Clinical trial NCT05038683: Holbæk Obesity Treatment (HOT) Versus Conventional Obesity Treatment (COT) in Children With Overweight or Obesity.
Official title: Holbæk Obesity Treatment (HOT) Versus Conventional Obesity Treatment (COT) in Children With Overweight or Obesity. An Investigator-initiated, Multi-center, Randomized, Parallel Group, Clinical Superiority Trial With Blinded Outcome Assessment. HOT Versus COT Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Overweight and Obesity
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: University of Copenhagen
name: Statens Serum Institut
name: University of Florida
name: Leeds Beckett University
name: University of Minnesota
name: Hebrew University of Jerusalem
name: Frederiksberg University Hospital
First posted: 2021-09-09
Enrollment: 554
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The HOT versus COT trial aims to compare the effectiveness of two different lifestyle interventions for treatment of childhood overweight and obesity with the purpose of informing future clinical practice guidelines within this field. The aim is to conduct this investigation in an optimal trial design with the lowest possible risk of bias.

Detailed description: Obesity is a chronic, progressive, and severe disease that compromises growth, development, and the general health and well-being of children, adolescents, and adults all around the globe. Current treatment within this field varies considerably, but the prevailing concept is that treatment should be lifelong with a focus on implementing and maintaining changes regarding diet, physical activity, sedentary behavior, sleep, etc. The Holbæk Obesity Treatment (HOT) is built on the understanding that obesity is a complex chronic disease regulated by a neuroendocrine system, where weight-reducing actions initiate counteractive mechanisms to defend fat mass. Conventional obesity treatment (COT) is based on a view that obesity results from energy imbalances and focuses on motivation, few changes at a time, and a narrative approach towards healthy energy intake and physical activity. These two approaches represent fundamentally different treatments of overweight and obesity.

Eligibility criteria: Inclusion Criteria:

* Overweight or obesity defined as BMI corresponding to or above the 90th percentile for age and sex (International Obesity Task Force cut-offs).
* Age six to \< 12 years at enrolment.
* Signed informed consent from both parents or legal guardians.

Exclusion Criteria:

* Participation in multidisciplinary obesity treatment (i.e. treatment involving more than one type of healthcare profession) within the past 12 months.
* Having a sibling already enrolled in the HOT versus COT trial.
* Both parents or legal guardians unable to communicate in Danish (written or oral).
* Child unable to communicate in Danish (oral).
* Current or previous clinical diagnosis of either anorexia or bulimia according to ICD-10.

Primary outcomes:
measure: BMI SDS
timeFrame: End of intervention (12 months)
measure: Quality of life (PedsQL)
timeFrame: End of intervention (12 months)
Secondary outcomes:
Other outcomes:
measure: Symptoms of depression and anxiety
timeFrame: End of intervention (12 months)
measure: Serious adverse events (SAE)
timeFrame: End of intervention (12 months)
measure: Anorexia or bulimia
timeFrame: End of intervention (12 months)
measure: School absence
timeFrame: End of intervention (12 months)
measure: Body composition
timeFrame: End of intervention (12 months)
measure: Waist circumference
timeFrame: End of intervention (12 months)
measure: Systolic blood pressure
timeFrame: End of intervention (12 months)
measure: Diastolic blood pressure
timeFrame: End of intervention (12 months)
measure: Serum leptin
timeFrame: End of intervention (12 months)
measure: Total cholesterol
timeFrame: End of intervention (12 months)
measure: Low density lipoprotein (LDL)
timeFrame: End of intervention (12 months)
measure: Triglycerides
timeFrame: End of intervention (12 months)
measure: Insulin
timeFrame: End of intervention (12 months)
Locations:
city: Nykøbing Falster
country: Denmark
facility: Municipality health center, Guldborgsund
state: Guldborgsund
city: Ballerup
country: Denmark
facility: Municipality heath center, Ballerup
city: Frederikssund
country: Denmark
facility: Municipality health center, Frederikssund Kommune
city: Lejre
country: Denmark
facility: Municipality heath center, Lejre
city: Solrød Strand
country: Denmark
facility: Municipality heath center, Solrød
Study officials:
affiliation: The Children's Obesity Clinic, Department of Pediatrics, Holbæk Hospital, Part of Copenhagen University Hospital
name: Jens-Christian Holm, Ph.d., MD
role: STUDY_CHAIR
References: