OverweightNCT02278705
Primary Care Clinical Practice Elements and Improving Overweight Children's Weight Status
An observational study of Overweight and Childhood Obesity, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to identify whether specific clinical practices-including attention to body-mass-index (BMI) screening/overweight/obesity, medical risk (from conditions associated with overweight/obesity such as high blood pressure), and following up to reassess progress-will improve the weight status of… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Overweight, Childhood Obesity
- What is being tested?
- Attention to BMI, Attention to high-BMI-related Medical Risk and No attention to high BMI or high-BMI-related medical risk
- How many people
- 7,192 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Sep 2015
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Overweight 6-12 year-old children followed by pediatricians at community-based and academic primary-care clinics. A random sample of controls will be matched to cases by age, gender, race/ethnicity, BMI-percentile category, and clinic site.
Who may be able to join
- 6-12 year-old children with ≥2 visits
- valid height and weight data at each visit
- BMI ≥85th percentile at the first visit
Who cannot join
- children <6 and >12 years old
- no valid height and weight data at two visits
- BMI <85th percentile at all 6-12 year-old well child visits
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern and Children's Medical Center
Dallas, Texas, 75390
About this study
The purpose of this study is to identify whether specific clinical practices-including attention to body-mass-index (BMI) screening/overweight/obesity, medical risk (from conditions associated with overweight/obesity such as high blood pressure), and following up to reassess progress-will improve the weight status of overweight school-age children.
Read the detailed description
The aim of this study is to identify specific clinical practice elements in pediatric primary care that predict improvement in weight status among overweight school-age children. Pediatricians are well-suited to regularly assess and treat school-age children who are overweight. Well-child visits present an important opportunity to assess and treat overweight children. Strategies are needed to maximize the effectiveness of this opportunity. Although the American Academy of Pediatrics endorses recommendations by the United States Preventive Services Task Force that clinicians screen for overweight, assess medical/behavior risk, and use a staged treatment approach that includes frequent reassessment, it is unclear whether these practices, when used in primary care, impact whether children make lifestyle changes or improve their weight status. It is essential to identify specific clinical practice elements and communication strategies associated with weight-status improvement in overweight children, to maximize the effectiveness of primary-care weight-management interventions. The investigators hypothesize that, during primary-care visits with overweight 6-12-year-old children, attention to high BMI, medical risk (from weight-related comorbidities such as high blood pressure), and reassessing progress (defined as having a primary-care visit with evidence of attention to BMI or completing a referral to a weight-management specialist or nutritionist) will be associated with improvement in weight status (assessed as decrease in percent overweight (percentage above the age/sex-specific 95th BMI percentile) at follow-up.
- Conditions
- Overweight, Childhood Obesity
- Being tested
- Attention to BMI, Attention to high-BMI-related Medical Risk, No attention to high BMI or high-BMI-related medical risk
- Keywords
- childhood obesity, childhood overweight, primary care, weight management
- Medical subject headings
- Overweight, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention to BMIOther
Also called BMI
Evidence (using electronic health record data) denoting provider attention to about high BMI.
Attention to high-BMI-related Medical RiskOther
Also called Medical Risk
Evidence (using electronic health record data) denoting provider attention to high-BMI-related medical risk, including from high blood pressure/hypertension, cholesterol/dyslipidemia, blood sugar/diabetes, liver enzymes/fatty liver, and low vitamin D/vitamin-D deficiency.
No attention to high BMI or high-BMI-related medical riskOther
Also called No BMI/Medical-Risk Attention
Lack of evidence (using electronic health record data) denoting provider attention to high BMI or high-BMI-related medical risk.
