2 weeks at 6 and 12 months. At baseline, participants got a functional assessment and an individual adjusted rehabilitation plan.

At all three stages: The intervention contains activity training with focus on joy of movement, strength- and cardio-training. There was lectures and cognitive therapy to promote self-care and lifestyle change. The intervention contained lectures on diet, nutrition and cooking-classes. Participants set goals at baseline and adjusting these during the progress. They developed exercise programs designed to use at home.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian Labour and Welfare Administration

OTHER

Sponsor Role: collaborator

Molde University College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geir Ove Vegsund

Role: STUDY_DIRECTOR

Muritunet

Other Identifiers

2014/697 REK South-East

Identifier Type: -

Identifier Source: org_study_id