Osteoporosis Clinical Trial
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
NCT number | NCT06028243 |
Other study ID # | 2021-12 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 26, 2021 |
Est. completion date | August 15, 2021 |
Verified date | August 2023 |
Source | Ankara Yildirim Beyazit University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 87 |
Est. completion date | August 15, 2021 |
Est. primary completion date | May 18, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 26 Years |
Eligibility | Inclusion Criteria: - having received no training on osteoporosis before - having no disability that prevents physical activity Exclusion Criteria: - involuntary |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Yildirim Beyazit University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara Yildirim Beyazit University |
Turkey,
Abay H, Kaplan S. Evaluation of the effectiveness of a training program for coping with PMS symptoms based on IMB model in university students. Women Health. 2021 Jul;61(6):550-561. doi: 10.1080/03630242.2021.1927286. Epub 2021 Jun 1. — View Citation
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. — View Citation
Alpar, R. (2022). Spor Saglik ve Egitim Bilimlerinden Örneklerle Uygulamali Istatistik ve Geçerlik Güvenirlik; (7th edition). Ankara: Detay Yayincilik.
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. — View Citation
Barley 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. — View Citation
Bonjour JP, Theintz G, Law F, Slosman D, Rizzoli R. Peak bone mass. Osteoporos Int. 1994;4 Suppl 1:7-13. doi: 10.1007/BF01623429. — View Citation
Bonjour, 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. — View Citation
EQUATOR guidelines. (2020). Checklist for reporting a randomised trial. Retrieved from: https://www.goodreports.org/reporting-checklists/consort/
Ficek K, Rajca J, Cholewinski J, Racut A, Gwiazdon P, Przednowek K, Hajduk G. Analysis of intercondylar notch size and shape in patients with cyclops syndrome after anterior cruciate ligament reconstruction. J Orthop Surg Res. 2021 Sep 8;16(1):554. doi: 10.1186/s13018-021-02706-w. — View Citation
Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455. — View Citation
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. — View Citation
Hernlund 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. — View Citation
Hong SY, Jun SY. Community Capacity Building Exercise Maintenance Program for Frail Elderly Women. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Sep;11(3):166-173. doi: 10.1016/j.anr.2017.06.001. Epub 2017 Aug 10. — View Citation
Hosseini, 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
Kiliç, 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.
Kim, Y. il, & Park, J. S. (2017). Development and evaluation of a joint health self-management program for the elderly with knee osteoarthritis in communities: applying the IMB model. Research in Community and Public Health Nursing, 28(1), 55-68. https://
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. — View Citation
Lee Y, Kim DH. A preliminary study on the effects of an osteoporosis prevention program based on an Information-Motivation-Behavioral skill model in older adult women: A cluster randomized controlled trial. Geriatr Nurs. 2022 May-Jun;45:55-63. doi: 10.101 — View Citation
Majumdar SR, Lier DA, McAlister FA, Johnson JA, Rowe BH, Beaupre LA. Cost-Effectiveness of Osteoporosis Interventions to Improve Quality of Care After Upper Extremity Fracture: Results From a Randomized Trial (C-STOP Trial). J Bone Miner Res. 2019 Jul;34(7):1220-1228. doi: 10.1002/jbmr.3699. Epub 2019 Mar 18. — View Citation
Morton, M., & Montgomery, P. (2011). Youth empowerment programs for improving self-efficacy and self-esteem of adolescents. Campbell Systematic Reviews, 7(1), 1-80. https://doi.org/10.4073/CSR.2011.5
Oka R, Ohira M, Suzuki S, Yoshida T, Koide H, Tanaka T, Tatsuno I. Fracture risk assessment tool (FRAX) and for the diagnosis of osteoporosis in Japanese middle-aged and elderly women: Chiba bone survey. Endocr J. 2018 Feb 26;65(2):193-202. doi: 10.1507/endocrj.EJ17-0331. Epub 2017 Nov 18. — View Citation
