Childhood OverweightNCT01281436
Health Information Technology to Support Clinical Decision Making in Obesity Care
A study testing HeartSmartKids & Web-based Provider Training and Web-based Provider Training in people with Childhood Overweight and Childhood Obesity, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this study is to address priority Research Area 3 in PAR-08-270: Health information technology (HIT) to improve health care decision making through the use of integrated data and knowledge management. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Overweight, Childhood Obesity
- What is being tested?
- HeartSmartKids & Web-based Provider Training and Web-based Provider Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- School Based Health Centers who serve children 5-12 years
- sees a minimum of 20 children per month for well-child care or sports physicals
- has internet access and printer
- has space for a small computer in the waiting room or check-in area
- has a primary care provider who reads English.
- read English or Spanish
Who cannot join
- centers that have implemented the HeartSmartKids program.
- children seen for immunizations, dental, or mental health care without a well-child visit.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arizona State University
Phoenix, Arizona, 85004
Danielle Dandreaux, Ph.D.
About this study
The purpose of this study is to address priority Research Area 3 in PAR-08-270: Health information technology (HIT) to improve health care decision making through the use of integrated data and knowledge management. The proposed study will evaluate the use of HIT for clinician decision support and tailored patient education on the implementation of the current guidelines for the prevention of obesity-related chronic conditions in health disparity populations of poor, minority youth who access care through SBHCs. The specific aims are:
- To evaluate the effectiveness of web-based training with and without computerized clinical decision support on provider's process and outcome behaviors related to implementing the current guidelines for prevention of obesity and related conditions.
- Process variables include the following: i. Provider knowledge, attitudes, and barriers to implementing the guidelines. ii. Parent perception of the interpersonal process of care (i.e., provider communication, collaborative decision making, and interpersonal style). iii. Parent perception of provider support for their child's healthy eating and exercise.
- Behavior outcomes include the following: i. Provider self-reported behaviors of identification and assessment of overweight, counseling on nutrition and physical activity, use of behavioral interventions, referrals, and cultural competency. ii. Documentation by chart review of body mass index (BMI) percentile for age and sex; appropriate diagnosis when BMI > 85th percentile; blood pressure (BP) percentile for age, height, and sex; and ordering appropriate laboratory tests when indicated.
- To explore the role of HIT in the processes of system change for implementation of the guidelines for prevention of obesity and related conditions, including the facilitators, barriers, and impact of the care model on change.
Read the detailed description
The prevalence of overweight youth nearly quadrupled in the past four decades. An alarming increase in the number of poor, underserved, overweight minority youth is reported. This dramatic increase in overweight youth has led to the emergence of associated co-morbidities such as dyslipidemia, hypertension, type 2 diabetes, musculoskeletal disorders, respiratory conditions, and emotional problems in youth as well as increased risks of cardiovascular disease and cancer as adults. School-based health centers (SBHCs) provide access to primary care for many underserved and minority youth at risk for obesity and related chronic conditions. Primary care providers (PCPs), however, including those at SBHCs, face a number of barriers to addressing weight management in children. The rising prevalence of obesity and difficulty in identifying, assessing, and maintaining healthy weight in children and adolescents led national groups to convene expert panels that have published evidence-based guidelines. These guidelines include screening for cardiovascular risk factors and using a family-centered and culturally sensitive approach to care. The recommendations incorporate the use of motivational interviewing (MI) and the chronic care model to collaborate with families on a plan of care to improve children's health outcomes. The publication of recommendations or guidelines, however, traditionally has not changed provider behavior. Studies have shown widespread failure to follow established guidelines for a variety of conditions. The barriers to implementing guidelines include inadequate tools or resources, insufficient knowledge and skills, lack of self-efficacy, lack of time, and insufficient reimbursement. Health information technology (HIT) serves as a mechanism for providing decision support and tailored patient education materials to improve evidence-based care for the prevention of obesity and related conditions. Self-efficacy regarding obesity counseling has been linked to access to HIT. Other studies indicate that patients who received written health information with graphics that depicted their response to therapy improved their motivation to adhere to the treatment plan and were more satisfied with care. The proposed study is a comparative-effectiveness trial evaluating the impact of web-based provider training with and without HIT for provider decision support and tailored patient education. The goal is to translate into practice the current evidence-based guidelines for the prevention of obesity-related chronic conditions. HeartSmartKids™ is a decision-making tool that integrates patient health information with evidence-based guidelines and generates graphic trends of cardiovascular risks and tailored recommendations to improve patient outcomes. Elimination of health disparities in the chronic conditions related to childhood obesity depends upon the translation of best evidence into practice by the providers who care to youth at-risk for these obesity-related conditions. The unique features of this study are the SBHC setting; comparative effectiveness of web-based training on current evidence-based recommendations with and without HIT to support providers' decision making and tailored patient education; and the use of the Health Disparities Collaborative, the Institute for Healthcare Improvement's Breakthrough Series quality improvement process, and the chronic care model for childhood obesity for training providers on the current guidelines.
- Conditions
- Childhood Overweight, Childhood Obesity
- Being tested
- HeartSmartKids & Web-based Provider Training, Web-based Provider Training
- Keywords
- childhood, overweight, obesity, Health information technology, HeartSmartKids, Motivational Interviewing
- Medical subject headings
- Pediatric Obesity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartSmartKids & Web-based Provider TrainingOther
The providers assigned to Group 2 will receive the web-based training described in the web-based training arm, plus the HeartSmartKids™ (HSK) system. HSK is a bilingual, HIT kiosk system with clinical decision support and tailored patient education.
Web-based Provider TrainingOther
The training will include information about implementing the recommendations of the AMA, the pediatric metabolic working group, and the HEATSM guidelines into their practice setting through the use of the chronic care model for childhood obesity. Training will include self-management support, decision support, delivery-system redesign, clinical information systems, practice self-assessment, and staff development on obtaining, assessing, documenting BMI and BP; counseling families on appropriate interventions; and quality improvement processes to evaluate the practice's performance strategies.
| Study group | Role | What they receive |
|---|---|---|
| Web-based Provider training | Other | The training will include information about implementing the recommendations of the AMA, the pediatric metabolic working group, and the HEATSM guidelines into their practice setting through the use of the chronic care model for childhood obesity. Training will include self-management support, decision support, delivery-system redesign, clinical information systems, practice self-assessment, and staff development on obtaining, assessing, documenting BMI and BP; counseling families on appropriate interventions; and quality improvement processes to evaluate the practice's performance strategies. Receives: Other: Web-based Provider Training |
| HeartSmartKids with web-based training | Active comparator | The providers assigned to Group 2 will receive the web-based training described in the other arm, plus the HeartSmartKids™ (HSK) system. HSK is a bilingual, HIT kiosk system with clinical decision support and tailored patient education. Receives: Other: HeartSmartKids & Web-based Provider Training; Other: Web-based Provider Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Life Science Institute(ILSI)Research Foundation Assessment of Overweight in Children and Adolescents
The 35-item survey asks providers to rate themselves using a Likert-type scale on the following: (a) definitions of overweight in various age groups, (b) calculation and documentation of BMI percentile, (c) routine counseling on nutrition, physical activity, and screen time, (d) assessment of overweight children, and (e) resources and barriers that providers encounter in dealing with childhood overweight.
Measured: every 9-12 months
Chronic Care Model Elements Survey (CCMES)
A 9-item survey that assesses the extent to which elements of the chronic care model are used in the routine care of patients in a practice. It was originally designed for patients with diabetes and was adapted for use in overweight/obesity. The total score is created as the mean of the 9 items, with the higher indicative of greater use of the elements of the CCM.
Measured: every 9-12 months
Secondary outcomes (2)
Interpersonal Process of Care (IPC)
A 29-item survey available in English and Spanish. It is a 5-point Likert-type scale that measures the patient-clinician relationship, quality, and satisfaction with care on three domains: communication, decision making, and interpersonal style. Health disparities may be attributable to differences between minorities and their counterparts in the interpersonal processes between the patients and clinicians.
Measured: every 9-12 months
Health-Care Climate Questionnaire (HCCQ)
A measure with 6 items for eating and 6 items for regular exercise that assesses the degree of support from healthcare providers for healthy behaviors. The HCCQ for diet and exercise are scored by combining the items on each scale.
Measured: every 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionJul 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood OverweightStudies of the same condition, open and under way.
- More trials run by Arizona State 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, University of Colorado, Denver
- Investigators
- Bonnie M Gance-Cleveland, Ph.D., Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281436
- Sponsor's protocol ID
- AHRQ
- Status last verified
- Jan 2011
- First submitted
- 14 Jan 2011
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Information Technology to Support Clinical Decision Making in Obesity Care
- ClinicalTrials.gov ID
- NCT01281436
- Acronym / sponsor ID
- AHRQ
- Conditions
- Childhood Overweight, Childhood Obesity
- Keywords
- childhood, overweight, obesity, Health information technology, HeartSmartKids, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- University of New Mexico, University of Colorado, Denver
- Study start
- Oct 2010
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 24 Jan 2011 (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 address priority Research Area 3 in PAR-08-270: Health information technology (HIT) to improve health care decision making through the use of integrated data and knowledge management. The proposed study will evaluate the use of HIT for clinician decision support and tailored patient education on the implementation of the current guidelines for the prevention of obesity-related chronic conditions in health disparity populations of poor, minority youth who access care through SBHCs. The specific aims are:
- To evaluate the effectiveness of web-based training with and without computerized clinical decision support on provider's process and outcome behaviors related to implementing the current guidelines for prevention of obesity and related conditions.
- Process variables include the following: i. Provider knowledge, attitudes, and barriers to implementing the guidelines. ii. Parent perception of the interpersonal process of care (i.e., provider communication, collaborative decision making, and interpersonal style). iii. Parent perception of provider support for their child's healthy eating and exercise.
- Behavior outcomes include the following: i. Provider self-reported behaviors of identification and assessment of overweight, counseling on nutrition and physical activity, use of behavioral interventions, referrals, and cultural competency. ii. Documentation by chart review of body mass index (BMI) percentile for age and sex; appropriate diagnosis when BMI > 85th percentile; blood pressure (BP) percentile for age, height, and sex; and ordering appropriate laboratory tests when indicated.
- To explore the role of HIT in the processes of system change for implementation of the guidelines for prevention of obesity and related conditions, including the facilitators, barriers, and impact of the care model on change.
Detailed description
The prevalence of overweight youth nearly quadrupled in the past four decades. An alarming increase in the number of poor, underserved, overweight minority youth is reported. This dramatic increase in overweight youth has led to the emergence of associated co-morbidities such as dyslipidemia, hypertension, type 2 diabetes, musculoskeletal disorders, respiratory conditions, and emotional problems in youth as well as increased risks of cardiovascular disease and cancer as adults. School-based health centers (SBHCs) provide access to primary care for many underserved and minority youth at risk for obesity and related chronic conditions. Primary care providers (PCPs), however, including those at SBHCs, face a number of barriers to addressing weight management in children. The rising prevalence of obesity and difficulty in identifying, assessing, and maintaining healthy weight in children and adolescents led national groups to convene expert panels that have published evidence-based guidelines. These guidelines include screening for cardiovascular risk factors and using a family-centered and culturally sensitive approach to care. The recommendations incorporate the use of motivational interviewing (MI) and the chronic care model to collaborate with families on a plan of care to improve children's health outcomes. The publication of recommendations or guidelines, however, traditionally has not changed provider behavior. Studies have shown widespread failure to follow established guidelines for a variety of conditions. The barriers to implementing guidelines include inadequate tools or resources, insufficient knowledge and skills, lack of self-efficacy, lack of time, and insufficient reimbursement. Health information technology (HIT) serves as a mechanism for providing decision support and tailored patient education materials to improve evidence-based care for the prevention of obesity and related conditions. Self-efficacy regarding obesity counseling has been linked to access to HIT. Other studies indicate that patients who received written health information with graphics that depicted their response to therapy improved their motivation to adhere to the treatment plan and were more satisfied with care. The proposed study is a comparative-effectiveness trial evaluating the impact of web-based provider training with and without HIT for provider decision support and tailored patient education. The goal is to translate into practice the current evidence-based guidelines for the prevention of obesity-related chronic conditions. HeartSmartKids™ is a decision-making tool that integrates patient health information with evidence-based guidelines and generates graphic trends of