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Completed

NCT Number: NCT04216264

Pattern - Reach Aim 2

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.

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Key information

Conditions

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

Age range

2 week–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard response

Behavioral

Parents pick from a menu of behavior changes

Targeted response

Behavioral

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

Primary outcomes

  1. Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire

    Time frame: 3 to 6 months after baseline assessment

    Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied

  2. Percentage of Successful Contacts With Families Via Telephone and/or in Clinic

    Time frame: 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 outcomes

  1. Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age

    Time frame: 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.

  2. Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age

    Time frame: 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

  3. Percent of Participants Reporting "Never" Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 2, 2020
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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