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Effects of Family-Based Health Behavior Development Program on Obesity Risk Factors and Body Mass Index in Obese and Overweight Primary School Children: A Randomized Controlled Trial

The Effect of Family-based Health Behavior Development Program on Obesity Risk Factors and Body Mass Index in Obese and Overweight Primary Scholl Children: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07514390
Acronym
FHEBIP
Enrollment
48
Registered
2026-04-07
Start date
2025-05-01
Completion date
2025-10-31
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese Children and Adolescents

Keywords

childhood obesity, body mass index, risk factors for obesity

Brief summary

The aim of this study was to examine the effects of the Family-Based Health Behavior Development Program (FHEBIP) on obesity risk factors and body mass index (BMI) to prevent the increasing prevalence of overweight and obesity in children. The randomized controlled trial sample consisted of 96 fourth-grade primary school students and their mothers in Aksaray province. Data were collected using questionnaires and the Family Nutrition and Physical Activity Scale, and height and weight measurements were taken. Ethics committee and institutional approvals were obtained.

Detailed description

Obesity is an important public health problem due to the many chronic and non-chronic diseases it causes. It is not only seen in adults, but its prevalence is increasing in children. According to WHO 2018 statistical reports; While the prevalence of overweight (obesity) in children aged 5-19 was 4% in 1975, it increased to 18% in 2016. While 43 million children were obese in 2010, according to 2016 statistics, 340 million children and adolescents were overweight or obese in the world. One in every four children in European countries and one in every three children in the United States of America (USA) are obese. In the studies conducted by the Ministry of Health, we see that the prevalence of obesity in children increases as the age groups change and the years increase. In order to prevent the increase in the prevalence of obesity, states globally offer various research and development (R&D) studies, incentives and support this with laws and regulations. Turkey, as one of these countries, closely follows the activities and takes part in the projects as a collaborator Although the causes of CBO are not fully known, it is known that many factors play a role in the development of CBO. Although the general mechanism is accepted as the energy intake being higher than the energy expenditure, there are factors that cause or support the development of obesity. Genetic factors, metabolism, hormones, psychological factors, sleep, screen time, socioeconomic level differences, unhealthy eating habits and physical inactivity, perinatal characteristics such as delivery method, birth weight and some environmental factors have been proven by studies to cause obesity. The vast majority of the causes of CBO are external factors (environmental factors) and excess energy intake, while a small portion is made up of biochemical factors such as genetic and endocrine causes. Studies on childhood overweight and obesity indicate four main environmental factors. These factors are nutrition, physical activity, screen time and sleep. In addition to the many factors that cause obesity, there are also various health problems that obesity brings with it. Children with CSA, in particular, have a higher risk of early onset of chronic diseases such as cardiovascular diseases, diabetes and hypertension, and psychological distress such as anxiety, depression, social stigma and bullying. The variety of factors that cause CSA, the difference in obesity management according to developmental stages in children, basic differences in family factors, the high probability of those who are obese in childhood to become obese in adulthood, chronic diseases caused by CSA and the scarcity of randomized controlled trials (RCTs) in this area indicate that more research with high level of evidence is needed.

Interventions

BEHAVIORALFAMILY BASED HEALTH BEHAVIOR IMPROVEMENT PROGRAM (FHEBIP)

Unlike other behavior change programs, FHEBIP is designed with a focus on motivational interviewing and play. In addition to being family-based, it aims to increase family time, make that time more productive, and increase family control over the child.

BEHAVIORALFHEBIP (Family-Based Health Behavior Improvement Program)

Unlike other behavior change programs, FHEBIP is designed with a focus on motivational interviewing and play. In addition to being family-based, it aims to increase family time, make that time more productive, and increase family control over the child.

Sponsors

Necmettin Erbakan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

No masking.

Intervention model description

The Inclusion Criteria Form, Sociodemographic Information Form, Obesity Risk Factors Form, and the Family Nutrition and Physical Activity Screening Tool (FNPA) will be used to measure maternal and child information and obesity risk behaviors. As a pretest, mothers will be asked to complete the Sociodemographic Information Form, Obesity Risk Factors Form, and the FNPA Scale. The children's height and weight will be measured by the researcher, and their BMI will be calculated. Motivational interviewing and four training modules will be implemented as part of the FHEBIP (Family-Based Health Behavior Improvement Program), and the training will be completed in five weeks. No training will be provided between the interim and final measurements. Mothers will be supported with reminder messages and game suggestions. Mothers will complete the Obesity Risk Factors Form and the FNPA Scale, and the children's body mass index will be calculated (kg/m²).

Eligibility

Sex/Gender
ALL
Age
9 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

* Mothers must be the primary provider of nutrition at home, * The child must be in fourth grade, * Mothers must be open to and accept communication via email, SMS, and WhatsApp.

Exclusion criteria

* Children with genetic disorders: Prader-Willi syndrome, Laurence-Moon-Biedl syndrome, Down syndrome, Cohen syndrome, Carpenter syndrome, Alstrom syndrome, Cowden syndrome, Turner syndrome, and other genetic diseases that cause obesity. * Children with endocrine disorders: Cushing syndrome, growth hormone deficiency, hypothyroidism, hypothalamic disorders, insulinoma, hypogonadal syndromes, and polycystic ovary syndrome. * Children with psychological disorders: Children taking lithium, tricyclic antidepressants, and other psychiatric disorders. * Children with hypertension and chronic conditions. * Children taking medications that cause obesity, including glucocorticoids, estrogen, and progesterone. * Children with a BMI \<85th percentile. * Mothers who do not speak advanced Turkish (this is intended to prevent potential communication problems due to Turkey being a country with high immigration).

Design outcomes

Primary

MeasureTime frameDescription
Body mass İndeks6 monthsChanges in Body Mass Index (BMI) will be considered the primary outcome measure. Data will be reported in BMI (kg/m²).

Secondary

MeasureTime frameDescription
FNPA scale scoreThe FHEBIP implementation period is 6 months. The interventions will be completed after the initial measurements are taken in 1 month. Interim measurements will be taken in the 3rd month, and final measurements will be taken in the 6th month.Changes in FNPA scale scores will be considered a secondary measurement outcome. The total scale score ranges from 20 to 80. As the total scale score approaches 80, obesity risk factor behaviors change in a positive direction.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORDilek DAYANIR, ASSOCIATE PROFESSOR

NECMETTİNEU

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026