Overview

This trial is active, not recruiting.

Condition childhood obesity
Treatments life-style intervention, physical activity only
Sponsor Soroka University Medical Center
Start date September 2008
End date December 2009
Trial size 258 participants
Trial identifier NCT01071551, SOR471208CTIL

Summary

Childhood socioeconomic status (SES) is related to poor physical health, obesity, elevated cardiovascular risk factors and iron deficiency anemia. We plan to offer a comprehensive framework allowing the "Nutrition Enrichment and Healthy Living Model" (NEHLM) among a low SES Kindergarten children. The model offered is designed to take into account the current economic status of the child's family. We shall conduct a randomized controlled trial to assess the efficacy of the intervention.

Our main objective:

To compare the influence of the intervention on changes in food consumption, physical activity and ,and caries rates in the children in kindergartens where it is applied versus the control kindergartens.

The research hypothesis:

Integrative Nutrition Enrichment and Healthy Living Model (NEHLM) will improve health behaviors among children and parents in comparison to control intervention (physical activity only).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
The "Nutrition Enrichment and Healthy Living Model" (NEHLM) is an Integrative model covering variety of lifestyle issues such as nutrition, dental care, and physical activity. The model will be applied to kindergartens and a sample of their parents. Children participating will be given 10 lessons in nutrition, 5 lessons in dental-care and 20 physical activity lessons. Parents for children in this group will be given 2 nutrition-education meetings and a meeting with a dental clinician.2 additional meetings will be held for parents and children together, one in nutrition and one in dental-care.
life-style intervention
The "Nutrition Enrichment and Healthy Living Model" (NEHLM) is an Integrative model covering variety of lifestyle issues such as nutrition, dental care, and physical activity. The model will be applied to kindergartens and a sample of their parents. Children participating will be given 10 lessons in nutrition, 5 lessons in dental-care and 20 physical activity lessons. Parents for children in this group will be given 2 nutrition-education meetings and a meeting with a dental clinician.2 additional meetings will be held for parents and children together, one in nutrition and one in dental-care.
(Active Comparator)
Children allocated to this group will attend physical activity classes only.
physical activity only
Children allocated to this group will attend 20 physical activity classes.

Primary Outcomes

Measure
Children's weight and Height
time frame: Baseline, post intervention and at 4 months post intervention termination

Secondary Outcomes

Measure
Caries rate (DMFT score)
time frame: Baseline, post intervention

Eligibility Criteria

Male or female participants from 48 months up to 84 months old.

Inclusion Criteria: - Kindergarten children aged 4-7 Children from kindergartens defined as Low- SES population (by local municipality) - Children whose parents agree to participate in the research Exclusion Criteria: - Children who suffer from any chronic disease - Children who suffer from developmental problems - Children who participate in a weight reduction treatment or program - Children or parents who have any psychiatric problem or diagnosis

Additional Information

Official title The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality.
Principal investigator Natalya Bilenko, MD, M.PH
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Soroka University Medical Center.