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

This study is currently recruiting participants. (see Contacts and Locations)
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

June 11, 2013
June 13, 2013
January 2013
June 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01878994 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children
Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Overweight
  • Obesity
  • Children
  • Behavioral: Counselling group
  • Behavioral: Nereu group
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Nereu group
Serra-Paya N, Ensenyat A, Real J, Castro-Viñuales I, Zapata A, Galindo G, Solé-Mir E, Bosch-Muñoz J, Mur JM, Teixidó C. Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol. BMC Public Health. 2013 Oct 23;13:1000. doi: 10.1186/1471-2458-13-1000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2015
June 2014   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
Yes
Contact: Conepció Teixidó, Phd cteixido.lleida.ics@gencat.cat
Contact: Noemí Serra, Mrs nserra@inefc.es
Spain
 
NCT01878994
PI12/02220
No
Jordi Gol i Gurina Foundation
Jordi Gol i Gurina Foundation
  • Associació NEREU
  • INEFC- Lleida
  • USR-ICS. Atenció Primària Lleida
Principal Investigator: Noemí Serra INEFC-LLEIDA, University of Lleida
Principal Investigator: Concepció Teixidó Institut Català de la Salut - Atenció primaria - Lleida
Jordi Gol i Gurina Foundation
June 2013

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