| Study group | Role | What they receive |
|---|---|---|
| Weight-status improved | Cases, termed, "weight-status improved," are defined as children whose BMI percent relative to their age/sex-specific BMI at the 95th percentile decreases from one visit to the next; and from one well-child visit to the next well-child (or primary-care visit approximately 9-18 months later). Receives: Other: Attention to BMI; Other: Attention to high-BMI-related Medical Risk; Other: No attention to high BMI or high-BMI-related medical risk | |
| Weight-status unchanged/worse | Controls are defined as children whose BMI percent relative to their age/sex-specific BMI at the 95th percentile remains unchanged or increases from one visit to the next; and from one well-child visit to the next well-child (or primary-care visit approximately 9-18 months later). Receives: Other: Attention to BMI; Other: Attention to high-BMI-related Medical Risk; Other: No attention to high BMI or high-BMI-related medical risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight-status improvement
Children with a decrease in BMI percent relative to the age/sex-specific BMI at the 95th percentile
Measured: From one visit to the next and from one well-child visit to the next
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startJan 2009
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 7,192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christy B Turer, MD, MHS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278705
- Sponsor's protocol ID
- 1K23HL118152-01A1 Aim 1
- Other IDs
- 1K23HL118152-01A1
- Status last verified
- May 2020
- First submitted
- 24 Oct 2014
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Turer CB, Montano S, Lin H, Hoang K, Flores G. Pediatricians' communication about weight with overweight Latino children and their parents. Pediatrics. 2014 Nov;134(5):892-9. doi: 10.1542/peds.2014-1282. Epub 2014 Oct 13.
PubMed 25311599Turer CB, Mehta M, Durante R, Wazni F, Flores G. Parental perspectives regarding primary-care weight-management strategies for school-age children. Matern Child Nutr. 2016 Apr;12(2):326-38. doi: 10.1111/mcn.12131. Epub 2014 Apr 10.
PubMed 24720565Upperman C, Palmieri P, Lin H, Flores G, Turer CB. What do parents want for their children who are overweight when visiting the paediatrician? Obes Sci Pract. 2015 Oct;1(1):33-40. doi: 10.1002/osp4.5. Epub 2015 Sep 10.
PubMed 28580163Turer CB, Upperman C, Merchant Z, Montano S, Flores G. Primary-Care Weight-Management Strategies: Parental Priorities and Preferences. Acad Pediatr. 2016 Apr;16(3):260-6. doi: 10.1016/j.acap.2015.09.001. Epub 2015 Sep 26.
PubMed 26514648Turer CB, Barlow SE, Montano S, Flores G. Discrepancies in Communication Versus Documentation of Weight-Management Benchmarks: Analysis of Recorded Visits With Latino Children and Associated Health-Record Documentation. Glob Pediatr Health. 2017 Feb 6;4:2333794X16685190. doi: 10.1177/2333794X16685190. eCollection 2017.
PubMed 28239625
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Clinical Practice Elements and Improving Overweight Children's Weight Status
- ClinicalTrials.gov ID
- NCT02278705
- Acronym / sponsor ID
- 1K23HL118152-01A1 Aim 1
- Conditions
- Overweight, Childhood Obesity
- Keywords
- childhood obesity, childhood overweight, primary care, weight management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,192 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2009
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Oct 2014 (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 purpose of this study is to identify whether specific clinical practices-including attention to body-mass-index (BMI) screening/overweight/obesity, medical risk (from conditions associated with overweight/obesity such as high blood pressure), and following up to reassess progress-will improve the weight status of overweight school-age children.
Detailed description
The aim of this study is to identify specific clinical practice elements in pediatric primary care that predict improvement in weight status among overweight school-age children. Pediatricians are well-suited to regularly assess and treat school-age children who are overweight. Well-child visits present an important opportunity to assess and treat overweight children. Strategies are needed to maximize the effectiveness of this opportunity. Although the American Academy of Pediatrics endorses recommendations by the United States Preventive Services Task Force that clinicians screen for overweight, assess medical/behavior risk, and use a staged treatment approach that includes frequent reassessment, it is unclear whether these practices, when used in primary care, impact whether children make lifestyle changes or improve their weight status. It is essential to identify specific clinical practice elements and communication strategies associated with weight-status improvement in overweight children, to maximize the effectiveness of primary-care weight-management interventions. The investigators hypothesize that, during primary-care visits with overweight 6-12-year-old children, attention to high BMI, medical risk (from weight-related comorbidities such as high blood pressure), and reassessing progress (defined as having a primary-care visit with evidence of attention to BMI or completing a referral to a weight-management specialist or nutritionist) will be associated with improvement in weight status (assessed as decrease in percent overweight (percentage above the age/sex-specific 95th BMI percentile) at follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-status improved | – | Other: Attention to BMI, Other: Attention to high-BMI-related Medical Risk, Other: No attention to high BMI or high-BMI-related medical riskCases, termed, "weight-status improved," are defined as children whose BMI percent relative to their age/sex-specific BMI at the 95th percentile decreases from one visit to the next; and from one well-child visit to the next well-child (or primary-care visit approximately 9-18 months later). |
| Weight-status unchanged/worse | – | Other: Attention to BMI, Other: Attention to high-BMI-related Medical Risk, Other: No attention to high BMI or high-BMI-related medical riskControls are defined as children whose BMI percent relative to their age/sex-specific BMI at the 95th percentile remains unchanged or increases from one visit to the next; and from one well-child visit to the next well-child (or primary-care visit approximately 9-18 months later). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Overweight 6-12 year-old children followed by pediatricians at community-based and academic primary-care clinics. A random sample of controls will be matched to cases by age, gender, race/ethnicity, BMI-percentile category, and clinic site.
