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
|Condition or disease||Intervention/treatment||Phase|
|Obesity, Childhood Feeding Behavior||Behavioral: Mealtime PREP Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Repeated Measures|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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).
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
|Contact: Angela R Caldwell, PhD||4123837231||ARL78@pitt.edu|
|Contact: Laura Waterstram, MOT||4123831055||LFW11@pitt.edu|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15260|
|Contact: Angela R Caldwell, PhD 412-383-7231 firstname.lastname@example.org|
|Contact: Laura Waterstram, MOT 412-383-1055 email@example.com|
|Principal Investigator:||Angela R Caldwell||University of Pittsburgh|