Trial Outcomes & Findings for Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial (NCT NCT02140957)

NCT ID: NCT02140957

Last Updated: 2016-02-05

Results Overview

Iron depletion (serum ferritin \< 10 μg/L).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 251 participants
• Primary outcome timeframe: Baseline, 2 years
• Results posted on: 2016-02-05

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	129	122
Overall Study COMPLETED	102	99
Overall Study NOT COMPLETED	27	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial

Baseline characteristics by cohort

Measure	Educational Intervention n=129 Participants 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.	Control n=122 Participants 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.	Total n=251 Participants Total of all reporting groups
Age, Continuous	9.25 months STANDARD_DEVIATION 0.38 • n=5 Participants	9.24 months STANDARD_DEVIATION 0.41 • n=7 Participants	9.25 months STANDARD_DEVIATION 0.40 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	53 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	69 Participants n=7 Participants	132 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 2 years

Iron depletion (serum ferritin < 10 μg/L).

Outcome measures

Measure	Educational Intervention n=102 Participants 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.	Control n=99 Participants 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.
Change in Iron Depletion Iron depletion - No	88 percentage of participants	83 percentage of participants
Change in Iron Depletion Iron depletion - Yes	12 percentage of participants	17 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Current daytime bottle use.

Outcome measures

Measure	Educational Intervention n=102 Participants 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.	Control n=99 Participants 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.
Current Bottle Use	15 participants	40 participants

SECONDARY outcome

Timeframe: 2 years

Current nighttime bottle use.

Outcome measures

Measure	Educational Intervention n=102 Participants 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.	Control n=99 Participants 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.
Current Nighttime Bottle Use	3 participants	10 participants

Adverse Events

Educational Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathon Maguire

St. Michael's Hospital

Phone: (416) 919-3462

Email: jonathon.maguire@utoronto.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place