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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00438555
First received: February 21, 2007
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Parents and children group
Behavioral: Parent's group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • BMI [ Time Frame: 24 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: October 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00438555

Locations
Israel
schneider children medical center of Israel
Petach Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Pfizer
Investigators
Principal Investigator: Moshe Phillip, Prof, MD Schneider Children Medical Center
Principal Investigator: Joseph Meyerovitch, Dr, MD Schneider Children Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00438555     History of Changes
Other Study ID Numbers: rmc004055ctil
Study First Received: February 21, 2007
Last Updated: July 29, 2014
Health Authority: Israel:Clalit Health Services

Keywords provided by Rabin Medical Center:
obesity,prevention,pediatric

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014