Childhood ObesityPhase 2HEATNCT01188616
IT-Supported Early Treatment Of Childhood Overweight
A Phase 2 study testing Telephone Linked Care-HEAT (TLC-HEAT) in people with Childhood Obesity and Technology Based Obesity Intervention, run by Boston Medical Center at 1 site in United States.
Trial summary
The goal of this exploratory/ developmental study is to develop and evaluate an integrated information system, Healthy Eating and Activity Today (HEAT), for promoting self-care in overweight children. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Childhood Obesity, Technology Based Obesity Intervention
- What is being tested?
- Telephone Linked Care-HEAT (TLC-HEAT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to May 2010
- Phase
- Phase 2
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children will be enrolled in the study if they meet a set of eligibility criteria which includes:
- 0-3 BMI points above the 95th %ile for age and gender
- age 9-12 years old
- a PCP at BMC
- an English speaking child and parent (based on interviewer assessment).
Who cannot join
- Children will be considered ineligible for the study if they:
- have a health condition for which dietary recommendations in TLC-HEAT would be contraindicated
- have cognitive impairment (not in a mainstream academic class in school)
- have a terminal illness, current or former diagnosis of an eating disorder, or other diagnosis that the PCP deems should exclude them from participation
- plan to move away from the Boston area in less than 12 months
- are participating in another clinical weight treatment program.
- Initial screening will be done by research assistants over the phone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated Self-management System to Promote Healthy Eating and Activity in Overweight Children
The goal of this exploratory/ developmental study is to develop and evaluate an integrated information system, Healthy Eating and Activity Today (HEAT), for promoting self-care in overweight children. HEAT is comprised of two components: 1)Telephone Linked Care-HEAT (TLC-HEAT), a self-care intervention delivered at home through totally automated telephone conversations; and 2) Primary Care-HEAT (PC-HEAT), a primary care intervention linked with TLC-HEAT and delivered through an electronic health record (EHR). The HEAT system will guide children in the early stages of overweight, i.e., children with Body Mass Index (BMI) 0-3 BMI points above the 95th percentile for age and gender, toward healthy weight management and assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.
Read the detailed description
For this project we will: 1) develop TLC-HEAT for use by children in the earliest stage of overweight and their parents; 2) integrate TLC-HEAT with an electronic health record to provide child- and parent-reported behavior summaries combined with evidence-based decision support to primary care providers (PCPs) at the point-of-care (PC-HEAT); and 3) conduct a pilot study of the combined HEAT system to explore the appropriateness of conducting a larger, randomized clinical trial in the future.
- Being tested
- Telephone Linked Care-HEAT (TLC-HEAT)
- Keywords
- Childhood Obesity, Obesity Intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Linked Care-HEAT (TLC-HEAT)Behavioural
A primary care intervention linked with Telephone Linked Care-HEAT (TLC-HEAT), and delivered through an electronic health record (EHR). The HEAT system will guide children in the early stages of overweight toward healthy weight management and assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJul 2005
- Primary completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- William Adams, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188616
- Sponsor's protocol ID
- H-24963
- Other IDs
- R21HD050939-01
- Acronym
- HEAT
- Status last verified
- Aug 2010
- First submitted
- 24 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Self-management System to Promote Healthy Eating and Activity in Overweight Children
- ClinicalTrials.gov ID
- NCT01188616
- Acronym / sponsor ID
- HEAT / H-24963
- Keywords
- Childhood Obesity, Obesity Intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2005
- Primary completion
- May 2010 (actual)
- First posted
- 25 Aug 2010 (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 exploratory/ developmental study is to develop and evaluate an integrated information system, Healthy Eating and Activity Today (HEAT), for promoting self-care in overweight children. HEAT is comprised of two components: 1)Telephone Linked Care-HEAT (TLC-HEAT), a self-care intervention delivered at home through totally automated telephone conversations; and 2) Primary Care-HEAT (PC-HEAT), a primary care intervention linked with TLC-HEAT and delivered through an electronic health record (EHR). The HEAT system will guide children in the early stages of overweight, i.e., children with Body Mass Index (BMI) 0-3 BMI points above the 95th percentile for age and gender, toward healthy weight management and assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.
Detailed description
For this project we will: 1) develop TLC-HEAT for use by children in the earliest stage of overweight and their parents; 2) integrate TLC-HEAT with an electronic health record to provide child- and parent-reported behavior summaries combined with evidence-based decision support to primary care providers (PCPs) at the point-of-care (PC-HEAT); and 3) conduct a pilot study of the combined HEAT system to explore the appropriateness of conducting a larger, randomized clinical trial in the future.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children will be enrolled in the study if they meet a set of eligibility criteria which includes:
Key exclusion criteria (7 listed)
- Children will be considered ineligible for the study if they:
- Initial screening will be done by research assistants over the phone.
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 |
|---|---|---|
| Telephone Linked Care-HEAT (TLC-HEAT)A primary care intervention linked with Telephone Linked Care-HEAT (TLC-HEAT), and delivered through an electronic health record (EHR). The HEAT system will guide children in the early stages of overweight toward healthy weight management and assist the child's parent(s) and primary care provider (PCP) to support the child's efforts. | Behavioural | – |
Primary outcome
Not reported in the source record.
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 Aug 2010.
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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 Adams, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telephone Linked Care-HEAT (TLC-HEAT) in people with Childhood Obesity and Technology Based Obesity Intervention, run by Boston 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 5 inclusion and 7 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 Aug 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 Aug 2010.