Effect of lifestyle change and stress management training on hypertensive children and adolescents compared to routine care on blood pressure, blood sugar and lipid profiles control
Determine the impact of stress management lifestyle training exercises on hypertensive children and adolescents compared to routine care on blood pressure control, glucose and lipid profile
Design
This study is a randomized controlled clinical trial with three arms performed in parallel groups. Individuals are assigned to groups using a simple randomization method and a random number table. This is a single-blind study. 144 children and adolescents are randomly selected.
Settings and conduct
This study was performed in three times at Shahid Sadoughi University of Medical Sciences in Yazd: time before intervention, time immediately after intervention, time 6 months after intervention. The analyser does not know where people are in groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Children and adolescents diagnosed with re-evaluation of hypertension (Stage I),
- If the consent for entry is completed by parents (for children under 15 years) or adolescents (for adolescents over 15 years).
Exclusion criteria:
- Children and adolescents taking hypertension medication,
- Children and adolescents who do not qualify for a class (with mental or physical disabilities that make it difficult for them to attend class).
Intervention groups
Groups are defined as group A (lifestyle improvement training group including nutrition modification and physical activity), group B (stress management training group) and group C (usual care group). People in group A are invited to 4 sessions (2 sessions of proper nutrition training and 2 sessions of physical activity training), people in group B receive 8 sessions of stress management training, and those in group C are also two question and answer session by a psychologist and a physician, are invited.
Main outcome variables
Blood pressure, glucose and blood lipid profiles
General information
Reason for update
Acronym
HCA
IRCT registration information
IRCT registration number:IRCT20191109045367N1
Registration date:2019-12-14, 1398/09/23
Registration timing:prospective
Last update:2019-12-14, 1398/09/23
Update count:0
Registration date
2019-12-14, 1398/09/23
Registrant information
Name
Nastaran Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3525 4068
Email address
ahmadi.psy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-05-04, 1399/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lifestyle change and stress management training on hypertensive children and adolescents compared to routine care on blood pressure, blood sugar and lipid profiles control
Public title
Effect of lifestyle change and stress management training on hypertensive children and adolescents compared to routine care on blood pressure, blood sugar and lipid profiles control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children and adolescents diagnosed with re-evaluation of hypertension (Stage I)
If the consent for entry is completed by parents (for children under 15 years) or adolescents (for adolescents over 15 years).
Exclusion criteria:
Children and adolescents taking hypertension medication
Children and adolescents who do not qualify for a class (with mental or physical disabilities that make it difficult for them to attend class).
Age
From 9 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are assigned to groups using a simple randomization method and a random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyser does not know where people are in groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Yazd Cardiovascular Research Center, Afshar Hospital, Jomhouri Boulevard, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8917945556
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.SSU.REC.1398.128
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
hypertension stage I
Timepoint
- Time 1: Time before intervention - Time 2: Time immediately after intervention Time 3: Time 6 months after intervention
Method of measurement
Blood pressure between 95 and 99 percentile
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lifestyle improvement training group includes nutrition modification and physical activity
Category
Lifestyle
2
Description
Intervention group: Stress Management Training
Category
Behavior
3
Description
Control group: Routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Nastaran Ahmadi
Street address
Yazd Cardiovascular Research Center, Afshar Hospital, Jomhouri Boulevard, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 4068
Email
ahmadi.psy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
Yazd Cardiovascular Research Center, Afshar Hospital, Jomhouri Boulevard, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 4068
Email
ahmadi.psy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Nastaran Ahmadi
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Yazd Cardiovascular Research Center, Afshar Hospital, Jomhouri Boulevard, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 4068
Email
ahmadi.psy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nastaran Ahmadi
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Yazd Cardiovascular Research Center, Afshar Hospital, Jomhouri Boulevard, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 4068
Email
ahmadi.psy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nastaran Ahmadi
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Yazd Cardiovascular Research Center, Afshar Hospital, Jomhouri Boulevard, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 3525 4068
Email
ahmadi.psy@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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Clinical study report
When the data will become available and for how long
Start of access period 6 months after publishing results
To whom data/document is available
Scientific people
Under which criteria data/document could be used
publish article
From where data/document is obtainable
نسترن احمدی
What processes are involved for a request to access data/document
The clinical study reportwill be sent within three weeks after receiving the request.