N/A
N=28
Pattern - Reach Aim 2
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04216264 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire — 4; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard response (Behavioral); Targeted response (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire |
4; 2 | — |
| PRIMARY Percentage of Successful Contacts With Families Via Telephone and/or in Clinic |
85.8; 100 | — |
| SECONDARY Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age |
71.4; 33.3 | — |
| SECONDARY Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age |
71.4; 33.3 | — |
| SECONDARY Percent of Participants Reporting "Never" Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age |
42.9; 100 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04216264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.