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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03559907
Other study ID # PRO17080038
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2018
Est. completion date November 5, 2019

Study information

Verified date January 2020
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.

1. 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.

2. 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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date November 5, 2019
Est. primary completion date November 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cooking Matters for Parents
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.
Mealtime PREP
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.

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh American Occupational Therapy Foundation

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 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 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). 6 months
Secondary 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. 6 months
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