Need assessment: in step 1 of IM, literature reviews were executed to gain insight into prevalence of CVMRFs in Iran. The surveillance findings of NCD risk factors in Iran on the 15 - 64 year old population showed, 44% people who were the age of 25 - 64 were suffering from obesity or being overweight, 16/09% of the individuals had a blood pressure of ≥ 140/90 mmHg and 6/12% had a blood pressure of ≥ 170/10 mmHg (
20). The overall frequency of high blood sugar was equal to 9/73%. It showed an upward trend with increasing age so that in the age group of 55 - 64 years, the prevalence of diabetes was 20/97%. The prevalence of high cholesterol was 32/9% (
20). Furthermore, respectively, 21/8% and 16/6% of men and women were suffering from high blood triglycerides. 88/20% of the 15 - 64 year age group consumes less than 5 unit fruits or vegetables daily, furthermore, 38/97% of people had low PA weekly (
20). Findings from the qualitative part of this study, which had already been published (
21,
22), have proved that unhealthy eating and physical inactivity were behaviors, which predict CVMRFs. Findings of the qualitative part show that personal determinants are the predisposing category (knowledge, attitude, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, and self efficacy), and among them, the determinants of perceived barriers and self efficacy for doing PA and HE were more important than other determinants. Moreover, among the environmental determinants that are included in structural factors or the enabling category (availability and accessibility of health resources, new skills, and law and policies) and social factor or the reinforcing category (social support, motivation to comply, and consequences of behavior), most barriers for performing PA and HE were often structural factors or the enabling category.
Findings of the quantitative part showed that among the identified determinants of both HE and PA behaviors, the determinants, which were strong predictors, should be highlighted for designing an intervention. Findings of the quantitative part, using SEM for HE behavior, showed (
Table 1) that determinants such as: knowledge, attitudes, perceived severity, perceived barriers, and self-efficacy were significant in predisposing category and, the determinants of perceived barriers and self-efficacy were stronger predictors. In the enabling category, the determinants of new skills, policies, and laws had a significant relation and were significant predictors. In the reinforcing category, the determinants of social support, motivation to comply and behavioral consequences showed a significant relation and the determinant of motivation comply was a stronger predictor than other determinants. Thus, these determinants should be targeted in designing a program to improve HE behavior. For PA behavior in the predisposing category (
Table 2), the determinants of perceived susceptibility, attitudes, perceived barriers, and self-efficacy had a significant relation, where the strongest predictors were self-efficacy and perceived barriers. In the enabling category, the only significant determinant was a new skill. In the reinforcing category, the determinants of social support, motivation to comply, and behavioral consequences were significant and, the determinant of motivation comply was stronger predictor. Thus, these determinants must be targeted in the design of a program to increase PA. All in all, findings of the quantitative part in the predisposing category confirmed results of the qualitative part, it means self-efficacy and perceived barriers were important personal determinants that caused the patients to not have enough PA and did not follow HE. While findings of the quantitative part in enabling and reinforcing categories did not confirm results of qualitative part, it means, in the qualitative section, structural factors (enabling category) were the important environmental determinants, however, in the quantitative section, social factors (reinforcing category) were the most important environmental determinants for PA and HE.
| Independent Variable | Dependent Variable | Standardized Coefficients | P Value |
|---|
| Enabling | Reinforcing | 0.36 | 0.001 |
| Reinforcing | Predisposing | 0.55 | 0.001 |
| Predisposing | Healthy Eating | 1.12 | 0.001 |
| Enabling | Healthy Eating | 0.38 | 0.11 |
| Reinforcing | Healthy Eating | 0.67 | 0.001 |
| Perceived susceptibility | Predisposing | 0.064 | 0.19 |
| Perceived severity | Predisposing | 0.30 | 0.001 |
| Knowledge | Predisposing | 0.14 | 0.005 |
| Attitude | Predisposing | 0.26 | 0.001 |
| Perceived benefits | Predisposing | 0.051 | 0.19 |
| Perceived barriers | Predisposing | -0.33 | 0.001 |
| Self efficacy | Predisposing | 0.49 | 0.001 |
| New skill | Enabling | 0.58 | 0.001 |
| Healthy resources | Enabling | 0.012 | 0.85 |
| Law and policies | Enabling | 0.36 | 0.01 |
| Social support | Reinforcing | 0.42 | 0.001 |
| Motivation to comply | Reinforcing | 0.81 | 0.001 |
| Consequences of behavior | Reinforcing | 0.17 | 0.005 |
| Independent Variable | Dependent Variable | P Value |
|---|
| Standardized Coefficients | |
|---|
| Enabling | Reinforcing | 1.017 | 0.11 |
| Reinforcing | Predisposing | 0.56 | 0.000 |
| Predisposing | Physical activity | 0.015 | 0.10 |
| Enabling | Physical activity | 0.001 | 0.34 |
| Reinforcing | Physical activity | 0.99 | 0.00 |
| Perceived susceptibility | Predisposing | -0.25 | 0.00 |
| Perceived severity | Predisposing | 0.012 | 0.82 |
| Knowledge | Predisposing | 0.060 | 0.23 |
| Attitude | Predisposing | 0.25 | 0.001 |
| Perceived benefits | Predisposing | 0.01 | 0.99 |
| Perceived barriers | Predisposing | -0.63 | 0.000 |
| Self efficacy | Predisposing | 0.90 | 0.000 |
| New skill | Enabling | 0.38 | 0.000 |
| Health resources | Enabling | 0.12 | 0.34 |
| Law and policies | Enabling | 0.16 | 0.09 |
| Social support | Reinforcing | 0.23 | 0.000 |
| Motivation to comply | Reinforcing | 0.47 | 0.000 |
| Consequences of behavior | Reinforcing | 0.009 | 0.17 |
Prepare matrices of change objectives: First, we wrote behavioral and environmental outcomes for both behaviors of a unhealthy diet and inactivity. Then, for any behavioral and environmental outcomes, we wrote performance objectives. Finally, by entering the performance objectives on the left side of the matrix and determinants along top, matrix of change objectives was formed. For example for dietary behavior, behavioral outcomes include: 1-Increase consumption of healthy foods (fruits, vegetables, whole grains, fish), 2-Reduce intake of harmful foods (salt, fat, simple carbohydrates), and the environmental outcomes including; supporting of the patients by family and HPs to follow a healthy diet. Performance objectives and sample of matrix of change objectives are listed below (
Table 3).
| Performance Objectives |
|---|
| 1 | Increasing consumption of the healthy foods (fiber, whole grains, fish) |
| 1 | Patients consume fruits at least 3 times or more per day. |
| 2 | Patients consume raw or cooked vegetables at least 3 times or more per day. |
| 3 | Patients consume fish at least once or twice a week. |
| 4 | Patients increase consumption of whole grains in their meals. |
| 5 | Patients balance calorie intake to the number of calories that they burn. |
Theory-based methods and practical applications: The chosen theoretical methods and the practical applications were identified in order to influence determinants and change objectives (
Table 4).
Table 5 shows an example of the theoretical methods and the practical applications in accordance with determinants.
| Performance Objectives | Knowledge | Attitude | Expected Outcomes/Consequences of Behavior. | Barriers | Efficacy/Skills | Subjective Norms/Motivation Comply |
|---|
| Patients increase consumption of whole grains in their meals | K1. Patients name the foods contain whole grains. | A1. Patients feel consumption of whole grains is useful for them. | EO1. Patients expect advised intake of whole grains will help to control the disease and prevent its complications | B1. Patients listed consumption barriers of grain foods. | E1. Patients express their ability to increase consumption of advised grain foods | SN1. Patients recognize the importance of consumption of advised amount of whole grains. |
| K2. Patients express advised intake of whole grains. | A2. Patients Prefer to eat whole grains. | | B2. Patients identify the ways to overcome the consumption barriers of grain foods. | E2. Patients arrange a program for regularly consumption of grain foods. | SN2. Patients consider importance of others advice about taking grain foods, and obeys it. |
| Determinants | Theoretical Methods | Practical Applications |
|---|
| Self-efficacy and skill | Goal Setting | Short term goals and then long term goals for the patient were determined by experts so that they make the patients be closer to these goals. |
| Modeling | Some of the group discussions had invited successful patients who could control their disease with diet and regular physical activity, they discuss about their successful methods of diet and physical activity and other patients modeled of their success. |
| Verbal persuasion | Send proper text messages and make phone calls to encourage the patients to follow an health diet and regular physical activity |
| Reinforcement | Patients who had controlled their weight, glucose, lipid and blood pressure were given awards to encouraged other patients for following an healthy diet and regular physical activity |
| Guided practice with feedback | Classes of skills training and calculating calories, setting a healthy diet, reading food labels, setting a regular physical activity programs and skills to have a plan for physical activity with others, healthy cooking manual for patients, especially women. |
| Public commitment | Design a daily check list for each patient to include his/her tasks for healthy diet and physical activities. |
| Self-monitoring | Health care providers making a contract with patients to oblige them for doing at least 30 minutes moderate-intensity physical activity everyday and follow healthy diet |
Producing program components and materials: the programs main theme was “Cardiovascular Metabolic Risk Factors Self- Management (CVMRFSM) program in community health Centers”. First, the HPs who have worked in community health centers will be trained for 4 sessions about instructional methods, how to make or choose appropriate instructional materials, theoretical methods and practical applications by experts of health education. Next, they will be trained for 2 sessions by nutritionist and the exercise physiologist. Finally, the patients will be trained for 4 sessions by HPs about CVMRFs and familiar with HE and PA to control their risk factors. In addition, the patient’s families will be trained for 2 sessions regarding familiar with CVMRFs, healthy diet and PA, and their supportive role to create opportunities in order to increase PA and HE behaviors. The duration of each session will be approximately 90 minutes and these meetings will be held once a week. The goal of training HPs is to increase their skills for patient education to change unhealthy behaviors of the patients.
Planning program adoption and implementation: the adaptors of the developed program will be policymakers in the health deputy, which is located in the Alborz province. Implementers of the program will be HPs in community health centers including GPs, the nurses, and the dieticians.
Plan for evaluation: the effectiveness of developed program will be evaluated in a randomized controlled trial using process and impact evaluation. For process evaluation, all instructional activities including educational methods based on theory and practical applications in the intervention group will be assessed through an interview with them. For impact evaluation, short and long term outcomes of developed program using intervention and control groups will be evaluated. In the control group, the patients will receive usual care from HPs, in the intervention group, the patients in addition to usual care, HPs, and the patients’s families will need to train 12 sessions, and these sessions will have been taken for 3 months. Patients in 2 groups, height, weight, waist, and hip circumference, blood pressure will have been measured by meter, scale, and standard gauge. Furthermore, their fasting blood sugar (FBS), triglycerides (TG), cholesterol (CHOL), HDL cholesterol (the good fats), and LDL cholesterol (the bad fats) will have been measured by free blood samples; information of the patients will have been completed on questionnaire. Before instructional sessions, both control and intervention groups will have complete the questionnaires about PA and HE. After educational sessions, control and intervention groups will complete the questionnaires again. The patients in both groups will be followed up after 3 months, during these 3 months, the patients in the intervention group, via phone calls, text messages, their leaders, and in-person meetings will have followed up. Again after 3 months, the questionnaires and anthropometric indices, such as body mass index, waist-hip ratio, and blood parameters (glucose, lipids and blood pressure) will have measured in both groups of the patients.