NCT04044833

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

July 29, 2019

Last Update Submit

August 1, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    16 weeks

Secondary Outcomes (1)

  • Measurements findings of menstruation pain according to the follow-up months of the students

    5 mounts

Study Arms (2)

intervention

(n=63)

Behavioral: Health life style behaviour ,

control

(n=65)

Behavioral: Health life style behaviour ,

Interventions

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)

Also known as: menstrual symptoms
controlintervention

Eligibility Criteria

Age14 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe research topic is menstrual symptoms and health life behaviours so we include girls as voluntary.
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Regular Menstruation
  • Obese
  • ,10,11. class student

You may not qualify if:

  • Unregular menstruation non-attendance to training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kalaba Mesleki Teknik ve High School

Ankara, Kecıoren, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pediatric ObesityMenstruation DisturbancesHealth Behavior

Interventions

Menstruation

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesBehavior

Intervention Hierarchy (Ancestors)

Menstrual CycleReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Hulya HE Erbaba, PhD

    University of Beykent

    PRINCIPAL INVESTIGATOR
  • sevil ss sahin, PhD

    UAnkara Yıldırım Beyazıt University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. PhD.

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 5, 2019

Study Start

September 1, 2017

Primary Completion

January 21, 2018

Study Completion

January 21, 2018

Last Updated

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

I can send when they want

Shared Documents
STUDY PROTOCOL
Time Frame
when they want I will send in a 30 day
Access Criteria
YÖKTEZ
More information

Locations