NCT05881850

Brief Summary

Summary Purpose: To examine the effect of the education program to increase osteoporosis awareness given to women aged 18-49. The research is carry out as a randomized controlled experimental in a pretest-posttest design. The population of the research consisted of women registered in four different women's cultural and education centers affiliated with Ankara Altındağ Municipality between the dates of data collection.The number of women to be included in the sample of the study was determined as 70 women, 35 of which were in the control group, in the analysis made using the G\*Power 3.1.9.2 program. Intervention and control groups were assigned to the groups by randomization method. The data collection tools used in the research are the Introductory Information Form, the Osteoporosis Health Belief Scale and the Osteoporosis Awareness Scale. In the implementation of the research, the education program to increase awareness of osteoporosis was carried out on certain days of the week with groups of at least two and at most five women. The education program aimed at raising awareness of osteoporosis was carried out in 3 sessions, one week apart, and each session lasted approximately 40-50 minutes. Before the first session of the education program, pre-test data were collected from the intervention and control groups. Post-test data will be collected through the Osteoporosis Health Belief Scale and the Osteoporosis Awareness Scale from women in the intervention and control groups twelve weeks after finishing the education program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

28 days

First QC Date

May 11, 2023

Last Update Submit

November 14, 2023

Conditions

Keywords

OsteoporosisOsteoporosis Health BeliefAwarenessEducation ProgramWomen Health

Outcome Measures

Primary Outcomes (1)

  • Pre-test data: An introductory information form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale

    1. Osteoporosis Awareness Scale: There are 27 questions and five sub-dimensions in the scale. The items in the scale are in four-point Likert type and classified as "I don't know at all" = 1, "I know a little" = 2, "I know" = 3, "I know very well" = 4. There are no reverse items and cut-off points in the scale. The total score obtained from the scale is minimum=27 maximum=108. As the score obtained from the scale increases, the level of awareness towards osteoporosis increases (Aktürk et al., 2021). 2. There are 42 questions and seven sub-dimensions in the scale. The items in the scale are five-point Likert type, and the answer "strongly disagree"=1, "disagree" =2, "undecided" =3, "agree"=4, and "strongly agree" is evaluated as 5 points.The lowest score that can be obtained from the scale is 42 and the highest score is 210. The high score of the scale directly affects the health protective and improving behaviors of the person (Kılıç and Erci, 2004).

    just before the education program (before first session)

Secondary Outcomes (1)

  • Post-test data: Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale

    Eight weeks after the pre-test data were collected

Study Arms (2)

Intervention group

EXPERIMENTAL

After the participants are given the necessary information about the research and written consent is obtained, the introductory information form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied by the researcher to the women in the intervention group who meet the inclusion criteria in the study to collect pre-test data just before the education program begins. Twelve weeks after finishing the education program the Osteoporosis Awareness Scale and the Osteoporosis Health Belief Scale will be administered to collect the posttest data.

Other: Education Program on Increasing Osteoporosis Awareness Given to Women Aged 18-49. The research is carry out as a randomized controlled experimental in a pretest-posttest design.

Control group

NO INTERVENTION

After the participants were given the necessary information about the study and written consents were obtained, the Introductory Information Form, Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied to the women in the control group who met the inclusion criteria in order to collect the pre-test data. Twelve weeks after finishing the education program, the Osteoporosis Awareness Scale and Osteoporosis Health Belief Scale will be applied to collect the post-test data.

Interventions

The education program consisting of three sessions was held once a week and each session lasted approximately 40-50 minutes. In the realization of the education program, a power point presentation consisting of the contents of the education booklet prepared for Osteoporosis awareness, a three-dimensional bone model with Osteoporosis and normal bone tissue, some food samples containing calcium during nutrition education, and measuring cups to show portions and amounts were used. During the training, a question and answer activity was also held. The education booklet was also given to the intervention group at the end of the first session.

Intervention group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be between the ages of 18-49,
  • Volunteering to participate in the study,
  • To be at least primary school graduate,
  • Not being pregnant or breastfeeding
  • Not having a condition that prevents him from exercising,
  • Not having a diet that limits daily calcium needs,
  • Not having a planned training on osteoporosis before,
  • Not being diagnosed with osteoporosis or osteopenia,
  • Not be in the menopausal period,
  • Not having a chronic disease
  • Not having a situation that prevents communication (vision, hearing impairment, etc.).

You may not qualify if:

  • Not participating in the entire training program,
  • Failure to fill in all of the data collection tools during the research process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altındağ Municipality; Karapürçek 1, Mimar Başak Cengiz, Yıldıztepe, Beşikkaya Women's Culture and Education Centers

Ankara, 6050, Turkey (Türkiye)

Location

Related Publications (12)

  • Eyimaya AO, Tezel A. The effect of nursing approaches applied according to Meleis' Transition Theory on menopause-specific quality of life. Health Care Women Int. 2021 Jan;42(1):107-126. doi: 10.1080/07399332.2020.1825440.

  • Choi E, Kim J, Chung M, Hwang K. [Development of an osteoporosis awareness scale for women]. J Korean Acad Nurs. 2008 Dec;38(6):813-21. doi: 10.4040/jkan.2008.38.6.813. Korean.

  • Kim KK, Horan ML, Gendler P, Patel MK. Development and evaluation of the Osteoporosis Health Belief Scale. Res Nurs Health. 1991 Apr;14(2):155-63. doi: 10.1002/nur.4770140210.

  • Alnuaimi K, Abuidhail J, Abuzaid H. The effects of an educational programme about preeclampsia on women's awareness: a randomised control trial. Int Nurs Rev. 2020 Dec;67(4):501-511. doi: 10.1111/inr.12626. Epub 2020 Sep 22.

  • Darawad MW, Shawashi TO, Al Duraidi H, Nofal B. Osteoporosis education: Evaluation of an awareness program among female university students. Int J Orthop Trauma Nurs. 2022 May;45:100926. doi: 10.1016/j.ijotn.2022.100926. Epub 2022 Feb 11.

  • Erenoglu R, Yaman Sozbir S. The Effect of Health Education Given to Syrian Refugee Women in Their Own Language on Awareness of Breast and Cervical Cancer, in Turkey: a Randomized Controlled Trial. J Cancer Educ. 2020 Apr;35(2):241-247. doi: 10.1007/s13187-019-01604-4.

  • Pınar G, Pınar T. The Impact of health belief model based educational ıntervention on women's knowledge, beliefs, preventive behaviors and clinical outcomes about osteoporosis. SAGE Open. 2020; 10(3), 2158244020941473.

    RESULT
  • Akürk SO, Meseri R, & Özentürk, MG. The psychometric property evaluation of the turkish version of the osteoporosis awareness scale. Turkish Journal of Osteoporosis/Turk Osteoporoz Dergisi. 2021; 27(3), 151-158.

    RESULT
  • ATEŞMAN, E. Türkçe'de okunabilirliğin ölçülmesi. A.Ü. Tömer Dil Dergisi. 1997; 58: 71-74

    RESULT
  • Kılıç D, Erci B. Osteoporoz sağlık inanç ölçeği, osteoporoz öz-etkililik/yeterlik ölçeği ve osteoporoz bilgi testi'nin geçerlilik ve güvenirliği. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi. 2004; 7(2); 89-102.

    RESULT
  • Gökdoğan F."Etkili bir hasta iletişimi için araç geliştirme: yazılı materyallerin uygunluğunun Değerlendirilmesi (DISCERN). Onkoloji Hemşireliği Derneği Bülteni.2003; 16-17: 8-16

    RESULT
  • Oz Yildirim O, Aydin Avci I, Yildirim E, Bostanci Y. The effect of the Incontinence Health Belief Development Program on women's urinary incontinence awareness and health beliefs: a randomized controlled trial. Int Urogynecol J. 2023 Jul;34(7):1385-1393. doi: 10.1007/s00192-022-05343-x. Epub 2022 Sep 21.

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Funda Ozturk, Assos. Prof.

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistical expert who performs the randomization of the study and the statistical expert who evaluates the pre- and post-intervention data obtained in the study are different from each other.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The research will be conducted in a pre-test-post-test order, as a randomized controlled experimental.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered nurse

Study Record Dates

First Submitted

May 11, 2023

First Posted

May 31, 2023

Study Start

June 30, 2023

Primary Completion

July 28, 2023

Study Completion

October 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations