Obesity, Lifestyle and Work Intervention
Does Adding A Work Intervention Into An Already Existing Life Style Intervention Improve Work Ability? A Randomized Controlled Trial Study
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Lifestyle and work intervention
Lifestyle intervention with work focus.
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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. |
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実験的：Lifestyle intervention
Lifestyle intervention without work focus.
|
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Full or partial return to work.
時間枠：Data collected during the interventions, baseline, 6 and 12 months.
|
Mapping changes in work employability and work related factors with survey data from the ARR form (http://www.arbeidoghelse.no).
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Data collected during the interventions, baseline, 6 and 12 months.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weight loss (kilograms)
時間枠：Data collected during the interventions, baseline, 6 and 12 months.
|
Measured changes with Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer.
|
Data collected during the interventions, baseline, 6 and 12 months.
|
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Return to work self-efficacy
時間枠：Data collected during the interventions, baseline, 6 and 12 months.
|
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).
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Data collected during the interventions, baseline, 6 and 12 months.
|
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Quality of Life (15D), health-related quality of life
時間枠：Data collected during the interventions, baseline, 6 and 12 months.
|
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).
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Data collected during the interventions, baseline, 6 and 12 months.
|
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Subjective somatic and psychological complaints
時間枠：Data collected during the interventions, baseline, 6 and 12 months.
|
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.
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Data collected during the interventions, baseline, 6 and 12 months.
|
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Vo2 peak
時間枠：Data collected during the interventions, baseline and 12 months.
|
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.
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Data collected during the interventions, baseline and 12 months.
|
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Body Mass Index
時間枠：Data collected during the interventions, baseline, 6 and 12 months.
|
Height will be added in Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer.
BMI will be reported in kg/m².
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Data collected during the interventions, baseline, 6 and 12 months.
|
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Waist circumstance (cm).
時間枠：Data collected during the interventions, baseline, 6 and 12 months.
|
Measured changes with Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer.
|
Data collected during the interventions, baseline, 6 and 12 months.
|
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Hight (centimetmeters)
時間枠：Data collected during the interventions, baseline.
|
The distance from the bottom of the feet to the top of the head, standing erect, measured with a stadiometer, in centimetres.
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Data collected during the interventions, baseline.
|
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Promoting and hindering factors for Return to work.
時間枠：Data collected during the interventions, baseline, 6 and 12 months.
|
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.
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Geir Ove Vegsund、Muritunet
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2014/697 REK South-East
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IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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