OsteoporosisNCT06028243
Awareness Model in Prevention of Osteoporosis
A study testing The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stage, The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stage and The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stage in people with Osteoporosis and University Students, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, University Students, Healthy Lifestyle
- What is being tested?
- The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stage, The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stage and The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2021to 15 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- having received no training on osteoporosis before
- having no disability that prevents physical activity
Who cannot join
- involuntary
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazit University
Ankara, 06760
About this study
Official title: 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
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?
Read the detailed description
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.
Osteoporosis health belief scale: The instrument 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 self-effective scale: The scale consists of 12 items and two subscales: The Osteoporosis Self-Efficacy Exercise Scale (six items: starting an exercise program, changing exercise habits, doing appropriate exercise, etc.) and the Osteoporosis Self-Efficacy Calcium Scale (six items: increasing calcium intake, choosing calcium-rich foods, maintaining dietary calcium intake, etc.). The total score of each subscale ranges from 0 to 600. The total score ranges from 0 to 1200, with higher scores indicating better self-efficacy in weight-bearing exercises and taking calcium.
International physical activity questionnaire short form: The form consists of seven items on physical activity. The total score is the "Metabolic Equivalent of Task minute/week (MET min/week)." The total score is calculated as "MET min/week" by multiplying the minute, day, and MET values. Physical activity levels are classified as low (<600 MET min/week), moderate (600-3000 MET min/week), or high (>3000 MET min/week) according to the total MET min/week values.
Healthy life diary: The researchers developed the Healthy Life Diary to monitor the intervention group participants' healthy lifestyle behaviors to protect themselves from osteoporosis. The intervention group participants filled out the diary regularly and noted their daily calcium intake, type and duration of exercise, duration and time of sunlight exposure, and amount of tobacco, coffee, tea, cola, etc.
Procedure: The data were collected online because of the COVID-19 pandemic. The researchers briefed students on the research procedure and texted them a link to the survey on WhatsApp. The first page of the survey was a consent form. After obtaining informed consent, the researchers directed all students who agreed to participate to the inclusion criteria section. Students are a vulnerable population. Thus, the researchers took measures to ensure students would not feel coerced to participate. The researchers informed all students about the research purpose and procedure. Participation was voluntary. The researchers kept all personal information confidential. All participants had pseudonyms.
Healthy living awareness program for the prevention of osteoporosis: The intervention group participants underwent the Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB) in three stages based on IMB.
Information stage: The researchers provided the intervention group participants with online training in healthy living awareness to prevent osteoporosis (400 minutes and two days). They held the training at all participants' convenience outside the class hours. The training consisted of four sections: osteoporosis and diagnosis-treatment methods, current approaches to the prevention of osteoporosis, osteoporosis and nutrition, and osteoporosis and physical exercise. The researchers employed interactive teaching methods and consulted three experts to prepare PowerPoint presentations. At the end of the training, the researchers taught the intervention group participants how to fill out the healthy life diary, such as calculating daily calcium intake. The researchers texted the intervention group participants all training videos on WhatsApp to allow them to watch them again. All participants filled out the OKT and OHSB (posttest) two and three weeks after the training. They filled them out again two months after the posttest (follow-up).
Motivation stage: The researchers regularly texted (WhatsApp) spot and reminder notifications concerning the prevention of osteoporosis. They asked them to assess the health behaviors they recorded in their diaries every week (daily calcium intake, weekly exercise duration, etc.) and the problems they experienced during the process. The researchers provided individual counseling to the participants by telephone (combating smoking, exercise barriers, food exchange for calcium sources, etc.)
Behavior skills stage: The target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity. The OSES was used to assess participants' self-efficacy to initiate and maintain behavior related to exercise and calcium taking, while the IPAQ-SF was used to assess their physical activity levels.
