Educational intervention for mental health and health behaviors in elderly Iranian women randomized controlled trial

The increasing elderly population, driven by advancements in healthcare and improved living conditions, represents one of the most significant challenges facing modern societies¹. By 2050, the proportion of individuals aged 60 years and older worldwide is expected to reach 21.4%². This demographic transition extends beyond developed countries; the World Health Organization (WHO) reports that the growth rate of the elderly population in low- and middle-income countries exceeds that in high-income countries³.

In response to this global challenge, the United Nations General Assembly designated the decade 2021–2030 as the “Decade of Healthy Ageing,” emphasizing the promotion of health, well-being, and active participation among older adults⁴. Research has shown that an unhealthy lifestyle is one of the major risk factors for chronic diseases in older adults⁵. According to WHO, 60% of global mortality and 80% of deaths in developing countries are attributed to unhealthy lifestyle choices⁶. Consequently, educational interventions and health promotion programs have emerged as critical strategies for improving quality of life among older adults⁴.

The importance of lifestyle modification is particularly pronounced for older women, who face greater vulnerability due to intersecting biological, cultural, social, and economic factors⁷. Compared to their male counterparts, older women experience significantly higher rates of mental health issues, including anxiety and depression⁸. Furthermore, the reduction in social interactions and evolving family roles in later life disproportionately affects women’s mental health⁹. In Iran, the feminization of aging presents a significant demographic challenge, with Statistical Center of Iran data (2022) revealing that elderly women numbered approximately 8 million in 2021, constituting nearly 60% of the elderly population¹⁰. This demographic shift, combined with higher mental health issue prevalence among older women, underscores the urgent need for tailored, gender-specific interventions promoting healthy lifestyle behaviors.

While WHO recommends that health promotion policies for older adults should encompass individual empowerment, education about healthy behaviors, and improved healthcare service access¹¹, such comprehensive approaches remain underdeveloped. Although these strategies demonstrate potential for enhancing physical and mental health outcomes while reducing healthcare costs^12,13, Iran’s healthcare system, despite providing free primary healthcare services to older adults through the Ministry of Health network, offers limited targeted interventions specifically designed to enhance health-promoting behaviors and improve health outcomes among this population.

Understanding the multidimensional nature of health-promoting behaviors becomes essential for developing effective interventions. Pender’s Health Promotion Model provides a comprehensive theoretical framework for understanding and modifying health behaviors through key constructs including perceived benefits of action (anticipated positive outcomes of health behaviors), perceived barriers to action (anticipated impediments to behavior adoption), perceived self-efficacy (confidence in one’s ability to execute behaviors), activity-related affect (subjective feelings before, during, and after behavior), interpersonal influences (cognitions concerning behaviors of significant others), and situational influences (perceptions of environmental factors that facilitate or impede behavior)¹⁴. Building upon Pender’s theoretical framework, Walker and colleagues identified six fundamental dimensions of health-promoting lifestyle: physical activity, nutrition, stress management, interpersonal relationships, spiritual growth, and health responsibility¹⁵.

Educational interventions have demonstrated effectiveness in improving mental health and health-promoting behaviors among older adults. Positive psychology interventions significantly reduce depression and anxiety, enhance life satisfaction^16,17,18, and promote sustained improvements in well-being^16,19. In addition, lifestyle interventions have been shown to improve their health^{20,21,22,23,24} .However, several critical gaps persist in the current literature.

Most existing interventions address specific behavioral dimensions rather than providing holistic coverage of all health-promoting domains simultaneously. While recent studies demonstrate success with targeted approaches—including diverse physical activity promotion strategies and nutrition-focused interventions^20,21,22—comprehensive interventions addressing all dimensions of health-promoting behaviors remain limited. This fragmented approach potentially undermines the synergistic effects that may emerge from simultaneously targeting multiple behavioral domains. Additionally, despite the demonstrated efficacy of positive psychology interventions^16,17,18,19, their integration with comprehensive lifestyle modification programs remains limited, representing a missed opportunity to leverage the interconnected nature of psychological well-being and behavioral health promotion.

