Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM. Background, Design and Conceptual Model of a Cluster Randomized Double-blinded Controlled Study Among Female Health Care Workers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 219
- Primary Endpoint
- Neck pain intensity as assessed by a 10 point Visual Analogue Scale
Study Overview
Brief Summary
Several RCT studies have aimed to reduce either musculoskeletal disorders, sickness presenteeism, sickness absenteeism or a combination of these among females with high physical work demands. These studies have provided evidence that workplace health promotion (WHP) interventions are effective, but long-term effects are still uncertain. These studies either lack to succeed in maintaining intervention effects or lack to document if effects are maintained past a one-year period. FRIDOM (FRamed Intervention to Decrease Occupational Muscle pain) is a WHP program among health care workers. A job group characterized by having high physical work demands, musculoskeletal disorders, high sickness presenteeism - and absenteeism.
FRIDOM aimed to reduce neck and shoulder pain and secondary to reduce sickness presenteeism and sickness absenteeism. An other secondary aim was to decrease lifestyle-diseases such as other musculoskeletal disorders as well as metabolic-, and cardiovascular disorders - and to maintain participation to regular physical exercise training, after a one year intervention period. The entire concept was tailored to a population of female health care workers. This was done through a multi-component intervention including 1) intelligent physical exercise training (IPET), dietary advice and weight loss (DAW) and cognitive behavioural training (CBT).
Detailed Description
The FRIDOM program was composed of four parts: 1) A planning phase according to intervention mapping principles, 2) a feasibility study to reveal issues of implementation and intervention content, 3) a randomized controlled trial (RCT) , and 4) a maintenance period. Below these components are further detailed.
Intervention mapping and time frame The main focus of the intervention was on sustainable behavioural life-style changes, therefore, a key point was a detailed planning of all phases to ease the final maintenance of the introduced health enhancing activities after the 12 months supervised intervention.
The FRIDOM-Feasibility study To prepare and facilitate the FRIDOM-RCT study a feasibility study was conducted which served several purposes. Before the intervention in the feasibility study was initiated, all eligible employees were asked to fill out a screening questionnaire and participate in a baseline-screening-test. To allow for subsequent adjustment of the intervention content and mode of practical implementation, the feasibility study was timed ahead of the RCT study, according to the same principal schedule as the RCT.
The FRIDOM-RCT study The FRIDOM-RCT was implemented as a cluster RCT with a "stepped wedge" design. Content of the intervention had to be given repeatedly, and it was an important step to avoid changes in intervention delivery to the successive cohorts.
The FRIDOM-Maintenance Besides the primary and secondary goals, it was a long term goal to implement the intervention elements as permanent activities at the workplace, maintained beyond the one-year intervention period. Therefore, the activities offered at the workplace should include not only baseline consenters, but also gradually involve new employees and employees returning to work.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants should be employed at the elderly care department at a Danish municipality (Sydjurs).
- •Working at least 15 hours per week.
- •Permanently employed, or
- •Have at least 12 months of work left before retirement.
Exclusion Criteria
- •Long-term sick listed.
- •Pregnancy, or
- •Working at a rehabilitation center, as these employees do not have work tasks within elderly care
Arms & Interventions
Multi-component lifestyle intervention 1
A multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)
Intervention: Multi-component lifestyle intervention (Behavioral)
Multi-component lifestyle intervention 2
A multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)
Intervention: Multi-component lifestyle intervention (Behavioral)
Multi-component lifestyle intervention 3
A multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)
Intervention: Multi-component lifestyle intervention (Behavioral)
Outcomes
Primary Outcomes
Neck pain intensity as assessed by a 10 point Visual Analogue Scale
Time Frame: 12 months follow-up
Shoulder pain intensity as assessed by a 10 point Visual Analogue Scale
Time Frame: 12 months follow-up
Secondary Outcomes
- Risk factors for lifestyle diseases - Aerobic fitness with the Wattmax test(Baseline, 1, 3 and 5 years)
- Risk factors for lifestyle diseases - Waist circumference using an ergonomic circumference measuring tape(Baseline, 1, 3 and 5 years)
- Risk factors for lifestyle diseases - Blood pressure with an electronic blood pressure monitoring device(Baseline, 1, 3 and 5 years)
- Risk factors for lifestyle diseases - Body fat using a bio impedance device(Baseline, 1, 3 and 5 years)
- Sickness absence retrieved from a local database(Baseline, 1, 3 and 5 years)
Investigators
Jeanette Reffstrup Christensen
PHD
University of Southern Denmark