Data analysis: The data were analyzed using the Statistical Package for Social Sciences. Percentage, mean, and standard deviation were used for descriptive analysis. The categorical variables were analyzed using the Pearson, Fisher χ2, and Marginal Homogeneity tests. The Mann-Whitney U test was used to compare two independent groups. The Wilcoxon Signed Rank test or Friedman nonparametric test was used for dependent measurement comparisons. The effect size (r or Kendall W) was calculated for each comparison. The following limit values were accepted for the interpretation of the effect sizes: r < 0.29 "small effect," r=0.30-0.49 "medium effect," r ≥ 0.50 "large effect." W effect size: <0.39 "small effect," 0.40-0.59 "medium effect,"≥ 0.60 "large effect". The Mann-Whitney U Test was used to compare the difference in age, menarche age, BMI, and scale scores between the groups. The Wilcoxon Signed Rank test was used to compare the pretest and posttest scores. Friedman test was used for repeated measures for dependent groups. Dunn's Bonferroni correction was used to determine the source of the difference.
- Conditions
- Osteoporosis, University Students, Healthy Lifestyle
- Being tested
- The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stage, The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stage, The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stage
- Keywords
- Osteoporosis, Health Behaviors, Health Beliefs, Motivation, Physical Activity, Program Planning, Self-Efficacy, Health Information
- Medical subject headings
- Osteoporosis, Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stageOther
The researchers provided the intervention group participants with online training in healthy living awareness to prevent osteoporosis (400 minutes and two days). They held the training at all participants' convenience outside the class hours. The training consisted of four sections: (1) osteoporosis and diagnosis-treatment methods, (2) current approaches to the prevention of osteoporosis, (3) osteoporosis and nutrition, and (4) osteoporosis and physical exercise. The researchers employed interactive teaching methods and consulted three experts to prepare PowerPoint presentations. At the end of the training, the researchers taught the intervention group participants how to fill out the healthy life diary, such as calculating daily calcium intake. The researchers texted the intervention group participants all training videos on WhatsApp to allow them to watch them again.
The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stageOther
The researchers regularly texted (WhatsApp) spot and reminder notifications concerning the prevention of osteoporosis. They asked them to assess the health behaviors they recorded in their diaries every week (daily calcium intake, weekly exercise duration, etc.) and the problems they experienced during the process. The researchers provided individual counseling to the participants by telephone (combating smoking, exercise barriers, food exchange for calcium sources, etc.)
The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stageBehavioural
The target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB) was implemented in three stages.
Information stage: The researchers provided the intervention group participants with online training in healthy living awareness to prevent osteoporosis. The training consisted of four sections: osteoporosis and diagnosis-treatment methods, current approaches to the prevention of osteoporosis, osteoporosis and nutrition, and osteoporosis and physical exercise. At the end of the training, the participants were informed about the healthy life diary and record.
Motivation stage: The researchers regularly texted reminder notifications concerning the prevention of osteoporosis. The records in their diaries were reviewed. The researchers provided individual counseling to the participants by telephone.
Behavior skills stage: The target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity. Receives: Other: The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stage; Other: The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stage; Behavioral: The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stage |
| Control Group | No intervention | The control group was not trained. Data collection forms applied to the intervention group were also applied to the control group simultaneously. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the program on the primary outcome-1 (Osteoporosis Knowledge Test)
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.
Measured: 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.
The effect of the program on the primary outcome-2 (Osteoporosis Health Belief Scale)
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).
Measured: 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.
Secondary outcomes (2)
The effect of the program on the secondary outcome-1 (Osteoporosis Self-Effective Scale)
Osteoporosis Self-Effective Scale consists of 12 items and two subscales: The Osteoporosis Self-Efficacy Exercise Scale (six items: starting an exercise program, changing exercise habits, doing appropriate exercise, etc.) and the Osteoporosis Self-Efficacy Calcium Scale (six items: increasing calcium intake, choosing calcium-rich foods, maintaining dietary calcium intake, etc.). The total score of each subscale ranges from 0 to 600. The total score ranges from 0 to 1200, with higher scores indicating better self-efficacy in weight-bearing exercises and taking calcium.
