ObesityNCT00788203
Prevention of Childhood Obesity
An observational study of Obesity, run by Stanford University at 1 site in United States.
Trial summary
This study is conducting preliminary testing to find out whether a particular educational program can alter parental overcontrol of their children's eating. There is evidence from previous studies that children who are irritable, cry a lot, tend to be overcontrolled and are at high risk for developing overweight. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2011
- Phase
- Observational
- 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 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 2-4 years at risk for overweight with at least one overweight/obese parent
Who may be able to join
- For study 1, 60 families (120 parents) with a child between the age of 2-4 years will be entered to the study. Children of these families will be at risk for overweight because the family will contain at least one obese parent. For study 2, 100 families (200 parents) will be entered to the study. Children of these families will be at risk for overweight and have a reactive temperament. The reason for using this population is that a combination of parental obesity and a child with a reactive temperament appears to put the child at high risk for the development of overweight.\

Who cannot join
- Not able to comprehend English well enough to participate in assessments or the intervention.
- Serious non-obesity related physical illness, (e.g., cancer), which would preclude participation in assessment or intervention.
- Serious current psychiatric disorder, e.g. schizophrenia, uncontrolled bipolar disorder, mental retardation that would preclude participation in assessment or intervention.
- Single parents
- Child exclusions:
- Serious physical illness or related treatments that would affect feeding or weight including history of feeding aversion, failure to thrive, and use of nasogastric or gastrostomy feeding.
- Prematurity below 37-weeks associated with prolonged hospitalization, ongoing need for nutritional supplementation, or naso-gastric feeding.(parental report)
- Serious current developmental problems including any that might interfere with self-feeding or require additional parental feeding support e.g. developmental delay, autism. (parental report).
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: The Development of an Early Intervention for the Prevention of Childhood Obesity
This study is conducting preliminary testing to find out whether a particular educational program can alter parental overcontrol of their children's eating. There is evidence from previous studies that children who are irritable, cry a lot, tend to be overcontrolled and are at high risk for developing overweight. If the education program can change parental behavior the next study would examine whether this affects children's weight over a longer period of time.
Read the detailed description
There are two main studies in this project. For both studies families with a child between 2 and 4-years will be entered to the study although only the parents will participate. At least one parent will be overweight with a BMI>27.5, and the child will have a reactive temperament assessed by the Children's Behavior Questionnaire (CBQ) completed by the parent with a combined score on the approach/impulsivity scales of 4.65 (possible range 1 - 7). The cut-points for parental BMI and their child's temperament derive from our previous prospective risk factor study. Screening will consist of a brief telephone screen to ascertain willingness to participate in further screening and self-reported BMI. Both parents will be invited to the laboratory to ascertain whether they meet BMI criteria. In Study 1 parents with a child with either reactive or non-reactive temperament patterns will be entered to this study. In Study 2 only parents with a child with a reactive temperament will be admitted to the study. There will be no randomization in Study 1. There will also be 2 focus groups each lasting 90-minutes to ascertain typical child feeding problems, and a pilot administration of the interventions. In Study 2 parents will be randomized to receive either the experimental intervention or a health education program aimed at enhancing their children's health. Each group session will last 90-minutes and there will be 10 group sessions at weekly intervals. Assessments in both studies will be similar and will consist of questionnaires aimed at assessing family and children's feeding behaviors and parental attitudes and behaviors concerning their own weight/shape and dieting. We estimate that the assessments will take approximately 60-minutes to complete in Study 1 and 45-minutes each in Study 2 because extraneous questions will be removed as a result of findings in Study 1.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 5-keys program | Counseling re family feeding behaviors. | |
| Lifestyle counseling | Counseling re healthy eating for child and family |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental restraint concerning eating
Measured: Prospective
Secondary outcomes (1)
Daily eating pattern
Parental report of feeding frequency
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- William Stewart Agras, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788203
- Sponsor's protocol ID
- SU-11052008-1335
- Other IDs
- R21HD055637
- Status last verified
- Jul 2011
- First submitted
- 6 Nov 2008
- Last updated
- 25 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of an Early Intervention for the Prevention of Childhood Obesity
- ClinicalTrials.gov ID
- NCT00788203
- Acronym / sponsor ID
- SU-11052008-1335
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Nov 2008 (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.
This study is conducting preliminary testing to find out whether a particular educational program can alter parental overcontrol of their children's eating. There is evidence from previous studies that children who are irritable, cry a lot, tend to be overcontrolled and are at high risk for developing overweight. If the education program can change parental behavior the next study would examine whether this affects children's weight over a longer period of time.
Detailed description
There are two main studies in this project. For both studies families with a child between 2 and 4-years will be entered to the study although only the parents will participate. At least one parent will be overweight with a BMI>27.5, and the child will have a reactive temperament assessed by the Children's Behavior Questionnaire (CBQ) completed by the parent with a combined score on the approach/impulsivity scales of 4.65 (possible range 1 - 7). The cut-points for parental BMI and their child's temperament derive from our previous prospective risk factor study. Screening will consist of a brief telephone screen to ascertain willingness to participate in further screening and self-reported BMI. Both parents will be invited to the laboratory to ascertain whether they meet BMI criteria. In Study 1 parents with a child with either reactive or non-reactive temperament patterns will be entered to this study. In Study 2 only parents with a child with a reactive temperament will be admitted to the study. There will be no randomization in Study 1. There will also be 2 focus groups each lasting 90-minutes to ascertain typical child feeding problems, and a pilot administration of the interventions. In Study 2 parents will be randomized to receive either the experimental intervention or a health education program aimed at enhancing their children's health. Each group session will last 90-minutes and there will be 10 group sessions at weekly intervals. Assessments in both studies will be similar and will consist of questionnaires aimed at assessing family and children's feeding behaviors and parental attitudes and behaviors concerning their own weight/shape and dieting. We estimate that the assessments will take approximately 60-minutes to complete in Study 1 and 45-minutes each in Study 2 because extraneous questions will be removed as a result of findings in Study 1.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-keys program | – | –Counseling re family feeding behaviors. |
| Lifestyle counseling | – | –Counseling re healthy eating for child and family |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 2-4 years at risk for overweight with at least one overweight/obese parent
Key inclusion criteria (1 listed)
- For study 1, 60 families (120 parents) with a child between the age of 2-4 years will be entered to the study. Children of these families will be at risk for overweight because the family will contain at least one obese parent. For study 2, 100 families (200 parents) will be entered to the study. Children of these families will be at risk for overweight and have a reactive temperament. The reason for using this population is that a combination of parental obesity and a child with a reactive temperament appears to put the child at high risk for the development of overweight.\

Key exclusion criteria (8 listed)
- Not able to comprehend English well enough to participate in assessments or the intervention.
- Serious non-obesity related physical illness, (e.g., cancer), which would preclude participation in assessment or intervention.
- Serious current psychiatric disorder, e.g. schizophrenia, uncontrolled bipolar disorder, mental retardation that would preclude participation in assessment or intervention.
- Single parents
- Serious physical illness or related treatments that would affect feeding or weight including history of feeding aversion, failure to thrive, and use of nasogastric or gastrostomy feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parental restraint concerning eating
Time frame: Prospective
1 secondary outcome
Daily eating pattern
Time frame: Weekly
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 25 Jul 2011.
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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.
William Stewart Agras principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Stanford University at 1 site in United States.
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 8 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 25 Jul 2011. 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 United States. 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?
Parental restraint concerning eating (time frame: Prospective). 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 25 Jul 2011.