Pattern - Reach Aim 2

NCT04216264 | Completed Results

• 2 other identifiers: Pro00102738U54MD012530
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

infant; mother-baby

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age

  3 to 6 months after baseline assessment

• Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age

  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

  3 to 6 months after baseline assessment

Study Arms (2)

Response

OTHER

Behavioral: Standard response

Non-response

OTHER

Behavioral: Targeted response

Interventions

Standard response BEHAVIORAL

Parents pick from a menu of behavior changes

Response

Targeted response BEHAVIORAL

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

Non-response

Eligibility Criteria

• Age: 2 Weeks - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Charles Wood
• Organization: Duke University

charles.wood@duke.edu

919-620-4772

Study Officials

• Charles Wood

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: May 7, 2020
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: November 16, 2022
• Results First Posted: November 16, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)