RecruitingNot ApplicableNCT05038683

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

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.


Sponsor

Holbaek Sygehus

Enrollment

554 participants

Start Date

Oct 26, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

The HOT versus COT trial is comparing two different clinical approaches to treating overweight and obesity in children aged 6 to 12: the Holbaek Obesity Treatment (HOT), which views obesity as a chronic neuroendocrine disease requiring long-term multidisciplinary management, versus conventional obesity treatment (COT), which focuses on energy balance and motivation-based lifestyle coaching. Both approaches involve dietary, physical activity, and behavioral components, but their underlying philosophy and delivery differ significantly. Children aged 6 to under 12 with a BMI at or above the 90th percentile for their age and sex, whose parents provide informed consent, are eligible; those already in multidisciplinary obesity treatment, with a sibling in the trial, who cannot communicate in Danish, or with a history of anorexia or bulimia are excluded. Participation involves attending scheduled clinic appointments over the trial period to assess changes in weight, health, and wellbeing under the assigned treatment model. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHolbæk 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.

BEHAVIORALConventional 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.


Locations(5)

Municipality heath center, Ballerup

Ballerup Municipality, Ballerup, Denmark

Municipality health center, Frederikssund Kommune

Frederikssund, Frederikssund, Denmark

Municipality health center, Guldborgsund

Nykøbing Falster, Guldborgsund, Denmark

Municipality heath center, Lejre

Lejre, Denmark

Municipality heath center, Solrød

Solrød Strand, Denmark

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NCT05038683


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