Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children (4055obesityprv)

Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.Patients will be randomly allocated into one of two behavior intervention groups or control group in ratio of 1:1:1.The study will consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in al 3 groups) at months 0, 3, 12 and 24.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Parent's group; Behavioral: Parents and children group

Detailed Description

Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.

Objectives:

1. To develop an intervention program for obesity prevention in children aged 5-10 years old, who are at risk to develop obesity
2. To compare between the efficacy of two different intervention programs and a control group in preventing obesity in the short and the long term.
3. To evaluate the role and significance of including parents in an intervention program for obesity prevention.
4. To identify demographic parameters, lifestyle characteristic and biochemical markers that predict the risk of developing obesity and the response for treatment.

Randomization:

Patients will be randomly allocated into one of two intervention groups or control group in ratio of 1:1:1. Each group will contain 12-15 participants.

Intervention groups:

1. parent's group- only parents will take part at the intervention program.
2. Parents and children group- both children and parents will take part at the intervention program, in two separate sessions.

Methods:

1. The study will be consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in all 3 groups) at months 0, 3, 12 and 24.
2. Height, weight, fat mass and waist circumference will be measured at 0, 3, 12 and 24 month. Height and weight of parents will also be measured at these visits.
3. Physical examination will be performed at 0, 3, 12 and 24 month.
4. Psychological and nutritional questionnaire (depression, quality of life and self estimation) will be filled at 0, 3, 12 and 24 month.
5. Fasting blood tests for: chemistry, hematology, lipids, glucose, insulin, TSH, adiponectin, IL-6 and TNFα will be performed at 0, 3, 12 and 24 month.

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel, 49202
    • Schneider Children Medical Center of Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children aged 5-10 years old
• BMI in 85-98 percentile
• Both parents signing informed consent form

Exclusion Criteria:

• Chronic disease or chronic use of medication
• Incapability to perform all study procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parent's group; 3 months workshop of parents intervention, guided by dietician and phycologist	Behavioral: Parent's group; 3 months workshop of parents intervention, guided by dietician and phycologist
Experimental: Parents and children group; 3 months workshops of parents and children intervention, guided by dietician and phycologist	Behavioral: Parents and children group; 3 months workshops of parents and children intervention, guided by dietician and phycologist
No Intervention: Control group; control group, no intervention, medical follow up only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BMI	24 month

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Pfizer
• Investigators: Principal Investigator: Moshe Phillip, Prof, MD, Schneider Children Medical Center; Principal Investigator: Joseph Meyerovitch, Dr, MD, Schneider Children Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 21, 2007
• First Submitted That Met QC Criteria: February 21, 2007
• First Posted (Estimate): February 22, 2007

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 18, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: obesity,prevention,pediatric
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: rmc004055ctil