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Clinical Trials/NCT03641716
NCT03641716CompletedNot Applicable

Family Empowerment for Enhanced Development

University of Pittsburgh2 sites in 1 country20 target enrollmentStarted: February 26, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
2 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months

Time Frame: baseline and 3 months

The 3-Day Food Diary is the preferred method of dietary assessment (intake and variety of food consumed) because of a balance between validity and burden. Includes all food consumed and approximate servings for 3 days. Servings of foods consumed from each food group will be tallied and compared to national daily recommendations. We calculated the number of unique foods consumed at baseline and the 3-month follow-up.

Secondary Outcomes

  • Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months(baseline and 3 months)
  • Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months(Baseline, 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Angela Caldwell

Assistant Professor

University of Pittsburgh

Study Sites (2)

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