Obesity, Lifestyle and Work Intervention

Obesity Clinical Trial

Official title:

Does Adding A Work Intervention Into An Already Existing Life Style Intervention Improve Work Ability? A Randomized Controlled Trial Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886870
• Other study ID #: 2014/697 REK South-East
• Status: Completed
• Phase: N/A
• Start date: September 3, 2014
• Est. completion date: February 1, 2018

Study information

• Verified date: March 2019
• Source: Molde University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 1, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Life Style
• Morbid Obesity
• Obesity
• Obesity, Morbid
• Sick-leave
• Work Related Illnesses

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Molde University College	Norwegian Labour and Welfare Administration

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full or partial return to work.	Mapping changes in work employability and work related factors with survey data from the ARR form (http://www.arbeidoghelse.no).	Data collected during the interventions, baseline, 6 and 12 months.
Secondary	Weight loss (kilograms)	Measured changes with Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer.	Data collected during the interventions, baseline, 6 and 12 months.
Secondary	Return to work self-efficacy	Mapping changes with the Return-to-work-efficacy scale (RTWSE-19). The 19-item RTWSE-19 scale is a new self-report measure intended to assess workers' beliefs of their current ability to resume normal job responsibilities following pain onset. Response range (1-10). 1 is "not sure at all" and 10 is "very sure". The 19 subscales are divided into three main categories, and the total score is the sum of these catagories. Higher value indicate better outcome. (Shaw et.al 2011).	Data collected during the interventions, baseline, 6 and 12 months.
Secondary	Quality of Life (15D), health-related quality of life	Mapping changes in 15D. The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL. 5 ordinal levels on each dimension, by which more or less of the attribute is distinguished. A set of utility or preference weights is used to generate the 15D score (single index number) on a 0-1 scale. The valuation system of the 15D is based on an application of the multiattribute utility theory. The single index (15D score) on a 0 1 scale, representing the overall HRQoL (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL) is calculated from the health state descriptive system by using a set of population based preference or utility weights. (Harri Sintonen, http://www.15d-instrument.net).	Data collected during the interventions, baseline, 6 and 12 months.
Secondary	Subjective somatic and psychological complaints	Mapping changes with the scoring system subjective health complaints (SHC). The SHC consists of 29 questions concerning severity and duration of subjective somatic and psychological complaints. Intensity of each complaint is scored on a four-point scale from 0-3, where 0 is no complaints and three is severe complaints. The SHC inventory yields scores on single items and a total number of health complaints categorized into five factors: musculoskeletal pain (alpha=0.74), pseudoneurology (alpha=0.73), gastrointestinal problems (alpha=0.62), allergy (alpha=0.58) and flu (alpha=0.67). Eriksen HR, Ihlebæk C, Ursin H. A scoring system for subjective Health complaints (SHC). Scand J Public Health. 1999;27:63-72.	Data collected during the interventions, baseline, 6 and 12 months.
Secondary	Vo2 peak	Measured changes in the maximum amount of oxygen the participant can utilize during intense exercise. Measured in litres of oxygen per minute (L/min) or as a relative rate in (for example) millilitres of oxygen per kilogram of body mass per minute (e.g., mL/(kg·min). Physical test on a treadmill.	Data collected during the interventions, baseline and 12 months.
Secondary	Body Mass Index	Height will be added in Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer. BMI will be reported in kg/m².	Data collected during the interventions, baseline, 6 and 12 months.
Secondary	Waist circumstance (cm).	Measured changes with Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer.	Data collected during the interventions, baseline, 6 and 12 months.
Secondary	Hight (centimetmeters)	The distance from the bottom of the feet to the top of the head, standing erect, measured with a stadiometer, in centimetres.	Data collected during the interventions, baseline.
Secondary	Promoting and hindering factors for Return to work.	Mapping contextual conditions and mechanisms that might be important in the process back to work through In-Depth interviews	Data collected during the interventions, baseline, 6 and 12 months.