AzTrials
AzTrials

Health Belief Model-Based Osteoporosis Education ProgrammeHBM-osteo-eduNCT07486076

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

A study testing Osteoporosis Education Based on the Health Belief Model in people with Health Belief Model-Based Osteoporosis Education Programme, run by Bartın Unıversity at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 years, women onlyHealthy volunteers can take part
What is being tested?
Osteoporosis Education Based on the Health Belief Model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Apr 2026to 25 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Inclusion Criteria: Individuals meeting the following criteria will be included in the study:
  • 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
Show all 14Show fewer
  • Having the cognitive and physical capacity to participate in the training sessions
  • Exclusion Criteria:Exclusion Criteria: Individuals with the following characteristics will be excluded from the study:
  • 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-

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Bartın State Hospital

    Bartın, 74000

Other trials in Turkey (Türkiye)

About this study

Official title: THE EFFECT OF A HEALTH BELIEF MODEL-BASED EDUCATION PROGRAMME ON OSTEOPOROSIS AWARENESS AND HEALTH BELIEFS IN WOMAN AT RISK OF OSTEOPOROSIS: A RANDOMISED CONTROLLED TRIAL

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.

Read the detailed description

Osteoporosis is the most common musculoskeletal disorder worldwide, characterized by low bone mass and deterioration of the microarchitecture of bone tissue. This condition, which can lead to functional loss and increased mortality, is a significant public health problem that is both preventable and treatable. Approximately 90% of peak bone mass is achieved by age 18 in women and age 20 in men; low peak bone mass is considered a primary determinant of osteoporotic fracture risk in later life. Studies indicate that the prevalence of osteoporosis among older individuals is significant, emphasizing that the foundations of the disease are laid during adolescence.

The most serious complications of osteoporosis are fractures, which are associated with high costs, loss of independence, and mortality. These fractures most commonly occur in the spine, wrist, and hip. In postmenopausal women, wrist and spinal fractures increase after age 50, while hip fractures typically appear at later ages. Epidemiological data show varying rates of osteoporosis prevalence globally, which is notably higher in postmenopausal women. In this context, early identification of osteoporosis risk in women is critical.

Osteoporosis is classified into primary and secondary categories. Primary osteoporosis results from decreased bone mineralization due to aging or menopause, appearing more frequently 10-15 years after menopause in women and between ages 75-80 in men. Primary osteoporosis is further divided into Type 1 (postmenopausal) and Type 2 (senile). Type 1 is related to estrogen deficiency, whereas Type 2 is a natural consequence of aging, involving both cortical and trabecular bone loss. Vitamin D deficiency, decreased calcium absorption, and reduced osteoblast activity accelerate the development of Type 2. Secondary osteoporosis is associated with bone loss resulting from specific diseases or medication use.

In determining osteoporosis risk, identifying women who have not yet been diagnosed but carry specific risk factors is of vital importance. Literature reports that osteoporosis is more prevalent in women than men due to decreasing bone mineral density and increasing fragility. Primary causes include advancing age, postmenopausal estrogen decline, low body mass index, smoking, and a family history of osteoporosis. Risk factors also include modifiable and non-modifiable elements such as low calcium and vitamin D intake, inadequate physical activity, and long-term corticosteroid use. Women at risk can be defined as those who, despite lacking a formal diagnosis, possess at least one of these biological, hormonal, or lifestyle risk factors.

In addition to these factors, a lack of knowledge, misconceptions, and low awareness among women adversely affect disease prevention. Knowledge levels are often lower in rural areas, where the role of primary care physicians in information dissemination is critical. Insufficient health beliefs and knowledge levels reduce participation in screening programs and hinder early preventive measures.

According to guidelines published by global health organizations, bone density measurement is recommended for individuals at risk. This includes all women aged 65 and older, all men aged 70 and older, and younger adults with fracture risks. Furthermore, for individuals aged 50 and over, DXA screening is advised in the presence of risk factors such as a history of minimal trauma fractures, glucocorticoid therapy, postmenopausal status, low body weight (<57 kg), family history of hip fracture, and smoking.

Organizations such as the American Association of Clinical Endocrinologists (AACE) and the National Osteoporosis Foundation (NOF) similarly recommend the routine use of DXA as a screening tool for specific age groups and clinical findings. Early diagnosis through bone density measurement, particularly in postmenopausal women and women under 65 with risk factors, is considered an effective strategy for fracture prevention. Assessing risk allows for the detection of osteoporosis during the asymptomatic stage, enabling timely preventive and therapeutic interventions. This prevents osteoporotic fractures and related complications. Individuals with a history of low-trauma fractures or those at risk for age-related bone loss should be included in regular health check-ups and monitored with bone density tests. Periodic repetition of DXA measurements is also important for monitoring treatment efficacy and assessing the progression of bone loss.

