Investigating the effect of a “My Plate” nutrition training program on anthropometric indices, muscular strength and function, and quality of life among older adults with overweight and/or obesity; application of Health Belief Model
Preparation and compilation of protocol and educational content for empowering the elderly with obesity and overweight as a suitable solution for weight control and prevention of loss of muscle mass and strength and increasing the quality of life
Design
The samples are selected from 4 comprehensive urban health centers located in Jahrom city, completely randomly and in a cluster, 2 centers and two bases from each center are selected randomly, and two bases are randomly selected as the control group and Two bases will be selected as the intervention group. the names of the eligible people were prepared from the Sib system, and then 25 elderly people were selected from each center by regular random method.
Settings and conduct
Training sessions will be held twice a week.
After the end of the training sessions, the members of the intervention group and one of their family members will become members of a virtual group. Three months after the initial measurements, the measurements will be repeated in both groups.
Participants/Inclusion and exclusion criteria
Body mass index of 25 and above
- They have not used any type of protein supplement in the past 6 months.
- Be able to walk
- At least have reading and writing literacy (completion of the third grade).
- Do not suffer from chronic diseases such as kidney disease and diabetes.
Intervention groups
an educational program including nutrition and exercise training according to the My Plate method and the 2020-2025 USDA guidelines will be implemented for the intervention group. The elderly who are in the comparison group (control) will receive a healthy nutrition brochure during the implementation of the project and a program They will experience the routines of health centers
Main outcome variables
Muscle strength,function, anthropometric indices, quality of life,physical activity, health belief mode
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110423006261N21
Registration date:2024-04-26, 1403/02/07
Registration timing:prospective
Last update:2024-04-26, 1403/02/07
Update count:0
Registration date
2024-04-26, 1403/02/07
Registrant information
Name
Mohammad Hussein Kaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
kaveh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-03, 1403/02/14
Expected recruitment end date
2024-05-08, 1403/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a “My Plate” nutrition training program on anthropometric indices, muscular strength and function, and quality of life among older adults with overweight and/or obesity; application of Health Belief Model
Public title
Investigating the effect of a “My Plate” nutrition training program on anthropometric indices, muscular strength and function, and quality of life among older adults with overweight and/or obesity; application of Health Belief Model
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index of 25 and above.
They have not used any type of protein supplement in the past 6 months
Be able to walk and be able to go to the health center without the help of others.
At least have reading and writing literacy (completion of the third grade).
Do not suffer from chronic diseases such as kidney disease and diabetes that require special diet and care.
Exclusion criteria:
Have an injury or an acute illness that requires special care.
To withdraw from continuing to participate in the study for any reason (disability, personal preference, illness).
Absent more than two sessions from training sessions
Their questionnaires are very distorted and incompletely completed (they have not answered more than 30% of the questions).
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In order to be able to generalize the results of the study and to reduce the socio-economic differences as much as possible, the samples of the two control and experimental groups from 4 comprehensive urban health centers located in Jahrom city, completely randomly and in a cluster, 2 centers and two bases from each center are selected and randomly two bases will be selected as the control group and two bases as the intervention group. In the selected centers, the names of eligible people include the elderly in both sexes, according to the different proportion of women and men in terms of obesity, which according to statistics, about 60% of women and about 40% of men have a body mass index above 25. 60% of the samples are women. And 40% are men Therefore, separate lists of men and women were prepared from the Sib system, and then 25 elderly people who met the study entry criteria were selected from each center by regular random method.
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the participants will be given an explanation about which group, intervention or control group they are in, while the control group will also receive a healthy eating brochure.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shiraz University of Medical Sciences
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.SUMS.REC.1402.607
Health conditions studied
1
Description of health condition studied
Overweight and/or obesity in the elderly
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Weight is measured using a scale.
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements
Method of measurement
The weight of the elderly is measured with a Seka scale, with an accuracy of 0.1 kg, and with minimal clothes and no shoes in the morning.
2
Description
Muscle strength
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements
Method of measurement
We will use Sammons Preston Hand Dynamometer, JAMAR Plus) hydraulic hand dynamometer.
3
Description
Quality of Life
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements
Method of measurement
Quality of Life Questionnaire for the Elderly (World Health Organization)
4
Description
Muscle function
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements
Method of measurement
Balance test with balance test TUG
5
Description
Around the waist around the hips WHR
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements
Method of measurement
It is measured with an inflexible tape measure with an accuracy of 0.1 cm
6
Description
physical activity
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the initial measurements
Three months after the initial measurements, the measurements will be repeated in both groups
Method of measurement
A researcher-made questionnaire to measure the constructs of the health belief model
2
Description
24-hour food reminder
Timepoint
First, before the start of the study, it is measured on two different days and three months later, it is measured again on two different days.
Method of measurement
Questionnaire learned 24 hours of food
Intervention groups
1
Description
Intervention group: Two groups of 25 people from two different comprehensive health centers, that is, a total of 50 people, who will receive training on the My Plate method and the necessary exercise as an intervention.
Category
Lifestyle
2
Description
Control group: two groups of 25 people from two sub-bases of the same comprehensive health center as the intervention group were sampled. This group will only receive healthy eating brochures.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahrom University of Medical Sciences
Full name of responsible person
Elham Foroodi Jahromy
Street address
Jimhoorie Aslamie Street
City
Jahrom
Province
Fars
Postal code
7417753161
Phone
+98 71 5423 4611
Email
elhamforoodi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
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
Mohammad Hossein Kaveh
Position
Professor of all academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Razi Blvd., in front of the Electrical Club of the Faculty of Health
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
Mhkaveh255@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
full Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Razi Street, Faculty of Health
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
Mhkaveh255@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Kaveh
Position
full Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Razi Street, Faculty of Health
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
Mhkaveh255@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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participants' data, including height and weight, anthropometric measurements, and muscle strength and function, will be shared after de-identification and after the end of the study.
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 and the Ministry of Health and Industry can apply for them.
Under which criteria data/document could be used
People who deal with the elderly or the elderly themselves
From where data/document is obtainable
Mr. Dr. Mohammad Hossein Kaveh: Mhkaveh255@gmail.com
Elham Foroodi: elhamforoodi@yahoo.com
What processes are involved for a request to access data/document
First, write the reason for the need for the data in a word, and then send an email, and the data will be sent after 30 days.