Osteoporosis Self-Effective Scale was applied twice (pretest and follow-up) with International Physical Activity Questionnaire Short Form to the study groups. It was applied as a pretest with other scales. It was applied as a follow-up 13 weeks after the training.
Measured: 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)
International Physical Activity Questionnaire Short Form consists of seven items on physical activity. The total score is the "Metabolic Equivalent of Task minute/week)." The total score is calculated as "Metabolic Equivalent of Task minute/week " by multiplying the minute, day, and Metabolic Equivalent of Task values. Physical activity levels are classified as low, moderate, or high according to the total Metabolic Equivalent of Task min/week values. International Physical Activity Questionnaire Short Form was applied twice (pretest and follow-up) with Osteoporosis Self-Effective Scale to the study groups. It was applied as a pretest with other scales. It was applied as a follow-up 13 weeks after the training.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start26 Mar 2021
- Primary completion18 May 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Peksoy Kaya, Ankara Yildirim Beyazıt University
- Investigators
- SİBEL PEKSOY KAYA, Asst. Prof., Principal investigator, ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEYSENA KAPLAN, Prof. Dr., Study director, ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEYESRA BAŞKAYA, Dr., Study director, ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028243
- Sponsor's protocol ID
- 2021-12
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Publications
Aktas O, Kaplan S, Sezer N. An assessment of the relation between bone mineral density and clinic-demographic properties and life quality during postmenopausal period. J Back Musculoskelet Rehabil. 2018;31(5):803-810. doi: 10.3233/BMR-170933.
PubMed 29865030Alpar, R. (2022). Spor Sağlık ve Eğitim Bilimlerinden Örneklerle Uygulamalı İstatistik ve Geçerlik Güvenirlik; (7th edition). Ankara: Detay Yayıncılık.
Bahrami Z, Zarani F. Application of the Information-Motivation and Behavioral Skills (IMB) model in risky sexual behaviors amongst male students. J Infect Public Health. 2015 Mar-Apr;8(2):207-13. doi: 10.1016/j.jiph.2014.09.005. Epub 2014 Nov 22.
PubMed 25466597Barley E, Lawson V. Using health psychology to help patients: theories of behaviour change. Br J Nurs. 2016 Sep 8;25(16):924-7. doi: 10.12968/bjon.2016.25.16.924.
PubMed 27615529Bonjour JP, Theintz G, Law F, Slosman D, Rizzoli R. Peak bone mass. Osteoporos Int. 1994;4 Suppl 1:7-13. doi: 10.1007/BF01623429.
PubMed 8081064Bonjour, P., Compston, J., Dawson-Hughes, B., Delmas, P., Lyon, H. E. H., Ms, F., Johansson, H., Kanis, J. A., Lau, E., Yuen, L., Centre, H., Kong, H., Dr, C., Lindsay, R., Mcclung, M. R., Oden, A., Pfleger, B., Teilen, M. G., Clark Hospital De Especialidades, P., … Toroptsova, N. (2007). Assessment of Osteoporosis at The Primary Health Care Level. www.who.int/chp/topics/rheumatic/en/index.html
Cooper, C., & Ferrari, S. (2019). IOF Compendium of Osteoporosis (2nd Edition). Switzerland: International Osteoporosis Foundation.
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694EQUATOR guidelines. (2020). Checklist for reporting a randomised trial. Retrieved from: https://www.goodreports.org/reporting-checklists/consort/
Haleem A, Javaid M, Vaishya R. Effects of COVID-19 pandemic in daily life. Curr Med Res Pract. 2020 Mar-Apr;10(2):78-79. doi: 10.1016/j.cmrp.2020.03.011. Epub 2020 Apr 3. No abstract available.
PubMed 32292804Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos. 2013;8(1):136. doi: 10.1007/s11657-013-0136-1. Epub 2013 Oct 11.
