- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03028233
Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
The intervention uses multiple delivery modalities to maintain novelty and prevent attrition/burden. These include home visits, telephone contacts, print (literacy sensitive newsletters), social media (Facebook), and community events. Parents and children will complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.
The Specific Aims are:
Aim 1: To determine the effectiveness of the intervention compared to the control condition on child physical activity, healthy eating, BMI and utilization of built environment resources.
Aim 2: To determine the effectiveness of the intervention compared to the control condition on parent physical activity, healthy eating, BMI.
Aim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) model.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Massachusetts
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Worcester, Massachusetts, Yhdysvallat, 01655
- UMass Medical School
-
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Eligible individuals for the research study are parents/guardians and their K-6th grade children attending one of 9 schools in the greater Worcester area. Parents and their children are recruited as parent-child dyads.
Exclusion Criteria:
- Has an inability or unwillingness to give informed consent or assent
- Is a prisoner
Exclusion (child only)
- The child has been told by a doctor that they cannot walk or eat fruits and vegetables.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Healthy Lifestyles
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention.
Barriers include social, environmental, and family issues.
|
A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.
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Active Comparator: Positive Parenting
The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
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A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
child BMI z-score
Aikaikkuna: 2 years
|
Weight and height is measured using standard methodology, with children wearing light clothing and no shoes.
Weight is measured to the nearest 0.5 lb on a digital scale.
Height is measured to the nearest tenth of a centimeter using a stadiometer.
BMI is calculated: weight (kg)/height squared (meters) for age and gender using United States Centers for Disease Control and Prevention BMI charts growth charts.
|
2 years
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Child Dietary Behaviors: Overall
Aikaikkuna: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
|
2 years
|
Child Dietary Behaviors for snacks
Aikaikkuna: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration:Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
|
2 years
|
Child Dietary Behaviors for Beverages
Aikaikkuna: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
|
2 years
|
Parent Dietary Behaviors: Overall
Aikaikkuna: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
|
2 years
|
Parent Dietary Behaviors for Snacks
Aikaikkuna: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
|
2 years
|
Parent Dietary Behaviors for Beverages
Aikaikkuna: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
|
2 years
|
Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
Aikaikkuna: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
|
2 years
|
Child Physical Activity and Sedentariness: C-PAQ and PAQ-C
Aikaikkuna: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
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2 years
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Child Physical Activity and Sedentariness: ActiGraph GT1M
Aikaikkuna: 2 years
|
Child physical activity and sedentariness are measured by the child wearing the ActiGraph Model GT1M for 7 days averaged.
This measure provides data on intensity and duration of activities.
|
2 years
|
Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
Aikaikkuna: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
|
2 years
|
Parent physical activity and sedentariness: C-PAQ and PAQ-C
Aikaikkuna: 2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
|
2 years
|
Parent physical activity and sedentariness: ActiGraph GT1M
Aikaikkuna: 2 years
|
Parent physical activity and sedentariness are measured by the parent wearing the ActiGraph Model GT1M for 7 days averaged.
This measure provides data on intensity and duration of activities
|
2 years
|
Parent BMI
Aikaikkuna: 2 years
|
BMI is calculated with weight and height measurements using standard methodology.
Weight is measured to the nearest 0.5 lb on a digital scale.
Height is measured to the nearest centimeter using a stadiometer.
BMI is calculated: weight (kg)/height squared (meters) for gender using United States Centers for Disease Control and Prevention BMI charts.
|
2 years
|
Child utilization of built environment resources
Aikaikkuna: 2 years
|
Child utilization of built environment resources is assessed by the children wearing a portable GPS unit (~size of a matchbox) when wearing an accelerometer.
The GPS unit records the geographic coordinates of the child's activities.
Measures of frequency and duration of activities by neighborhood space (e.g., parks) can be ascertained.
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2 years
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Milagros C Rosal, PhD, UMass Medical School
- Päätutkija: Wenjun Li, PhD, UMass Medical School
Julkaisuja ja hyödyllisiä linkkejä
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
- H00005048
- U48DP005031 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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