Assessment of the Effectiveness of the Healthy Living Awareness Program for the Prevention of Osteoporosis Based on the Information- Motivation- Behavioral Skills Model in University Students: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- The effect of the program on the primary outcome-1 (Osteoporosis Knowledge Test)
研究概览
简要总结
This study investigated the effectiveness of a Healthy Living Awareness Program for the Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model (HLAPPO-IMB) in university students. The study adopted a randomized controlled trial intervention pretest, posttest, and follow-up research design. Participants were randomized into intervention (n=43) and control groups (n=44). Data were collected using a personal information form, the Osteoporosis Knowledge Test, the Osteoporosis Health Belief Scale, the Osteoporosis Self-Effective Scale, and the International Physical Activity Questionnaire Short Form.
The primary outcome measure was the participants' knowledge and health beliefs about osteoporosis. The secondary outcome measure was the participants' healthy lifestyle behavior skills (self-efficacy in weight-bearing exercises, taking calcium, and engaging in physical activity).
Research questions (RQ) RQ1: Does "Healthy Living Awareness Program for the Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model" expand participants' knowledge of osteoporosis? RQ2: Does "Healthy Living Awareness Program for the Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model" enhance participants' health beliefs? RQ3: Does "Healthy Living Awareness Program for the Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model" improve participants' self-efficacy in doing weight-bearing exercises and taking calcium? RQ4: Does "Healthy Living Awareness Program for the Prevention of Osteoporosis based on the Information-Motivation-Behavioral Skills Model" improve participants' self-efficacy in engaging in physical activity?
详细描述
This study adopted a randomized controlled trial pretest, posttest, and follow-up research design. The study was conducted between March and August 2021 at a public university in Türkiye. The study adhered to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. Participants were randomized into intervention and control groups. Eligible students were randomized to intervention group or control group using block randomization technique. Blinding in the study was not feasible. Blinding could not be performed because the researchers were aware of the interventions and carried out the implementation. The intervention group attended the HLAPPO-IMB, which had three stages: information, motivation, and behavioral skills development. The control group did not undergo the intervention.
The study population consisted of 125 fifth-semester nursing students in the fall term of the 2020-2021 academic year. The undergraduate nursing programs in Türkiye are eight-semester programs. The mean Osteoporosis Knowledge Test (OKT) scores were used to determine the sample size. Power analyses were performed based on the difference between two independent means by G*Power 3.1.9.7. A power analysis was performed to determine the sample size in line with the literature [OKT: experimental group X̅±SD: 18.95±4.98 and control group X̅±SD: 15.18±3.88]. The results showed that a sample of 76 would be large enough to detect significant differences (0.84 effect size, 0.05 level of error, and 95% power). All students who met the inclusion criteria were recruited to avoid missing data. The first sample consisted of 87 participants, who were randomized to intervention (n=43) and control (n=44) groups. However, one student from the intervention group declined to participate. Therefore, the final sample consisted of 86 participants.
The data were collected using a personal information form, the Osteoporosis Knowledge Test (OKT), the Osteoporosis Health Belief Scale (OHSB), the Osteoporosis Self-Effective Scale (OSES), and the International Physical Activity Questionnaire Short Form (IPAQ-SF).
The personal information form: This form was prepared by the researchers. The form consisted of 30 items on sociodemographic characteristics and factors that might affect bone mineral density. Each participant's BMI, body weight, and body height were calculated based on his/her self-report.
Osteoporosis knowledge test: The instrument consists of 24 items. The total score ranges from 0 to 24, with higher scores indicating more osteoporosis-related knowledge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Blinding in the study was not feasible. Blinding could not be performed because the researchers were aware of the interventions and carried out the implementation.
入排标准
- 年龄范围
- 20 Years 至 26 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •having received no training on osteoporosis before
- •having no disability that prevents physical activity
排除标准
- •involuntary
结局指标
主要结局
The effect of the program on the primary outcome-1 (Osteoporosis Knowledge Test)
时间窗: Pretest: 3 weeks, Completion of training: 2 weeks, Posttest: 2 weeks (2-3 weeks after training), Follow-up: 2 weeks (2 months after posttest). Total period of research: 20 weeks. Total application time of this scale: 7weeks.
Osteoporosis Knowledge Test consists of 24 items. The total score ranges from 0 to 24, with higher scores indicating more osteoporosis-related knowledge. Osteoporosis Knowledge Test with Osteoporosis Health Belief Scale was applied three times (pretest, posttest and follow-up) to the intervention and control groups. Training was given to the intervention group after completing the Osteoporosis Knowledge Test (with other scales) as a pretest. After the training, it was applied to the participants as a posttest and follow-up. All participants filled out the Osteoporosis Knowledge Test with Osteoporosis Health Belief Scale (posttest) two and three weeks after the training. They filled them out again two months after the posttest (follow-up). In the study protocol, pretest postest and follow up times are given in detail.
The effect of the program on the primary outcome-2 (Osteoporosis Health Belief Scale)
时间窗: Pretest: 3 weeks, Completion of training: 2 weeks, Posttest: 2 weeks (2-3 weeks after training), Follow-up: 2 weeks (2 months after posttest). Total period of research: 20 weeks. Total application time of this scale: 7weeks.
Osteoporosis Health Belief Scale consists of 42 items rated on a Likert-type scale. The total score ranges from 42 to 210, with higher scores indicating more positive health beliefs about osteoporosis. Osteoporosis Health Belief Scale with Osteoporosis Knowledge Test was applied three times (pretest, posttest and follow-up) to the intervention and control groups. Training was given to the intervention group after completing the Osteoporosis Health Belief Scale (with other scales) as a pretest. After the training, it was applied to the participants as a posttest and follow-up. All participants filled out the Osteoporosis Health Belief Scale with Osteoporosis Knowledge Test (posttest) two and three weeks after the training. They filled them out again two months after the posttest (follow-up).
次要结局
- The effect of the program on the secondary outcome-1 (Osteoporosis Self-Effective Scale)(Pretest: 3 weeks, training and follow-up period: 15 weeks, Follow-up: 2 weeks. Total period of research: 20 weeks. Total application time of this scale: 5 weeks.)
- The effect of the program on the primary outcome-2 (International Physical Activity Questionnaire Short Form)(Pretest: 3 weeks, training and follow-up period: 15 weeks, Follow-up: 2 weeks. Total period of research: 20 weeks. Total application time of this scale: 5 weeks.)
研究者
Sibel Peksoy Kaya
Asst. Prof.
Ankara Yildirim Beyazıt University
