ObesityTIDENCT01768533
Pediatric Behavioral Informatics to Prevent Cancer
An observational study of Obesity, run by University of Massachusetts, Boston at 1 site in United States.
Trial summary
The goal of this study is to do formative research which will lead ultimately to the development of a computer-based system called Tailored Information for Diet and Exercise or TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in children. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 305 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2011
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population of parents with children ages 4-10 years who reside in the Greater Boston area. Parents are defined as primary care givers or legal guardians who take primary responsibility for the child's health which includes attending the child's well-care visits.
Who may be able to join
- primary care givers or legal guardians of children 4-10 years of age who has attended the last two well-child visits with their child
Who cannot join
- parent cares for a child who is on a special diet prescribed by pediatrician
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to do formative research which will lead ultimately to the development of a computer-based system called Tailored Information for Diet and Exercise or TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in children. The system will be used by physicians and parents/primary care givers in pediatric primary care practices with the aim of improving parent-pediatrician interactions related to counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of the child in the waiting room and assesses topic areas related to energy balance behaviors (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey administration.
- Conditions
- Obesity
- Keywords
- pediatric, obesity, prevention, health behaviors, guidelines
- Medical subject headings
- Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Survey | A lifestyle survey was administered to primary-care givers or legal guardians who take their children 4-10 y/o to the pediatric well-child visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sugar-sweetened beverages
Behavioral outcome measure of the amount of sugar-sweetened beverages consumed.
Measured: one time point (baseline only)
Secondary outcomes (1)
BMI
weight status as defined by body mass index (BMI)
Measured: one time point (baseline only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completionAug 2011
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 ObesityStudies 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Wright, University of Massachusetts, Boston
- Investigators
- Julie A Wright, PhD, Principal investigator, UMass Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768533
- Sponsor's protocol ID
- 5K07CA113643
- Acronym
- TIDE
- Status last verified
- Jan 2013
- First submitted
- 26 Dec 2012
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wright JA, Whiteley JA, Watson BL, Sheinfeld Gorin SN, Hayman LL. Tailored communications for obesity prevention in pediatric primary care: a feasibility study. Health Educ Res. 2018 Feb 1;33(1):14-25. doi: 10.1093/her/cyx063.
PubMed 29112721Wright JA, Adams WG, Laforge RG, Berry D, Friedman RH. Assessing parental self-efficacy for obesity prevention related behaviors. Int J Behav Nutr Phys Act. 2014 Apr 22;11:53. doi: 10.1186/1479-5868-11-53.
PubMed 24750693
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Behavioral Informatics to Prevent Cancer
- ClinicalTrials.gov ID
- NCT01768533
- Acronym / sponsor ID
- TIDE / 5K07CA113643
- Conditions
- Obesity
- Keywords
- pediatric, obesity, prevention, health behaviors, guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Jan 2013 (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 do formative research which will lead ultimately to the development of a computer-based system called Tailored Information for Diet and Exercise or TIDE for short. TIDE will target energy balance behaviors to prevent the onset of obesity in children. The system will be used by physicians and parents/primary care givers in pediatric primary care practices with the aim of improving parent-pediatrician interactions related to counseling and anticipatory guidance on energy balance behaviors. The aim of this study is to develop a one-two page, paper-pencil proxy questionnaire that is used to query the parent of the child in the waiting room and assesses topic areas related to energy balance behaviors (EBB). The questionnaire will be referred to as the energy balance behaviors questionnaire (EBB-Q). This will require focus groups, cognitive testing of the questionnaire, and survey administration.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey | – | –A lifestyle survey was administered to primary-care givers or legal guardians who take their children 4-10 y/o to the pediatric well-child visits. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population of parents with children ages 4-10 years who reside in the Greater Boston area. Parents are defined as primary care givers or legal guardians who take primary responsibility for the child's health which includes attending the child's well-care visits.
Key inclusion criteria (1 listed)
- primary care givers or legal guardians of children 4-10 years of age who has attended the last two well-child visits with their child
Key exclusion criteria (1 listed)
- parent cares for a child who is on a special diet prescribed by pediatrician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sugar-sweetened beverages
Time frame: one time point (baseline only)
Behavioral outcome measure of the amount of sugar-sweetened beverages consumed.
1 secondary outcome
BMI
Time frame: one time point (baseline only)
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 15 Jan 2013.
- Derived from this study: PubMed 29112721Wright JA, Whiteley JA, Watson BL, Sheinfeld Gorin SN, Hayman LL. Tailored communications for obesity prevention in pediatric primary care: a feasibility study. Health Educ Res. 2018 Feb 1;33(1):14-25. doi: 10.1093/her/cyx063.
- Derived from this study: PubMed 24750693Wright JA, Adams WG, Laforge RG, Berry D, Friedman RH. Assessing parental self-efficacy for obesity prevention related behaviors. Int J Behav Nutr Phys Act. 2014 Apr 22;11:53. doi: 10.1186/1479-5868-11-53.
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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.
Julie A Wright, PhD principal investigator
UMass Boston
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 Obesity, run by University of Massachusetts, Boston 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 1 inclusion and 1 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 15 Jan 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?
sugar-sweetened beverages (time frame: one time point (baseline only)). 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 NCT01768533, 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 15 Jan 2013; AzTrials last refreshed its copy on 4 Nov 2026.