PubMed 24113837Hosseini, Z., Karimi, Z., Mohebi, S., Reza Sharifirad, G., Rahbar, A., & Gharlipour, Z. (2017). Nutritional preventive behavior of osteoporosis in female students: Applying health belief model (HBM). International Journal of Pediatrics, 5(37). https://doi.org/10.22038/ijp.2016.7560
Kılıç, D., & Erci, B. (2010). The reliability and validity of the osteoporosis health belief scale, osteoporosis self-efficacy scale and osteoporosis knowledge test. Journal of Anatolia Nursing and Health Sciences, 7(2), 89-102. https://dergipark.org.tr/en/pub/ataunihem/issue/2627/33798
Kim, K., Horan, M., & Gendler, P. (1991). Osteoporosis Knowledge Test, Osteoporosis Health Belief Scale, and Osteoporosis Self-efficacy Scale Allendale: MI: Grand Valley State University; Allendale. Masterson R. A descript.
Kline J, Tang A, Levin B. Smoking, alcohol and caffeine in relation to two hormonal indicators of ovarian age during the reproductive years. Maturitas. 2016 Oct;92:115-122. doi: 10.1016/j.maturitas.2016.07.010. Epub 2016 Jul 21.
PubMed 27621248
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06028243
- Acronym / sponsor ID
- 2021-12
- Conditions
- Osteoporosis, University Students, Healthy Lifestyle
- Keywords
- Osteoporosis, Health Behaviors, Health Beliefs, Motivation, Physical Activity, Program Planning, Self-Efficacy, Health Information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 18 May 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Osteoporosis health belief scale: The instrument 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 self-effective scale: The scale consists of 12 items and two subscales: The Osteoporosis Self-Efficacy Exercise Scale (six items: starting an exercise program, changing exercise habits, doing appropriate exercise, etc.) and the Osteoporosis Self-Efficacy Calcium Scale (six items: increasing calcium intake, choosing calcium-rich foods, maintaining dietary calcium intake, etc.). The total score of each subscale ranges from 0 to 600. The total score ranges from 0 to 1200, with higher scores indicating better self-efficacy in weight-bearing exercises and taking calcium.
International physical activity questionnaire short form: The form consists of seven items on physical activity. The total score is the "Metabolic Equivalent of Task minute/week (MET min/week)." The total score is calculated as "MET min/week" by multiplying the minute, day, and MET values. Physical activity levels are classified as low (<600 MET min/week), moderate (600-3000 MET min/week), or high (>3000 MET min/week) according to the total MET min/week values.
Healthy life diary: The researchers developed the Healthy Life Diary to monitor the intervention group participants' healthy lifestyle behaviors to protect themselves from osteoporosis. The intervention group participants filled out the diary regularly and noted their daily calcium intake, type and duration of exercise, duration and time of sunlight exposure, and amount of tobacco, coffee, tea, cola, etc.
Procedure: The data were collected online because of the COVID-19 pandemic. The researchers briefed students on the research procedure and texted them a link to the survey on WhatsApp. The first page of the survey was a consent form. After obtaining informed consent, the researchers directed all students who agreed to participate to the inclusion criteria section. Students are a vulnerable population. Thus, the researchers took measures to ensure students would not feel coerced to participate. The researchers informed all students about the research purpose and procedure. Participation was voluntary. The researchers kept all personal information confidential. All participants had pseudonyms.
Healthy living awareness program for the prevention of osteoporosis: The intervention group participants underwent the Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB) in three stages based on IMB.
Information stage: The researchers provided the intervention group participants with online training in healthy living awareness to prevent osteoporosis (400 minutes and two days). They held the training at all participants' convenience outside the class hours. The training consisted of four sections: osteoporosis and diagnosis-treatment methods, current approaches to the prevention of osteoporosis, osteoporosis and nutrition, and osteoporosis and physical exercise. The researchers employed interactive teaching methods and consulted three experts to prepare PowerPoint presentations. At the end of the training, the researchers taught the intervention group participants how to fill out the healthy life diary, such as calculating daily calcium intake. The researchers texted the intervention group participants all training videos on WhatsApp to allow them to watch them again. All participants filled out the OKT and OHSB (posttest) two and three weeks after the training. They filled them out again two months after the posttest (follow-up).
