Obesity, AdolescentNuFaMeSTraNCT04044833
Evaluation of the Effects of Planned Trainings Given to Obese Adolescent Girls on Healthy Lifestyle Behaviors and Menstrual Symptoms
An observational study of Obesity, Adolescent and Menstrual Problem, run by Hulya Erbaba at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent, Menstrual Problem, Health Behavior
- What is being tested?
- Health life style behaviour ,
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 21 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Study population: : 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.
Who may be able to join
- Regular Menstruation
- Obese
- 9,10,11. class student
Who cannot join
- Unregular menstruation non-attendance to training
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kalaba Mesleki Teknik ve High School
Ankara, Kecıoren, 06000
About this study
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.
Read the detailed description
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.
- Conditions
- Obesity, Adolescent, Menstrual Problem, Health Behavior
- Being tested
- Health life style behaviour ,
- Medical subject headings
- Pediatric Obesity, Menstruation Disturbances, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health life style behaviour ,Behavioural
Also called menstrual symptoms
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)
| Study group | Role | What they receive |
|---|---|---|
| intervention | (n=63) Receives: Behavioral: Health life style behaviour , | |
| control | (n=65) Receives: Behavioral: Health life style behaviour , |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Health Life Style Behaviour Scale Points of Obese Adolescent Girls
Pretest intervention applied before to control and intervention groups. Nutrition, Physical Activity and Menstrual Symtoms Training given to intervention group (n=63) during the 16 weeks. After training posttest applied control and intervention groups. The health Life Style Behaviour Scale used for collect these data.
Measured: 16 weeks
Measurement Menstruation Scale Points of Obese Adolescent Girls
Pretest intervention applied before to control and intervention groups. Nutrition, Physical Activity and Menstrual Symtoms Training given to intervention group (n=63) during the 16 weeks. After training posttest applied to control and intervention groups. The Menstruation Symptoms Scale used for collect these data.
Measured: 16 weeks
Secondary outcomes (1)
Measurements findings of menstruation pain according to the follow-up months of the students
The students menstruation pain followed up with a follow up form in control and intervention groups.
Measured: 5 mounts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Sep 2017
- Primary completion21 Jan 2018
- Study completion21 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hulya Erbaba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hulya Erbaba, University of Beykent
- Investigators
- Hulya HE Erbaba, PhD, Principal investigator, University of Beykentsevil ss sahin, PhD, Study director, UAnkara Yıldırım Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044833
- Sponsor's protocol ID
- 521
- Acronym
- NuFaMeSTra
- Status last verified
- Aug 2019
- First submitted
- 29 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I can send when they want
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04044833
- Acronym / sponsor ID
- NuFaMeSTra / 521
- Conditions
- Obesity, Adolescent, Menstrual Problem, Health Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hulya ErbabaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 21 Jan 2018 (actual)
- Study completion
- 21 Jan 2018 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | – | Behavioral: Health life style behaviour ,(n=63) |
| control | – | Behavioral: Health life style behaviour ,(n=65) |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- : 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.
Key inclusion criteria (3 listed)
- Regular Menstruation
- Obese
- 9,10,11. class student
Key exclusion criteria (1 listed)
- Unregular menstruation non-attendance to training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health life style behaviour ,Also: menstrual symptomsTraining: 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) | Behavioural | control, intervention |
Primary outcome
Measurement of Health Life Style Behaviour Scale Points of Obese Adolescent Girls
Time frame: 16 weeks
Pretest intervention applied before to control and intervention groups. Nutrition, Physical Activity and Menstrual Symtoms Training given to intervention group (n=63) during the 16 weeks. After training posttest applied control and intervention groups. The health Life Style Behaviour Scale used for collect these data.
Measurement Menstruation Scale Points of Obese Adolescent Girls
Time frame: 16 weeks
Pretest intervention applied before to control and intervention groups. Nutrition, Physical Activity and Menstrual Symtoms Training given to intervention group (n=63) during the 16 weeks. After training posttest applied to control and intervention groups. The Menstruation Symptoms Scale used for collect these data.
1 secondary outcome
Measurements findings of menstruation pain according to the follow-up months of the students
Time frame: 5 mounts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Individual participant dataSharing planned: Yes. I can send when they want
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hulya HE Erbaba, PhD principal investigator
University of Beykent
sevil ss sahin, PhD study director
UAnkara Yıldırım Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Adolescent and Menstrual Problem, run by Hulya Erbaba at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Health Life Style Behaviour Scale Points of Obese Adolescent Girls (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.