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)
Recruitment status was: Active, not recruiting
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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: None (Open Label) Primary Purpose: Prevention |
| Official Title: | The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality. |
- Children's weight and Height [ Time Frame: Baseline, post intervention and at 4 months post intervention termination ]
- Caries rate (DMFT score) [ Time Frame: Baseline, post intervention ]
| 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.
|
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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
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| Ages Eligible for Study: | 48 Months to 84 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071551
| Israel | |
| Kindergardens | |
| Beer-Sheva, Israel | |
| Principal Investigator: | Natalya Bilenko, MD, M.PH | Ben Gurion Universty of the Negev Israel |
More Information
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 |
| First Submitted: | February 18, 2010 |
| 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 |