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Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers

22. april 2019 opdateret af: Children's Hospital of Philadelphia

Home Plate: A Randomized Controlled Trial of a Community-Engaged Intervention to Improve Home Food Preparation Practices and Health During Early Childhood

This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Barriers to healthy eating and active living are at the heart of the obesity epidemic. This study focuses on a key factor underlying healthy eating: home food preparation. This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children. The investigators will partner with community-based organizations serving families with children ages 1 to 3 years in West Philadelphia aiming specifically to:

  1. Test the intervention's effect on diet and physical health.

    Hypothesis 1: The intervention group will have improved home food preparation practices and a healthier diet compared to the control group.

  2. Test the intervention's effect on family health.

    Hypothesis 2: The intervention group will report improved parenting skills and more hopeful patterns of thinking.

  3. Identify factors present at baseline and during engagement with the intervention that distinguish intervention participants who have improved diet, physical health, and family health from those who do not.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

115

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • The Children's Hospital of Philadelphia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria: mentees

  1. English-speaking
  2. Able to give informed consent.
  3. Legal guardian and caregiver of at least one child, age 1-3 years

Inclusion Criteria: children

  1. 1-3 year old children of mentee primary caregivers enrolled in the study
  2. If a mentee caregiver has more than one child, then all their eligible children (ages 1-3 years) will be enrolled in the study.

Inclusion Criteria: peer mentors

  1. Eligible peer mentors should meet the inclusion criteria set forth above for mentees. (Children of peer mentors will not be eligible for this study.)

    In addition,

  2. The study team will decide which participants will be invited to be peer mentors, based on attributes including interest, leadership ability, and home food preparation skills.

Exclusion Criteria

  1. Caregivers and children not meeting the inclusion criteria above.
  2. Caregivers who are pregnant at the time of enrollment.
  3. Caregivers or children with a medical condition that significantly affects their diet or eating habits. (The study team will ask during the time of recruitment if subjects or their children have a medical condition that significantly affects diet or eating habits.)
  4. Subjects who, in the opinion of the Investigator, may be unable to participate in the study schedules or procedures.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
Behavioral: Home Plate intervention
Adfærdsmæssigt: Home Plate
Home Plate is a community-based, peer mentored intervention aimed at improving home food preparation practices in families with young children. Through 6 classes, this intervention explores topics related to regularly preparing healthy foods at home.
Eksperimentel: Delayed Entry Control
This Arm will receive the Home Plate intervention 3 months after the Intervention Arm completes the intervention.
Adfærdsmæssigt: Home Plate
Home Plate is a community-based, peer mentored intervention aimed at improving home food preparation practices in families with young children. Through 6 classes, this intervention explores topics related to regularly preparing healthy foods at home.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dietary Energy Density (Child Participants)
Tidsramme: 19-30 weeks from baseline
Child participants' 24-hour dietary recalls will be collected by trained study staff from adult caregivers. 24-hour dietary recalls will be collected on a minimum of 2 and a maximum of 3 separate days. The results will then be used to calculate the energy density of the child's diet.
19-30 weeks from baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Home Food Preparation Practices
Tidsramme: 19-30 weeks from baseline
Adult participants will complete surveys to assess the foods they usually prepare at home, as well as the time, energy, and confidence they have to prepare meals for their household.
19-30 weeks from baseline
Home Food Environment
Tidsramme: 19-30 weeks from baseline
Adult participants will complete surveys to assess the foods currently available in their homes, how they feel about managing food-related tasks, and the interactions they have with their child(ren) regarding food and eating.
19-30 weeks from baseline
Household Routines
Tidsramme: 19-30 weeks from baseline
Adult participants will complete surveys to assess their household routines related to activities such as sleep, physical activity, and screen time.
19-30 weeks from baseline
Emotional and Family Health
Tidsramme: 19-30 weeks from baseline
Adult participants will complete surveys to assess the their emotional health and the health of their families.
19-30 weeks from baseline
Body mass index
Tidsramme: 19-30 weeks from baseline
Heights and weights will be measured by trained study staff and will be used to calculate body mass index (BMI) of adult and child participants.
19-30 weeks from baseline
Dietary Energy Density (Adult Participants)
Tidsramme: 19-30 weeks from baseline
24-hour dietary recalls will be collected by trained study staff from adult study participants. 24-hour dietary recalls will be collected on a minimum of 2 and a maximum of 3 separate days. The results will then be used to calculate dietary energy density.
19-30 weeks from baseline
Diet Quality
Tidsramme: 19-30 weeks from baseline
In addition to dietary energy density, 24-hour dietary recall data will be used to calculate both child and adult study participants' intake of fruits, vegetables, whole grains, and added sugars.
19-30 weeks from baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Hospital of Philadelphia

Samarbejdspartnere

University of Pennsylvania

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2015

Primær færdiggørelse (Faktiske)

1. juli 2017

Studieafslutning (Faktiske)

13. juli 2017

Datoer for studieregistrering

Først indsendt

28. maj 2015

Først indsendt, der opfyldte QC-kriterier

29. maj 2015

Først opslået (Skøn)

1. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15-011720

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Home Plate

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner