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Observational studies support an association between bottle feeding beyond 15 to 18 months of age and lower socioeconomic status, excessive milk intake, dental caries, iron deficiency, behavioral issues and obesity. Yet many parents, particularly those from low socioeconomic households, choose to feed their children by bottle much beyond this age. Recognizing the need for further educational interventions for bottle feeding, the TARGet Kids! Research Collaboration recently developed a 5-minute bottle weaning educational intervention for the 9 month well-child visit. We undertook a pragmatic randomized controlled trial to evaluate its effectiveness involving 251 children recruited through TARGet Kids! (PMID: 20624802) The goal was to determine whether an office-based, educational intervention for parents of 9-month-old children could reduce bottle use and iron depletion at 2 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Intervention | Experimental | Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling. |
|
| Control | Placebo Comparator | Parents in this arm received a placebo which consisted of standard nutritional counseling alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Behavioral | Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Iron Depletion | Iron depletion (serum ferritin < 10 μg/L). | Baseline, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Current Bottle Use | Current daytime bottle use. | 2 years |
| Current Nighttime Bottle Use | Current nighttime bottle use. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathon Maguire, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Educational Intervention | Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling. Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information. |
| FG001 | Control | Parents in this arm received a placebo which consisted of standard nutritional counseling alone. Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Educational Intervention | Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling. Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Iron Depletion | Iron depletion (serum ferritin < 10 μg/L). | Posted | Number | percentage of participants | Baseline, 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Educational Intervention | Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling. Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathon Maguire | St. Michael's Hospital | (416) 919-3462 | jonathon.maguire@utoronto.ca |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
| BG001 | Control | Parents in this arm received a placebo which consisted of standard nutritional counseling alone. Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Control | Parents in this arm received a placebo which consisted of standard nutritional counseling alone. Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information. |
|
|
| Secondary | Current Bottle Use | Current daytime bottle use. | Posted | Number | participants | 2 years |
|
|
|
| Secondary | Current Nighttime Bottle Use | Current nighttime bottle use. | Posted | Number | participants | 2 years |
|
|
|
| 0 |
| 129 |
| 0 |
| 129 |
| EG001 | Control | Parents in this arm received a placebo which consisted of standard nutritional counseling alone. Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information. | 0 | 122 | 0 | 122 |
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| D011314 | Preventive Health Services |