Panahi R, Siboni FS, Kheiri M, Ghoozlu KJ, Shafaei M, Dehghankar L. Promoting the adoption of behaviors to prevent osteoporosis using the health belief model integrated with health literacy: quasi-experimental intervention study. BMC Public Health. 2021 D — View Citation
Park SJ, Jung JH, Kim MS, Lee HJ. High dairy products intake reduces osteoporosis risk in Korean postmenopausal women: A 4 year follow-up study. Nutr Res Pract. 2018 Oct;12(5):436-442. doi: 10.4162/nrp.2018.12.5.436. Epub 2018 Oct 1. — View Citation
Pouresmaeili F, Kamalidehghan B, Kamarehei M, Goh YM. A comprehensive overview on osteoporosis and its risk factors. Ther Clin Risk Manag. 2018 Nov 6;14:2029-2049. doi: 10.2147/TCRM.S138000. eCollection 2018. — View Citation
Qi BB, Resnick B, Smeltzer SC, Bausell B. Self-efficacy program to prevent osteoporosis among Chinese immigrants: a randomized controlled trial. Nurs Res. 2011 Nov-Dec;60(6):393-404. doi: 10.1097/NNR.0b013e3182337dc3. — View Citation
Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284. — View Citation
Shawashi, T. O., & Darawad, M. (2020). Osteoporosis knowledge, beliefs and self-efficacy among female university students: a descriptive study. The Open Nursing Journal, 14(1), 211-219. https://doi.org/10.2174/1874434602014010211
Shell DF, Newman IM, Perry CM, Folsom AR. Changing intentions to use smokeless tobacco: an application of the IMB model. Am J Health Behav. 2011 Sep;35(5):568-80. doi: 10.5993/ajhb.35.5.6. — View Citation
Si M, Su X, Jiang Y, Wang W, Zhang X, Gu X, Ma L, Li J, Zhang S, Ren Z, Liu Y, Qiao Y. Effect of an IMB Model-Based Education on the Acceptability of HPV Vaccination Among College Girls in Mainland China: A Cluster RCT. Cancer Control. 2022 Jan-Dec;29:10732748211070719. doi: 10.1177/10732748211070719. — View Citation
Tastekin Ouyaba A, Ozyurek P, Sevil U. The effect of an information, motivation, and behavioral skills model intervention on young women's intention to get an HPV vaccine. Psychol Health Med. 2023 Mar;28(3):732-742. doi: 10.1080/13548506.2021.1975780. Epu — View Citation
TC. Saglik Bakanligi Halk Sagligi Kurumu. (2016). Türkiye Beslenme Rehberi 2015 (TÜBER). T.C. Saglik Bakanligi Yayin No: 1031. Ankara.
Tsamlag L, Wang H, Shen Q, Shi Y, Zhang S, Chang R, Liu X, Shen T, Cai Y. Applying the information-motivation-behavioral model to explore the influencing factors of self-management behavior among osteoporosis patients. BMC Public Health. 2020 Feb 6;20(1):198. doi: 10.1186/s12889-020-8292-x. — View Citation
Tuzun S, Eskiyurt N, Akarirmak U, Saridogan M, Senocak M, Johansson H, Kanis JA; Turkish Osteoporosis Society. Incidence of hip fracture and prevalence of osteoporosis in Turkey: the FRACTURK study. Osteoporos Int. 2012 Mar;23(3):949-55. doi: 10.1007/s00198-011-1655-5. Epub 2011 May 19. — View Citation
Upadhyaya GK, Iyengar K, Jain VK, Vaishya R. Challenges and strategies in management of osteoporosis and fragility fracture care during COVID-19 pandemic. J Orthop. 2020 Jun 2;21:287-290. doi: 10.1016/j.jor.2020.06.001. eCollection 2020 Sep-Oct. Erratum In: J Orthop. 2020 Dec 15;24:292. — View Citation
World Health Organization (WHO). A healthy lifestyle-WHO recommendations (2023). Retrieved from: https://www.who.int/europe/news-room/fact-sheets/item/a-healthy-lifestyle---who-recommendations
Yeager DS, Dahl RE, Dweck CS. Why Interventions to Influence Adolescent Behavior Often Fail but Could Succeed. Perspect Psychol Sci. 2018 Jan;13(1):101-122. doi: 10.1177/1745691617722620. Epub 2017 Dec 12. — View Citation
Yekefallah, L., Dehghankar, L., Aliakbari, M., & Mafi, M. (2019). Lifestyle and preventive behaviors of osteoporosis among women of reproductive age in Qazvin-Iran: A cross sectional study. Social Health and Behavior, 2(2), 70. https://doi.org/10.4103/SHB.SHB_50_18
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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. | |
Primary | 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). |
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 | 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. |
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. | |
Secondary | 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. | 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. |
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