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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014