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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01040897 |
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Date of registration:
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28/12/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Addressing Health Literacy and Numeracy to Prevent Childhood Obesity
GreenLight |
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Scientific title:
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Addressing Health Literacy and Numeracy to Prevent Childhood Obesity |
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Date of first enrolment:
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April 28, 2010 |
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Target sample size:
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865 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01040897 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Shonna Yin, MD MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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NYU |
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Name:
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Russell L Rothman, MD MPP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University |
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Name:
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Kori Flower, MD MS MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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UNC Chapel Hill |
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Name:
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Alan Delamater, LP PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Miami |
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Name:
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Eliana Perrin, MD MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke University |
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Name:
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Lee Sanders, MD MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Key inclusion & exclusion criteria
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Specific Inclusion Criteria at the parent-child dyad level will include:
- Consent from a primary caregiver (i.e., parent or legal guardian)
- Caregiver's ability to speak English or Spanish
- Infant presenting for a 2 month well-child visit (child is 6 = 12 weeks old)
- Caregiver agrees to participate in the study, and agrees to bring their child to all
well-child care visits until their 2 year well-child care visit.
Specific Exclusion Criteria at the parent-child dyad level will include:
- Child born prior to 32 weeks' gestational age or with a birth weight < 1500 grams
- Child with weight/length < 3rd percentile at 2 months of age
- Child with a diagnosis of failure to thrive or with weight that has dropped = 2
percentile curves since the previous well child visit
- Child with known medical problems that may affect their ability to thrive or requires
a special diet (e.g. metabolic disease, uncorrected congenital heart disease, renal
disease, lung disease)
- Caregiver with significant mental or neurologic illness likely to impair their ability
to participate
- Caregiver age < 18 years
- Caregiver with known plans to move out of the immediate area during the study period
- Caregiver with poor visual acuity (i.e. vision worse than 20/50 with Rosenbaum Pocket
Screener as assessed at the time of recruitment)
Specific Inclusion Criteria at the Pediatric Resident level will include:
- Participation in the medical center's pediatric resident training program
- Providing regular care (> 3 sessions per month) in the pediatric resident primary care
clinic; AND
- Consent to participate in the study
Specific Exclusion Criteria at the Pediatric Resident level will include:
- Providing no regular care in the pediatric resident primary care clinic (e.g.,
transitional-year resident, Medicine/Pediatrics resident); OR
- Known plans to leave the training program during the ensuing 6 months
Age minimum:
6 Weeks
Age maximum:
12 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity Prevention
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Intervention(s)
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Behavioral: Injury Prevention Arm
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Behavioral: Health Communication and Obesity Prevention
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Primary Outcome(s)
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Percent of children overweight or obese (BMI = 85th%) at 2 years of life
[Time Frame: 2 years]
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Secondary Outcome(s)
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BMI z score
[Time Frame: 2 years]
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Change in Weight/Length z-score over time
[Time Frame: 2 years]
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Physician knowledge and satisfaction
[Time Frame: 2 years]
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Parental report of infant eating and physical activity behaviors
[Time Frame: assessed at each well child visit]
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Parental assessment of physician communication
[Time Frame: each clinic visit]
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Parental self-efficacy
[Time Frame: 2 years]
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Secondary ID(s)
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1R01HD059794-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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