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NCT Number: NCT05038683

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

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.

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Key information

Conditions

Childhood Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Municipality heath center, Ballerup, Ballerup Municipality, Ballerup, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Holbæk Obesity Treatment

Behavioral

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.

Conventional Obesity Treatment

Behavioral

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.

Primary outcomes

  1. BMI SDS

    Time frame: End of intervention (12 months)

    BMI SDS assessed according to the International Obesity Task Force cut-offs.

  2. Quality of life (PedsQL)

    Time frame: End of intervention (12 months)

    Quality of life assessed by Pediatric Quality of Life Inventory (PedsQL)

Other outcomes

  1. Symptoms of depression and anxiety

    Time frame: End of intervention (12 months)

    Symptoms of depression and anxiety assessed with the questionnaire RCADS.

  2. Serious adverse events (SAE)

    Time frame: End of intervention (12 months)

    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.

  3. Anorexia or bulimia

    Time frame: End of intervention (12 months)

    Proportion of participants with a clinical diagnosis of anorexia or bulimia

  4. School absence

    Time frame: End of intervention (12 months)

    Number of days absent from kindergarten and school (excluding holidays).

  5. Body composition

    Time frame: End of intervention (12 months)

    Body composition, defined as % body fat by using bioelectrical impedance analysis (BIA)

  6. Waist circumference

    Time frame: End of intervention (12 months)

    Waist circumference

  7. Systolic blood pressure

    Time frame: End of intervention (12 months)

    Systolic blood pressure

  8. Diastolic blood pressure

    Time frame: End of intervention (12 months)

    Diastolic blood pressure

  9. Serum leptin

    Time frame: End of intervention (12 months)

    Concentrations of serum leptin

  10. Total cholesterol

    Time frame: End of intervention (12 months)

    Concentrations of serum total cholesterol

  11. Low density lipoprotein (LDL)

    Time frame: End of intervention (12 months)

    Concentrations of serum low density lipoprotein (LDL) cholesterol

  12. Triglycerides

    Time frame: End of intervention (12 months)

    Concentrations of serum triglycerides

  13. Insulin

    Time frame: End of intervention (12 months)

    Concentrations of serum insulin

Study contacts

Contact information is provided by the study sponsor or research team.

Jens-Christian Holm, Ph.d., MD

CONTACT

[email protected]

+4559484192

Sponsors and collaborators

Lead sponsor

Holbaek Sygehus

Other

Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Frederiksberg University Hospital
  • Hebrew University of Jerusalem
  • Leeds Beckett University
  • Statens Serum Institut
  • University of Copenhagen
  • University of Florida
  • University of Minnesota

Registry information

Official study 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.

Acronym: HOT vs COT

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2021
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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