Childhood ObesityNEHLMNCT01071551
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
A study testing Life-style intervention and Physical activity only in people with Childhood Obesity, run by Soroka University Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 84 monthsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Life-style intervention and Physical activity only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 84 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality.
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:
Read more
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).
- Conditions
- Childhood Obesity
- Being tested
- Life-style intervention, Physical activity only
- Keywords
- Children, Obesity, Lifestyle, LSES, Caries
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life-style interventionBehavioural
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 onlyBehavioural
Children allocated to this group will attend 20 physical activity classes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Life-style intervention |
| Physical activity only | Active comparator | Children allocated to this group will attend physical activity classes only. Receives: Behavioral: Physical activity only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's weight and Height
Measured: Baseline, post intervention and at 4 months post intervention termination
Secondary outcomes (1)
Caries rate (DMFT score)
Measured: Baseline, post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Natalya Bilenko, MD, M.PH, Principal investigator, Ben Gurion Universty of the Negev Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071551
- Sponsor's protocol ID
- SOR471208CTIL
- Acronym
- NEHLM
- Status last verified
- Nov 2009
- First submitted
- 18 Feb 2010
- Last updated
- 19 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23620192
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality.
- ClinicalTrials.gov ID
- NCT01071551
- Acronym / sponsor ID
- NEHLM / SOR471208CTIL
- Conditions
- Childhood Obesity
- Keywords
- Children, Obesity, Lifestyle, LSES, Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2011 (estimated)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle and health promotion | Experimental | Behavioral: Life-style interventionThe "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 | Active comparator | Behavioral: Physical activity onlyChildren allocated to this group will attend physical activity classes only. |
Who may qualify
- Ages
- 48 to 84 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life-style interventionThe "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. | Behavioural | Lifestyle and health promotion |
| Physical activity onlyChildren allocated to this group will attend 20 physical activity classes. | Behavioural | Physical activity only |
Primary outcome
Children's weight and Height
Time frame: Baseline, post intervention and at 4 months post intervention termination
1 secondary outcome
Caries rate (DMFT score)
Time frame: Baseline, post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2010.
- Derived from this study: PubMed 23620192Kaufman-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalya Bilenko, MD, M.PH principal investigator
Ben Gurion Universty of the Negev Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life-style intervention and Physical activity only in people with Childhood Obesity, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's weight and Height (time frame: Baseline, post intervention and at 4 months post intervention termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01071551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2010.