Pattern - Reach Aim 2

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Targeted response; Behavioral: Standard response

• Registration Number: NCT04216264
• Lead Sponsor: Duke University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Study Start: 2020-05-07
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Results First Submitted: 2022-07-21
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-21
• Last Update Submitted: 2022-10-21
• Results First Posted: 2022-11-16
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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Exclusion Criteria

• non-English-speaking; infant with serious disease or disorder affecting growth and nutrition

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Non-response	Targeted response	-
Response	Standard response	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age	3 to 6 months after baseline assessment	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.
Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age	3 to 6 months after baseline assessment	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
Percent of Participants Reporting "Never" Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age	3 to 6 months after baseline assessment	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

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States