Pattern - Reach Aim 2

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216264
• Other study ID #: Pro00102738
• Secondary ID: U54MD012530
• Status: Completed
• Phase: N/A
• Start date: May 7, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: October 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Weeks to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Standard response
Parents pick from a menu of behavior changes
• Targeted response
Stepped up phone interaction with parents based on menu of behavior changes

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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