Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
1 maj 2019 uppdaterad av: Milagros Rosal, University of Massachusetts, Worcester
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
244
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Massachusetts
-
Worcester, Massachusetts, Förenta staterna, 01655
- UMass Medical School
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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
4 år och äldre (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
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: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv komparator: Positive Parenting
The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
|
A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
child BMI z-score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Child Dietary Behaviors: Overall
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Child Physical Activity and Sedentariness: ActiGraph GT1M
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Milagros C Rosal, PhD, UMass Medical School
- Huvudutredare: Wenjun Li, PhD, UMass Medical School
Publikationer och användbara länkar
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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
1 september 2014
Primärt slutförande (Faktisk)
22 april 2019
Avslutad studie (Faktisk)
22 april 2019
Studieregistreringsdatum
Först inskickad
10 januari 2017
Först inskickad som uppfyllde QC-kriterierna
19 januari 2017
Första postat (Uppskatta)
23 januari 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 maj 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 maj 2019
Senast verifierad
1 maj 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H00005048
- U48DP005031 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
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NEJ
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