Pattern - Reach Aim 2

Study Overview
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Brief Summary
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The purpose of this research study is to learn about different approaches to promoting healthy growth among infants, and understanding parents' likes and dislikes of an approach to reducing risk factors for obesity later in life. The study includes filling out some forms with questions about your baby and your thoughts about your baby's growth and health, and engaging in a pattern of changes in or prevention of risk factors in the first year of life. Parents will receive information about changes and some tools and materials to take home with them. Some parents may receive phone calls between visits as well. The study takes place from soon after birth through the infant's age of 9 months. The estimated total time of interaction between the study staff and parents during the study period is 4 hours.

Detailed Description
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As this is a dyad study, each dyad is considered to be a participant and demographic information will reflect the infant in the dyad, per parent report.

Official Title
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Pilot Adaptive Tool To Encourage Risk Reduction in iNfancy (PATTERN)

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Standard response
* Behavioral: Targeted response


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-Hispanic black (as documented in MaestroCare) parents/caregivers with; infants ages 2 weeks to 2 months of age; infant birthweight between 2500g and 4000g; infant gestational age is at least 36 weeks Exclusion Criteria: non-English-speaking; infant with serious disease or disorder affecting growth and nutrition

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Response<br> | Behavioral: Standard response<br>* Parents pick from a menu of behavior changes<br>|
| Other: Non-response<br> | Behavioral: Targeted response<br>* Stepped up phone interaction with parents based on menu of behavior changes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire | Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied | 3 to 6 months after baseline assessment | 
| Percentage of Successful Contacts With Families Via Telephone and/or in Clinic | Number of successful contacts with families divided by number of attempts to contact by research staff x 100 | 3 to 6 months after baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age | Dyad caregivers were asked what type of milk was being consumed by the infant, with 4 options available: 1) Formula only, 2) Mostly formula and some breast milk, 3) Mostly breast milk, but some formula, or 4) Breast milk only. | 3 to 6 months after baseline assessment | 
| Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age | Dyads caregivers were asked, Is your baby eating solid foods yet or do you put any solid foods in the bottle?, with 2 options available: 1) Yes or 2) No | 3 to 6 months after baseline assessment | 
| Percent of Participants Reporting Never Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age | Dyad caregivers were asked I watch TV or look at or use my phone while feeding my baby and responded with one of 5 Likert-scale responses: 1) Never, 2) Seldom, 3) Half of the time, 4) Most of the time, 5) Always | 3 to 6 months after baseline assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mother-baby, infant