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Family Empowerment for Enhanced Development (Project FEED)

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ClinicalTrials.gov Identifier: NCT03641716
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Angela Caldwell, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Feeding Behavior Behavioral: Mealtime PREP Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Repeated Measures
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Family Empowerment for Enhanced Development
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Mealtime PREP Intervention
Parents of young children will receive 6 weekly sessions, each lasting approximately one-hour, in the home environment. An occupational therapy clinician will deliver the Mealtime PREP intervention to the family.
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.
Other Name: Promoting Routines of Exploration and Play during Mealtime




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) at 3 months [ Time Frame: baseline and 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.

  2. Change from Baseline Nutrition Screening Tool for Every Preschooler (nutritional risk) at 3 months [ Time Frame: baseline and 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).



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641716


Contacts
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Contact: Angela R Caldwell, PhD 4123837231 ARL78@pitt.edu
Contact: Laura Waterstram, MOT 4123831055 LFW11@pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Angela R Caldwell, PhD    412-383-7231    arl78@pitt.edu   
Contact: Laura Waterstram, MOT    412-383-1055    lfw11@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Angela R Caldwell University of Pittsburgh

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Responsible Party: Angela Caldwell, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03641716     History of Changes
Other Study ID Numbers: PRO17070504
UL1TR001857 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angela Caldwell, University of Pittsburgh:
early childhood, family, occupational therapy
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms