Family Empowerment for Enhanced Development
Phase: NA
Conditions: Obesity, Childhood, Feeding Behavior
Sponsor: University of Pittsburgh

 
 
 
 
 
 
 
 
 
Study Protocol  
Official Title: Family Empowerment for Enhanced 
Development (Project FEED) 
ClinicalTrials.gov ID (NCT number): NCT03641716 
Protocol Date: 5/14/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Scientific Background: Despite increased public awareness, childhood obesity 
rates have nearly tripled over the past four decades and remain high. Child onset obesity takes 
a toll on all aspects of health, as it increases risk for poor school performance, social isolation, 
Type 2 diabetes, sleep apnea and predicts obesity as an adult. Low-income preschoolers are 
disproportionately affected; approximately 15% of preschoolers from low-income families are 
obese prior to their fifth birthday, as compared with 8% observed in the general population. 
Building preventative healthy habits during early childhood is crucial, as rates of obesity 
increase among school-age children. While it is clear that genetics and social factors, such as 
income, ethnicity, and minority status, influence obesity, poor nutrition and lack of physical 
activity are recognized as the primary causal mechanisms. Therefore, the World Health 
Organization has called for interventions to improve nutrition and physical activity early in life. 
Specific to building healthy dietary variety, early intervention is vital because children are more 
receptive to trying new foods prior to age five, and early food preferences in young children are 
likely to carry forward into adulthood. Partnering with families to build healthy dietary habits 
early is a pivotal component of obesity prevention efforts. Our study will focus on this outcome, 
promoting healthy nutrition, among low-income preschoolers. 
Because parents are responsible for the timing, setting, and foods offered during child meals, 
they hold the key to shifting the mealtime routines of young children. Embedding parent-
mediated intervention strategies into a child’s daily natural environment has been widely 
endorsed as best practice, yet evidence to support current methods of parent-training in the 
home is limited. Innovative parent-training strategies are needed, as parents of young children 
report difficulty incorporating new skills into established daily routines. Our pilot data support the 
premise that training parents to create a mealtime environment enriched with healthy role 
models and repeated exposure to a variety of foods can improve child nutrition. We predict that 
these behavioral and environmental changes are more likely to persist when routines are family-
centered and practiced in the natural environment. 
Motivational interviewing and anticipatory guidance have been used to change home routines of 
preschoolers. While these techniques have improved routines related to sleep and television 
watching, changes in mealtime have not been observed and effects on child nutrition are 
unclear. Many of these studies offer disparate strategies to support healthy weight management 
without connecting these strategies to existing family routines or considering unique family 
dynamics. These strategies can be modified to meet the needs of each family, but this 
opportunity is often overlooked. This is particularly important for low-income parents who are 
likely to be focused on surviving life stressors, and have limited resources to independently 
solve these problems. Additionally, these interventions are delivered in a variety of formats 
(face-to-face, mail, phone calls, text messages), some of which lack the capacity for 
individualized problem solving to overcome barriers. While parents perceive mailed and phone-
based intervention-delivery as convenient, they may lack the structure and support required for 
long-term behavior change. 
 
Furthermore, few studies include formal follow-up procedures related to successes and failures 
implementing new routines or strategies. Our prior research highlights the importance of 
individualized feedback during routine family activities. In a small pilot trial of the Mealtime 
PREP intervention, we found that those children whose parents received feedback during actual 
family meals were significantly more likely to respond to treatment than those who had received 
feedback based on parent report. Occupational therapists are uniquely trained to examine the 
dynamic transaction between the person (family), environment, and activity that they are 
engaged in to provide customized feedback or recommendations to support optimal 
performance. Evaluation of this dynamic interplay is lacking in current health promotion 
interventions of early childhood; the Mealtime PREP intervention provides a systematic 

framework to deliver this feedback. 
In our early pilot work, the Mealtime PREP intervention empowered parents from middle to high-
income families to increase the frequency of family meals, feel confident about managing daily 
meals, and change daily mealtime routines. However, this study focused on children with 
Sensory Food Aversions and our convenience sample was homogenous and lacked diversity. 
Because of the complex barriers faced by low-income families, further investigation is required 
to determine how to best serve these families. Despite economic, attitudinal and accessibility 
limitations, longitudinal surveillance of this population has revealed that positive parenting 
interventions to prevent behavioral issues and aggression appear to have a protective capacity 
against obesity. While not the primary intent of these interventions, this evidence provides a 
signal that early intervention focused on parent education, empowerment, and behavior change 
is a promising approach for obesity prevention. While we are not able to test whether the 
Mealtime PREP intervention effectively prevents obesity over a 12-week period, the purpose of 
this trial is to gather data to optimize our approach and meet the needs of low-income families 
for future trials with long-term follow-up. 
 
Study Objectives: The purpose of this pilot project is to trial the Mealtime PREP 
intervention program with a sample of low-income families. 
 
Specifically, we aim: 
1. To examine the feasibility and acceptability of the Mealtime PREP intervention among low-
income families with a preschooler. 
2. To estimate the effects of Mealtime PREP on dietary variety, nutrition, and mealtime 
behaviors of low-income preschoolers. 
 
Study Design& Methods: We plan to use a prospective, repeated-measures 
study design with data collection occurring at baseline, 6 weeks (post-intervention), and 12 
weeks (follow-up). Twenty low-income families with a preschooler will be recruited from waiting 
rooms and/or staff referral at local WIC, Head Start, and pediatric primary care offices. 
Interested parents will undergo basic screening procedures (i.e. providing responses to 
screening questions to determine eligibility) prior to being consented to participate in the study. 
 
After eligibility has been confirmed, interested parent participants will undergo the consent 
process with a trained research assistant and/or the principal investigator in the home 
environment or an agreed upon alternative in the community. Following informed consent, 
baseline assessments (including video-recording a typical child meal) will take place. If the child 
meal is of average length (approximately 20 minutes), this session will last approximately 60-90 
minutes. Additionally, they will be asked to complete a 3 day food diary where they log their 
child's food intake for three days. 
 
Trained research interventionists will then schedule six weekly sessions to take place in the 
family home or an agreed upon alternative in the community. Each session will last 
approximately one-hour and will include didactic and practice portions with the therapist 
demonstrating techniques during a child meal and providing feedback as needed. The entire 
session will be video-recorded by the interventionist. 
 
Mealtime PREP – Parent Experience: Parents are trained to deliver each intervention 
component during mealtimes using a step-wise, behavioral activation approach. The parent-

training prong of the Mealtime PREP intervention incorporates four active ingredients of 
behavioral activation (1. skills training; 2. goal-setting; 3. activity scheduling; and 4. activity 
monitoring) to help parents build a family meal routine that is enriched with techniques to 
promote child nutrition (Figure 1). Trained research interventionists with experience in pediatric 
occupational therapy will lead six weekly parent-training sessions in the home. During each 
session a new intervention component (e.g. Family Meals, Positive Reinforcement) to promote 
healthy child feeding habits will be introduced and parents will be provided direct feedback while 
practicing new skills during a child meal. Parents will work with the therapist to set-up a plan and 
set a goal to practice delivering intervention components in the home between parent-training 
sessions. 
 
Mealtime PREP – Child Experience: The child-focused prong of the Mealtime PREP 
intervention embeds positive reinforcement of healthy eating habits and repeated exposure to 
targeted healthy foods into a consistent family meal routine. Parents will incorporate intervention 
components (Family Meals, Positive Reinforcement, Food Exploration and Food Play) into the 
child’s routine sequentially, as they are trained to deliver them. In essence, the parent will 
provide a predictable family meal routine, encourage active child participation, reward healthy 
eating habits and redirect unhealthy behaviors to acceptable alternatives. Parents will also 
model healthy eating habits and demonstrate various ways to learn about healthy foods using 
exploration and play. The intervention will be customized to accommodate a variety of 
environments, address unique family barriers and incorporate child-centered play. 
 
Trained research assistants and/or the principal investigator will conduct follow-up assessments 
within two weeks of intervention completion and approximately 12 weeks following baseline. 
Each assessment session is predicted to last approximately 60-90 minutes. They will also be 
provided with a 3-Day Food Diary and Self-addressed envelope at each of these sessions. 
 
Primary outcomes include: 
3-Day Food Diary (Caregiver Reported) Child Intake and Variety of Healthy Foods Preferred 
method of dietary assessment because of a balance between validity and burden. Includes all 
food consumed and approximate servings for 3 days. 
NutriSTEP and NutriSTEP Toddler Child Risk of Nutritional Deficiency 17 item, validated screen 
for young children (1–5 years) that categorizes risk of nutritional deficiency into 3 categories 
(low, moderate, and high).  
Parenting Stress Inventory-Short Form Parental Stress Validated tool to assess and categorize 
parental stress. 
 
Eligibility Criteria: Families will be eligible for participation if they have a child in 
the age range of two to five years old and reside in a low-income household (as specified by 
income within the range to qualify for WIC services). Parent participants will be eligible for 
participation if they are > 18 years old, speak English, read at a 6th grade level, and agree to 
deliver intervention during daily meals. 
  
Statistical Considerations 
Data Analysis: Specific Aim 1: To examine the feasibility and acceptability of the Mealtime 
PREP intervention among low-income families, we will rely on descriptive statistics (raw scores, 
frequencies, and percentages) to determine if each benchmark of feasibility has been met. 
Specific Aim 2: To estimate the effects (child dietary variety, nutrition risk, parental stress) of the 

Mealtime PREP intervention, we will calculate effect sizes (Cohen’s d) based on mean scores of 
the sample at each time point. Effect sizes will be used to predict effects among low-income 
families and calculate appropriate sample sizes for future studies. For each outcome of interest, 
we will run exploratory paired t-tests (alpha =.05) using IBM SPSS Statistics, Version 24. If the 
data is not normally distributed or if there are outliers upon data exploration, we will switch to 
equivalent non-parametric tests (e.g. Wilcoxon Signed-Rank). These results will serve as a 
signal of the ability of this intervention to change behavior over time.