cardiovascular risks and tailored recommendations to improve patient outcomes. Elimination of health disparities in the chronic conditions related to childhood obesity depends upon the translation of best evidence into practice by the providers who care to youth at-risk for these obesity-related conditions. The unique features of this study are the SBHC setting; comparative effectiveness of web-based training on current evidence-based recommendations with and without HIT to support providers' decision making and tailored patient education; and the use of the Health Disparities Collaborative, the Institute for Healthcare Improvement's Breakthrough Series quality improvement process, and the chronic care model for childhood obesity for training providers on the current guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based Provider training | Other | Other: Web-based Provider TrainingThe training will include information about implementing the recommendations of the AMA, the pediatric metabolic working group, and the HEATSM guidelines into their practice setting through the use of the chronic care model for childhood obesity. Training will include self-management support, decision support, delivery-system redesign, clinical information systems, practice self-assessment, and staff development on obtaining, assessing, documenting BMI and BP; counseling families on appropriate interventions; and quality improvement processes to evaluate the practice's performance strategies. |
| HeartSmartKids with web-based training | Active comparator | Other: HeartSmartKids & Web-based Provider Training, Other: Web-based Provider TrainingThe providers assigned to Group 2 will receive the web-based training described in the other arm, plus the HeartSmartKids™ (HSK) system. HSK is a bilingual, HIT kiosk system with clinical decision support and tailored patient education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- School Based Health Centers who serve children 5-12 years
- sees a minimum of 20 children per month for well-child care or sports physicals
- has internet access and printer
- has space for a small computer in the waiting room or check-in area
- has a primary care provider who reads English.
Key exclusion criteria (2 listed)
- centers that have implemented the HeartSmartKids program.
- children seen for immunizations, dental, or mental health care without a well-child visit.
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 |
|---|---|---|
| HeartSmartKids & Web-based Provider TrainingThe providers assigned to Group 2 will receive the web-based training described in the web-based training arm, plus the HeartSmartKids™ (HSK) system. HSK is a bilingual, HIT kiosk system with clinical decision support and tailored patient education. | Other | HeartSmartKids with web-based training |
| Web-based Provider TrainingThe training will include information about implementing the recommendations of the AMA, the pediatric metabolic working group, and the HEATSM guidelines into their practice setting through the use of the chronic care model for childhood obesity. Training will include self-management support, decision support, delivery-system redesign, clinical information systems, practice self-assessment, and staff development on obtaining, assessing, documenting BMI and BP; counseling families on appropriate interventions; and quality improvement processes to evaluate the practice's performance strategies. | Other | HeartSmartKids with web-based training, Web-based Provider training |
Primary outcome
International Life Science Institute(ILSI)Research Foundation Assessment of Overweight in Children and Adolescents
Time frame: every 9-12 months
The 35-item survey asks providers to rate themselves using a Likert-type scale on the following: (a) definitions of overweight in various age groups, (b) calculation and documentation of BMI percentile, (c) routine counseling on nutrition, physical activity, and screen time, (d) assessment of overweight children, and (e) resources and barriers that providers encounter in dealing with childhood overweight.
Chronic Care Model Elements Survey (CCMES)
Time frame: every 9-12 months
A 9-item survey that assesses the extent to which elements of the chronic care model are used in the routine care of patients in a practice. It was originally designed for patients with diabetes and was adapted for use in overweight/obesity. The total score is created as the mean of the 9 items, with the higher indicative of greater use of the elements of the CCM.
2 secondary outcomes
Interpersonal Process of Care (IPC)
Time frame: every 9-12 months
Health-Care Climate Questionnaire (HCCQ)
Time frame: every 9-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
Related trials for Childhood Overweight
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
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.
Bonnie M Gance-Cleveland, Ph.D. principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartSmartKids & Web-based Provider Training and Web-based Provider Training in people with Childhood Overweight and Childhood Obesity, run by Arizona State 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 6 inclusion and 2 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 24 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danielle M Dandreaux, Ph.D. (480-496-0822, danielle.dandreaux@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Life Science Institute(ILSI)Research Foundation Assessment of Overweight in Children and Adolescents (time frame: every 9-12 months). The study lists 2 primary outcomes in all. 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 24 Jan 2011.