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

NCT ID: NCT01071551

Last Updated: 2010-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Life-style intervention

Intervention Type BEHAVIORAL

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 physical activity classes only.

Group Type ACTIVE_COMPARATOR

Physical activity only

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Physical activity only

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

48 Months

Maximum Eligible Age

84 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ben-Gurion University of the Negev Israel

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Natalya Bilenko, MD, M.PH

Role: PRINCIPAL_INVESTIGATOR

Ben Gurion Universty of the Negev Israel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kindergardens

Beersheba, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23620192 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SOR471208CTIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Examining the Impact of Behavior Change Intervention
NCT06408844 ENROLLING_BY_INVITATION NA
MoST-Influenced Behavioral Intervention for Walking
NCT05425641 ACTIVE_NOT_RECRUITING PHASE2
Physical Activity Intervention
NCT07029685 NOT_YET_RECRUITING NA