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Designing and evaluating the impact of the empowerment program on the health and quality of life of postmenopausal women: The application of the PRECEDE‑PROCEED model and the Longwe empowerment framework

Protocol summary

Study aim
Evaluation of the impact of an empowerment program on the quality of life and health of postmenopausal women using the model.
Design
The health centers in Shiraz will be categorized into three groups based on the socio-economic status of the region. Using PASS software, two centers will be randomly selected from each region. These selected centers will then be assigned to either the intervention or control group using the block randomization method. Within these centers, women will be chosen using the consecutive sampling method. The estimated sample size for this study is 150 women, as determined by the PASS software.
Settings and conduct
The empowerment program will be designed and implemented based on the Longwe framework for Menopausal women in Shiraz health centers. According to the PPM, an assessment (pre-test) and evaluation (post-test) of the program will be conducted before, two weeks after, and four months after the intervention, respectively.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Menopausal women aged 45 to 65 with a history of at least one year of menopause, possessing literacy skills, and willing to sign an informed consent form. Exclusion criteria: suffering from mental illnesses, chronic diseases, or cancer; history of hormone therapy, hysterectomy, or oophorectomy; abnormal vaginal bleeding.
Intervention groups
Intervention Group: A problem-based and participation-oriented educational program will be implemented in a face-to-face setting, comprising of 8 sessions lasting 90 minutes each. The participants will be given educational booklets on menopause and self-care, adhering to the guidelines established by the Ministry of Health, Iran. Control Group: The control group will receive standard care and will be provided with a training booklet after the final post-test.
Main outcome variables
Quality of life; Health status; Self-care.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230716058792N1
Registration date: 2023-08-14, 1402/05/23
Registration timing: prospective

Last update: 2023-08-14, 1402/05/23
Update count: 0
Registration date
2023-08-14, 1402/05/23
Registrant information
Name
Khadijeh Khademi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
khadijehkhademi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-28, 1402/08/06
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and evaluating the impact of the empowerment program on the health and quality of life of postmenopausal women: The application of the PRECEDE‑PROCEED model and the Longwe empowerment framework
Public title
The impact of the empowerment program on the health and quality of life of postmenopausal women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be between the ages of 45 and 65. According to the scientific definition, they are considered menopause. At least one year has passed since their menopause. Have reading and writing literacy at least the end of the third grade or equivalent or higher. To participate in the study, declare your agreement and sign the informed consent form.
Exclusion criteria:
under the care of a psychiatrist due to suffering from mental illnesses. Suffering from chronic diseases (including diabetes, hypertension, heart failure, kidney failure) and cancer. Use of hormone therapy during the last 6 months. History of hysterectomy and oophorectomy. Suffering from abnormal vaginal bleeding.
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
With the formation of the elite panel and based on their opinions, 43 health centers in Shiraz are considered and divided into three groups of health centers in prosperous (rich), medium urban (relatively rich) and undeveloped (less rich) areas. In this study, the health centers of Shiraz city were selected as clusters, which were randomly selected using NCSS-PASS version 15 (2020) software from each of the 2 cluster areas, and were selected as control and intervention groups using randomization allocation method with equal blocks of each of these 2 clusters. Then, by referring to the selected health centers and reviewing the records of postmenopausal women covered by the center, postmenopausal women eligible to participate in the study will be invited by telephone to participate in the research project with consecutive sampling until the desired sample size is reached in each cluster.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Health school., Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2023-06-25, 1402/04/04
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.049

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
Quality of life score in World Health Organization Questionnaire
Timepoint
Before, 2 weeks and 4 months after the educational intervention.
Method of measurement
World Health Organization Quality of Life Questionnaire

2

Description
Health score in Women's Health Questionnaire
Timepoint
Before, 2 weeks and 4 months after the educational intervention.
Method of measurement
Women's Health Questionnaire

Secondary outcomes

1

Description
Self-care score in Menopause Self-care Questionnaire
Timepoint
Before, 2 weeks and 4 months after the educational intervention.
Method of measurement
Menopause Self-care Questionnaire

2

Description
The score of knowledge and attitude towards menopause in the knowledge and attitude towards menopause questionnaire
Timepoint
Before, 2 weeks and 4 months after the educational intervention.
Method of measurement
knowledge and attitude towards menopause questionnaire

3

Description
Self-care knowledge and attitude score in self-care knowledge and attitude questionnaire
Timepoint
Before, 2 weeks and 4 months after the educational intervention.
Method of measurement
Self-care knowledge and attitude questionnaire

4

Description
Self-efficacy score in the General Self-Efficacy beliefs Scale
Timepoint
Before, 2 weeks and 4 months after the educational intervention.
Method of measurement
General Self-Efficacy beliefs Scale

5

Description
Perceived health control score in MHLC- C for postmenopausal women
Timepoint
Before, 2 weeks and 4 months after the educational intervention.
Method of measurement
MHLC- C for postmenopausal women

6

Description
Social support score in MSPSS
Timepoint
Before, 2 weeks and 4 months after the educational intervention.
Method of measurement
MSPSS

7

Description
The score of enabling factors in the women's perceived health enablers questionnaire
Timepoint
Before, 2 weeks and 4 months after the educational intervention.
Method of measurement
women's perceived health enablers questionnaire

Intervention groups

1

Description
Intervention group: The educational program for the intervention group is designed to cater to their specific needs and literacy levels. It is conducted through face-to-face meetings, lasting 90 minutes each, once a week. The timing of these meetings is agreed upon by the participants. The sessions are conducted in a collaborative manner, with group discussions focusing on problem-solving and feedback provision.The participants are provided with a booklet that contains information on various aspects related to menopause. This includes education on menopause symptoms, healthy nutrition, physical activity, menopause health, seeking healthcare, and social support. The content of the booklet is based on the guidelines provided by the Office of Education and Health Promotion as well as the Office of Population, Family Health, and Madrasa under the deputy health department of Iran's Ministry of Health, Treatment, and Medical Education.
Category
Behavior

2

Description
Control group: No intervention is performed and they only receive routine care. However, after the last post-test, they will be provided with an educational booklet aimed at increasing their knowledge about menopause and self-care practices during this period.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
The health centers covered by the Health and Treatment Networks of Englab and Wal-Fajr
Full name of responsible person
Khadijeh Khademi
Street address
Shiraz
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Email
khademikhadijeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Kaveh
Street address
Health school., Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Email
Kaveh@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Khademi
Position
PhD candidate of health education and promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Health school., Razi Blvd.
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Email
khademikhadijeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Kaveh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Health school., Razi Blvd
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1005
Email
Kaveh@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Khademi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Health school., Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71536775541
Phone
+98 71 3725 1005
Email
khademikhadijeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Confirmation of Professor Mohammad Hossein Kaveh.
From where data/document is obtainable
Kaveh@sums.ac.ir
What processes are involved for a request to access data/document
Through the corresponding author of the articles within a period of 1 week to 1 month.
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