- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03559907
Partnering for Prevention: Building Healthy Habits in Underserved Communities (P4P)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overall purpose of this research study is to estimate the nutritional benefits (in terms of intake and variety) of the Mealtime PREP intervention, as compared to, and in combination with nutrition education programming being offered in underserved neighborhoods of the greater Pittsburgh area. This project will examine the effects of Mealtime PREP groups as compared with established nutrition education groups, Cooking Matters for Parents. More importantly, this study will determine if offering these interventions in combination offers greater benefits than each in isolation. There are two specific aims of this pilot trial.
- To examine the effects of a combined program (Cooking Matters + Mealtime PREP) in comparison to offering each of these programs (Cooking Matters vs. Mealtime PREP) in isolation on child nutrition over time.
- To explore the effects of each of these programs (Cooking Matters vs. Mealtime PREP) and the combined program (Cooking Matters + Mealtime PREP) on parental stress and parent/child interaction over time.
The investigators predict that children in all three arms (Cooking Matters, Mealtime PREP, and Cooking Matters + Mealtime PREP) will demonstrate improved nutrition. The investigators also predict that participants who receive the Mealtime PREP intervention will demonstrate better stability of gains over time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15260
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parent to a child aged 1-5 years
- Speaks English
- Willing to participate in 6 or 12 weekly group sessions at local Family Support Center
Exclusion Criteria:
- Previously completed a Cooking Matters for Parents cooking class
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cooking Matters for Parents
Trained instructors with a background in nutrition or culinary arts will lead six weekly, two-hour sessions to groups of 10 parent participants at local Family Support Centers.
|
Cooking Matters for Parents focuses on teaching parents of young children important lessons about self-sufficiency in the kitchen.
Participants have the opportunity to practice fundamental lessons including knife skills, reading ingredient labels, cutting up a whole chicken, and making a healthy meal for a family of four on a budget of ten dollars.
Each session includes meal preparation, didactic teaching, and sharing the meal as a group.
Instructors share their education and experience and discuss how to choose healthy, affordable fruits and vegetables at the grocery store.
Each week, adults take home a bag of groceries after each class so they can practice the recipes taught that day.
|
|
Experimental: Mealtime PREP
Trained group leaders with experience in pediatric occupational therapy will lead six weekly, two-hour, Mealtime PREP sessions to groups of 10 parent participants at local Family Support Centers.
|
Parents are trained to deliver each intervention component during mealtimes using a step-wise, behavioral activation approach.
The parent-training prong of the Mealtime PREP intervention incorporates four active ingredients of behavioral activation (1.
skills training; 2. goal-setting; 3. activity scheduling; and 4. activity monitoring) to help parents build a family meal routine that is enriched with techniques to promote child food acceptance.
Each week, parents will take home healthy groceries to practice making healthy snacks and side dishes in the home.
Other Names:
|
|
Experimental: Cooking Matters + Mealtime PREP
Parents will receive both programs in succession.
They will attend Cooking Matters for Parents followed by Mealtime PREP.
In total, this will equal 12 weekly, two-hour sessions delivered to groups of 10 parent participants at a local Family Support Center.
|
Cooking Matters for Parents focuses on teaching parents of young children important lessons about self-sufficiency in the kitchen.
Participants have the opportunity to practice fundamental lessons including knife skills, reading ingredient labels, cutting up a whole chicken, and making a healthy meal for a family of four on a budget of ten dollars.
Each session includes meal preparation, didactic teaching, and sharing the meal as a group.
Instructors share their education and experience and discuss how to choose healthy, affordable fruits and vegetables at the grocery store.
Each week, adults take home a bag of groceries after each class so they can practice the recipes taught that day.
Parents are trained to deliver each intervention component during mealtimes using a step-wise, behavioral activation approach.
The parent-training prong of the Mealtime PREP intervention incorporates four active ingredients of behavioral activation (1.
skills training; 2. goal-setting; 3. activity scheduling; and 4. activity monitoring) to help parents build a family meal routine that is enriched with techniques to promote child food acceptance.
Each week, parents will take home healthy groceries to practice making healthy snacks and side dishes in the home.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline 3-Day Food Diary (dietary variety) at 6 months
Time Frame: 6 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.Frequencies of foods consumed from different food groups and basic nutritional intake related to the numbers of servings of food in each food group consumed will be calculated.
Servings in each category will be compared to national daily recommendations.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Nutrition Screening Tool for Every Preschooler (nutritional risk) at 6 months
Time Frame: 6 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).
|
6 months
|
|
Change from Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) at 6 months
Time Frame: 6 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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO17080038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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