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ObesitySTARNCT01537510

Study of Technology to Accelerate Research

A study testing STAR - Study of Technology to Accelerate Research in people with Obesity, run by Harvard Pilgrim Health Care at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Childhood obesity is highly prevalent and is associated with both short- and long-term adverse outcomes. Despite availability of guidelines for nearly a decade and more recent comparative effectiveness research (CER) evidence, the health care system has been slow to adopt recommended practices. Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
STAR - Study of Technology to Accelerate Research
Could I receive a placebo?
No, everyone receives an active treatment
How many people
549 participants
Where
1 siteUnited States
Study dates
Dec 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 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • child is age 6.0 through 12.9 years at baseline
  • child's BMI exceeds the 95th percentile for age and sex (CDC criteria
  • parent can respond to interviews and questionnaires in English
  • child has obtained well-child care from HVMA for at least the previous 15 months.

Who cannot join

  • children who do not have at least one parent who is able to follow study procedures for 1 year
  • families who plan to leave HVMA within the study time frame
  • families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or mental difficulties
  • children with chronic conditions that substantially interfere with growth

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Harvard Vanguard Medical Associates

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Accelerating Adoption of Childhood Obesity Comparative Effectiveness Research

Childhood obesity is highly prevalent and is associated with both short- and long-term adverse outcomes.

Despite availability of guidelines for nearly a decade and more recent comparative effectiveness research (CER) evidence, the health care system has been slow to adopt recommended practices. Although pediatric health care providers often cite barriers such as limited time, skill, and resources, a frequently overlooked barrier is the lack of data systems to efficiently and accurately assess guideline implementation and to improve quality of care for childhood obesity. Health information technology (HIT) offers potential for accelerating the adoption of CER evidence regarding childhood obesity screening and management, for establishing treatment benchmarks, and for supporting patients and their clinical teams in care improvement. Incorporation of HIT may be especially effective if augmented by outreach to parents and children.

Read more

The goal of this study is to develop and test system-level interventions to accelerate the adoption of CER evidence on childhood obesity screening and management, and ultimately improve obesity-related health care quality and outcomes. To achieve this goal, the investigators will work with two health care systems in Massachusetts with strong track records of research collaboration: Cambridge Health Alliance (CHA), an integrated academic public health system, and Harvard Vanguard Medical Associates (HVMA), a large multi-site group practice. Both systems use an electronic medical record for all aspects of ambulatory care, including point of care services such as electronic order entry and centralized functions such as patient scheduling.

In these settings of innovation and commitment to improving quality of care, the investigators will develop and test two systematic strategies for adoption of CER evidence. The first incorporates computerized point of care decision alerts to pediatric primary care providers during routine office visits, linked to CER-based algorithms of care. The second augments this HIT approach with direct-to-parent communication of child's body mass index (BMI) along with recommended evaluation and management. The specific aims of this study are:

  1. In 18 community health centers of CHA, to identify barriers to and facilitators of adoption of an existing set of computerized point of care decision alerts for childhood obesity screening and management. The investigators will achieve this aim through in-depth interviews and surveys with primary care clinicians, which will inform the design of the investigators proposed intervention.
  2. In 14 practices of HVMA, to conduct a cluster-randomized controlled trial to examine the extent to which computerized point of care decision alerts to pediatric primary care providers, with or without direct-to-parent communications, will increase adoption of CER evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥ 95th percentile. The investigators will determine the extent to which each of the 2 intervention conditions, compared with the usual care control condition and with each other, results in:
  3. Increased screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling,
  4. A smaller age-associated increase in BMI over a 1-year period, and,
  5. Improved specific dietary, physical activity, and sedentary behaviors over a 1-year period.
  6. To evaluate each intervention's costs (including clinician and family time) and cost-effectiveness in terms of children's change in BMI and weight-related behaviors.
  7. To develop a detailed dissemination guide to further accelerate adoption of CER evidence on childhood obesity in practices and communities interested in implementing similar interventions.

