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

Childhood Obesity Clinical Trial

— NEHLM  

Official title:

The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01071551
• Other study ID #: SOR471208CTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: February 18, 2010
• Last updated: February 18, 2010
• Start date: September 2008
• Est. completion date: September 2011

Study information

• Verified date: November 2009
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 258
• Est. completion date: September 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 48 Months to 84 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

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.
• Physical activity only
Children allocated to this group will attend 20 physical activity classes.

Locations

Country	Name	City	State
Israel	Kindergardens	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's weight and Height		Baseline, post intervention and at 4 months post intervention termination	No
Secondary	Caries rate (DMFT score)		Baseline, post intervention	No