Childhood ObesityNCT00995267
Eating Habits and Obesity in First and Second Grade School Children
A study testing parent-child interaction/activities based on Adler's methods in people with Childhood Obesity, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Purpose: In the framework of a randomized concurrent controlled trial, to assess the effectiveness of a feasible educational mechanism based on the principles of Alfred Adler, that focuses on the family, to improve the dietary habits of schoolchildren, to induce them to increase their physical activity, and to prevent… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- parent-child interaction/activities based on Adler's methods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2008to Feb 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children in regular first grade classes in 4 schools whose parents provided informed consent
Who cannot join
- Schools with separate classes for boys and girls, and schools/classes for children with special needs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the Family as Agents of Change on Eating Habits and Obesity in First and Second Grade School Children in Israel.
Purpose: In the framework of a randomized concurrent controlled trial, to assess the effectiveness of a feasible educational mechanism based on the principles of Alfred Adler, that focuses on the family, to improve the dietary habits of schoolchildren, to induce them to increase their physical activity, and to prevent obesity and diseases related to obesity. Primary Objectives for Children: 1.To increase intake of fruits and vegetables, to reduce intake of sweets and unhealthy snacks at home and in school, to increase exercise and to reduce sedentary activities. Primary Objective for the Parents: Increase the involvement of parents in the education of their children regarding nutrition.
Description: Study population: Approximately 600 students and 600 parents from 24 first grade classes in 4 schools. Schools are randomized into intervention and control groups. The intervention comprises a 5-session parental workshop and 5 joint parent-child school-based activities. The control group will be offered the intervention after conclusion of the trial.
Read more
Participants are recruited in first grade, anthropometrics are measured, and pupils and parents are interviewed on eating habits and exercise. Snacks are observed. The intervention takes place in the second grade, and outcome assessment is done at the end of the 2nd grade and beginning of the 3rd grade. In-depth interviews will be conducted with parents of obese children.
Significance: Most interventions geared to prevention of childhood obesity have failed dismally. A new approach that focuses on the parent-child interaction may be contributory.
Read the detailed description
Of the 743 children in 23 2nd grade classes in 4 schools, parents provided informed consent for 508 (68%), and again for 432 (58%) at the 3rd grade follow-up.
First stage of Recruiting 2007-2008: 3 first grade in each of 4 schools participating in the study. Total 12 classes. After the recruitment, initial data collection was conducted.
2008-2009: Allocation of students in 2nd grade from cycle 1 to intervention and control groups. Intervention in the experimental group. Data collection at the beginning and end of second grade. Recruiting new first grade classes (cycle 2), Primary data collection was conducted.
2009-2010: Completion of the follow-up cycle I. Last data collection at the beginning of the third grade. Allocation students 2nd grade from cycle 2 for intervention or control groups. Intervention in the experimental group of cycle 2. Data collection at the beginning and end of the second grade.
2010-2011: End of follow-up cycle 2. Collect data at the beginning of the third grade.
Description of the Intervention:
- 5 joint parent-child classroom activities on the subject of nutrition, undertaken separately in the 12 intervention classes of the 4 clusters (ie. 60 sessions).
- 5 workshops based on the approach of Adler that were restricted to parents, undertaken separately in the evenings for the 12 intervention classes (ie 60 sessions).
The control group (11 classes) had no intervention, but was identically monitored from first through third grade.
- Conditions
- Childhood Obesity
- Being tested
- parent-child interaction/activities based on Adler's methods
- Keywords
- childhood obesity, nutrition, exercise, Alfred Adler, schoolchildren, intervention study, community-based trial, parent-child interaction, nutritional behaviors
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parent-child interaction/activities based on Adler's methodsBehavioural
Description of the Intervention:
5 joint classroom activities (parents and children together, involving children in food choices/food preparation-sense of belonging/decision making): 1. Healthy breakfasts and 10 o'clock snacks 2. Fats and oils in the diet, cooking methods, setting limits to oily food intake. 3. Fruit and vegetables in the daily diet, adults as role models. 4. Learning about food categories \& pyramid, healthy eating and growth. 5. Limiting consumption of sweets and snacks.
Workshop for Parents: Explaining nutritional needs of children; how to encourage good eating habits, how to deal with children's manipulations, providing tools to elicit change; use of food to attract parental attention; practical tools to deal with their children's eating habits/obesity/refusal to eat/chronic health problems/failure to grow; ways to prevent use of food as an answer to childhood frustrations.
| Study group | Role | What they receive |
|---|---|---|
| behavioral intervention | Experimental | Behavioral intervention arm comprises 5 joint parent-child school-based nutritional activities in which nutritional information was combined with Adler's behavioral concepts. and a 5-session parental workshop. Receives: Behavioral: parent-child interaction/activities based on Adler's methods |
| control arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: change in intake of fruits, vegetables, sweets and unhealthy snacks at home, and exercise (questionnaire-based); and observed intake in school snacks
Measured: first grade to third grade
Secondary outcomes (1)
change in BMI and waist circumference
Measured: first grade to third grade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tori Goldstein, MSC, Principal investigator, Hebew University Faculty of MedicineJeremy D Kark, MD PhD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995267
- Sponsor's protocol ID
- LBoo1-HMO-CTIL
- Status last verified
- Oct 2009
- First submitted
- 14 Oct 2009
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Family as Agents of Change on Eating Habits and Obesity in First and Second Grade School Children in Israel.
- ClinicalTrials.gov ID
- NCT00995267
- Acronym / sponsor ID
- LBoo1-HMO-CTIL
- Conditions
- Childhood Obesity
- Keywords
- childhood obesity, nutrition, exercise, Alfred Adler, schoolchildren, intervention study, community-based trial, parent-child interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Oct 2009 (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.
Purpose: In the framework of a randomized concurrent controlled trial, to assess the effectiveness of a feasible educational mechanism based on the principles of Alfred Adler, that focuses on the family, to improve the dietary habits of schoolchildren, to induce them to increase their physical activity, and to prevent obesity and diseases related to obesity. Primary Objectives for Children: 1.To increase intake of fruits and vegetables, to reduce intake of sweets and unhealthy snacks at home and in school, to increase exercise and to reduce sedentary activities. Primary Objective for the Parents: Increase the involvement of parents in the education of their children regarding nutrition.
Description: Study population: Approximately 600 students and 600 parents from 24 first grade classes in 4 schools. Schools are randomized into intervention and control groups. The intervention comprises a 5-session parental workshop and 5 joint parent-child school-based activities. The control group will be offered the intervention after conclusion of the trial.
Participants are recruited in first grade, anthropometrics are measured, and pupils and parents are interviewed on eating habits and exercise. Snacks are observed. The intervention takes place in the second grade, and outcome assessment is done at the end of the 2nd grade and beginning of the 3rd grade. In-depth interviews will be conducted with parents of obese children.
Significance: Most interventions geared to prevention of childhood obesity have failed dismally. A new approach that focuses on the parent-child interaction may be contributory.
Detailed description
Of the 743 children in 23 2nd grade classes in 4 schools, parents provided informed consent for 508 (68%), and again for 432 (58%) at the 3rd grade follow-up.
First stage of Recruiting 2007-2008: 3 first grade in each of 4 schools participating in the study. Total 12 classes. After the recruitment, initial data collection was conducted.
2008-2009: Allocation of students in 2nd grade from cycle 1 to intervention and control groups. Intervention in the experimental group. Data collection at the beginning and end of second grade. Recruiting new first grade classes (cycle 2), Primary data collection was conducted.
2009-2010: Completion of the follow-up cycle I. Last data collection at the beginning of the third grade. Allocation students 2nd grade from cycle 2 for intervention or control groups. Intervention in the experimental group of cycle 2. Data collection at the beginning and end of the second grade.
2010-2011: End of follow-up cycle 2. Collect data at the beginning of the third grade.
Description of the Intervention:
- 5 joint parent-child classroom activities on the subject of nutrition, undertaken separately in the 12 intervention classes of the 4 clusters (ie. 60 sessions).
- 5 workshops based on the approach of Adler that were restricted to parents, undertaken separately in the evenings for the 12 intervention classes (ie 60 sessions).
The control group (11 classes) had no intervention, but was identically monitored from first through third grade.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behavioral intervention | Experimental | Behavioral: parent-child interaction/activities based on Adler's methodsBehavioral intervention arm comprises 5 joint parent-child school-based nutritional activities in which nutritional information was combined with Adler's behavioral concepts. and a 5-session parental workshop. |
| control arm | No intervention | – |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children in regular first grade classes in 4 schools whose parents provided informed consent
Key exclusion criteria (1 listed)
- Schools with separate classes for boys and girls, and schools/classes for children with special needs
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 |
|---|---|---|
| parent-child interaction/activities based on Adler's methodsDescription of the Intervention: 5 joint classroom activities (parents and children together, involving children in food choices/food preparation-sense of belonging/decision making): 1. Healthy breakfasts and 10 o'clock snacks 2. Fats and oils in the diet, cooking methods, setting limits to oily food intake. 3. Fruit and vegetables in the daily diet, adults as role models. 4. Learning about food categories \& pyramid, healthy eating and growth. 5. Limiting consumption of sweets and snacks. Workshop for Parents: Explaining nutritional needs of children; how to encourage good eating habits, how to deal with children's manipulations, providing tools to elicit change; use of food to attract parental attention; practical tools to deal with their children's eating habits/obesity/refusal to eat/chronic health problems/failure to grow; ways to prevent use of food as an answer to childhood frustrations. | Behavioural | behavioral intervention |
Primary outcome
Primary outcome: change in intake of fruits, vegetables, sweets and unhealthy snacks at home, and exercise (questionnaire-based); and observed intake in school snacks
Time frame: first grade to third grade
1 secondary outcome
change in BMI and waist circumference
Time frame: first grade to third grade
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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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.
Tori Goldstein, MSC principal investigator
Hebew University Faculty of Medicine
Jeremy D Kark, MD PhD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parent-child interaction/activities based on Adler's methods in people with Childhood Obesity, run by Hadassah Medical Organization 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcome: change in intake of fruits, vegetables, sweets and unhealthy snacks at home, and exercise (questionnaire-based); and observed intake in school snacks (time frame: first grade to third grade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2018.