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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Soroka University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01071551
First received: February 18, 2010
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention
Childhood Obesity
Behavioral: Life-style intervention
Behavioral: Physical activity only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality.

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Children's weight and Height [ Time Frame: Baseline, post intervention and at 4 months post intervention termination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Caries rate (DMFT score) [ Time Frame: Baseline, post intervention ] [ Designated as safety issue: No ]

Enrollment: 258
Study Start Date: September 2008
Estimated Study Completion Date: September 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   48 Months to 84 Months
Genders Eligible for Study:   Both
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
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: NCT01071551

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

No publications provided by Soroka University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Natalya Bilenko, Ben-Gurion University of the Negev Israel
ClinicalTrials.gov Identifier: NCT01071551     History of Changes
Other Study ID Numbers: SOR471208CTIL
Study First Received: February 18, 2010
Last Updated: February 18, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
Children
Obesity
Lifestyle
LSES
Caries

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

ClinicalTrials.gov processed this record on October 19, 2014