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Pediatric Behavioral Informatics to Prevent Cancer (TIDE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Wright, University of Massachusetts, Boston
ClinicalTrials.gov Identifier:
NCT01768533
First received: December 26, 2012
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Pediatric Behavioral Informatics to Prevent Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Obesity
U.S. FDA Resources

Further study details as provided by University of Massachusetts, Boston:

Primary Outcome Measures:
  • sugar-sweetened beverages [ Time Frame: one time point (baseline only) ] [ Designated as safety issue: No ]
    Behavioral outcome measure of the amount of sugar-sweetened beverages consumed.


Secondary Outcome Measures:
  • BMI [ Time Frame: one time point (baseline only) ] [ Designated as safety issue: No ]
    weight status as defined by body mass index (BMI)


Other Outcome Measures:
  • Physical activity [ Time Frame: one time point (baseline only) ] [ Designated as safety issue: No ]
    amount of time spent in moderate or greater physical activity

  • fruit and vegetables [ Time Frame: one time point (baseline only) ] [ Designated as safety issue: No ]
    amount of fruit servings and vegetable servings consumed per day.

  • screen time [ Time Frame: one time point (baseline only) ] [ Designated as safety issue: No ]
    amount of time spent watching television or recreational videos or computers


Enrollment: 305
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • parent cares for a child who is on a special diet prescribed by pediatrician
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768533

Locations
United States, Massachusetts
UMass Boston
Boston, Massachusetts, United States, 02155
Sponsors and Collaborators
University of Massachusetts, Boston
Investigators
Principal Investigator: Julie A Wright, PhD UMass Boston
  More Information

No publications provided

Responsible Party: Julie Wright, Assistant Professor, University of Massachusetts, Boston
ClinicalTrials.gov Identifier: NCT01768533     History of Changes
Other Study ID Numbers: 5K07CA113643
Study First Received: December 26, 2012
Last Updated: January 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Boston:
pediatric
obesity
prevention
health behaviors
guidelines

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013