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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)

Primary Purpose

Childhood Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Life-style intervention
Physical activity only
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Children, Obesity, Lifestyle, LSES, Caries

Eligibility Criteria

48 Months - 84 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kindergardens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle and health promotion

Physical activity only

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Children's weight and Height

Secondary Outcome Measures

Caries rate (DMFT score)

Full Information

First Posted
February 18, 2010
Last Updated
February 18, 2010
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01071551
Brief Title
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
Acronym
NEHLM
Official Title
The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Children, Obesity, Lifestyle, LSES, Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle and health promotion
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical activity only
Arm Type
Active Comparator
Arm Description
Children allocated to this group will attend physical activity classes only.
Intervention Type
Behavioral
Intervention Name(s)
Life-style intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity only
Intervention Description
Children allocated to this group will attend 20 physical activity classes.
Primary Outcome Measure Information:
Title
Children's weight and Height
Time Frame
Baseline, post intervention and at 4 months post intervention termination
Secondary Outcome Measure Information:
Title
Caries rate (DMFT score)
Time Frame
Baseline, post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
84 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalya Bilenko, MD, M.PH
Organizational Affiliation
Ben Gurion Universty of the Negev Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kindergardens
City
Beer-Sheva
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
23620192
Citation
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.
Results Reference
derived

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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

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