Partnering for Prevention: Building Healthy Habits in Underserved Communities (P4P)
3 januari 2020 uppdaterad av: Angela Caldwell, University of Pittsburgh
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
53
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15260
- University of Pittsburgh
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline 3-Day Food Diary (dietary variety) at 6 months
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline Nutrition Screening Tool for Every Preschooler (nutritional risk) at 6 months
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 september 2018
Primärt slutförande (Faktisk)
5 november 2019
Avslutad studie (Faktisk)
5 november 2019
Studieregistreringsdatum
Först inskickad
15 maj 2018
Först inskickad som uppfyllde QC-kriterierna
5 juni 2018
Första postat (Faktisk)
18 juni 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 januari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 januari 2020
Senast verifierad
1 januari 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PRO17080038
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .