Pilot Adaptive Tool To Encourage Risk Reduction in iNfancy (PATTERN)
Phase: NA
Conditions: Obesity
Sponsor: Duke University

 
 
 
 
 
 
 
 
Pilot Adaptive Tool To Encourage Risk reduction in iNfancy (PATTERN) 
 
NCT04216264 
 
Document Date: May 27, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose of the Study 
  
The primary objective of this study is to collect information on feasibility and 
acceptability of an adaptive design for behavior change in obesity risk reduction. The 
hypothesis is that there will be high parent-reported acceptability at 6 months after undergoing 
the intervention pathways. 
 
Background & Significance 
 
Obesity is a public health crisis with significant disparities and roots in the first years of 
life. Obesity prevalence among Hispanic and non-Hispanic black populations is high and begins 
early, with infants more likely to have high infant weight-for-length from birth to 2 years of age. 
A recent detailed analysis of the Early Childhood Longitudinal Study Birth Cohort determined 
that weight gain in the first 9 months of life was the most important contributor to early 
childhood obesity and infancy weight gain varied significantly by race/ethnicity.  Differences in 
the rate of infant weight gain accounted for 71% of the explained gap in BMI z-score between 
white and African-American boys. Using a “one-size-fits-all” approach to early obesity risk 
reduction among racial and ethnic minorities without exploring beliefs is inappropriate and 
likely to be unsuccessful. 
 
Design & Procedures 
 
This is a behavior change intervention with the primary intervention is targeted support 
messages relevant to three main domains: feeding, sleep, and physical activity. Participants will 
be screened for eligibility and if eligible and they consent, complete a questionnaire identifying 
current potential risks for obesity in infancy. Once one of the three domains is identified, 
parents will be given targeted educational and supportive messaging relevant to the domain 
(delivered to participants using a standardized script, which has been uploaded).  For example, 
if the parent identifies mixed bottle and breast feeding and mother desires to breastfeed more, 
the parent will be given information on breastfeeding sufficiency and connected with lactation 
support. There will be an interim period of 1-2 months, at which point the risk and parent 
desires are reassessed and if the goal for intervention is not met, the dyad is randomized to 
either: 1) receive messages and tools relevant to a second domain or; 2) step up the messaging 
in the existing domain to include connecting with families between regular visits, essentially 
doubling the contact with the behavior change messaging. There will be 3 possible in-person 
contact points corresponding to well child care visits around the time of enrollment (when the 
child is between 2 weeks and 2 months of age, 6-10 weeks later, and 16-18 weeks later). There 
will be 4 potential by-phone contact points in the “stepped up” intervention arm. The final end 
point will be at 9 months and occur in person or by phone.  
Participants will complete a questionnaire at each timepoint about their baby's feeding, 
sleep, and activity. This will be done in person at their baby's clinic appointment, or by phone.   

The study team will abstract infant growth data from the EMR for well child visits from 
enrollment through 12 months of age, including: infant name, date of visit, length, weight, WFL. 
We will also be recording information about the follow-up calls including: date of 
attempt, duration, if contact was made, context and content of call. 
 
Selection of Subjects 
  
Inclusion: non-Hispanic black (as documented in MaestroCare) parents/caregivers with; infants 
seen in the DCPC Roxboro Road, Brier Creek, or South Durham, under 2 months of age, 
birthweight between 2500 and 4000g, gestational age is at least 36 weeks. 
 
Exclusion: non-English-speaking; infant with serious disease or disorder affecting growth and 
nutrition 
 
Subject Recruitment and Compensation 
 
In person recruitment: The study team member (either PI or CRC) will approach 
parent/caregiver confidentially to discuss study; if they are on restricted research 
communication, the study team will have a provider or nurse ask the family if it is okay for us to 
approach them. Phone recruitment: the study team member will call the parent/caregiver after 
the baby has had their clinic appointment to discuss the study; alternatively, the study team 
may ask the provider to mention the study to the family and let them know that we will follow 
up by phone unless the provider tells us otherwise.  
 
The study is focused on racial and ethnic disparities in obesity, and therefore the 
population of interest is black parents and families. Otherwise, the limited exclusion criteria 
should provide an equitable opportunity to participate. 40 dyads will be recruited and each 
parent/caregiver will be given a $20 payment on a Clincard for their time participating in each 
of 3 possible in-person (or phone, if needed) contact points corresponding to well child care 
visits to compensate for time with surveys. 
 
Risk/Benefit Assessment 
 
There are no forseeable risks other than potential psychological risk of asking about 
infant health, feeding, and sleep and supporting changes to these activities. The participants 
will be allowed to defer or not respond to any questions or engage in any conversation themes 
that make them uncomfortable and can withdraw at any time. The benefits to participants are 
related to reflection on their parenting related to an infant. No other forseeable direct benefits 
to patients other than the improvement of potential interventions that their child or 
subsequent child may benefit from in a later study. 
 

Data Analysis & Statistical Considerations 
 
Analysis of the primary outcome will be description of feasibility and acceptability 
components collected throughout the study and at the endpoint corresponding to the infant’s 9 
month well visit. Analysis will be descriptive. Given small sample size and qualitative focus, 
there are no sample size calculations or quantitative statistical methods beyond descriptive 
statistics. 
 
Data & Safety Monitoring 
 
We do not anticipate any increased risks to the infants while carrying out this research. 
There is a small possibility that infants of parents receiving feeding related guidance may have 
noticeable growth changes. Parents will be told that they are able to feed the usual volume as 
required by the infant, and will not be given specific information on the volume to feed. 
However, some parents may interpret using, for example, smaller bottles and needing to feed a 
smaller volume than is needed by the infant. Due to regular follow up at 1, 2, 4, 6, and 9  
months, these infants’ growth will be regularly monitored by both our research team and the 
primary pediatrics. If for any reason at these visits, an infant’s growth is dropping below the 3rd 
percentile weight-for-age, plateauing, or decreasing, the infant’s provider will diagnose and 
intervene as appropriate, and contact the research team to review, who will also review the 
records. The clinical research coordinator and I will regularly monitor each enrolled infant’s 
growth throughout the course of the study, and if growth faltering is detected, we will contact 
the family in addition to the primary provider of the patient.