OSTEOPOROSIS EDUCATION AND ITS IMPACT ON OSTEOPOROSIS HEALTH BELIEFS AND AWARENESS IN WOMEN AT RISK OF OSTEOPOROSIS

NCT07486076 | Not Yet Recruiting

• 1 other identifier: HBM-osteo-edu
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoporosis is a significant public health problem characterized by low bone mass and deterioration in the microarchitecture of bone tissue, leading to an increased risk of fractures. Risk factors such as advanced age, female gender, inadequate calcium and vitamin D intake, physical inactivity, smoking, and alcohol use play a critical role in its development. As in many countries, the prevalence of osteoporosis is increasing in Turkey, accelerated by an aging population and lifestyle changes. However, it is reported that the level of awareness and knowledge about osteoporosis in the community is often insufficient. This study is a randomized controlled experimental trial with a two-group pretest-posttest design, conducted between February 1 and June 1, 2026, among women aged 45 and older who have not been diagnosed with osteoporosis but carry at least one osteoporosis risk factor, attending the Physical Therapy and Rehabilitation outpatient clinic at Bartın State Hospital. From the study population, participants who meet the inclusion criteria and volunteer will be randomly assigned to intervention and control groups. The sample size is determined as 74, calculated with a 95% confidence level and a 5% margin of error. While the intervention group receives a structured education program based on the Health Belief Model, the control group will receive no education. The dependent variables of the study are osteoporosis awareness and health beliefs. These variables will be measured before and after the intervention using the Osteoporosis Awareness Scale and the Osteoporosis Health Belief Scale, which includes subdimensions of perceived susceptibility, seriousness, benefits, and barriers. The effectiveness of the education program will be evaluated through inter-group and intra-group comparisons.

Conditions

Health Belief Model-Based Osteoporosis Education Programme

Keywords

Health Belief Model-Based Education; Osteoporosis Awareness; Health Beliefs in Woman; Osteoporosis risk

Outcome Measures

Primary Outcomes (9)

• Change in Osteoporosis Awareness Scale (OAS) score.

  The Osteoporosis Awareness Scale (OAS) consists of 27 items with a total score ranging from a minimum of 27 to a maximum of 108, where higher scores indicate a greater level of osteoporosis awareness, representing a better outcome.

  Baseline and 4 weeks post-intervention.

• Change in Osteoporosis Health Belief Scale Score

  The Total Osteoporosis Health Belief Scale (OHBS) score is the sum of 42 items ranging from 42 to 210, where higher scores indicate more positive health beliefs and stronger perceptions toward osteoporosis prevention, representing a better outcome.

  Baseline and 4 weeks post-intervention..

• Change in Osteoporosis Health Belief Scale - Perceived Seriousness Sub-dimension Score.

  The Perceived Susceptibility sub-dimension (6 items) assesses the individual's perceived risk of developing osteoporosis with scores ranging from 6 to 30, where higher scores indicate a stronger perception of personal risk, representing a better outcome.

  Baseline and 4 weeks post-intervention.

• Change in Osteoporosis Health Belief Scale - Benefits of Exercise Sub-dimension Score.

  The Barriers to Exercise sub-dimension (6 items) identifies perceived obstacles to regular physical activity with scores ranging from 6 to 30, where lower scores indicate fewer perceived barriers, representing a better outcome.

  Baseline and 4 weeks post-intervention.

• Change in Osteoporosis Health Belief Scale - Benefits of Calcium Intake Sub-dimension Score.

  The Barriers to Calcium Intake sub-dimension (6 items) evaluates perceived difficulties in maintaining adequate calcium consumption with scores ranging from 6 to 30, where lower scores indicate fewer perceived obstacles, representing a better outcome.

  Baseline and 4 weeks post-intervention.

• Change in Osteoporosis Health Belief Scale - Barriers to Exercise Sub-dimension Score.

  This sub-dimension consists of 6 items (Items 25-30) identifying perceived obstacles to engaging in regular exercise. The minimum score is 6 and the maximum score is 30. Higher scores indicate greater perceived barriers to exercise. (Note: In this context, a decrease in this score post-intervention would typically be the desired clinical goal.)

  Baseline and 4 weeks post-intervention.

• Change in Osteoporosis Health Belief Scale - Barriers to Calcium Intake Sub-dimension Score.

  This sub-dimension consists of 6 items (Items 31-36) identifying perceived difficulties in maintaining adequate calcium intake. The minimum score is 6 and the maximum score is 30. Higher scores indicate greater perceived barriers to calcium consumption.

  Baseline and 4 weeks post-intervention.

• Change in Osteoporosis Health Belief Scale - Health Motivation Sub-dimension Score.

  The Health Motivation sub-dimension (6 items) assesses the individual's general drive to engage in health-protective behaviors with scores ranging from 6 to 30, where higher scores indicate greater motivation to maintain bone health.

  Baseline and 4 weeks post-intervention.

• Changes in Perceived Susceptibility Sub-dimension Score

  The Perceived Susceptibility sub-dimension (6 items) assesses the individual's perceived risk of developing osteoporosis with scores ranging from 6 to 30, where higher scores indicate a stronger perception of personal risk, representing a better outcome.

  Baseline and 4 weeks post-intervention.

Study Arms (2)

The Control Group: The group not receiving HBM based osteoporosis training

NO INTERVENTION

Participants in the control group will receive only routine information without any additional educational intervention.Questionnaires will be administered before and four weeks after the intervention.

Experimental: The group receiving HBM based osteoporosis training

EXPERIMENTAL

Participants in the intervention group will receive an osteoporosis education program developed by the researchers based on the Health Belief Model. The educational content includes the definition of osteoporosis, risk factors, prevention methods, and healthy lifestyle behaviors, structured according to perceived susceptibility, severity, benefits, and barriers.

Behavioral: Osteoporosis Education Based on the Health Belief Model

Interventions

Osteoporosis Education Based on the Health Belief Model BEHAVIORAL

Intervention Description This study evaluates a hybrid educational program based on the Health Belief Model (HBM), focusing on perceived susceptibility, severity, benefits, and barriers. 1. Baseline Assessment: Participants in both groups complete questionnaires on osteoporosis awareness and health beliefs. 2. Educational Intervention (Intervention Group): Initial Session: A 45-60 minute structured face-to-face training covering osteoporosis definition, risk factors, and prevention through nutrition and exercise. Digital Support: A 4-week follow-up via WhatsApp, involving twice-weekly distribution of educational videos, digital brochures, and podcasts to reinforce healthy behaviors. 3. Final Assessment: Four weeks post-intervention, both groups repeat the baseline questionnaires. Control Group: Receives routine clinical information only. To prevent contamination, all educational materials are shared with this group only after the final data collection is completed.

Experimental: The group receiving HBM based osteoporosis training

Eligibility Criteria

• Age: 45 Years - 80 Years
• Gender Eligibility Details: females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a woman aged 45 and over
• Not having been diagnosed with osteoporosis
• Having at least one of the risk factors for osteoporosis development as stated in the literature (being in menopause, family history of osteoporosis, low level of physical activity, insufficient calcium/vitamin D intake, low body mass index, etc.)
• Having applied to the Physical Therapy and Rehabilitation Outpatient Clinic of Bartın State Hospital
• Volunteering to participate in the study and signing the informed consent form
• Having the cognitive and physical capacity to participate in the training sessions

You may not qualify if:

• Having a previous diagnosis of osteoporosis
• Having a serious endocrine or rheumatological disease affecting bone metabolism
• Having a history of long-term (≥ 3 months) systemic corticosteroid use
• Having participated in a structured education program related to osteoporosis within the last 6 months
• Having hearing, vision, or cognitive impairment that would prevent participation in the education program
• Wishing to withdraw from the study or being unable to complete the follow-up process-

Sponsors & Collaborators

• Bartın Unıversity: lead

Study Sites (1)

Bartın State Hospital

Bartın, 74000, Turkey (Türkiye)

Location

Related Publications (8)

• Ocak Aktürk, S., Meseri, R., & Özentürk, M. G. (2021). The psychometric property evaluation of the Turkish version of the Osteoporosis Awareness Scale. Turkish Journal of Osteoporosis, 27(3), 151-158.https://doi.org/10.4274/tod.galenos.2021.22590

  BACKGROUND

• Kılıç, D., & Erci, B. (2004). Osteoporoz sağlık ölçeği, osteoporoz öz-etkililik-yeterlik ölçeği ve osteoporoz bilgi testinin geçerlilik ve güvenirliği. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 7(2), 89-102

  BACKGROUND

• Huo, R., Wei, C., Huang, X., Yang, Y., Huo, X., Meng, D., … Lin, J. (2024). Osteoporosis and pathological fracture-related mortality in the United States (1999-2020): A multiple-cause-of-death study. Journal of Orthopaedic Surgery and Research, 19(1), 568.

  BACKGROUND

• Greenblatt, M. B., Tsai, J. N., & Wein, M. N. (2017). Bone turnover markers in the diagnosis and monitoring of metabolic bone disease. Clinical Chemistry, 63(2), 464-474. https://doi.org/10.1373/clinchem.2016.259085

  BACKGROUND

• Eastell, R., O'Neill, T. W., Hofbauer, L. C., Langdahl, B., Reid, I. R., Gold, D. T., & Cummings, S. R. (2016). Postmenopausal osteoporosis. Nature Reviews Disease Primers, 2(1), 1-18.

  BACKGROUND

• Cosman, F., de Beur, S. J., LeBoff, M. S., Lewiecki, E. M., Tanner, B., Randall, S., & Lindsay, R. (2014). Clinician's guide to prevention and treatment of osteoporosis. Osteoporosis International, 25(10), 2359-2381.

  BACKGROUND

• Camacho, P. M., Petak, S. M., Binkley, N., Diab, D. L., Eldeiry, L. S., Farooki, A., … Watts, N. B. (2020). American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis-2020 update. Endocrine Practice, 26, 1-46.https://doi.org/10.4158/GL-2020-0524SUPPL

  BACKGROUND

• Kanis, J. A., Norton, N., Harvey, N. C., Jacobson, T., Johansson, H., Lorentzon, M., … Borgström, F. (2021). SCOPE 2021: A new scorecard for osteoporosis in Europe. Archives of Osteoporosis, 16(1), 82.

  BACKGROUND

Study Officials

• Taqwa İbrahim Hasan Hasan Hasan Hasan, bachelor

  Bartın Unıversity

  PRINCIPAL INVESTIGATOR

• Ayfer Bayındır Çevik Çevik Çevik, Professor

  Bartın Unıversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayfer Bayındır Çevik Prof.Dr.Ayfer Bayındır Çevik, Professor

CONTACT

+90 532 556 97 87; ayfercevik@bartin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.Ayfer Bayındır Çevik

Model Details: Participants in the intervention group will receive a four-week virtual osteoporosis education program developed by the researcher based on the Health Belief Model. The education will include information about osteoporosis, risk factors, prevention methods, healthy lifestyle behaviors, calcium and vitamin D intake, and physical activity. Educational videos, visual materials, e-brochures, podcasts, and regular communication via WhatsApp will be used, and participants will be encouraged to perform simple home-based exercises such as walking and muscle-strengthening exercises. The control group will not receive any educational intervention during the study. Questionnaires will be completed by both groups before and four weeks after the intervention. After the study is completed, the educational materials will also be shared with the control group.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)