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Motivation Approach for Childhood Obesity Treatment (OBEMAT)

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ClinicalTrials.gov Identifier: NCT02889406
Recruitment Status : Not yet recruiting
First Posted : September 5, 2016
Last Update Posted : September 5, 2016
Sponsor:
Collaborator:
University Rovira i Virgili
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief Summary:

In a recent study, we 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 cheap cooking methods that would be useful specially in low income families (with a higher prevalence of childhood obesity).

The aim of this study is assessing the clinical and metabolic efficacy of a family intervention, coordinated between the clinical and primary care services from the Tarragona health-care region, using a motivational therapy at individual and group levels, which involves e-Health tools (wearable), focusing on families with an 8 to 13 years old obese child.

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.


Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Motivational intervention Not Applicable

Detailed Description:

MAIN OBJECTIVE To evaluate the effectiveness of a motivational intervention for the treatment of childhood obesity, coordinated between primary care and specialized services, multicomponent, integrating techniques of fast and healthy cooking and eHealth tools (wearable), compared to the usual intervention performed in paediatrics.

SPECIFIC OBJECTIVES

  1. To evaluate the effectiveness of a multicomponent motivational intervention compared to usual intervention performed in regular paediatrics clinical practice

    1. On BMI control of obese children between 8 and 13 years old
    2. On metabolic control of obese children between 8 and 13 years old,
    3. On increasing physical activity of obese children between 8 and 13 years old,
    4. On acquiring a healthy eating pattern in obese children between 8 and 13 years old.
  2. To establish methodological background for implantation of a motivational intervention coordinated between primary care services and specialized services.
  3. To validate the use of bioelectrical impedance analysis (BIA) and dual X-ray absorptiometry (DXA) in the follow up and treatment of childhood obesity compared to four-compartment model of body composition.

5. METHODOLOGY

5.1 Design Randomized controlled clinical trial cluster, with an intervention group (IG) which will receive 12 months of motivational counselling, together with workshops focused on family nutrition education and techniques of fast and healthy cooking and physical activity; and with eHealth tools (wearable) to support; and a control group (CG) that will follow the usual recommendations.

5.2 STUDY POPULATION The Health Region of Tarragona includes a population of 600,000 people (36,000 children from 8 to 13 years). With regard to the 6.6% of childhood obesity prevalence in our country (Schroder 2014), we estimate an eligible population of 2376 obese children aged 8-13 years old.

5.3 SAMPLE SIZE The number of individuals of a simple random design, multiplied by the design effect has been considered to calculate the sample size of each stratum (Basic Care Unit). Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 98 subjects were needed in each group to detect a difference equal to or greater than 0.36 units of BMI z-score. It is assumed that common standard deviation is 0.75. A 30% lost to follow up rate (GRANMO 7.12) has been estimated. To calculate the design effect, estimates of intracluster correlation coefficient in cluster randomized trials in primary care are generally lower than 0.05. The effect of the design corresponds to 1.7. Assuming these values, the final size of the study sample would be of 167 subjects in each group (12 individuals for each primary care centre, in 15 basic care units (BCUs)).

5.4 RANDOMIZATION AND BLINDING Basic Care Units (BCU) doctor-nurse are the unit of randomization. Randomization will be 1: 1 and will be made with EPIDAT 3.0 statistical program. Given the nature of the intervention participants or researchers cannot be blinded. Professional in charge of statistical analysis will be blinded as well.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Motivational intervention

Following the motivational interviewing schema, structured in 2 phases of treatment (motivational and intervention) and organised in 11 visits (one each month). The first and last visits will be performed in consultations of endocrinology unit from referral hospitals; the other visits will be held in paediatric primary care setting. Visits will be scheduled monthly and each one will last between 15 and 20 minutes.

In addition to individualized visits, three group workshops focused in nutrition education for families will be organized. Each workshop will last 45 minutes and will target parents/mothers and obese children, separately.

Behavioral: Motivational intervention
motivational interviewing schema

No Intervention: Control group
Children who are assigned to the control group will follow the usual treatment performed in paediatrics, what is following the Clinical Practice Guideline on the prevention and treatment of child and adolescent obesity. Monthly visits will be conducted in which weight, height and waist circumference will be measured and compliance with the initial advice will be reviewed.



Primary Outcome Measures :
  1. Changes in BMI z-score [ Time Frame: 12 months ]
    Changes in BMI z-score between the first visit and 12 months



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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese patients which are between 8 and 13 years at enrolment, using as diagnostic criteria of obesity values of body mass index (BMI) above the 97th percentile of Hernandez references from 1988

Exclusion Criteria:

  • Participants who do not sign the informed consent
  • Children with eating disorders
  • Families not available to attend to intervention scheduled visits
  • Simultaneous participation in another randomized trial
  • Presence of endocrine disorders (GH disorder, hypothyroidism, Cushing's disease, precocious puberty or other)
  • Illiteracy or lack knowledge of local languages

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889406


Contacts
Contact: Josep Basora, MD +34977778515 jbasora.tarte.ics@gencat.cat

Locations
Spain
Unitat Suport a la Recerca (Tarragona-Reus) Idiap Jordi Gol
Reus, Tarragona, Spain, 43202
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
University Rovira i Virgili
Investigators
Study Director: Josep Basora, MD IDIAP Jordi Gol

Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT02889406     History of Changes
Other Study ID Numbers: PI15/01411
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms