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

Phase 4

• Conditions: Overweight; Obesity; Children

• Registration Number: NCT01878994
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-06
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-13
• Last Update Submitted: 2013-06-13
• Study First Posted: 2013-06-17
• Last Update Posted: 2013-06-17
• Primary Completion: 2014-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Body mass index z score (BMIz)	4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention	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

Name	Time	Method
Change from baseline in Physical activity habits	4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention	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.

Trial Locations

Locations (1)

USR- Lleida. Atenció primaria. IDIAP Jordi Gol; 🇪🇸 Lleida, Spain