The Health Belief Model (HBM) provides an important theoretical framework for understanding the factors that shape health-related behaviors. This model focuses on the beliefs and perceptions that influence the adoption of health behaviors. The primary goal of the HBM is to explain the beliefs necessary for individuals to engage in health-promoting behaviors. In addition to individual characteristics, the model emphasizes that environmental factors play a significant role. Education and interventions can help individuals modify these perceptions, resulting in positive changes in health behaviors.

International literature features various studies using the Health Belief Model as an effective framework for explaining and guiding osteoporosis-related knowledge, attitudes, and preventive behaviors. Research indicates that following a structured education program, participants show a significant increase in awareness regarding preventive behaviors-such as exercise, vitamin D, and calcium intake-alongside positive shifts in health belief components, including perceived susceptibility, seriousness, benefits, barriers, and self-efficacy.

Being tested
Osteoporosis Education Based on the Health Belief Model
Keywords
Health Belief Model-Based Education, Osteoporosis Awareness, Health Beliefs in Woman, Osteoporosis risk

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Osteoporosis Education Based on the Health Belief ModelBehavioural

    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.

Study groups in NCT07486076
Study groupRoleWhat they receive
The Control Group: The group not receiving HBM based osteoporosis trainingNo interventionParticipants 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 trainingExperimentalParticipants 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.
Receives: Behavioral: Osteoporosis Education Based on the Health Belief Model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 4 weeks post-intervention.

  2. 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.

    Measured: Baseline and 4 weeks post-intervention..

  3. 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.

    Measured: Baseline and 4 weeks post-intervention.

  4. 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.

    Measured: Baseline and 4 weeks post-intervention.

  5. 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.

    Measured: Baseline and 4 weeks post-intervention.

  6. 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.)

    Measured: Baseline and 4 weeks post-intervention.

  7. 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.

    Measured: Baseline and 4 weeks post-intervention.

  8. 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.

    Measured: Baseline and 4 weeks post-intervention.

  9. 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.

    Measured: Baseline and 4 weeks post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2026
  2. Study start25 Apr 2026
  3. Primary completion20 Jan 2027 (estimated)
  4. Study completion25 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07486076
Sponsor's protocol ID
HBM-osteo-edu
Acronym
HBM-osteo-edu
Status last verified
Aug 2026
First submitted
17 Mar 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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

  • Huo R, Wei C, Huang X, Yang Y, Huo X, Meng D, Huang R, Huang Y, Zhu X, Yang Y, Lin J. Mortality associated with osteoporosis and pathological fractures in the United States (1999-2020): a multiple-cause-of-death study. J Orthop Surg Res. 2024 Sep 16;19(1):568. doi: 10.1186/s13018-024-05068-1.

    PubMed 39285484
  • Greenblatt MB, Tsai JN, Wein MN. Bone Turnover Markers in the Diagnosis and Monitoring of Metabolic Bone Disease. Clin Chem. 2017 Feb;63(2):464-474. doi: 10.1373/clinchem.2016.259085. Epub 2016 Dec 9.

    PubMed 27940448
  • Eastell R, O'Neill TW, Hofbauer LC, Langdahl B, Reid IR, Gold DT, Cummings SR. Postmenopausal osteoporosis. Nat Rev Dis Primers. 2016 Sep 29;2:16069. doi: 10.1038/nrdp.2016.69.

    PubMed 27681935
  • Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R; National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15.

    PubMed 25182228
  • Camacho PM, Petak SM, Binkley N, Diab DL, Eldeiry LS, Farooki A, Harris ST, Hurley DL, Kelly J, Lewiecki EM, Pessah-Pollack R, McClung M, Wimalawansa SJ, Watts NB. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS/AMERICAN COLLEGE OF ENDOCRINOLOGY CLINICAL PRACTICE GUIDELINES FOR THE DIAGNOSIS AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS-2020 UPDATE. Endocr Pract. 2020 May;26(Suppl 1):1-46. doi: 10.4158/GL-2020-0524SUPPL.

    PubMed 32427503
  • Kanis JA, Norton N, Harvey NC, Jacobson T, Johansson H, Lorentzon M, McCloskey EV, Willers C, Borgstrom F. SCOPE 2021: a new scorecard for osteoporosis in Europe. Arch Osteoporos. 2021 Jun 2;16(1):82. doi: 10.1007/s11657-020-00871-9.

    PubMed 34080059

Questions about this trial

What is this clinical trial studying?

A study testing Osteoporosis Education Based on the Health Belief Model in people with Health Belief Model-Based Osteoporosis Education Programme, run by Bartın Unıversity at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Osteoporosis Awareness Scale (OAS) score. (time frame: Baseline and 4 weeks post-intervention.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07486076, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in