Educational Intervention and Toddler Bottle Use
Conditions
Keywords
Toddler Bottle Use, Educational Intervention, Pediatrics, Iron Deficiency
Brief summary
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.
Interventions
BEHAVIORALEducational 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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Months to 1 Years
Healthy volunteers
Yes
Inclusion criteria
* Children and their families who participated in The Applied Research Group for Kids (TARGet Kids!) pragmatic RCT
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Iron Depletion | Baseline, 2 years | Iron depletion (serum ferritin \< 10 μg/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Current Bottle Use | 2 years | Current daytime bottle use. |
| Current Nighttime Bottle Use | 2 years | Current nighttime bottle use. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 129 |
| 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. | 122 |
| Total | 251 |
Baseline characteristics
| Characteristic | Educational Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 9.25 months STANDARD_DEVIATION 0.38 | 9.24 months STANDARD_DEVIATION 0.41 | 9.25 months STANDARD_DEVIATION 0.4 |
| Sex: Female, Male Female | 66 Participants | 53 Participants | 119 Participants |
| Sex: Female, Male Male | 63 Participants | 69 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 129 | 0 / 122 |
| serious Total, serious adverse events | 0 / 129 | 0 / 122 |
Outcome results
Primary
Change in Iron Depletion
Iron depletion (serum ferritin \< 10 μg/L).
Time frame: Baseline, 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Educational Intervention | Change in Iron Depletion | Iron depletion - No | 88 percentage of participants |
| Educational Intervention | Change in Iron Depletion | Iron depletion - Yes | 12 percentage of participants |
| Control | Change in Iron Depletion | Iron depletion - No | 83 percentage of participants |
| Control | Change in Iron Depletion | Iron depletion - Yes | 17 percentage of participants |
Secondary
Current Bottle Use
Current daytime bottle use.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Educational Intervention | Current Bottle Use | 15 participants |
| Control | Current Bottle Use | 40 participants |
Secondary
Current Nighttime Bottle Use
Current nighttime bottle use.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Educational Intervention | Current Nighttime Bottle Use | 3 participants |
| Control | Current Nighttime Bottle Use | 10 participants |