The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality, Physical Activity and Dental Health Among Children From Socioeconomically Disadvantaged Families in Beer Sheva (NEHLM)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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).

Condition or disease	Intervention/treatment	Phase
Childhood Obesity	Behavioral: Life-style intervention; Behavioral: Physical activity only	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	258 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality.
Study Start Date :	September 2008
Actual Primary Completion Date :	December 2009
Estimated Study Completion Date :	September 2011

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Lifestyle and health promotion; 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.	Behavioral: 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: Physical activity only; Children allocated to this group will attend physical activity classes only.	Behavioral: Physical activity only; Children allocated to this group will attend 20 physical activity classes.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Children's weight and Height [ Time Frame: Baseline, post intervention and at 4 months post intervention termination ]

Secondary Outcome Measures :

1. Caries rate (DMFT score) [ Time Frame: Baseline, post intervention ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	48 Months to 84 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Israel
Kindergardens
Beer-Sheva, Israel

Sponsors and Collaborators

Soroka University Medical Center

Investigators

Principal Investigator:	Natalya Bilenko, MD, M.PH	Ben Gurion Universty of the Negev Israel

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kaufman-Shriqui V, Werbeloff N, Faroy M, Meiri G, Shahar DR, Fraser D, Novack Y, Bilenko N, Vardi H, Elhadad N, Pietrzak RH, Harpaz-Rotem I. Posttraumatic stress disorder among preschoolers exposed to ongoing missile attacks in the Gaza war. Depress Anxiety. 2013 May;30(5):425-31. doi: 10.1002/da.22121.

Responsible Party:	Natalya Bilenko, Ben-Gurion University of the Negev Israel
ClinicalTrials.gov Identifier:	NCT01071551 History of Changes
Other Study ID Numbers:	SOR471208CTIL
First Posted:	February 19, 2010
Last Update Posted:	February 19, 2010
Last Verified:	November 2009

Keywords provided by Soroka University Medical Center:

Children; Obesity; Lifestyle; LSES; Caries

Additional relevant MeSH terms:

Pediatric Obesity; Obesity; Overnutrition; Nutrition Disorders	Overweight; Body Weight; Signs and Symptoms