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

Obesity Clinical Trial

— NEREU  

Official title:

Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01878994
• Other study ID #: PI12/02220
• Status: Recruiting
• Phase: Phase 4
• First received: June 11, 2013
• Last updated: June 13, 2013
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2013
• Source: Jordi Gol i Gurina Foundation
• Contact: Conepció Teixidó, Phd
• Email: cteixido.lleida.ics[@]gencat.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Children
• Obesity
• Overweight

Intervention

Behavioral:
• Counselling group

• Nereu group

Locations

Country	Name	City	State
Spain	USR- Lleida. Atenció primaria. IDIAP Jordi Gol	Lleida

Sponsors (4)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Associació NEREU, INEFC- Lleida, USR-ICS. Atenció Primària Lleida

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Body mass index z score (BMIz)	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).	4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention	No
Secondary	Change from baseline in Physical activity habits	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.	4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention	No