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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in Osteoporosis Awareness Scale (OAS) score.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •Having the cognitive and physical capacity to participate in the training sessions
排除标准
- •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-
研究组 & 干预措施
Experimental: The group receiving HBM based osteoporosis training
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.
干预措施: Osteoporosis Education Based on the Health Belief Model (Behavioral)
The Control Group: The group not receiving HBM based osteoporosis training
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.
结局指标
主要结局
Change in Osteoporosis Awareness Scale (OAS) score.
时间窗: Baseline and 4 weeks post-intervention.
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.
Change in Osteoporosis Health Belief Scale Score
时间窗: Baseline and 4 weeks post-intervention..
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.
Change in Osteoporosis Health Belief Scale - Perceived Seriousness Sub-dimension Score.
时间窗: Baseline and 4 weeks post-intervention.
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.
Change in Osteoporosis Health Belief Scale - Benefits of Exercise Sub-dimension Score.
时间窗: Baseline and 4 weeks post-intervention.
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.
Change in Osteoporosis Health Belief Scale - Benefits of Calcium Intake Sub-dimension Score.
时间窗: Baseline and 4 weeks post-intervention.
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.
Change in Osteoporosis Health Belief Scale - Barriers to Exercise Sub-dimension Score.
时间窗: Baseline and 4 weeks post-intervention.
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.)
Change in Osteoporosis Health Belief Scale - Barriers to Calcium Intake Sub-dimension Score.
时间窗: Baseline and 4 weeks post-intervention.
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.
Change in Osteoporosis Health Belief Scale - Health Motivation Sub-dimension Score.
时间窗: Baseline and 4 weeks post-intervention.
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.
Changes in Perceived Susceptibility Sub-dimension Score
时间窗: Baseline and 4 weeks post-intervention.
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.
Changes in osteoporosis awareness levels.
时间窗: Before the training program (baseline) and 4 weeks after the completion of the training program.
Participants' knowledge and awareness levels regarding osteoporosis will be assessed before and after the training program using an osteoporosis awareness test or a similar valid and reliable scale.
次要结局
- Changes in osteoporosis health beliefs(Before the training program (baseline) and 4 weeks after the completion of the training program.)
研究者
Ayfer Bayındır Çevik
Prof.Dr.Ayfer Bayındır Çevik
Bartın Unıversity