- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07566143
Social Cognitive Theory-Based Education for Improving Health Outcomes in Older Adults (SCT-OLD)
Effect of a Social Cognitive Theory-Based Education Program on Self-Efficacy, Healthy Lifestyle Behaviors, and Health Literacy in Older Adults Attending Primary Care Centers: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed as a randomized controlled trial to evaluate the impact of a Social Cognitive Theory-based educational intervention on self-efficacy, healthy lifestyle behaviors, and health literacy among older adults. The study will be conducted in a primary care setting and will include individuals aged 65 years and older who meet the inclusion criteria and provide informed consent.
Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive a structured education program based on Social Cognitive Theory, delivered in three weekly face-to-face sessions, each lasting approximately 30 minutes. The content of the program includes health promotion, healthy nutrition, physical activity, chronic disease management, self-efficacy enhancement, and health literacy improvement. The control group will receive routine primary care services without additional intervention.
Data will be collected at two time points: baseline (pre-test) and 4-6 weeks after the completion of the intervention (post-test). Outcome measures include self-efficacy, assessed using the General Self-Efficacy Scale; healthy lifestyle behaviors, assessed using the Health-Promoting Lifestyle Profile; and health literacy, assessed using the Health Literacy Scale (short form).
The study is expected to provide evidence on the effectiveness of theory-based educational interventions in promoting health behaviors and improving health literacy among older adults in primary care settings.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammet Faruk Yiğit, PhD
- Phone Number: +90 542 424 76 29
- Email: muhammetfarukyigit@yyu.edu.tr
Study Locations
-
-
Van
-
Van, Van, Turkey (Türkiye), 65100
- Tuşba Bardakçı Family Health Center
-
Contact:
- Muhammet Faruk Yiğit, PhD
- Phone Number: 0-432-215-04-75
- Email: muhammetfarukyigit@yyu.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 years and older
- Able to communicate in Turkish
- Willing to participate and provide informed consent
- Having sufficient cognitive ability to follow the education program
Exclusion Criteria:
- Severe cognitive impairment
- Severe psychiatric disorder
- Acute or life-threatening medical condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants in this group will receive a structured Social Cognitive Theory-based education program consisting of three weekly face-to-face sessions, in addition to routine primary care services.
|
A structured face-to-face education program based on Social Cognitive Theory, delivered in three weekly sessions covering health promotion, nutrition, physical activity, self-efficacy, and health literacy.
|
|
No Intervention: Arm Type: Control Group (No Intervention)
Participants in this group will receive routine primary care services without any additional educational intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy Level
Time Frame: Baseline and 4-6 weeks after intervention
|
Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES).
The scale consists of 10 items scored on a 4-point Likert scale (1-4), with a total score ranging from 10 to 40.
Higher scores indicate higher levels of self-efficacy (better outcome).
|
Baseline and 4-6 weeks after intervention
|
|
Healthy Lifestyle Behaviors
Time Frame: Baseline and 4-6 weeks after intervention
|
Healthy lifestyle behaviors will be measured using the Health-Promoting Lifestyle Profile II (HPLP-II).
The scale includes 52 items rated on a 4-point Likert scale (1-4), with total scores ranging from 52 to 208.
Higher scores indicate more positive health-promoting lifestyle behaviors (better outcome).
|
Baseline and 4-6 weeks after intervention
|
|
Health Literacy Level
Time Frame: Baseline and 4-6 weeks after intervention
|
Health literacy will be assessed using the Health Literacy Scale-Short Form (HLS-SF).
The scale consists of items rated on a Likert-type scale, with total scores ranging from 0 to 50.
Higher scores indicate higher health literacy levels (better outcome).
|
Baseline and 4-6 weeks after intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Nutbeam D. Health literacy as a public health goal: 25 years on. Health Promot Int. 2025 Jul 1;40(4):daaf119. doi: 10.1093/heapro/daaf119. No abstract available.
- Sorensen K, Pelikan JM, Rothlin F, Ganahl K, Slonska Z, Doyle G, Fullam J, Kondilis B, Agrafiotis D, Uiters E, Falcon M, Mensing M, Tchamov K, van den Broucke S, Brand H; HLS-EU Consortium. Health literacy in Europe: comparative results of the European health literacy survey (HLS-EU). Eur J Public Health. 2015 Dec;25(6):1053-8. doi: 10.1093/eurpub/ckv043. Epub 2015 Apr 5.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-228384
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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