Childhood Overweight and Obesity
Conditions
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.
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.
Sponsors
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Copenhagen
Statens Serum Institut
University of Florida
Leeds Beckett University
University of Minnesota
Hebrew University of Jerusalem
Frederiksberg University Hospital
Holbaek Sygehus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Due to the nature of the interventions, it will not be possible to blind the healthcare providers administering the interventions. We will attempt to blind the participants by not informing them about which intervention group we consider experimental and which group we consider control. However, the participants included in HOT will be governed by a digital solution where Dr. Holm will be identifiable and thus revealing the HOT. In all other aspects of the trial, we will employ blinding, incl. outcome assessment. Statisticians, and investigators drawing conclusions will be fully blinded. We will conduct the statistical analyses with the intervention groups coded as eg. 'A' and 'B'. The steering committee will write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken.
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI SDS | End of intervention (12 months) | BMI SDS assessed according to the International Obesity Task Force cut-offs. |
| Quality of life (PedsQL) | End of intervention (12 months) | Quality of life assessed by Pediatric Quality of Life Inventory (PedsQL) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anorexia or bulimia | End of intervention (12 months) | Proportion of participants with a clinical diagnosis of anorexia or bulimia |
| School absence | End of intervention (12 months) | Number of days absent from kindergarten and school (excluding holidays). |
| Body composition | End of intervention (12 months) | Body composition, defined as % body fat by using bioelectrical impedance analysis (BIA) |
| Waist circumference | End of intervention (12 months) | Waist circumference |
| Systolic blood pressure | End of intervention (12 months) | Systolic blood pressure |
| Symptoms of depression and anxiety | End of intervention (12 months) | Symptoms of depression and anxiety assessed with the questionnaire RCADS. |
| Serum leptin | End of intervention (12 months) | Concentrations of serum leptin |
| Total cholesterol | End of intervention (12 months) | Concentrations of serum total cholesterol |
| Low density lipoprotein (LDL) | End of intervention (12 months) | Concentrations of serum low density lipoprotein (LDL) cholesterol |
| Triglycerides | End of intervention (12 months) | Concentrations of serum triglycerides |
| Insulin | End of intervention (12 months) | Concentrations of serum insulin |
| Diastolic blood pressure | End of intervention (12 months) | Diastolic blood pressure |
| Serious adverse events (SAE) | 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. |
Countries
Denmark
Contacts
Primary ContactJens-Christian Holm, Ph.d., MD
Outcome results
None listed