HS305 Unit 10 Research Proposal Outline Example

Question, Design, Sample, Ethics: A Unit 10 Research Proposal Outline for a Twelve-Week Sit-Stand Desk Trial in Two Workplaces

[Student Name]

Purdue University Global

HS305: Research Methods for Health Sciences

Unit 10 Research Proposal Outline

[Instructor Name]

[Date]

The employers, timeline and figures in brackets are composite; the reporting guideline, ethics report and instruments cited are real.

1. Title

Sit-stand desks and low back pain in office workers: a twelve-week randomized trial at two employers.

2. Background and Gap

Many adults spend most of their working day seated, and low back pain is one of the commonest reasons desk workers lose time or function at work.

A Cochrane review found that sit-stand desks reduce sitting at work in the short term, but evidence on whether they change health outcomes such as pain is limited and of low certainty (Shrestha et al., 2018).

My Unit 5 search found [9] relevant studies; most measured sitting time, few measured pain, and only [2] followed people for longer than eight weeks.

The gap this study fills is a randomized comparison with back pain, not sitting time, as the main outcome.

3. Research Question and Hypothesis

Question: In adults with recurring low back pain who work thirty or more hours a week at a desk, does twelve weeks with a sit-stand desk lower average pain intensity compared with a standard desk?

Hypothesis: mean pain at twelve weeks will be lower in the sit-stand group, by at least the two-point change commonly treated as meaningful to patients.

Null hypothesis: at twelve weeks, mean pain will not differ between the two arms.

4. Design

A two-arm, parallel-group randomized controlled trial with a 1 to 1 allocation. The Unit 6 comparison showed this is the only design among those considered that can test whether giving someone the desk changes their pain, because chance, not choice, decides who gets it.

Allocation is concealed: a statistician outside the study team holds the computer-generated sequence, stratified by employer, and releases each assignment only after a participant has enrolled.

Neither participants nor their managers can be blinded. Data entry and analysis use coded group labels until the analysis plan is locked.

The trial will be reported following the CONSORT 2010 statement, including a flow diagram of everyone screened, enrolled, allocated and analyzed (Schulz et al., 2010).

5. Setting and Sample

Setting: two employers in one metropolitan area, an insurance claims center and a county administration building, both with open-plan floors and assigned desks.

Eligibility: the Unit 8 criteria, adults aged 18 to 65 rostered for thirty or more desk hours a week with back pain on at least half of the past 28 days and a recent average of 3 or higher out of 10; excluding current height-adjustable desk users, spinal surgery in the past year, pregnancy, a screening flag for a specific cause of pain, and planned leave over two weeks.

Recruitment: one email and one intranet notice from each employer's human resources office, linking to an online screening form.

Target: [64] participants, [32] per arm, from a calculation based on a two-point difference, a standard deviation of [2.5], 80 percent power, a two-sided 0.05 level and [20] percent attrition.

6. Intervention and Comparison

Intervention: an electric sit-stand desk installed at the participant's own workstation in week one, with a fifteen-minute setup visit covering desk and monitor height. Participants receive one printed suggestion to alternate positions every thirty to sixty minutes, with no further coaching.

Comparison: the participant's existing fixed desk. Participants in this arm are offered a sit-stand desk after the twelve-week follow-up, which makes enrollment fairer and may reduce dropout.

7. Measures and Timing

Primary outcome: average low back pain over the past week on a 0 to 10 numeric scale, recorded at enrollment, at the midpoint and at the final visit.

Secondary outcome: Oswestry Disability Index, a ten-item measure of how back pain limits daily activities, scored from 0 to 100 percent, at the same points (Fairbank & Pynsent, 2000).

Process measure: sitting time during work hours from a thigh-worn monitor over five working days at baseline and week twelve.

Background: age, sex, job role, desk hours and pain duration, collected once at enrollment.

8. Analysis Plan

The main analysis compares mean pain at twelve weeks between arms, adjusting for baseline pain and employer, using everyone in the arm they were assigned to.

A secondary analysis repeats this for disability scores.

A descriptive comparison of sitting time shows whether the desk was actually used. If pain differs but sitting time does not, the report will say the mechanism is unclear.

Missing data will be described by arm, and a sensitivity analysis will test whether the result changes when missing scores are filled in under different assumptions.

9. Ethics

Approval: the protocol goes to an institutional review board before any recruitment.

Recruiting through an employer creates a pressure that ordinary trials do not face, because staff may worry that declining, or reporting that the new desk did not help, will be noticed by the people who decide their reviews and promotions.

Steps against that pressure:

1. Managers will not see who enrolled. The study team, not human resources, holds the enrollment list.

2. Consent is taken by research staff, away from the participant's floor, and says plainly that declining has no effect on employment.

3. Survey answers go directly to the research team and are never shared with the employer in a form that identifies anyone.

4. The employers receive only group-level results, and only after the trial ends.

The Belmont Report's principles guide these choices: respect for persons through voluntary, informed consent; beneficence through limiting risk, which here is mainly mild discomfort while adjusting to standing; and justice through offering the desk to the comparison group at the end (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979).

Data from the activity monitors are stored on an encrypted server under study codes, and the code key is kept separately.

10. Limitations

Self-reported pain, with no blinding, may favor the arm that received something new.

Two employers in one city limit how far results can be generalized.

Twelve weeks cannot show whether any benefit lasts beyond a quarter of a year.

Volunteers may have more interest in their health than coworkers who did not respond.

11. Timeline

Months 1 to 2: approval, employer agreements, desk purchase.

Months 3 to 4: recruitment, baseline measures, desk installation.

Months 5 to 7: twelve-week follow-up for all participants.

Month 8: analysis and report.

12. What the Results Would Change

A clear benefit would give employers evidence beyond sitting time for investing in sit-stand desks for staff with back pain. A null result, with the monitor showing that people did stand more, would suggest that reducing sitting alone does not relieve back pain, and would point future work toward other approaches.

References

Fairbank, J. C. T., & Pynsent, P. B. (2000). The Oswestry Disability Index. Spine, 25(22), 2940-2953. https://doi.org/10.1097/00007632-200011150-00017

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health, Education, and Welfare.

Schulz, K. F., Altman, D. G., & Moher, D. (2010). CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMJ, 340, c332. https://doi.org/10.1136/bmj.c332

Shrestha, N., Kukkonen-Harjula, K. T., Verbeek, J. H., Ijaz, S., Hermans, V., & Pedisic, Z. (2018). Workplace interventions for reducing sitting at work. Cochrane Database of Systematic Reviews, 2018(12), CD010912. https://doi.org/10.1002/14651858.CD010912.pub5