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Partnering for Prevention: Building Healthy Habits in Underserved Communities (P4P)

Primary Purpose

Parenting, Child Nutrition Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cooking Matters for Parents
Mealtime PREP
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parenting focused on measuring prevention, nutrition, early childhood, parent training, underserved

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cooking Matters for Parents

Mealtime PREP

Cooking Matters + Mealtime PREP

Arm Description

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.

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 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.

Outcomes

Primary Outcome Measures

Change from Baseline 3-Day Food Diary (dietary variety) at 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.

Secondary Outcome Measures

Change from Baseline Nutrition Screening Tool for Every Preschooler (nutritional risk) at 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).
Change from Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) at 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.

Full Information

First Posted
May 15, 2018
Last Updated
January 3, 2020
Sponsor
University of Pittsburgh
Collaborators
American Occupational Therapy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03559907
Brief Title
Partnering for Prevention: Building Healthy Habits in Underserved Communities
Acronym
P4P
Official Title
Partnering for Prevention: Building Healthy Habits in Underserved Communities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
November 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
American Occupational Therapy Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot study will estimate the unique and additive benefits of two parent-training programs (Cooking Matters for Parents and Promoting Routines of Exploration and Play during Mealtime) offered in undeserved communities.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting, Child Nutrition Disorders
Keywords
prevention, nutrition, early childhood, parent training, underserved

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi-Experimental: Three community sites will be randomized to receive on of three prevention interventions: Cooking Matters for Parents Promoting Routines of Exploration and Play during Mealtime (Mealtime PREP) Combined (Cooking Matters + Mealtime PREP)
Masking
Outcomes Assessor
Masking Description
Outcomes assessors who are rating intervention fidelity will be blinded to intervention assignment.
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cooking Matters for Parents
Arm Type
Experimental
Arm Description
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.
Arm Title
Mealtime PREP
Arm Type
Experimental
Arm Description
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.
Arm Title
Cooking Matters + Mealtime PREP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cooking Matters for Parents
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mealtime PREP
Other Intervention Name(s)
Promoting Routines for Exploration and Play during Mealtime
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline 3-Day Food Diary (dietary variety) at 6 months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from Baseline Nutrition Screening Tool for Every Preschooler (nutritional risk) at 6 months
Description
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).
Time Frame
6 months
Title
Change from Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) at 6 months
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Caldwell, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Partnering for Prevention: Building Healthy Habits in Underserved Communities

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