Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children

NCT01878994 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-06-17

No results posted yet for this study

Summary

Objectives: To evaluate the effectiveness of the Nereu program compared to standard care (advice on increased physical activity and nutrition) such as a health intervention tool for the childhood obesity management

Methods/Design: The study design is a randomized controlled multicenter clinical trial using two types of treatment. Population and sample: Children 6 to 12 years with overweight or obesity, according to the z score of body mass index (BMI z) \>= 1 for age and gender defined by International Obesity Task Force (IOTF). It is considered necessary to recruit 100 children: 50 control group (CG) and 50 Intervention (IG). Study Intervention: Nereu Group: 8 month intervention with 3 weekly training sessions doing physical exercise for children and a weekly session for parents of physical activity and healthy eating habits and behaviour strategies, that involves both parental and child participation. The control group will receive a monthly session of healthy physical and eating habits. Main Outcome Measures: Improvement of BMI z, physical activity and nutrition habits, behaviour components and quality life related to health at the end, 6 and 12 months after intervention.

Conditions

Interventions

BEHAVIORAL

Counselling group

BEHAVIORAL

Nereu group

Sponsors & Collaborators

  • Associació NEREU

    collaborator UNKNOWN
  • INEFC-Lleida

    collaborator OTHER
  • USR-ICS. Atenció Primària Lleida

    collaborator UNKNOWN
  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • Noemí Serra · INEFC-LLEIDA, University of Lleida

  • Concepció Teixidó · Institut Català de la Salut - Atenció primaria - Lleida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-06-30
Completion
2015-12-31

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01878994 on ClinicalTrials.gov