Holbæk Obesity Treatment (HOT) Versus Conventional Obesity Treatment (COT) in Children With Overweight or Obesity. (HOT vs COT)

Holbaek Sygehus

Status: Enrolling

Conditions: Childhood Overweight and Obesity

Treatments: Behavioral: Conventional Obesity Treatment; Behavioral: Holbæk Obesity Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05038683

HOT vs COT trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 554 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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554 participants in 2 patient groups

HOT

Experimental group

Description:

Holbæk Obesity Treatment

Treatment:

Behavioral: Holbæk Obesity Treatment

COT

Active Comparator group

Description:

Conventional Obesity Treatment

Treatment:

Behavioral: Conventional Obesity Treatment