OverweightNCT01029834
Treating Pre-School Children at Risk for Overweight in the Primary Care Setting
A study testing family based lifestyle and behavioral counseling and counseling focused on the child in people with Overweight, run by State University of New York at Buffalo at 2 sites in United States.
Trial summary
The goal of this study is to test, in the primary care setting, the efficacy of an innovative intervention program for children aged 2-5 years with a BMI over the 85th percentile and one overweight parent (BMI >27 kg/m2. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- family based lifestyle and behavioral counseling and counseling focused on the child
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Jun 2013
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2-5 year old with a BMI greater than the 85th% for age and sex
- one overweight parent (BMI>27kg/m2)
- child with normal developmental milestones
- history of adherence to 90% of scheduled primary care visits
- parent must be at 5th grade reading and speaking of English language or the spanish language
- no plans on moving out of the area for the 2 years subsequent to enrollment
Who cannot join
- child with a height 2 SD below the mean for age and sex and/or pathological growth velocity
- SGA
- any chronic disorders influencing energy intake and/or growth
- any orthopedic disorder preventing the child or the parent from ambulation normally and performing the activity prescribed by the program
- any medication known to have the potential of affecting weight changes
- parent or child with psychiatric and/or eating disorder
- participating mother who is pregnant or planning a pregnancy
- parent being acquainted with the parent of a previously randomized study participant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
WNY urban practices
Buffalo, New York
WNY suburban practices
Williamsville, New York
About this study
Official title: Treating Overweight Youth: A Family Based Approach in Primary Care
The goal of this study is to test, in the primary care setting, the efficacy of an innovative intervention program for children aged 2-5 years with a BMI over the 85th percentile and one overweight parent (BMI >27 kg/m2.
- Conditions
- Overweight
- Being tested
- family based lifestyle and behavioral counseling, counseling focused on the child
- Keywords
- BMI >85%for age and gender
- Medical subject headings
- Overweight, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family based lifestyle and behavioral counselingBehavioural
16 group meetings
counseling focused on the childBehavioural
16 meetings
| Study group | Role | What they receive |
|---|---|---|
| Intervention- Lifestyle family based | Experimental | Behavioral family based Receives: Behavioral: family based lifestyle and behavioral counseling |
| Information control | Active comparator | Child intervention only Receives: Behavioral: counseling focused on the child |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent BMI overweight for child and parent
Measured: baseline-6,12,18, 24 months
Secondary outcomes (1)
Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity
Measured: baseline, 6,12,18,24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Care provider
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Quattrin, State University of New York at Buffalo
- Investigators
- Teresa Quattrin, MD, Principal investigator, University at Buffalo/Women and Children's Hospital of Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029834
- Sponsor's protocol ID
- 1R01HD053773-01
- Status last verified
- Apr 2023
- First submitted
- 9 Dec 2009
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Treatment outcomes of overweight children and parents in the medical home. Pediatrics. 2014 Aug;134(2):290-7. doi: 10.1542/peds.2013-4084.
PubMed 25049340Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Efficacy of family-based weight control program for preschool children in primary care. Pediatrics. 2012 Oct;130(4):660-6. doi: 10.1542/peds.2012-0701. Epub 2012 Sep 17.
PubMed 22987879
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Overweight Youth: A Family Based Approach in Primary Care
- ClinicalTrials.gov ID
- NCT01029834
- Acronym / sponsor ID
- 1R01HD053773-01
- Conditions
- Overweight
- Keywords
- BMI >85%for age and gender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Dec 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.
The goal of this study is to test, in the primary care setting, the efficacy of an innovative intervention program for children aged 2-5 years with a BMI over the 85th percentile and one overweight parent (BMI >27 kg/m2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention- Lifestyle family based | Experimental | Behavioral: family based lifestyle and behavioral counselingBehavioral family based |
| Information control | Active comparator | Behavioral: counseling focused on the childChild intervention only |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 2-5 year old with a BMI greater than the 85th% for age and sex
- one overweight parent (BMI>27kg/m2)
- child with normal developmental milestones
- history of adherence to 90% of scheduled primary care visits
- parent must be at 5th grade reading and speaking of English language or the spanish language
Key exclusion criteria (8 listed)
- child with a height 2 SD below the mean for age and sex and/or pathological growth velocity
- SGA
- any chronic disorders influencing energy intake and/or growth
- any orthopedic disorder preventing the child or the parent from ambulation normally and performing the activity prescribed by the program
- any medication known to have the potential of affecting weight changes
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 |
|---|---|---|
| family based lifestyle and behavioral counseling16 group meetings | Behavioural | Intervention- Lifestyle family based |
| counseling focused on the child16 meetings | Behavioural | Information control |
Primary outcome
Percent BMI overweight for child and parent
Time frame: baseline-6,12,18, 24 months
1 secondary outcome
Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity
Time frame: baseline, 6,12,18,24
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 28 Apr 2023.
- Derived from this study: PubMed 25049340Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Treatment outcomes of overweight children and parents in the medical home. Pediatrics. 2014 Aug;134(2):290-7. doi: 10.1542/peds.2013-4084.
- Derived from this study: PubMed 22987879Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Efficacy of family-based weight control program for preschool children in primary care. Pediatrics. 2012 Oct;130(4):660-6. doi: 10.1542/peds.2012-0701. Epub 2012 Sep 17.
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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.
Teresa Quattrin, MD principal investigator
University at Buffalo/Women and Children's Hospital of Buffalo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing family based lifestyle and behavioral counseling and counseling focused on the child in people with Overweight, run by State University of New York at Buffalo at 2 sites 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 6 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Percent BMI overweight for child and parent (time frame: baseline-6,12,18, 24 months). 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 NCT01029834, which also lists 2 linked publications.
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 28 Apr 2023.