Motivation Approach for Childhood Obesity Treatment

NCT02889406 | Unknown

• 1 other identifier: PI15/01411
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in BMI z-score

  Changes in BMI z-score between the first visit and 12 months

  12 months

Study Arms (2)

Motivational intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Motivational intervention BEHAVIORAL

motivational interviewing schema

Motivational intervention

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• University Rovira i Virgili: collaborator

Study Sites (1)

Unitat Suport a la Recerca (Tarragona-Reus) Idiap Jordi Gol

Reus, Tarragona, 43202, Spain

Location

Related Publications (1)

• Luque V, Feliu A, Escribano J, Ferre N, Flores G, Monne R, Gutierrez-Marin D, Guillen N, Munoz-Hernando J, Zaragoza-Jordana M, Gispert-Llaurado M, Rubio-Torrents C, Nunez-Roig M, Alcazar M, Ferre R, Basora JM, Hsu P, Alegret-Basora C, Arasa F, Venables M, Singh P, Closa-Monasterolo R. The Obemat2.0 Study: A Clinical Trial of a Motivational Intervention for Childhood Obesity Treatment. Nutrients. 2019 Feb 16;11(2):419. doi: 10.3390/nu11020419.

  PMID: 30781525 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Josep Basora, MD

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  STUDY DIRECTOR

Central Study Contacts

Josep Basora, MD

CONTACT

+34977778515; jbasora.tarte.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: September 5, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2019
• Last Updated: September 5, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)