Anticipatory Guidance to Prevent Childhood Obesity (MOMS)
| Tracking Information | |||||
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| First Received Date ICMJE | March 26, 2012 | ||||
| Last Updated Date | March 27, 2012 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Infant weight for height [ Time Frame: One year after study entry ] [ Designated as safety issue: No ] Infant weight for height will be assessed to see if proportions of elevated weight for height are lower in intervention groups as compared to usual care. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01565525 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Maternal feeding behaviors [ Time Frame: One year after study entry. ] [ Designated as safety issue: No ] Several maternal feeding behaviors, including amount of vegetables and fruit offered to infant, eating as a 'family', amount of television watching by the infant, and juice intake by the infant were secondary outcomes. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Anticipatory Guidance to Prevent Childhood Obesity | ||||
| Official Title ICMJE | Can Changing How Moms Eat Prevent Obesity in Toddlers? | ||||
| Brief Summary | The purpose of this pilot project is to test anticipatory guidance, which is information given to families during a well child visit to prevent obesity during childhood. The objectives were to compare two styles of anticipatory guidance during the first year of life, maternal focused and infant focused, versus usual care and determine which style, if any, showed the most ideal infant feeding behaviors at age 1 year and to see if there were any differences in infant weight for height at one year of age. The investigators hypothesized that mothers who received the maternal focused anticipatory guidance (which gave information on eating family meals, not having tv on during meals, and maternal nutrition) would actually have the best infant feeding behaviors and weight for height of infants at one year. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
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| Condition ICMJE | Childhood Obesity | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 306 | ||||
| Completion Date | July 2007 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Maternal/infant pairs Infant under 2 months of age Mother English speaking Exclusion Criteria: History of Neonatal ICU stay in infant Gestation less than 37 weeks in infant chronic disease in infant known genetic disorder in infant foster care placement in infant |
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| Gender | Both | ||||
| Ages | up to 2 Months | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01565525 | ||||
| Other Study ID Numbers ICMJE | HD50944 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Judith Groner, Nationwide Children's Hospital | ||||
| Study Sponsor ICMJE | Nationwide Children's Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nationwide Children's Hospital | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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