NCT02843269

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

1.7 years

First QC Date

June 23, 2016

Last Update Submit

July 20, 2016

Conditions

Neck PainShoulder PainLifestyle

Keywords

RCTMulti-component interventionHealth personnelPhysical exercise training

Outcome Measures

Primary Outcomes (2)

  • Neck pain intensity as assessed by a 10 point Visual Analogue Scale

    12 months follow-up

  • Shoulder pain intensity as assessed by a 10 point Visual Analogue Scale

    12 months follow-up

Secondary Outcomes (5)

  • 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

  • Risk factors for lifestyle diseases - Waist circumference using an ergonomic circumference measuring tape

    Baseline, 1, 3 and 5 years

  • Risk factors for lifestyle diseases - Aerobic fitness with the Wattmax test

    Baseline, 1, 3 and 5 years

  • Sickness absence retrieved from a local database

    Baseline, 1, 3 and 5 years

Study Arms (3)

Multi-component lifestyle intervention 1

ACTIVE COMPARATOR

A multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)

Behavioral: Multi-component lifestyle intervention

Multi-component lifestyle intervention 2

ACTIVE COMPARATOR

A multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)

Behavioral: Multi-component lifestyle intervention

Multi-component lifestyle intervention 3

ACTIVE COMPARATOR

A multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)

Behavioral: Multi-component lifestyle intervention

Interventions

Multi-component lifestyle interventionBEHAVIORAL

The exact same intervention was given to the three Stepped-wedge groups - but each of the three groups were started up three months apart. The waiting groups served as control groups. Thus, the intervention were for all three groups a multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)

Multi-component lifestyle intervention 1Multi-component lifestyle intervention 2Multi-component lifestyle intervention 3

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Long-term sick listed.
  • Pregnancy, or
  • Working at a rehabilitation center, as these employees do not have work tasks within elderly care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ilvig PM, Bredahl TVG, Justesen JB, Jones D, Lundgaard JB, Sogaard K, Christensen JR. Attendance barriers experienced by female health care workers voluntarily participating in a multi-component health promotion programme at the workplace. BMC Public Health. 2018 Dec 4;18(1):1340. doi: 10.1186/s12889-018-6254-3.

    PMID: 30514352DERIVED

  • Christensen JR, Bredahl TV, Hadrevi J, Sjogaard G, Sogaard K. Background, design and conceptual model of the cluster randomized multiple-component workplace study: FRamed Intervention to Decrease Occupational Muscle pain - "FRIDOM". BMC Public Health. 2016 Oct 24;16(1):1116. doi: 10.1186/s12889-016-3758-6.

    PMID: 27776506DERIVED

MeSH Terms

Conditions

Neck PainShoulder Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Jeanette R Christensen, PHD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

June 23, 2016

First Posted

July 25, 2016

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2025

Last Updated

July 25, 2016

Record last verified: 2016-07