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

This study is currently recruiting participants.
Verified June 2013 by Jordi Gol i Gurina Foundation
Sponsor:
Collaborators:
Associació NEREU
INEFC- Lleida
USR-ICS. Atenció Primària Lleida
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01878994
First received: June 11, 2013
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Overweight
Obesity
Children
Behavioral: Counselling group
Behavioral: Nereu group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Change from Baseline in Body mass index z score (BMIz) [ Time Frame: 4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention ] [ Designated as safety issue: No ]
    Weight is measured to the nearest of 0.1 kg using an electronic scale and height (Ht) to the nearest of 0.1 cm with a stadiometer, in lightly dressed and without shoes. The BMIz is calculated according z score of BMI adjusted by age and gender (IOTF).


Secondary Outcome Measures:
  • Change from baseline in Physical activity habits [ Time Frame: 4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention ] [ Designated as safety issue: No ]
    To measure physical activity will be used an Actigraph accelerometers (GT3X+ models), it will be wear by participants during all day for seven consecutive days.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Counselling Group
Each family will receive a single monthly meeting, a total of 8 with 10 minutes duration each one. The sessions will take place in the consultation of the paediatrician and it will be delivered by the child's nurse or/and paediatrician. The sessions' contents are about promotion of healthy eating and physical activity habits.
Behavioral: Counselling group
Experimental: Nereu Group
The Nereu treatment program is an intensive family-based behavioural multi-component lifestyle intervention. Consist in an intensive treatment of 8 months duration (from October to May, that is, an academic year). The intervention is a multidisciplinary intervention consisting in 4 structured components: (a) physical activity training for children, (b) family theoretical and practical sessions for parents, (c) behaviour strategies, that involves both parental and child participation (d) weekend extra activities.
Behavioral: Nereu group

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children aged between 6 to 12 years old
  • Overweight or obese according to the IOTF criteria

Exclusion Criteria:

  • Medical co-morbidities: Diabetes mellitus or hypercholesterolemia or cardiovascular disease that could be contraindicate the sport practice.
  • Use of medication that might have an effect on weight loss.
  • previous enrolment in another similar treatment program based on reducing obesity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01878994

Contacts
Contact: Conepció Teixidó, Phd cteixido.lleida.ics@gencat.cat
Contact: Noemí Serra, Mrs nserra@inefc.es

Locations
Spain
USR- Lleida. Atenció primaria. IDIAP Jordi Gol Recruiting
Lleida, Spain, 25001
Contact: Conxita Teixidó, Dra       cteixido.lleida.ics@gencat.cat   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Associació NEREU
INEFC- Lleida
USR-ICS. Atenció Primària Lleida
Investigators
Principal Investigator: Noemí Serra INEFC-LLEIDA, University of Lleida
Principal Investigator: Concepció Teixidó Institut Català de la Salut - Atenció primaria - Lleida
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01878994     History of Changes
Other Study ID Numbers: PI12/02220
Study First Received: June 11, 2013
Last Updated: June 13, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Jordi Gol i Gurina Foundation:
Overweight
Obesity
Children
Behaviour
Physical Activity
Nutrition

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

ClinicalTrials.gov processed this record on April 15, 2014