Key inclusion criteria (3 listed)
- 6-12 year-old children with ≥2 visits
- valid height and weight data at each visit
- BMI ≥85th percentile at the first visit
Key exclusion criteria (3 listed)
- children <6 and >12 years old
- no valid height and weight data at two visits
- BMI <85th percentile at all 6-12 year-old well child visits
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 |
|---|---|---|
| Attention to BMIAlso: BMIEvidence (using electronic health record data) denoting provider attention to about high BMI. | Other | Weight-status improved, Weight-status unchanged/worse |
| Attention to high-BMI-related Medical RiskAlso: Medical RiskEvidence (using electronic health record data) denoting provider attention to high-BMI-related medical risk, including from high blood pressure/hypertension, cholesterol/dyslipidemia, blood sugar/diabetes, liver enzymes/fatty liver, and low vitamin D/vitamin-D deficiency. | Other | Weight-status improved, Weight-status unchanged/worse |
| No attention to high BMI or high-BMI-related medical riskAlso: No BMI/Medical-Risk AttentionLack of evidence (using electronic health record data) denoting provider attention to high BMI or high-BMI-related medical risk. | Other | Weight-status improved, Weight-status unchanged/worse |
Primary outcome
weight-status improvement
Time frame: From one visit to the next and from one well-child visit to the next
Children with a decrease in BMI percent relative to the age/sex-specific BMI at the 95th percentile
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 19 May 2020.
- Background: PubMed 25311599Turer CB, Montano S, Lin H, Hoang K, Flores G. Pediatricians' communication about weight with overweight Latino children and their parents. Pediatrics. 2014 Nov;134(5):892-9. doi: 10.1542/peds.2014-1282. Epub 2014 Oct 13.
- Background: PubMed 24720565Turer CB, Mehta M, Durante R, Wazni F, Flores G. Parental perspectives regarding primary-care weight-management strategies for school-age children. Matern Child Nutr. 2016 Apr;12(2):326-38. doi: 10.1111/mcn.12131. Epub 2014 Apr 10.
- Background: PubMed 28580163Upperman C, Palmieri P, Lin H, Flores G, Turer CB. What do parents want for their children who are overweight when visiting the paediatrician? Obes Sci Pract. 2015 Oct;1(1):33-40. doi: 10.1002/osp4.5. Epub 2015 Sep 10.
- Background: PubMed 26514648Turer CB, Upperman C, Merchant Z, Montano S, Flores G. Primary-Care Weight-Management Strategies: Parental Priorities and Preferences. Acad Pediatr. 2016 Apr;16(3):260-6. doi: 10.1016/j.acap.2015.09.001. Epub 2015 Sep 26.
- Background: PubMed 28239625Turer CB, Barlow SE, Montano S, Flores G. Discrepancies in Communication Versus Documentation of Weight-Management Benchmarks: Analysis of Recorded Visits With Latino Children and Associated Health-Record Documentation. Glob Pediatr Health. 2017 Feb 6;4:2333794X16685190. doi: 10.1177/2333794X16685190. eCollection 2017.
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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.
Christy B Turer, MD, MHS principal investigator
University of Texas Southwestern Medical Center
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 Overweight and Childhood Obesity, run by University of Texas Southwestern Medical Center 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 3 inclusion and 3 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 19 May 2020. 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?
weight-status improvement (time frame: From one visit to the next and from one well-child visit to the next). 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 NCT02278705, which also lists 5 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 19 May 2020; AzTrials last refreshed its copy on 30 Oct 2026.