- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02458833
Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers
Home Plate: A Randomized Controlled Trial of a Community-Engaged Intervention to Improve Home Food Preparation Practices and Health During Early Childhood
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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:
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.
Test the intervention's effect on family health.
Hypothesis 2: The intervention group will report improved parenting skills and more hopeful patterns of thinking.
- 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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Yhdysvallat, 19104
- The Children's Hospital of Philadelphia
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria: mentees
- English-speaking
- Able to give informed consent.
- Legal guardian and caregiver of at least one child, age 1-3 years
Inclusion Criteria: children
- 1-3 year old children of mentee primary caregivers enrolled in the study
- 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
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,
- 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
- Caregivers and children not meeting the inclusion criteria above.
- Caregivers who are pregnant at the time of enrollment.
- 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.)
- Subjects who, in the opinion of the Investigator, may be unable to participate in the study schedules or procedures.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Intervention
Behavioral: Home Plate intervention
|
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.
|
Kokeellinen: Delayed Entry Control
This Arm will receive the Home Plate intervention 3 months after the Intervention Arm completes the intervention.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Dietary Energy Density (Child Participants)
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Home Food Preparation Practices
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 15-011720
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Home Plate
-
Children's Hospital of PhiladelphiaUniversity of Pennsylvania; McClay Foundation; The Leo and Peggy Pierce Family...Rekrytointi
-
Stanford UniversityValmisRuokavalio, ruoka ja ravitsemusYhdysvallat
-
University Hospital TuebingenGerman Federal Ministry of Education and ResearchValmis
-
Al-Azhar UniversityValmisKomplikaatio, Leikkauksen jälkeinen | HypospadiasEgypti
-
H. Lee Moffitt Cancer Center and Research InstituteValmisGI Syöpä | RavitsemuspuutosYhdysvallat
-
Inova Health Care ServicesValmisLapsuusajan lihavuus | Terveyskäyttäytyminen | Ruokavalio, TerveYhdysvallat
-
University of Santa Cruz do SulTuntematonIkääntyminen | Oksidatiivista stressiä
-
Advocate Health CarePeruutettuDyspepsia | Ruokavalion muutosYhdysvallat
-
Emory UniversityCenters for Disease Control and PreventionValmis