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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Childhood Overweight and Obesity
• Intervention / Treatment: Behavioral: Conventional Obesity Treatment; Behavioral: Holbæk Obesity Treatment

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 Type: Interventional
• Enrollment (Estimated): 554
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jens-Christian Holm, Ph.d., MD; Phone Number: +4559484192; Email: jhom@regionsjaelland.dk

Study Locations

• Denmark
  • Ballerup, Denmark, 2750
    • Recruiting
    • Municipality heath center, Ballerup
    • Contact: Lotte Stentz, RN
  • Frederikssund, Denmark, 3600
    • Recruiting
    • Municipality health center, Frederikssund Kommune
    • Contact: Bodil M Gjøl, RN
  • Lejre, Denmark, 4330
    • Recruiting
    • Municipality heath center, Lejre
    • Contact: Susan Tanzer, RN
  • Solrød Strand, Denmark, 2680
    • Recruiting
    • Municipality heath center, Solrød
    • Contact: Marthinne Düring, RN
  • Guldborgsund
    • Nykøbing Falster, Guldborgsund, Denmark, 4800
      • Recruiting
      • Municipality health center, Guldborgsund
      • Contact: Hanne Ryttesgaard, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: COT; Conventional Obesity Treatment	Behavioral: Conventional Obesity Treatment; Obesity is viewed as a chronic disease that is ultimately thought to result from an imbalance between energy intake and energy expenditure. However, multiple factors, both environmental and genetic, are thought to influence the disease as well. As obesity reflects energy imbalances, the treatment plan should be designed to induce a slightly negative energy balance by focusing on diet, physical activity, and inactivity through behavior change. Taking one step at a time, will in the end lead to the same energy balance result (i.e. weight loss) and will be more sustainable for the participant whose motivation is absolutely pivotal in this process. COT is administered by healthcare nurses and dietitians at healthcare centers in Danish municipalities. Each treatment will be conducted as face-to-face sessions totalling a range of six to 12 hours for 12 months.
Experimental: HOT; Holbæk Obesity Treatment	Behavioral: Holbæk Obesity Treatment; Obesity is a chronic, progressive, severe, recidivistic, and complex disease, which mandates that children and adolescents with overweight or obesity have access to a professional medical healthcare service as other pediatric chronic diseases, implying a lifelong course of treatment. The HOT method is further based on the physiological insight into the endocrine regulation of fat mass; especially on how the body adapts when it is challenged by weight loss. These insights include an understanding where the body shifts into an energy-preserving mode when the individual is initiating weight-reducing actions, such as a reduced caloric intake or an increased level of physical activity, which has numerous impacts on communication and pedagogy. HOT is administered by healthcare nurses and dietitians at healthcare centers in Danish municipalities. Each treatment will be conducted as face-to-face sessions totalling a range of six to 12 hours for 12 months.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of depression and anxiety	Symptoms of depression and anxiety assessed with the questionnaire RCADS.	End of intervention (12 months)
Serious adverse events (SAE)	Proportion of participants with one or more SAEs defined as any adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability or incapacity.	End of intervention (12 months)
Anorexia or bulimia	Proportion of participants with a clinical diagnosis of anorexia or bulimia	End of intervention (12 months)
School absence	Number of days absent from kindergarten and school (excluding holidays).	End of intervention (12 months)
Body composition	Body composition, defined as % body fat by using bioelectrical impedance analysis (BIA)	End of intervention (12 months)
Waist circumference	Waist circumference	End of intervention (12 months)
Systolic blood pressure	Systolic blood pressure	End of intervention (12 months)
Diastolic blood pressure	Diastolic blood pressure	End of intervention (12 months)
Serum leptin	Concentrations of serum leptin	End of intervention (12 months)
Total cholesterol	Concentrations of serum total cholesterol	End of intervention (12 months)
Low density lipoprotein (LDL)	Concentrations of serum low density lipoprotein (LDL) cholesterol	End of intervention (12 months)
Triglycerides	Concentrations of serum triglycerides	End of intervention (12 months)
Insulin	Concentrations of serum insulin	End of intervention (12 months)

Collaborators and Investigators

• Sponsor: Holbaek Sygehus
• Collaborators: University of Copenhagen; University of Florida; University of Minnesota; Hebrew University of Jerusalem; Frederiksberg University Hospital; Statens Serum Institut; Copenhagen Trial Unit, Center for Clinical Intervention Research; Leeds Beckett University
• Investigators: Study Chair: Jens-Christian Holm, Ph.d., MD, The Children's Obesity Clinic, Department of Pediatrics, Holbæk Hospital, Part of Copenhagen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HOT vs COT trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the results have been published, the aim is to make a depersonalised dataset publicly available on e.g. ClinicalTrials.gov and/or the European Union (EU) Zenodo database (https://zenodo.org/). The final choice will reflect which platform(s) that are compliant with current legislation at that time.
• IPD Sharing Time Frame: When the results have been published
• IPD Sharing Access Criteria: Researchers with a protocol for their planned study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No