Efficacy of a workplace osteoporosis prevention intervention: a cluster randomised trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000079448
• Date of registration: 25/01/2016
• Prospective Registration: No
• Primary sponsor: Ai May Tan
• Public title: Efficacy of a workplace osteoporosis prevention intervention: a cluster randomised trial
• Scientific title: Efficacy of a workplace osteoporosis prevention intervention: a cluster randomised trial
• Date of first enrolment: 20/06/2005
• Target sample size: 416
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000079448.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Singapore

Contacts

• Name: Ms Ai May Tan

• Name: Ms Ai May Tan

Key inclusion & exclusion criteria

Inclusion criteria: Workplace (cluster) inclusion criteria
* Workplaces in sectors or industries that were primarily office based and sedentary in nature, such as government administration departments and finance;
*Workplaces that were able to recruit at least 30 female employees engaged in desk-based jobs (sitting for at least 50% of working hours); and
*Agreement to permit up to 10 hours of paid work time during the course of the study (12 months) for the recruited employees to participate in pre-post data collection and intervention activities.

Eligibility for recruitment of employees within selected workplaces:
*Being female;
*Age 25–49 years of age; and
*Being in a sedentary job (at least 50% of work hours seated)


Exclusion criteria: Exclusion criteria were:
*Being pregnant or lactating;
*Diagnosed osteoporosis;
*Diagnosed kidney problems; and
*Participation in another health program that addressed diet and/or physical activity.

Age minimum: 25 Years
Age maximum: 49 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Osteoporosis

Public Health - Health service research

Osteoporosis; musculoskeletal condition;
Osteoporosis; musculoskeletal condition

Intervention(s)

Intervention methodologies:
Subjects from workplaces assigned to the intervention group received three intensive workshops targeting behaviour change over a period of 6 weeks. The intervention design had a strong focus on behavioural strategies and was participatory in nature. Bandura’s Self–Efficacy Model was used to guide the workshop design for the intervention group.
The workshop design focused on individual goal setting and on building skill sets to attain individual goals. The design avoided presentation style communication and focused on behavioural strategies such as participatory skill building through hands-on activities, goal setting exercises, peer support and problem solving discussions. Attention was placed on helping participants identify individual barriers and build their capacity to overcome them. The intervention also addressed diet and physical activity as different entities that required different behavioural strategies. Though guided by the same principles, the workshops for diet and physically activity were unique in the nature and design of their activities.

Intervention strategy development for calcium intake:
Our study reviewed the content of interventions that reported positive outcomes for dietary calcium intake. The intervention workshops, run by a dietician, included participatory activities such as food preparation and tasting, nutrition label reading exercises, group discussions with exchange of ideas. Emphasis was placed on using specific examples relevant to the participants' lifestyles and tastes as well incorporating local food sources into activities.
In addition, we incorporated quantitative and qualitative dietary information collected at baseline to help tailor intervention strategies. The dietary records were

Primary Outcome(s)

Calcium intake in milligrams per day.

Calcium intake was measured using a three-day diet record. This method involved each participant keeping a detailed written record of the foods and beverages consumed
over three days. Three day recording was selected as recording periods of more than three or four days were reported to be unreliable due to respondent fatigue. Specific emphasis was put on the correct description of portion sizes so that an accurate estimate of calcium
content could be derived.
An appointment was scheduled to meet each participant individually to provide specific instructions for completion of the three-day diet record. The three days would include
two representative weekdays and one representative weekend day. Completed dietary records were collected and sent to a qualified nutritionist for analysis to establish the calcium content. The nutritionist was blinded to the treatment arms and the identities of the workplaces and participants.[Baseline, four weeks post intervention and six months post intervention.]

Load-bearing moderate to vigorous physical activity in minutes per week.

Physical activity was measured using the EPIC Norfolk
Physical Activity Questionnaire 2 (EPAQ-2). The EPAQ-2 was designed to measure the different sub-dimensions of physical activity in the Norfolk cohort of the European
Prospective Investigation into Cancer (EPIC-Norfolk) in 1999. It is a self-reported questionnaire on disaggregated physical activity enabling the data be re-aggregated
to the dimension of physical activity of interest, for example load-bearing activity of relevance to osteoporosis prevention. The EPAQ-2 has been validated against fourday
heart rate measurement and was concluded to have the validity and repeatability/reliability to be used in a large-scale epidemiological study. The questionnaire consists of three sections: activity at home, work and recreation.
Permission was obtained from Wareham and Jakes to adapt and use the instrument for this study.
The content of the EPAQ-2 was assessed for cultural appropriateness by a panel that included experts from inside and outside the Health Promotion Board (Singapore).
Minor modifications were made to the list of recreation activities. Activities that were not relevant to local context, such as “digging, shovelling or chopping wood” were removed,
and replaced with common local activities not included in the version developed for use in Europe, such as Tai Chi. Seventeen women at a workplace (not involved in the study) assessed the ease of reading using the Flesch reading ease score. They also provided feedback on the ease of understanding and the ease of completing the
modified EPAQ-2. Minor changes were made to the language of instructions on the questionnaires to further increase ease of understanding. Prompts were added in sections where extra information needed to be provided, for example duration of each session recreation activity, to facilitate thorough completion of the questionnaire.
A copy of the EPAQ-2 was sent to each participant through the workplace coordinator. The participants completed the questionnaire independently and submitted it to the investigator at each data collection point. The investigator checked that the EPAQ-2 was completed according to instructions.

[Baseline, four weeks post intervention and six months post intervention]

Secondary Outcome(s)

Self-efficacy scores for calcium intake

Self-efficacy was measured using the osteoporosis self-efficacy scale developed and evaluated by Horan et al. in 1998. Written permission was sought from the authors
to use the instrument.
The content of the questionnaire was assessed for appropriateness to local context by a panel that included experts internal and external to the Health Promotion Board (Singapore). It was also validated for internal consistency and test-retest repeatability through an evaluation process involving 17 women at a workplace (not involved
in the study). The original content was found to be relevant to the local context and the questionnaire to have appropriate reliability for use in this study.
Each subject was sent a physical copy of the questionnaire through the workplace coordinator. The completed questionnaires were returned to the workplace coordinator
who collated the submissions and dispatched them to the investigator.[Baseline, four weeks post intervention and six months post intervention.]

Self-efficacy scores for exercise

Self-efficacy was measured using the osteoporosis self-efficacy scale developed and evaluated by Horan et al. in 1998. Written permission was sought from the authors
to use the instrument.
The content of the questionnaire was assessed for appropriateness to local context by a panel that included experts internal and external to the Health Promotion Board (Singapore). It was also validated for internal consistency and test-retest repeatability through an evaluation process involving 17 women at a workplace (not involved
in the study). The original content was found to be relevant to the local context and the questionnaire to have appropriate reliability for use in this study.
Each subject was sent a physical copy of the questionnaire through the workplace coordinator. The completed questionnaires were returned to the workplace coordinator
who collated the submissions and dispatched them to the investigator.[Baseline, four weeks post intervention and six months post intervention.]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Health Promotion Board (Singapore)

Ethics review

Status: Approved
Approval date:
Contact:

Health Promotion Board (Singapore)

Status: Approved
Approval date:
Contact:

University of Melbourne, School of Population Health Human Ethics Advisory Group (SPH HEAG)