Furthermore, most comprehensive lifestyle interventions have been developed in Western populations, with limited Middle Eastern representation^11,25. The few Iranian studies have focused on specific behavioral domains without integrating mental health outcomes with comprehensive health-promoting behaviors^23,24. Cultural and religious considerations in intervention design also remain inadequately addressed, particularly the need for gender-specific approaches for older Muslim women in Iranian Islamic contexts.

In response to these identified gaps, the present study aims to evaluate the impact of an educational intervention based on Pender’s Health Promotion Model on mental health and health-promoting behaviors among older women enrolled in the Family Physician Program in Fars Province, southern Iran.

All 140 randomized participants completed the study (100% retention) and were equally allocated to intervention (n = 70) and control (n = 70) groups. Table 1 presents the demographic characteristics of participants. Statistical analyses indicate that prior to the intervention, no significant differences were observed between the groups in terms of demographic variables (p > 0.05, independent t-test for continuous variables and chi-square test for categorical variables). This homogeneity ensures that any observed changes in subsequent analyses can be attributed to the intervention rather than pre-existing differences between the groups.

According to the results presented in Table 2, at the beginning of the study, there was no significant difference between the intervention and control groups in terms of health-promoting behaviors across various dimensions, including spiritual growth and self-actualization, health responsibility, interpersonal relationships, stress management, and physical activity (p > 0.05, independent t-test).

By the end of the study, however, the intervention group demonstrated a significant increase in health-promoting behaviors (p < 0.001, paired t-test), whereas no significant changes were observed in the control group (p > 0.05, paired t-test). This improvement was so notable that 100% of the participants in the intervention group achieved higher than those in the control group (Cohen’s U3 = 100%).

Similarly, the comparison of mental health variables—including somatic symptoms, anxiety and insomnia, social dysfunction, and severe depression—indicated no significant differences between the two groups at baseline (p > 0.05, independent t-test).

One-month post-intervention, a significant reduction in all mental health indicators was observed in the intervention group (p < 0.001, paired t-test), whereas the control group exhibited no significant changes (p > 0.05, paired t-test). Overall, 98.1% of the participants in the intervention group achieved better mental health scores compared to those in the control group (Cohen’s U3 = 98.1%) (Table 3).

The present study aimed to assess the impact of an educational intervention on mental health and health-promoting behaviors in elderly women enrolled in the Family Physician Program in Pasargad County, southern Iran. The results indicated that, despite no significant differences in baseline demographic characteristics and other study variables, the seven-session educational intervention led to significant improvements in both mental health and health-promoting behaviors. Specifically, the intervention significantly improved mental health scores, including somatic symptoms, anxiety and insomnia, social dysfunction, and severe depression (as measured by GHQ-28), as well as health-promoting behaviors such as spiritual growth and self-actualization, health responsibility, interpersonal relationships, stress management, and physical activity (as measured by HPLP-II) in the intervention group compared to the control group.

These results are consistent with previous studies reporting that multidimensional and culturally adapted interventions are generally more effective than single-focus programs in elderly populations^21,23,24. The observed improvements in both psychological outcomes and health-promoting behaviors in the present study are consistent with previous studies demonstrating that multidomain interventions incorporating educational, behavioral, and psychosocial components yield more comprehensive benefits than single-domain approaches^26,27.

Several possible mechanisms may help explain these improvements. From a psychological perspective, encouraging participants to view aging as a natural and meaningful stage of life may have fostered resilience and openness to change. Prior evidence indicates that older adults with positive attitudes toward aging often report better mental health and higher life satisfaction²⁸. Similarly, the emphasis on positive thinking and cognitive reframing may have reduced negative thought patterns, an approach shown in previous studies to lower depression and anxiety^16,17,29. Activities related to spiritual growth might also have contributed by promoting meaning, purpose, and a sense of usefulness³⁰, factors associated with reduced loneliness and greater well-being in later life³¹.

Behavioral and physiological pathways could also be relevant. Participation in physical activity education and practice may have improved physical function and energy levels, which in turn could enhance self-confidence and motivation for further engagement. Such changes are consistent with evidence that physical activity reduces anxiety and depression while improving sleep quality^32,33,34. Stress management and mindfulness techniques introduced during the sessions may likewise have helped reduce stress responses and improved coping skills, mechanisms supported by prior research in elderly populations^35,36.

Social mechanisms provide another plausible explanation. The group-based format and opportunities for peer interaction may have created a sense of belonging and interpersonal support, which is known to protect against loneliness, anxiety, and depression^37,38. Research indicates that social interactions through participatory activities are associated with positive mental health outcomes in older adults³⁹. The interactive approach and peer learning might also have enhanced adherence and self-efficacy, as sustainable changes in older adults often require interactive, multi-phase educational approaches²³. Moreover, the use of technology-assisted reinforcement through SMS reminders may have supported continuity of practice, as studies demonstrate that technology-assisted communication contributes to positive mental health outcomes³⁹.

Taken together, the observed improvements are likely to result from the interplay of multiple factors—psychological, behavioral, social, and spiritual—rather than from any single component. This interpretation aligns with Pender’s Health Promotion Model, which emphasizes the combined influence of individual, interpersonal, and environmental determinants of health behavior¹⁴. The findings therefore suggest that comprehensive, culturally tailored, and multi-component interventions may provide a particularly effective approach to promoting health and well-being in elderly populations.

Implications

The findings of this study have several practical implications for geriatric healthcare and community-based health promotion. The significant improvements observed suggest that brief, structured, and culturally tailored interventions can be feasibly integrated into existing primary care systems such as the Family Physician Program. Healthcare providers may therefore consider adopting multidimensional approaches that simultaneously address psychological, physical, social, and spiritual aspects of elderly well-being, rather than focusing on a single domain.

The success of technology-assisted reinforcement, even among older adults, challenges assumptions about limited digital engagement in this population. While face-to-face peer interaction remains essential, mobile-based reminders and follow-up activities may serve as cost-effective tools to extend intervention reach and support adherence. These findings highlight the potential for hybrid models that combine interpersonal and technological strategies to optimize health outcomes in elderly populations.

Strengths and limitations of the study

The primary strength of this study lies in its comprehensive multi-dimensional educational approach that integrated interactive face-to-face sessions, experiential peer learning through sharing successful aging stories, practical skill-building activities, technology-assisted reinforcement, and continuous behavioral challenges with self-reflection components. This interactive model, grounded in Pender’s Health Promotion Model, simultaneously addressed multiple dimensions of health-promoting behaviors and was specifically adapted to Iranian cultural values, emphasizing respect for elderly wisdom and community-based support systems. The intervention design carefully considered the physical and cognitive characteristics of older adults by keeping sessions short, using simple and native language, and providing technological support through motivational SMS reminders and audio-visual materials, which likely contributed to higher participation rates and intervention effectiveness. Previous research has demonstrated that interventions tailored to the specific characteristics of older adults can enhance adherence and commitment to behavioral changes⁴⁰.

However, this study also had several limitations. The first limitation was the short one-month follow-up period, which does not provide sufficient information on the long-term sustainability of the intervention’s effects. Therefore, longer follow-ups, such as six or twelve months, are necessary to evaluate its lasting impact. Additionally, the study was conducted exclusively on older women, limiting the generalizability of the findings to elderly men. Another limitation was the use of self-reported measures, which could be influenced by social desirability bias, potentially distorting the results. Finally, the lack of control over variables such as family support, socioeconomic status, and access to healthcare services might have affected the outcomes, making it difficult to attribute the observed effects solely to the intervention.

Study design and population

This study was a parallel-group cluster randomized controlled trial with a pretest-posttest design in two family physician clinics in Pasargad County, southern Iran, during the second half of 2023.

The target population comprised exclusively older women, selected based on both epidemiological and practical considerations. From an epidemiological perspective, older women in Iran exhibit higher prevalence of mental health disorders and experience greater socioeconomic vulnerabilities than their male counterparts. From a practical standpoint, prevailing cultural norms in Pasargad necessitate gender-segregated educational sessions to ensure participant comfort and promote candid discussion of sensitive health-related issues. The presence of mixed-gender groups could potentially discourage participation and limit the openness of dialogue.

The sample size was calculated using the standardized effect size formula for two independent groups:

Using NCSS-PASS software (version 15),with a 95% confidence level (Z₁₋α/₂ = 1.96), 90% statistical power (Z₁₋β = 1.28), 0.05 significance level, and an effect size (d) of 0.57 derived from Abu-Salehi et al. (2021), which utilized similar educational interventions and the same outcome measure (GHQ-28) for mental health assessment in elderly populations⁴¹, the calculated sample size was 64 participants per group. Accounting for a 10% potential attrition rate, the final sample size was determined as 70 participants per group, totaling 140 elderly women divided equally into intervention and control groups.

This study used a modified two-stage cluster randomization approach. In the first stage, two clinics were randomly selected from five family physician clinics in Pasargad County using simple random sampling through a lottery method. In the second stage, these clinics were randomly allocated to either intervention or control groups through coin flip, with one clinic serving as the intervention group and the other as the control group. This cluster-level allocation was chosen to minimize potential contamination between study groups and facilitate the group-based educational intervention. The randomization process was conducted by an independent statistician who had no involvement in participant recruitment or intervention delivery. To ensure allocation concealment, participants were not informed of their clinic’s allocation status and were told only that they were participating in a health promotion study for elderly women. Following clinic allocation, we identified all registered elderly women in both clinics through the Integrated Health System (SIB) database. From the initial 172 elderly women identified, 153 met the eligibility criteria. The intervention clinic contained 74 eligible women, while the control clinic had 79 eligible participants. Given that the number of eligible participants in each clinic exceeded our required sample size, we randomly selected 70 participants from each clinic using a random number table in Microsoft Excel. Due to the educational nature of the intervention, blinding participants and facilitators was not feasible, resulting in an open-label design. However, we implemented single blinding for outcome assessors who collected and entered post-test data without knowledge of group allocation. Baseline characteristics were compared between groups to confirm the success of the randomization process.

Inclusion criteria

Participants were eligible to enroll in the study if they met the following criteria:

• Aged 60 years or older.

• Registered in the SIB electronic health system and under family physician coverage.

• Ability to communicate (no severe visual or hearing impairments).

• Ability to participate in light physical activities appropriate for older adults.

Exclusion criteria

Those meeting the following criteria were removed prior to randomization:

• Diagnosed mental health disorders based on SIB system records or initial assessment.

• Unwillingness to participate in the study after project explanation.

Withdrawal criteria

Participants would be withdrawn from the study if any of the following occurred:

• Unwillingness to continue participation.

• Absence from more than one educational session.

• Death or migration of participant.

• Failure to complete posttest questionnaire.

The participant recruitment and retention process are illustrated in the CONSORT flow diagram (Fig. 1).

CONSORT flow diagram illustrating participant flow from enrollment through analysis.

Full size image

Data collection

The data collection tools included a researcher-designed demographic questionnaire and two standardized questionnaires, as detailed below:

Demographic questionnaire

The demographic questionnaire collected data on variables such as age, marital status, educational level, presence of chronic diseases, independent living (living alone), exposure to adverse life events, sleep problems, daily sleep duration, economic status, and perceived health status. Economic status was assessed using a three-point self-reported scale (“Poor/Below Poverty Line,” “Average,” “Above Average”), and perceived health status was assessed using a single-item question: “How would you rate your health status?“, measured on a four-point Likert scale (poor, moderate, good, excellent).

Health-Promoting lifestyle profile II (HPLP-II)

The Health-Promoting Lifestyle Profile II (HPLP-II) was developed by Walker et al. (1987) based on Pender’s Health Promotion Model. It consists of 52 items across six subscales: health responsibility, physical activity, nutrition, interpersonal relations, stress management, and spiritual growth/self-actualization. Items are scored on a five-point Likert scale ranging from “never” (1) to “always” (5). The total score ranges from 52 to 208, with higher scores indicating a more health-promoting lifestyle.

In this study, the nutrition subscale was excluded due to the intervention’s focus on mental health, resulting in a modified total score range of 45 to 180. Higher scores reflected a better lifestyle among participants.

Walker et al. reported a Cronbach’s alpha of 0.91 for the entire scale, with subscale reliabilities ranging from 0.79 to 0.91¹⁵. The Persian version of the questionnaire demonstrated a Cronbach’s alpha of 0.82 for the overall tool, with subscale reliabilities between 0.79 and 0.91⁴². In this study, reliability was confirmed using Cronbach’s alpha (pre = 0.863, post = 0.874) and McDonald’s omega (pre = 0.843, post = 0.867).

General health questionnaire (GHQ-28)

The General Health Questionnaire (GHQ-28) was developed by Goldberg et al. (1972) and consists of 28 items across four subscales: Somatic symptoms, Anxiety and insomnia, Social dysfunction, Severe depression. Items are scored on a four-point Likert scale, ranging from “not at all” (0) to “very much” (3), with a total score range of 0 to 84. Higher scores indicate poorer mental health.

Goldberg et al. (1972) reported Cronbach’s alpha values between 0.87 and 0.95 across different samples⁴³. In the Persian version of the questionnaire, Nazifi et al. (2013) reported a Cronbach’s alpha of 0.92 for the overall tool, with subscale reliabilities above 0.74⁴⁴. In this study, reliability was confirmed with Cronbach’s alpha (pre = 0.821, post = 0.879) and McDonald’s omega (pre = 0.835, post = 0.874).

Intervention and procedure

The educational intervention was developed based on Pender’s Health Promotion Model (HPM), and its constructs—such as perceived benefits, perceived barriers, self-efficacy, and others—were purposefully employed to enhance five key health-promoting behavior dimensions: health responsibility, physical activity, interpersonal relationships, stress management, and spiritual growth. Nutrition was intentionally excluded to emphasize behavioral and psychosocial factors affecting mental health.

The educational package was developed based on national, evidence-based guidelines, including Mental Health in Older Adults⁴⁵ and Physical Activity in Older Adults⁴⁶, which were commissioned by the Iranian Ministry of Health and distributed as official educational resources for primary healthcare providers. Content was adapted to suit the cognitive and cultural characteristics of the target population, using language simplification, culturally relevant examples, and modifications to physical activity content in alignment with local dress codes and privacy needs.

Before implementation, the content underwent pilot testing with 15 older women who met inclusion criteria but were not part of the main study sample. At the end of each pilot session, structured interviews and focus group discussions were conducted to evaluate participants’ comprehension, feasibility of the activities, and cultural appropriateness. Based on session-specific feedback, adjustments were made to pacing, exercise design, and terminology. All educational materials were reviewed by faculty experts in health education and gerontology to ensure clarity, scientific accuracy, and relevance to older adults.

The intervention consisted of seven weekly, 60-minute, in-person educational sessions conducted over eight consecutive weeks, with one consolidation week allowing participants to practice learned skills without new content introduction. Sessions were held at a comprehensive health center at 10:00 AM, a time selected based on participant preferences to ensure alertness and minimize fatigue. Participants were divided into groups of 7–10 to facilitate interaction while allowing for individual attention.

All sessions were facilitated by a licensed clinical psychologist with specialized training in geriatric health promotion and HPM. Each session addressed specific HPM constructs through varied teaching methods including interactive lectures, group discussions, practical demonstrations, role-playing exercises, and multimedia presentations. The physical environment included comfortable seating arrangements, adequate lighting and acoustics, easy restroom access, and light refreshments tailored to common chronic health conditions among participants, including diabetes, hypertension, and hyperlipidemia.

Participant comprehension was assessed through brief informal questioning during sessions and review of weekly assignment completion. Session evaluation forms assessed clarity of concepts, relevance to personal goals, and confidence in implementing strategies. SMS reminders were sent weekly to reinforce learning, and weekly practical challenges were assigned. To ensure intervention fidelity, all sessions used identical protocols and materials with no modifications were made to the core intervention protocol during implementation.

The control group received routine geriatric care provided by Family Physician Clinics but participated in no additional educational activities. To address ethical considerations, the educational package was offered to control group participants after study completion.

During the pretest phase, participants completed demographic questionnaires and baseline assessments. The intervention was delivered from April 30, 2023, to August 28, 2023. Posttest assessments were conducted one month after the final session to evaluate intervention effects. Detailed session content, objectives, teaching methods, target constructs, and weekly challenges are presented in Table 4.

Statistical analysis

The collected data were coded and analyzed using IBM SPSS Statistics version 27 (IBM Corp., Armonk, NY, United States). The normality of data distribution was assessed and confirmed using the Kolmogorov-Smirnov test. Demographic variables were analyzed using the Chi-square test and descriptive statistics, including mean and standard deviation. Economic status was dichotomized from three original categories into “Average and Above” versus “Poor/Below Poverty Line” due to small numbers in the “Above Average” group.

To compare means and examine differences between the two groups in the pre-test and post-test phases, independent t-test and Paired t-test were employed. To assess the effectiveness of the intervention, effect size indices including Cohen’s d and Cohen’s U3 were calculated. Cohen’s d was used to measure the standardized mean difference in both within-group comparisons (pre-test and post-test) and between-group comparisons (intervention and control). Additionally, Cohen’s U3 was employed to provide an intuitive interpretation of the intervention’s effect, indicating the percentage of participants in the intervention group who scored above the mean of the control group.

All statistical analyses were conducted in SPSS. However, Cohen’s U3, which is not supported in SPSS, was computed using the method described by Magnusson⁴⁷. A significance level of less than 0.05 was considered for all statistical analyses.

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Authors and Affiliations

1. Department of Health Promotion and Education, Faculty of Health, Shiraz University of Medical Sciences, P.O. Box 75541-71536, Shiraz, Iran

   Razieh Asadi, Mahin Nazari & Abdolrahim Asadollahi

2. Student Research Committee, Department of Health Promotion and Education, school of health, University of Medical Sciences, P.O. Box 75541- 71536, Shiraz, Iran

   Narges Mobasheri

Contributions

M.N. and A.A. contributed to study conception and design. R.A. performed data collection. A.A. conducted the statistical analysis. N.M. and R.A. wrote the first draft of the manuscript. All authors commented on previous versions of the manuscript, read and approved the final version.

Corresponding author

Correspondence to Mahin Nazari.

Competing interests

The authors declare no competing interests.

Ethical approval

This study was conducted in accordance with ethical research principles, including the confidentiality of participants’ information and the non-registration of personal identifiers. All participants received comprehensive explanations regarding the study’s objectives and methodologies before signing a written informed consent form. The study was approved by the Ethics Committee of Shiraz University of Medical Sciences under the ethics code IR.SUMS.SCHEANUT.REC.1402.012 on April 30, 2023. Additionally, the study was registered in the Iranian Registry of Clinical Trials (IRCT) under the registration code IRCT20111017007816N20 on June 7, 2023. All research procedures were conducted in compliance with the Helsinki Declaration (2013) and the CONSORT guidelines (2009).

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