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Motivational Approach to Treat Childhood Obesity (OBEMAT20)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749200
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
Institut Català de la Salut
Hospital Universitari Joan XXIII de Tarragona.
Hospital Universitari Sant Joan de Reus
Instituto de Salud Carlos III
Jordi Gol i Gurina Foundation
University Rovira i Virgili
Information provided by (Responsible Party):
Ricardo Closa, Institut Investigacio Sanitaria Pere Virgili

Tracking Information
First Submitted Date  ICMJE October 8, 2018
First Posted Date  ICMJE November 21, 2018
Last Update Posted Date November 21, 2018
Actual Study Start Date  ICMJE January 1, 2016
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
Body Mass Index z-score [ Time Frame: 12 (+3) months ]
Changes in BMI z-score between the baseline visit and the final assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Motivational Approach to Treat Childhood Obesity
Official Title  ICMJE Clinical and Metabolic Efficacy of the Motivational Approach, Coordinated Between Primary Care and the Clinical Health Services for Childhood Obesity Treatment: Randomized Clinical Trial
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized clustered clinical trial, with treatment on obese children in 2 arms: a control group (CG) that will follow the usual recommendations of pediatricians and nurses in the primary care centres and an intervention group (IG) that will receive a structured motivation-based interview combined with group therapy and eHealth. the treatment of the two arms will last 12 (+3) months
Masking: None (Open Label)
Masking Description:
Given the nature of the intervention participants or researchers could not be blinded.
Primary Purpose: Treatment
Condition  ICMJE
  • Childhood Obesity
  • Metabolic Syndrome
  • Body Composition
Intervention  ICMJE
  • Other: Obemat2.0 therapy
  • Other: Regular practise in primary care
Study Arms  ICMJE
  • Experimental: Obemat2.0 Intervention Group
    Intervention: Obemat2.0 therapy (11 Motivational Interview Visits, 3 Workshops) Duration: 12 months (+3 months). Setting: Primary care centers Providers: pediatritians and nurses trained to perform motivational interview Visits description: The interviews follow a structure: 1. Checking the accomplishment of objectives to congratulate and motivate the patient. 2. A specific topic per visit is explained to the participant and family. 3. A task related to the topic (i.e. to plan a weekly menu for the family) is given to be brought back at the next visit. 4th. Objectives about diet, weight and physical activity are defined to be accomplished until the next visit. The follow-up of the structure is ensured by means of a printed material that the therapists provide each visit to participants.
    Intervention: Other: Obemat2.0 therapy
  • Active Comparator: Control Group
    Control Intervention: regular practise in primary care (11 individual monthly visits) Duration: 12 months (+3 months). Setting: Primary care centers. Providers: standard pediatritians and nurses Children and their families receive the usual recommendations conducted in primary care centers based on the Clinical Practice Guidelines on the Prevention and Treatment of Child and Adolescent Obesity. At visits, the family receive explanations about carrying out a balanced diet, divided into 5 meals, to provide a moderate energy reduction from the previous intake. An increase in physical activity, both in terms of leisure activity, as sports regular practise is recommended. Monthly visits are organized in which weight and height are measured and compliance with advice is reviewed.
    Intervention: Other: Regular practise in primary care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 20, 2018)
319
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03749200
Other Study ID Numbers  ICMJE PI15/00970
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ricardo Closa, Institut Investigacio Sanitaria Pere Virgili
Study Sponsor  ICMJE Institut Investigacio Sanitaria Pere Virgili
Collaborators  ICMJE
  • Institut Català de la Salut
  • Hospital Universitari Joan XXIII de Tarragona.
  • Hospital Universitari Sant Joan de Reus
  • Instituto de Salud Carlos III
  • Jordi Gol i Gurina Foundation
  • University Rovira i Virgili
Investigators  ICMJE Not Provided
PRS Account Institut Investigacio Sanitaria Pere Virgili
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP