Health Behavior Clinical Trial
Official title:
Evaluation of the Effects of Planned Trainings Given to Obese Adolescent Girls on Healthy Lifestyle Behaviors and Menstrual Symptoms:A Randomise Controlled Trial
The aim of this study is to evaluate the effects of training given to obese female students in mid-adolescence period for improving nutrition, physical activity, and menstrual symptoms on the improvement of their healthy lifestyle behaviors and menstrual symptoms. The research sample consisted of 128 obese female students divided into groups as intervention and control. In this randomized controlled trial, pretest-posttest control group and random process were used. In the first stage of the study, total of 12 hours of training, 120 minutes for each course per week, was provided. In the second stage, 120 minutes of reinforcement training were given every month for three months. The study lasted 16 weeks totally. Personal Information Form, Healthy Lifestyle Behavior Scale II (HLBS-II), Menstrual Symptom Questionnaire (MSQ) and Student Follow-up Schedule were used as data collection tools. Statistical analysis was performed using SPSS Statistics 23 Version. Hypotheses were (i) there was a difference between the total HLBS-II and MSQ scores of the students before and after the training and (ii) there was a correlation between the scales.
Method The research was carried out as a randomized controlled trial to identify menstrual
symptoms and healthy lifestyle behaviors of obese adolescent girls and to determine the
effects of planned trainings given to them for improving nutrition, physical activity, and
menstrual symptoms on the improvement of their healthy lifestyle behaviors and menstrual
symptoms.
Research Hypotheses: H1: There is a difference between the mean scores of Healthy Lifestyle
Behavior Scale II (HLBS-II) and H2: Menstrual Symptom Questionnaire (MSQ) before and after
the trainings given to obese adolescent girls. H3: There is a correlation between the mean
scores of HLBS-II and MSQ.
Study population and data collection tools: The study was carried out in three state high
schools providing full-time education in a district of Ankara on September 1, 2017-January
21, 2018 and included 128 obese female students who accepted to participate voluntarily.
These schools were chosen because the number of students was high and there were students
from different socioeconomic levels. The study was approved by Yıldırım Beyazıt University
Ethics Committee (decision numbered 12.04.2017/15 and coded 522). We obtained corporate
permission from Ankara Provincial Directorate of National Education and informed consents of
the students and their parents. Personal Information Form, HLBS-II, MSQ, and Student
Follow-up Schedule, which were created by the researcher in accordance with the literature,
were used as data collection tools.
Personal Information Form was prepared by examining the literature on the relevant age group
to examine the demographic, nutritional, physical activity, and menstrual characteristics of
the participants.10,11,14,16-19,22,23 Student Follow-up Schedule was developed for the
students to record their menstrual pain and symptoms, weight and body mass index (BMI)
measurements during the specified periods.
Menstrual Symptom Questionnaire was developed by Chesney and Tasto to assess menstrual pain
and symptoms in 1975, and the usability of the questionnaire on adolescents was assessed by
Negriff et al.24 and they updated the questionnaire in 2009. In 2013, Güvenç et al.24
conducted the reliability and validity study. Following the adaptation process, the
questionnaire was prepared as 5-point Likert type and to involve 22 items. The MSQ score is
calculated by taking the average of the total scores of the items in the scale. The increase
in the mean score indicates that the severity of menstrual symptoms increases. The Cronbach's
Alpha value of the scale is 0.86. In our study, it was found to be 0.91 and 0.92 before and
after the trainings, respectively.
Healthy Lifestyle Behavior Scale II (HLSB-II): The scale was developed by Walker et al.25 in
1987 and updated in 1996 and named as Healthy Lifestyle Behavior Scale II. Bahar et al.26
studied the validity and reliability of its Turkish version in 2008. The 4-point Likert type
scale consists of 52 items. Cronbach's Alpha value of the scale is 0.92. In our study, the
Cronbach's Alpha value of the scale was found to be 0.91 and 0.92 before and after the
trainings, respectively.
Treatment and control groups: The study population covers all female high school students.
Study sample: In accordance with BMI-for-Age Percentile for Girls (kg/m2) determined by WHO,2
the study population was determined via two stages and consisted of volunteer female obese
students aged 14 (BMI 26,7), 15 (BMI> 27,6) and 16 years (BMI> 28,2), who were currently at
ninth, 10th and 11th grade in high school. In the first stage, BMIs, heights, and weights of
1300 female students who participated in the study voluntarily were measured and the students
who met the criteria were included in the study. In the second stage, students, who agreed to
participate in training and monitoring, were determined and they were, then, randomly divided
into two groups, namely intervention (n=63) and control (n=65) groups.
The steps in the Implementation Phase are as follows: a) Sampling: measuring the BMIs,
heights, and weights of 1300 female students, determining the sample group, and obtaining
informed consent from them and their parents; b) Before the Training: applying Personal
Information Form, HLBS-II, and MSQ to the intervention and control groups determined randomly
and distributing the Student Follow-up Schedules; c) Providing trainings to the intervention
group; d) Monitoring the weights, BMIs, and menstrual symptoms of intervention and control
groups; and e) After the Training: Applying HLBS-II and MSQ scales to intervention and
control groups, collecting the follow-up schedules, and providing training to the control
group and all other students. Trainings: First stage: 120 minutes basic training per week for
four weeks (40 minutes on diet, 40 minutes on physical activity, and 40 minutes on menstrual
symptoms) . Second stage: Reinforcement trainings of 120 minutes were given once a month for
three months. Periodic follow-up of intervention and control groups was carried out by
recording their BMIs (Tanita BC 730 branded calibrated professional body analyzer was used to
determine weight and BMI , which were measured three times in three periods) and menstrual
symptoms ( participants were asked to mark Menstrual Pain and Symptoms in the first three
days of menstruation in five periods) .
Statistical Analysis: Data was analyzed by using SPSS Statistics for Windows, Version 23.0
(IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp). Descriptive data was
compared using Chi-Square and Mann-Whitney U tests, while Wilcoxon's and McNemar's tests were
used to compare the menstruation findings of the students before and after the training.
Dependent Samples t-Test was used in the intragroup comparison of total HLBS-II, MSQ, and
sub-dimension scores. Comparison of differences between groups was performed by using the
Independent Samples t-Test. Pearson's correlation analysis was used to determine the
relationship between total HLBS-II and MSQ scores.
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