NCT01071551

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 19, 2010

Status Verified

November 1, 2009

Enrollment Period

1.2 years

First QC Date

February 18, 2010

Last Update Submit

February 18, 2010

Conditions

Keywords

ChildrenObesityLifestyleLSESCaries

Outcome Measures

Primary Outcomes (1)

  • Children's weight and Height

    Baseline, post intervention and at 4 months post intervention termination

Secondary Outcomes (1)

  • Caries rate (DMFT score)

    Baseline, post intervention

Study Arms (2)

Lifestyle and health promotion

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.

Behavioral: Life-style intervention

Physical activity only

ACTIVE COMPARATOR

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

Behavioral: Physical activity only

Interventions

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.

Lifestyle and health promotion

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

Physical activity only

Eligibility Criteria

Age48 Months - 84 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kindergardens

Beersheba, Israel

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Natalya Bilenko, MD, M.PH

    Ben Gurion Universty of the Negev Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

September 1, 2008

Primary Completion

December 1, 2009

Study Completion

September 1, 2011

Last Updated

February 19, 2010

Record last verified: 2009-11

Locations