Motivation stage: The researchers regularly texted (WhatsApp) spot and reminder notifications concerning the prevention of osteoporosis. They asked them to assess the health behaviors they recorded in their diaries every week (daily calcium intake, weekly exercise duration, etc.) and the problems they experienced during the process. The researchers provided individual counseling to the participants by telephone (combating smoking, exercise barriers, food exchange for calcium sources, etc.)
Behavior skills stage: The target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity. The OSES was used to assess participants' self-efficacy to initiate and maintain behavior related to exercise and calcium taking, while the IPAQ-SF was used to assess their physical activity levels.
Data analysis: The data were analyzed using the Statistical Package for Social Sciences. Percentage, mean, and standard deviation were used for descriptive analysis. The categorical variables were analyzed using the Pearson, Fisher χ2, and Marginal Homogeneity tests. The Mann-Whitney U test was used to compare two independent groups. The Wilcoxon Signed Rank test or Friedman nonparametric test was used for dependent measurement comparisons. The effect size (r or Kendall W) was calculated for each comparison. The following limit values were accepted for the interpretation of the effect sizes: r < 0.29 "small effect," r=0.30-0.49 "medium effect," r ≥ 0.50 "large effect." W effect size: <0.39 "small effect," 0.40-0.59 "medium effect,"≥ 0.60 "large effect". The Mann-Whitney U Test was used to compare the difference in age, menarche age, BMI, and scale scores between the groups. The Wilcoxon Signed Rank test was used to compare the pretest and posttest scores. Friedman test was used for repeated measures for dependent groups. Dunn's Bonferroni correction was used to determine the source of the difference.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stage, Other: The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stage, Behavioral: The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stageThe Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB) was implemented in three stages. Information stage: The researchers provided the intervention group participants with online training in healthy living awareness to prevent osteoporosis. The training consisted of four sections: osteoporosis and diagnosis-treatment methods, current approaches to the prevention of osteoporosis, osteoporosis and nutrition, and osteoporosis and physical exercise. At the end of the training, the participants were informed about the healthy life diary and record. Motivation stage: The researchers regularly texted reminder notifications concerning the prevention of osteoporosis. The records in their diaries were reviewed. The researchers provided individual counseling to the participants by telephone. Behavior skills stage: The target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity. |
| Control Group | No intervention | –The control group was not trained. Data collection forms applied to the intervention group were also applied to the control group simultaneously. |
Who may qualify
- Ages
- 20 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- having received no training on osteoporosis before
- having no disability that prevents physical activity
Key exclusion criteria (1 listed)
- involuntary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stageThe researchers provided the intervention group participants with online training in healthy living awareness to prevent osteoporosis (400 minutes and two days). They held the training at all participants' convenience outside the class hours. The training consisted of four sections: (1) osteoporosis and diagnosis-treatment methods, (2) current approaches to the prevention of osteoporosis, (3) osteoporosis and nutrition, and (4) osteoporosis and physical exercise. The researchers employed interactive teaching methods and consulted three experts to prepare PowerPoint presentations. At the end of the training, the researchers taught the intervention group participants how to fill out the healthy life diary, such as calculating daily calcium intake. The researchers texted the intervention group participants all training videos on WhatsApp to allow them to watch them again. | Other | Intervention Group |
| The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stageThe researchers regularly texted (WhatsApp) spot and reminder notifications concerning the prevention of osteoporosis. They asked them to assess the health behaviors they recorded in their diaries every week (daily calcium intake, weekly exercise duration, etc.) and the problems they experienced during the process. The researchers provided individual counseling to the participants by telephone (combating smoking, exercise barriers, food exchange for calcium sources, etc.) | Other | Intervention Group |
| The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stageThe target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity. | Behavioural | Intervention Group |
Primary outcome
The effect of the program on the primary outcome-1 (Osteoporosis Knowledge Test)
Time frame: 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)
Time frame: 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).
