Oral health promotion interventions based on Health Action Process Approach model among elderly in Tehran in 2021

Determining the effect of oral health promotion interventions based on the Health Action Process Approach model (HAPA)in Tehran elderly in 2021

Cluster randomized controlled trial with parallel groups, double-blind, target population of the elderly aged 60 years and older living in Tehran, two intervention groups(each group of 150)

Samples are collected from the houses of active neighborhoods under the municipalities of 22 districts of Tehran by random multi-stage cluster sampling. The clusters are 24 houses of Tehran Municipality neighborhood in three geographical regions of north, south and center that are randomly selected. In each cluster, 15 elderly people who are randomly selected to participate in the study are invited to participate in the study.. Data collection: by completing the information form and Geriatric Oral Health Assessment Index and Health Action Process Approach questionnaire: oral examinations Follow-ups: one to three months after the intervention The examiner will be different in the baseline and follow up stages. Examiners in the baseline and follow-up stages are unaware of the study groups and how they are allocated (Double blind).

Inclusion criteria: Age 60 years and older; Ability to communicate with researchers; sign the informed consent form Exclusion criteria: Debilitating disease; Uncontrolled systemic disease; Non-Iranian citizens

Group A: Practical training in oral health by a dentist with an educational pamphlet (both containing Health Action Process Approach model structures) Group B (control group): Practical oral health training by the head of the neighborhood health center with an educational pamphlet (both containing Health Action Process Approach model structures)

Oral Hygiene Index; Oral health behaviors

To sample this study, a controlled clinical trial is performed by randomized multistage cluster sampling. According to the geographical map of Tehran, it is divided into three regions: north, center, and south. Tehran has 22 municipal districts, of which the north of Tehran includes 6 districts (1, 2, 3, 4, 5, and 22), the center of Tehran includes 10 districts (6, 7, 8, 9, 10, 11, 12, 13, 14 and 21) and the south of Tehran includes 6 districts (15, 16, 17, 18, 19 and 20). Using the index and rand functions of Excel software, two regions and a total of 6 municipal regions are selected randomly from each of these three regions of north, south, and center (stratified randomization). The city of Tehran includes 354 active neighborhood houses, each of the 22 districts of Tehran includes a number of these neighborhood houses. After randomly selecting 6 regions, the number of subdirectories of each of these regions is determined separately and entered into Excel software. From among the neighborhoods of each region, 4 houses are randomly selected with Excel software. Eventually, we will have 24 neighborhood halls (clusters). From the 4 houses selected in each area, 2 houses by simple randomization are assigned to intervention A and 2 houses to intervention B (control). According to the sample size of 300 people in this study, about 15 elderly people from each of the 24 selected clusters (24 neighborhood halls) will participate. To select people in each neighborhood home, we act in such a way that we prepare a list of elderly people who are members of the neighborhood home and using Excel software, 15 people are randomly selected from them and they are contacted and asked for Participation in the study is invited. If several people do not attend the study, we randomly select alternative people from the same list

1. The examiner will be different in the baseline and follow up stages. Calibration of the examiners (inter-examiner) and each examiner will be done with himself (intra-examiner). 2. Examiners in the baseline and follow up stage are unaware of the study groups and how to allocate. 3. The people who do the training in group A (dentist) and group B (in charge of the neighborhood health center) will be different and are not study researchers. These people are trained to intervene. 4. When entering SPSS, the data will be entered with special codes so that the analyzer is not informed about the clusters and groups. 5. The researcher conducting the analysis is unaware of the intervention and allocation groups.