Pattern - Reach Aim 2

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT04216264

Collaborator

(none)

Enrollment

Location

Arms

11.9

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Standard response Behavioral: Targeted response	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 7, 2020

Actual Primary Completion Date :

May 4, 2021

Actual Study Completion Date :

May 4, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Response

Behavioral: Standard response

Parents pick from a menu of behavior changes

Other: Non-response

Behavioral: Targeted response

Stepped up phone interaction with parents based on menu of behavior changes

Outcome Measures

Primary Outcome Measures

Percent of participants satisfied or very satisfied with information given to them, as measured by follow up questionnaire [10 minutes]
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 [6 months]
Number of successful contacts with families divided by number of attempts to contact by research staff

Secondary Outcome Measures

Breastfeeding, as measured by questionnaire [4 months]
Percent of participants exclusively breastfeeding at 4 months postnatal age
Delayed complementary feeding [4 months]
Percent of participants delaying complementary feeding until 4 months postnatal age
Screen/TV time [4 months]
Percent of participants reporting "never" engaging in screentime while feeding and with '0' minutes of active TV watching at 4 months postnatal age

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Weeks to 2 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27705

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator: Charles Wood, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT04216264

Other Study ID Numbers:

Pro00102738

First Posted:

Jan 2, 2020

Last Update Posted:

Jun 28, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Duke University

infant

mother-baby

Study Results

No Results Posted as of Jun 28, 2021