- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03559907
Partnering for Prevention: Building Healthy Habits in Underserved Communities (P4P)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15260
- University of Pittsburgh
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
Experimentální: 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.
Ostatní jména:
|
Experimentální: 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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change from Baseline 3-Day Food Diary (dietary variety) at 6 months
Časové okno: 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.
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6 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change from Baseline Nutrition Screening Tool for Every Preschooler (nutritional risk) at 6 months
Časové okno: 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).
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6 months
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Change from Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) at 6 months
Časové okno: 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.
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6 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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Klinické studie na Cooking Matters for Parents
-
Boston CollegeMassachusetts General Hospital; Harvard School of Public Health (HSPH); University... a další spolupracovníciPozastavenoObezita | Dětská obezitaSpojené státy