To achieve the investigators aims, the investigators have assembled a research team with extensive experience in obesity prevention, clinician and child behavior change, clinical informatics, statistical methodology in cluster randomized controlled trials, cost-effectiveness analyses, and dissemination science. If successful, this project will provide new and sustainable approaches for accelerating adoption of CER evidence for childhood obesity screening and management and for improving quality of care for childhood obesity in pediatric primary care.

Conditions
Obesity
Being tested
STAR - Study of Technology to Accelerate Research
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STAR - Study of Technology to Accelerate ResearchBehavioural

    In 14 pediatric practices, to conduct a cluster-randomized controlled trial to examine the extent to which computerized point of care decision alerts to pediatric primary care providers, with or without direct-to-parent communications, will increase adoption of comparative effectiveness research evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥ 95th percentile.

Study groups in NCT01537510
Study groupRoleWhat they receive
Usual CareActive comparatorNot described
Receives: Behavioral: STAR - Study of Technology to Accelerate Research
Clinician intervention onlyExperimentalThis arm will entail the development and deployment of alerts and access to a SmartSet at the time of a well child visit with a child between the ages of 6-12 years with a BMI ≥ 95th percentile.
Receives: Behavioral: STAR - Study of Technology to Accelerate Research
Clinician intervention plus Direct-to-parent communicationExperimentalParents of children enrolled in this intervention arm will receive mailings, text messages and a series of 4 calls with a health coach to encourage behavior change in addition to the intervention received by the clinicians.
Receives: Behavioral: STAR - Study of Technology to Accelerate Research

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling

    Measured: Baseline and 1 Year

Secondary outcomes (3)
  1. Change in Body Mass Index

    Outcomes at 1 year will include changes from baseline in Body mass index defined as the ratio of weight (kg) to the square of standing height (m)

    Measured: Baseline and 1 year

  2. Change in Health Behaviors

    1. Sugar-sweetened beverage intake, 2) Fast food, 3) Physical activity, 4) TV viewing and 5) sleep.

    Measured: Baseline and 1 year

  3. Costs (including clinician and family time) and cost-effectiveness in terms of children's change in BMI and weight-related behaviors

    We will study the costs of our intervention with two goals: (a) to inform clinicians and policymakers about what investment would be required to adopt this intervention in other settings, and (b) to generate key assumptions for analysis of the cost-effectiveness of the intervention.

    Measured: For the duration of the intervention, from planning through completion of the intervention, up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2012 (estimated)
  2. Study startDec 2010
  3. Primary completionAug 2013
  4. Study completionSep 2013

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
549 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01537510
Sponsor's protocol ID
1R18AE000026
Acronym
STAR
Status last verified
Sep 2013
First submitted
7 Feb 2012
Last updated
27 Sep 2013
Results posted
No

Publications

  • Fiechtner L, Fonte ML, Castro I, Gerber M, Horan C, Sharifi M, Cena H, Taveras EM. Determinants of Binge Eating Symptoms in Children with Overweight/Obesity. Child Obes. 2018 Nov/Dec;14(8):510-517. doi: 10.1089/chi.2017.0311. Epub 2018 Aug 28.

    PubMed 30153037
  • Taveras EM, Marshall R, Kleinman KP, Gillman MW, Hacker K, Horan CM, Smith RL, Price S, Sharifi M, Rifas-Shiman SL, Simon SR. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial. JAMA Pediatr. 2015 Jun;169(6):535-42. doi: 10.1001/jamapediatrics.2015.0182.

    PubMed 25895016
  • Taveras EM, Marshall R, Horan CM, Gillman MW, Hacker K, Kleinman KP, Koziol R, Price S, Simon SR. Rationale and design of the STAR randomized controlled trial to accelerate adoption of childhood obesity comparative effectiveness research. Contemp Clin Trials. 2013 Jan;34(1):101-8. doi: 10.1016/j.cct.2012.10.005. Epub 2012 Oct 22.

    PubMed 23099100

Questions about this trial

What is this clinical trial studying?

A study testing STAR - Study of Technology to Accelerate Research in people with Obesity, run by Harvard Pilgrim Health Care 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 4 inclusion and 4 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 27 Sep 2013. 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?

Change in screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling (time frame: Baseline and 1 Year). 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 NCT01537510, which also lists 3 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 27 Sep 2013.

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