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Completed

NCT Number: NCT07514390

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 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.

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Key information

Age range

9 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kılıçarslan Primary School, Selçuk Primary School, Emlak Kredi Primary School, Kamber Gülüzar Primary School and Hacı Mustafa Demir Primary School

Aksaray, Merkez, 68100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

FAMILY BASED HEALTH BEHAVIOR IMPROVEMENT PROGRAM (FHEBIP)

Behavioral

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.

Other names: FHEBIP

FHEBIP (Family-Based Health Behavior Improvement Program)

Behavioral

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.

Primary outcomes

  1. Body mass İndeks

    Time frame: 6 months

    Changes in Body Mass Index (BMI) will be considered the primary outcome measure. Data will be reported in BMI (kg/m²).

Secondary outcomes

  1. FNPA scale score

    Time frame: The 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.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Acronym: FHEBIP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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