The Effectiveness of healthy lifestyle–based interventions on intrinsic capacity in older women adults.
Design
Randomized clinical trial with control
Settings and conduct
This study will be conducted as a cluster randomized clinical trial in the elderly center of Babol. After selecting 10 qualified elderly women, we will determine the type of intervention based on randomization list. The primary outcomes will be assessed at the beginning and the end of the trial.
Participants/Inclusion and exclusion criteria
Women aged 60-80 years
Healthy women who do not have any diagnosed neurological, physical or mental disorders
Unwillingness to participate in the study
Hormone therapy in the last two months
History of substance abuse, addiction, smoking or alcohol
History of eating disorders.
Having a severe physical activity
Participate in another study at the same time
Having a special diet, such as being vegetarian or eating raw foods.
Intervention groups
Interventions will be conducted in 24 focused groups of 10 people during 8 sessions with a time of 30 to 45 minutes. According to the selected topics and the objectives of study, there will be a discussion and consultation for each cluster.Also, educational pamphlets will be provided to the intervention group according to the predetermined topics and objectives. In the control group, there is no special intervention, and at the end of the course, the educational content will be provided to the control group.
Main outcome variables
Intrinsic capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230328057780N1
Registration date:2023-06-26, 1402/04/05
Registration timing:prospective
Last update:2023-06-26, 1402/04/05
Update count:0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
mahsa rouhani otaghsara
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3245 4043
Email address
m.rohani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of healthy lifestyle–based interventions on intrinsic capacity in older women adults
Public title
Healthy lifestyle–based interventions on intrinsic capacity
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 60-80 years
Healthy women who do not have any diagnosed neurological, physical or mental disorders
Exclusion criteria:
Unwillingness to participate in the study
Hormone therapy in the last two months
History of substance abuse, addiction, smoking or alcohol
History of eating disorders.
Having severe physical activity
Participate in another study at the same time
Having a special diet, such as being vegetarian or eating raw foods.
Age
From 60 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
A computer-generated balanced block randomization (Sealedenvelope.com) in a 1:1 ratio will be conducted. The sample size of the study will be 240 women, which will be arranged in 24 clusters of 10. For the allocation of the participants, an investigator with no clinical involvement in the trial generated the randomization sequence with 1:1 allocation ratio using random block sizes of 6. Allocation concealment will be performed by preparing 24 sealed and unnumbered envelopes containing a piece of paper printed with the word ‘Intervention’ or ‘Control’.
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 Babol University of Medical Sciences
Street address
Ganj Afrooz Ave., Babol, Iran.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2023-06-13, 1402/03/23
Ethics committee reference number
1401.242
Health conditions studied
1
Description of health condition studied
Elderly women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Inherent capacity
Timepoint
The inherent capacity will be assessed at the beginning and the end of trial.
Method of measurement
The primary outcome of the present study is intrinsic capacity. The five main areas of intrinsic capacity include mobility, vitality, cognitive, psychological and sensory. 1. Mobility: SPPB (Short Physical Performance Battery) and TUG (Timed Up and Go Vitality: Mini-Nutrition assessment questionnaire. Cognitive: Mini-Cog questionnaire. Psychological: Geriatric Depression Scale (GDS) questionnaire. Sensory: hearing from Whisper self test, vision from WHO simple eye chart.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the healthy-life program in the elderly people affiliated to Department of Elderly Health of the Ministry of Health will be used. This program has different parts, which include: a- nutrition, b- physical exercises, c- happy life, d- depression, e- balance. The interventions included eight sessions, with a time of 30 to 45 minutes. In each session, discussion and consultation will be done according to the selected topics and the objectives of the trial. The predetermined questions will be asked from participants. Intervention in the control group: No specific intervention is performed in the control group. And at the end of the course, after the completion of the intervention in the test group, the educational content will be provided to the control group.
Category
Lifestyle
2
Description
Intervention in the control group: No specific intervention is performed in the control group. And at the end of the course, after the completion of the intervention in the test group, the educational content will be provided to the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Day care center for the elderly
Full name of responsible person
Mahsa rouhani
Street address
No 102, 26th Baharan, Janbazan Street
City
Babol
Province
Mazandaran
Postal code
4718658135
Phone
+98 911 661 6410
Email
mahsarouhani1374@gmail.com
2
Recruitment center
Name of recruitment center
Shafa Clinic
Full name of responsible person
Mahsa Rohani
Street address
No 8, Tohid 39, Janbazan Street
City
Babol
Province
Mazandaran
Postal code
4714863843
Phone
+98 911 661 6410
Email
mahsarouhani1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 911 661 6410
Email
mahsarouhani1374@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
shabnam omidvar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
011 32199592-1
Email
shomidvar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
shabnam omidvar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery faculty, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
011 32199592-1
Email
shomidvar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
mahsa rouhani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 911 661 6410
Email
mahsarouhani1374@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
There are no plans to release it
When the data will become available and for how long
There are no plans to release it
To whom data/document is available
There are no plans to release it
Under which criteria data/document could be used
There are no plans to release it
From where data/document is obtainable
There are no plans to release it
What processes are involved for a request to access data/document