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 (FHEBIP)

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

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.

Study Overview

• Status: Completed
• Conditions: Obese Children and Adolescents
• Intervention / Treatment: Behavioral: FAMILY BASED HEALTH BEHAVIOR IMPROVEMENT PROGRAM (FHEBIP); Behavioral: FHEBIP (Family-Based Health Behavior Improvement Program)

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Merkez
    • Aksaray, Merkez, Turkey (Türkiye), 68100
      • Kılıçarslan Primary School, Selçuk Primary School, Emlak Kredi Primary School, Kamber Gülüzar Primary School and Hacı Mustafa Demir Primary School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FHEBIP applied group; The FHEBIP intervention group will be administered a Sociodemographic Information Form, Obesity Risk Factors Form, and FNPA Scale to measure maternal and child knowledge and obesity risk behaviors at pretest, interim, and posttest. The researcher will measure height and weight to calculate body mass index. Unlike the control group, the intervention group will receive motivational interviewing, family nutrition education, physical activity education, screen time education, and sleep education. Reminders and motivational messages appropriate to the educational content will be sent to the intervention group to maintain motivation during the interim and posttest intervals.	Behavioral: FAMILY 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.; Other Names: FHEBIP; Behavioral: FHEBIP (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.
No Intervention: Group not receiving FHEBIP; The FHEBIP control group will use the Inclusion Criteria form for the pretest, interim test, and posttest, along with a Sociodemographic Information Form, Obesity Risk Factors Form, and the FNPA Scale to measure maternal and child information and obesity risk behaviors. Children's height and weight will be measured, and their body mass index will be calculated. The control group will not receive any motivational interviews or training. No motivational or reminder messages will be sent during the interim and posttest intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass İndeks	Changes in Body Mass Index (BMI) will be considered the primary outcome measure. Data will be reported in BMI (kg/m²).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FNPA scale score	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.	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.

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Investigators: Study Director: Dilek DAYANIR, ASSOCIATE PROFESSOR, NECMETTİNEU

Publications and helpful links

General Publications

• Yabancı N, Kısaç İ, Karakuş SŞ. The Effects of Mother's Nutritional Knowledge on Attitudes and Behaviors of Children About Nutrition. Procedia- Social and Behavioral Sciences, 2014;116:4477-81.
• Simon SL, Goetz AR, Meier M, Brinton J, Zion C, Stark LJ. Obezite olan okul öncesi çağındaki çocuklarda uyku süresi ve yatma zamanı: Kilo yönetimi müdahalesini takiben BMI ve diyet ilişkisi. Pediatr Obes, 2019; 14(11): 1-9.
• Muthuri SK, Wachira L-JM, Leblanc AG, Francis CE, Sampson M, Onywera VO, et al. Temporal trends and correlates of physical activity, sedentary behaviour, and physical fitness among school-aged children in Sub-Saharan Africa: A systematic review. Int J Environ Res Public Health 2014; 11: 3327- 59.
• Landgren K, Quaye AA, Hallström E, Tiberg I. Family-based prevention of overweight and obesity in children aged 2-6 years: a systematic review and narrative analysis of randomized controlled trials. CHILD AND ADOLESCENT OBESITY (CHAO), 2020;3(1):57-104.
• Foster C, Moore JB, Singletary CR, Skelton JA. Fiziksel aktivite ve aile temelli obezite tedavisi: Gençlerde fiziksel aktivite üzerine uzman tavsiyelerinin gözden geçirilmesi. Clin Obes, 2018; 8(1): 68-79.
• Bean MK, Thornton LM, Jeffers AJ, Gow RW, Mazzeo SE. Motivasyonel görüşmenin ebeveynlere özel bir pediatrik obezite müdahalesine katılım üzerindeki etkisi: NOURISH+MI'nin randomize kontrollü çalışması. Pediatr Obes, 2019; 14(4): e12484.
• Ahmad N, Shariff ZM, Mukhtar F, Lye MS. Malay ilkokul çocuklarının adipozitesini iyileştirmek için yüz yüze oturumları ve sosyal medyayı kullanan aile temelli müdahale: Malezya REDUCE programının randomize kontrollü bir saha denemesi. Beslenme J, 2018; 17(1): 1-13.
• World Health Organization (WHO). Obesity and overweight. Erişim: https://www.who.int/en/news-room/fact-sheets/detail/obesity-and-overweight Erişim tarihi:18.06.2022.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: body mass index; childhood obesity; risk factors for obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: NEU-SBF-BZ-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Laws in Türkiye do not allow the sharing of personal data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No