Evaluation of the effects of adolescent health promotion training package on treatment of polycystic ovary syndrome
Design
This study is a longitudinal clinical trial.
Settings and conduct
In this study, 100 adolescents with poly cystic ovary syndrome (50 in each group) were randomly selected from the students in Tehran high schools. In the intervention group the training was done by lecture method and the second group was control (no training).
Participants/Inclusion and exclusion criteria
inclusion criteria: 14-18 years old girls, signed written consent form by parents and student; no history of disease; no drug use, no drug addiction.
exclusion criteria: Unwillingness of the teenager or her parents to participate in the study, Lack of teen participation in one-third of educational classes,
Adolescent drug use
Intervention groups
Face-to-face teaching to poly cystic ovary syndrome adolescents is conducted in eight 60-minute sessions of lecture, question and answer provided by the researcher. The adolescent health promotion package was designed based on the Nice Clinical Guidelines Model. Based on this model, the package was designed after searching the guides, books, sexual health packages of various countries as well as available articles. Then, Delphi method was used to validate the sexual health package by specialists and experts in different cities of Iran. Designed in two parts for the adolescent and adolescent lifestyle educator, the package is designed to include the most important aspects of adolescent health during education years.
Main outcome variables
• Changes in nutritional status score) FFQ, recall 24 h questionnaire(
• Changes in physical activity status score (Caspian questionnaire )
• Changes in the status of blood bio markers
• Changes in status of ultrasound items
• Changes in the quality of life of adolescents( kids Screening Questionnaire)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200114046123N1
Registration date:2020-01-23, 1398/11/03
Registration timing:registered_while_recruiting
Last update:2020-01-23, 1398/11/03
Update count:1
Registration date
2020-01-23, 1398/11/03
Registrant information
Name
somayeh abdolahian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4429 8292
Email address
abdolahian.s@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of adolescent health promotion training package on treatment of poly cystic ovary syndrome
Public title
Evaluation of the effects of adolescent health promotion training package on treatment of poly cystic ovary disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Written parental and student agreement
Girls ages 14 to 18 who are single and without sexual relation
At least 2 years passed from the juvenile menarche
According to ASRM criteria, 2 items of PCOS symptoms were diagnosed
Be healthy in terms of all diseases including liver, kidney, thyroid, heart and skeletal diseases
Have not taken any female hormone or metformin medication for at least three months before entering the study
Have no smoking at least three months before the intervention
Do not use drugs or alcohol
Not have severe mental illness (which requires medication)
Do not exercise professionally or attend school sports team
Do not follow a specific diet
Exclusion criteria:
Adolescents who failed to perform 1/3 of the recommended physical activities per month for any reason
Adolescents who for any reason failed to attend 1/3 of the classes held at the school.
Adolescents who have not completed any form of physical activity and diet assessment for at least one month for any reason.
Adolescents who affected by a specific illness or need to take a particular drug after entering the plan.
Adolescents who they or their parents are reluctant to continue in the project for any reason.
Age
From 14 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is random cluster sampling in the educational districts of Tehran. At first Tehran are divided into five educational districts (East, West, North, South and Center). The areas in the five districts are written separately on paper and were drawn randomly. Then again, in each cluster, the girls' secondary schools are written separately on a single paper and randomly drawn. In the draw, the first school name in each district is placed in the intervention group respectively; the second school name in that district is placed in the control group (two schools in each district).
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 Shahid Beheshti University of Medical Sciences
life style modification in adolescent with poly cystic ovarian syndrome
Timepoint
before intervention, 6 and 12 after intervention
Method of measurement
lifestyle kid screen, diet and physical activity questionnaire
Secondary outcomes
1
Description
Blood bio markers
Timepoint
before intervention and after 12 months
Method of measurement
Blood test
2
Description
Sonography Items
Timepoint
before intervention and after 12 months
Method of measurement
Transabdominal Sonography
Intervention groups
1
Description
"Intervention group:" Face-to-face teaching to polycystic ovary syndrome adolescents is conducted in eight 60-minute sessions of lecture, question and answer provided by the researcher. The adolescent health promotion package was designed based on the Nice Clinical Guidelines Model. Based on this model, the package was designed after searching the guides, books, sexual health packages of various countries as well as available articles. Then, Delphi method was used to validate the sexual health package by specialists and experts in different cities of Iran. Designed in two parts for the adolescent and adolescent lifestyle educator, the package is designed to include the most important aspects of adolescent health during education years.
Category
Lifestyle
2
Description
"Control group: " The control group receive only routine care and receive no intervention and training packages. Routine care includes blood pressure control, weight measurement, blood biomarkers and ultrasound measurement.