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Obese Children and AdolescentsFHEBIPNCT07514390

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

A study testing FAMILY BASED HEALTH BEHAVIOR IMPROVEMENT PROGRAM (FHEBIP) and FHEBIP (Family-Based Health Behavior Improvement Program) in people with Obese Children and Adolescents, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Obese Children and Adolescents
What is being tested?
FAMILY BASED HEALTH BEHAVIOR IMPROVEMENT PROGRAM (FHEBIP) and FHEBIP (Family-Based Health Behavior Improvement Program)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2025to 31 Oct 2025
Phase
Interventional
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 9 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kılıçarslan Primary School, Selçuk Primary School, Emlak Kredi Primary School, Kamber Gülüzar Primary School and Hacı Mustafa Demir Primary School

    Aksaray, Merkez, 68100

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read the 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.

Being tested
FAMILY BASED HEALTH BEHAVIOR IMPROVEMENT PROGRAM (FHEBIP), FHEBIP (Family-Based Health Behavior Improvement Program)
Keywords
childhood obesity, body mass index, risk factors for obesity
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FAMILY BASED HEALTH BEHAVIOR IMPROVEMENT PROGRAM (FHEBIP)Behavioural

    Also called 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.

  • FHEBIP (Family-Based Health Behavior Improvement Program)Behavioural

    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.

Study groups in NCT07514390
Study groupRoleWhat they receive
FHEBIP applied groupExperimentalThe 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.
Receives: Behavioral: FAMILY BASED HEALTH BEHAVIOR IMPROVEMENT PROGRAM (FHEBIP); Behavioral: FHEBIP (Family-Based Health Behavior Improvement Program)
Group not receiving FHEBIPNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Body mass İndeks

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

    Measured: 6 months

Secondary outcomes (1)
  1. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study start1 May 2025
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07514390
Sponsor's protocol ID
NEU-SBF-BZ-01
Acronym
FHEBIP
Status last verified
Mar 2026
First submitted
24 Sep 2025
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Laws in Türkiye do not allow the sharing of personal data.

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. Sleep duration and bedtime in preschool-age children with obesity: Relation to BMI and diet following a weight management intervention. Pediatr Obes. 2019 Nov;14(11):e12555. doi: 10.1111/ijpo.12555. Epub 2019 Jun 19.

    PubMed 31215768
  • Muthuri SK, Wachira LJ, Leblanc AG, Francis CE, Sampson M, Onywera VO, Tremblay MS. 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 Mar 20;11(3):3327-59. doi: 10.3390/ijerph110303327.

    PubMed 24658411
  • 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. Physical activity and family-based obesity treatment: a review of expert recommendations on physical activity in youth. Clin Obes. 2018 Feb;8(1):68-79. doi: 10.1111/cob.12230. Epub 2017 Dec 10.

    PubMed 29224232
  • Bean MK, Thornton LM, Jeffers AJ, Gow RW, Mazzeo SE. Impact of motivational interviewing on engagement in a parent-exclusive paediatric obesity intervention: randomized controlled trial of NOURISH+MI. Pediatr Obes. 2019 Apr;14(4):e12484. doi: 10.1111/ijpo.12484. Epub 2018 Dec 4.

    PubMed 30515995
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing FAMILY BASED HEALTH BEHAVIOR IMPROVEMENT PROGRAM (FHEBIP) and FHEBIP (Family-Based Health Behavior Improvement Program) in people with Obese Children and Adolescents, run by Necmettin Erbakan University 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 7 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 7 Apr 2026. 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?

Body mass İndeks (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07514390, which also lists 8 linked publications.

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 7 Apr 2026.

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