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

Not Applicable

Recruiting

• Conditions: Childhood Overweight and Obesity
• Interventions: Behavioral: Conventional Obesity Treatment; Behavioral: Holbæk Obesity Treatment

• Registration Number: NCT05038683
• Lead Sponsor: Holbaek Sygehus

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.

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-09
• Study Start: 2022-10-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 554

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COT	Conventional Obesity Treatment	Conventional Obesity Treatment
HOT	Holbæk Obesity Treatment	Holbæk Obesity Treatment

Primary Outcome Measures

Name	Time	Method
Quality of life (PedsQL)	End of intervention (12 months)	Quality of life assessed by Pediatric Quality of Life Inventory (PedsQL)
BMI SDS	End of intervention (12 months)	BMI SDS assessed according to the International Obesity Task Force cut-offs.

Trial Locations

Locations (5)

Municipality heath center, Lejre; 🇩🇰 Lejre, Denmark

Municipality heath center, Solrød; 🇩🇰 Solrød Strand, Denmark

Municipality health center, Guldborgsund; 🇩🇰 Nykøbing Falster, Guldborgsund, Denmark

Municipality heath center, Ballerup; 🇩🇰 Ballerup, Denmark

Municipality health center, Frederikssund Kommune; 🇩🇰 Frederikssund, Denmark