Awareness Model in Prevention of Osteoporosis

NCT06028243 | Completed DMC

• 1 other identifier: 2021-12
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Osteoporosis; University Students; Healthy Lifestyle

Keywords

Osteoporosis; Health Behaviors; Health Beliefs; Motivation; Physical Activity; Program Planning; Self-Efficacy; Health Information

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• 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.

Study Arms (2)

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.

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.

Interventions

The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Information stage OTHER

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.

Intervention Group

The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Motivation stage OTHER

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.)

Intervention Group

The Healthy Living Awareness Program for the Prevention of Osteoporosis (HLAPPO-IMB)- Behavior skills stage BEHAVIORAL

The target behavior skills were improved self-efficacy in doing weight-bearing exercises, taking calcium, and engaging in physical activity.

Intervention Group

Eligibility Criteria

• Age: 20 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• having received no training on osteoporosis before
• having no disability that prevents physical activity

You may not qualify if:

• involuntary

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, 06760, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Osteoporosis; Health Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• SİBEL PEKSOY KAYA, Asst. Prof.

  ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY

  PRINCIPAL INVESTIGATOR

• SENA KAPLAN, Prof. Dr.

  ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY

  STUDY DIRECTOR

• ESRA BAŞKAYA, Dr.

  ANKARA YILDIRIM BEYAZIT UNIVERSITY, ANKARA, TURKEY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 8, 2023
• Study Start: March 26, 2021
• Primary Completion: May 18, 2021
• Study Completion: August 15, 2021
• Last Updated: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)