Clinical trial NCT03641716: Family Empowerment for Enhanced Development
Official title: Family Empowerment for Enhanced Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Feeding Behavior
Keywords: early childhood, family, occupational therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated Measures
Primary purpose: PREVENTION

Brief summary: This study evaluates the feasibility and preliminary effects of offering the Mealtime PREP intervention to low-income families with young children. All enrolled families will receive the Mealtime PREP intervention in the home to evaluate the effects on child nutrition.

Detailed description: Children have not been spared from the obesity epidemic. There is a great need for innovative interventions to help families build healthy habits early in life for obesity prevention. Low-income preschoolers have a disproportionately high rate of childhood obesity, and their families face complex barriers to healthy behavior change. This proposed pilot study will examine the feasibility of delivering the Promoting Routines of Exploration and Play during Mealtime (Mealtime PREP) intervention in a sample of low-income families with young children (ages 2-5). Our parent-mediated intervention is designed to promote healthy dietary variety using routine family meals, positive reinforcement, social modeling, and food exploration and play. By harnessing the behavior change capacity of behavioral activation to alter daily mealtimes incrementally, parents are empowered to overcome barriers to healthy habit formation. Each family will participate in a six-week intervention that is delivered by occupational therapy clinicians in the home environment. Each session will last approximately one hour and include individualized parent-training and a parent-led mealtime with direct feedback from the clinician. We planned to screen up to 100 potential parent and child participants, with a plan to deliver intervention to 20 child participants.

Eligibility criteria: Inclusion Criteria:

Child:

* within age range 2-5 years
* reside in a low-income household (as specified by income within the range to qualify for Special Supplemental Nutrition Program for Women, Infants, and Children.

Parent:

* \>18 years old
* ability to read and speak in English
* willing to participate in 6 home-based intervention sessions

Exclusion Criteria:

* None

Primary outcomes:
measure: Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months
timeFrame: Baseline, 3 months
measure: Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Angela R Caldwell
role: PRINCIPAL_INVESTIGATOR
References: