Family Empowerment for Enhanced Development

Obesity, Childhood Clinical Trial

— Project FEED  

Official title:

Family Empowerment for Enhanced Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641716
• Other study ID #: PRO17070504
• Secondary ID: UL1TR001857
• Status: Completed
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: January 2, 2020

Study information

• Verified date: November 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Feeding Behavior
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Mealtime PREP Intervention
Each session will include didactic elements and skills training along with skills practice and feedback. Parents will learn to build structured mealtime routines, manage child mealtime behavior, and incorporate exploration and play into routines.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline 3-Day Food Diary (Dietary Variety) at 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.	baseline and 3 months
Secondary	Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months	36 item scale validated in a sample of low-income families with preschoolers to assess parental stress in three domains and overall. Raw scores are converted to percentiles for interpretation using this tool. For the total parenting stress score, and all three domain scores (Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child), higher percentiles are interpreted as higher stress (range =1-99%) with scores >90% indicating clinically significant levels of parenting stress. We are reporting the Total parenting stress score.	Baseline, 3 months
Secondary	Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months	17 item, validated screen for young children (1-5 years) that categorizes risk of nutritional problems into 3 categories (score range = 1 (minimum) - 68 (maximum); 1 - 20 = low risk, 21-25 = moderate risk, and 26+ = high risk). Higher scores indicate higher risk for nutritional problems (i.e. lower scores are better).	baseline and 3 months