NCT Number: NCT03749200
Motivational Approach to Treat Childhood Obesity
The treatment of childhood obesity is challenging. Although dietary and physical activity recommendations are widely known, the willingness to change lifestyles within the family is not easy to be achieved. Motivational interviewing has been shown as a possibly effective method to increase adherence to dietary recommendations in the obese adult.
There is scarce evidence showing whether implementing a motivational interview in obese children could be effective.
The aim of this clinical trial is assessing the effect of a motivational interview, coordinated between the clinical and primary care services on 8 to 14 years old obese children.
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Notify MeKey information
Conditions
Age range
8 year–15 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Faculty of Medicine, C/ Sant Llorenç 21, Reus, Tarragona, Spain
About this study
In a recent study, the investigators have demonstrated that the motivational therapy approach to treat childhood obesity is highly effective at clinical and metabolic levels. This efficacy has been proved in a clinical outpatient setting. However, a standardized collaborative approach between the clinic and the primary care services would allow a faster and easier approach to childhood obesity treatment. Furthermore, this motivational and educational intervention would benefit from the current technologic facilities, the long term effect of the education at group level, in terms of food shopping plan, healthy, fast and easy cooking methods.
The aim of this clinical trial is to test the efficacy of a multicomponent motivational intervention for the treatment of childhood obesity, coordinated between primary care and hospital specialized services, integrating motivational individual interviews, educational groups and eHealth tools (wearable), compared to the usual intervention performed in paediatrics.
The design will be a clustered randomized control trial, with an intervention group that will receive a multicomponent motivational and educational plan which will be compared to a control group receiving the usual recommendations performed in primary care centres (n=167 per group). The treatment of both study groups will last 12 months and will be performed at the primary care centres. In parallel, the study team will validate the methodology used to assess body composition in obese children as well as the changes produced by the intervention.
Children assigned to the control group receive advices as recommended by the Clinical Practice Guidelines (17). At visits, the family receive explanations about carrying out a balanced diet, divided into 5 meals, in order to provide a moderate energy intake reduction. An increase in physical activity, both in terms of leisure activity, as sports regular practise are recommended. Monthly visits are organized in which weight and height are measured, and compliance with recommendations are actually taking place.
Children assigned to the intervention group receive similar recommendations to those in the control group but under a motivational interview schema. This means that each visit, objectives from the last visit are fulfiled, the therapists try to make the family recongnizing the changes to be done by themselves, rather than imposing by demonstrating ambivalences, and objectives for the next visit are agreed. Furthermore, three workshops as group therapy are organized with the following topics: 1. Increasing physical actty sing an eHEalth monitor, 2. Food choices and dietary balance, and 3. Cooking methods.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age range between 8 and <14 years at enrolment (so that, children would end the treatment at maximum age of 15 years
- BMI > 97th percentile of Hernandez references from 1988 (Hernández et al., 1988) as indicated by the Guidelines for Clinical Practice of the Spanish Health System (Grupo de trabajo de la Guía de Práctica Clínica sobre la Prevención y el Tratamiento de la Obesidad Infantojuvenil. Ministerio de Ciencia e Innovación [Spanish Ministry of Sciencee and Innovation], 2009) for the diagnose of the childhood obesity.
Exclusion criteria
- Children with eating disorders
- Families not available to attend to scheduled visits
- Simultaneous participation in another clinical trial
- Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, early puberty or other)
- Lack of command of local languages
Treatment and study plan
Regular practise in primary care
OtherPrimary outcomes
-
Body Mass Index z-score
Time frame: 12 (+3) months
Changes in BMI z-score between the baseline visit and the final assessment
Secondary outcomes
-
Abdominal obesity (waist circumference)
Time frame: 12 (+3) months
Changes in waist circumference (cm) between the baseline visit and the final assessment
-
Abdominal obesity (waist to height)
Time frame: 12 (+3) months
Changes in waist-to-height circumference (ratio) between the baseline visit and the final assessment
-
Body composition: fat mass (kg)
Time frame: 12 (+3) months
Changes in fat mass (kg) between the baseline visit and the final assessment
-
Body composition: lean mass (kg)
Time frame: 12 (+3) months
Changes in lean mass (kg) between the baseline visit and the final assessment
-
Body composition: fat mass index (kg/m2)
Time frame: 12 (+3) months
Changes in fat mass index between the baseline visit and the final assessment
-
Body composition: lean mass index (kg/m2)
Time frame: 12 (+3) months
Changes in lean mass index between the baseline visit and the final assessment
-
HOMA-IR
Time frame: 12 (+3) months
Changes in insulin resistance between the baseline visit and the final assessment
-
Blood Pressure
Time frame: 12 (+3) months
Changes in systolic and diastoli blood pressure (s-score) between the baseline visit and the final assessment
-
Tryglycerides
Time frame: 12 (+3) months
Changes in tryglycerides (mg/dl) between the baseline visit and the final assessment
Sponsors and collaborators
Lead sponsor
Institut Investigacio Sanitaria Pere Virgili
Other
Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Hospital Universitari Joan XXIII de Tarragona.
- Hospital Universitari Sant Joan de Reus
- Institut Català de la Salut
- Instituto de Salud Carlos III
- University Rovira i Virgili
Registry information
Official study title
Clinical and Metabolic Efficacy of the Motivational Approach, Coordinated Between Primary Care and the Clinical Health Services for Childhood Obesity Treatment: Randomized Clinical Trial
Acronym: OBEMAT20
Important dates
- Study start
- 2016
- Primary completion
- 2020
- Study completion
- 2021
- First posted
- Nov 21, 2018
- Registry last updated
- Jun 3, 2024
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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