2 secondary outcomes
The effect of the program on the secondary outcome-1 (Osteoporosis Self-Effective Scale)
Time frame: 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)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Background: PubMed 29865030Aktas O, Kaplan S, Sezer N. An assessment of the relation between bone mineral density and clinic-demographic properties and life quality during postmenopausal period. J Back Musculoskelet Rehabil. 2018;31(5):803-810. doi: 10.3233/BMR-170933.
- BackgroundAlpar, R. (2022). Spor Sağlık ve Eğitim Bilimlerinden Örneklerle Uygulamalı İstatistik ve Geçerlik Güvenirlik; (7th edition). Ankara: Detay Yayıncılık.
- Background: PubMed 25466597Bahrami Z, Zarani F. Application of the Information-Motivation and Behavioral Skills (IMB) model in risky sexual behaviors amongst male students. J Infect Public Health. 2015 Mar-Apr;8(2):207-13. doi: 10.1016/j.jiph.2014.09.005. Epub 2014 Nov 22.
- Background: PubMed 27615529Barley E, Lawson V. Using health psychology to help patients: theories of behaviour change. Br J Nurs. 2016 Sep 8;25(16):924-7. doi: 10.12968/bjon.2016.25.16.924.
- Background: PubMed 8081064Bonjour JP, Theintz G, Law F, Slosman D, Rizzoli R. Peak bone mass. Osteoporos Int. 1994;4 Suppl 1:7-13. doi: 10.1007/BF01623429.
- BackgroundBonjour, P., Compston, J., Dawson-Hughes, B., Delmas, P., Lyon, H. E. H., Ms, F., Johansson, H., Kanis, J. A., Lau, E., Yuen, L., Centre, H., Kong, H., Dr, C., Lindsay, R., Mcclung, M. R., Oden, A., Pfleger, B., Teilen, M. G., Clark Hospital De Especialidades, P., … Toroptsova, N. (2007). Assessment of Osteoporosis at The Primary Health Care Level. www.who.int/chp/topics/rheumatic/en/index.html
- BackgroundCooper, C., & Ferrari, S. (2019). IOF Compendium of Osteoporosis (2nd Edition). Switzerland: International Osteoporosis Foundation.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- BackgroundEQUATOR guidelines. (2020). Checklist for reporting a randomised trial. Retrieved from: https://www.goodreports.org/reporting-checklists/consort/
- Background: PubMed 32292804Haleem A, Javaid M, Vaishya R. Effects of COVID-19 pandemic in daily life. Curr Med Res Pract. 2020 Mar-Apr;10(2):78-79. doi: 10.1016/j.cmrp.2020.03.011. Epub 2020 Apr 3. No abstract available.
- Background: PubMed 24113837Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos. 2013;8(1):136. doi: 10.1007/s11657-013-0136-1. Epub 2013 Oct 11.
- BackgroundHosseini, Z., Karimi, Z., Mohebi, S., Reza Sharifirad, G., Rahbar, A., & Gharlipour, Z. (2017). Nutritional preventive behavior of osteoporosis in female students: Applying health belief model (HBM). International Journal of Pediatrics, 5(37). https://doi.org/10.22038/ijp.2016.7560
- Individual participant dataSharing planned: No. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SİBEL PEKSOY KAYA, Asst. Prof. principal investigator
ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY
SENA KAPLAN, Prof. Dr. study director
ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY
ESRA BAŞKAYA, Dr. study director
ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stage, The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stage and The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stage in people with Osteoporosis and University Students, run by Ankara Yildirim Beyazıt University 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 8 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effect of the program on the primary outcome-1 (Osteoporosis Knowledge Test) (time frame: 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.). The study lists 2 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 NCT06028243, which also lists 41 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 8 Sep 2023.