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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status and phase: Unknown; Phase 4

Conditions: Overweight; Children; Obesity

Treatments: Behavioral: Nereu group; Behavioral: Counselling group

Study type: Interventional

Funder types: Other

Identifiers

NCT01878994

PI12/02220

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Counselling Group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Counselling group

Nereu Group

Experimental group

Description:

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.

Treatment:

Behavioral: Nereu group