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Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention

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ClinicalTrials.gov Identifier: NCT03028233
Recruitment Status : Active, not recruiting
First Posted : January 23, 2017
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Oak Hill Community Development Corporation
Worcester Public Schools
Information provided by (Responsible Party):
Milagros Rosal, University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE January 23, 2017
Last Update Posted Date March 6, 2019
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
child BMI z-score [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03028233 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
  • Child Dietary Behaviors: Overall [ Time Frame: 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)
  • Child Dietary Behaviors for snacks [ Time Frame: 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)
  • Child Dietary Behaviors for Beverages [ Time Frame: 2 years ]
    This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
  • Parent Dietary Behaviors: Overall [ Time Frame: 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)
  • Parent Dietary Behaviors for Snacks [ Time Frame: 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)
  • Parent Dietary Behaviors for Beverages [ Time Frame: 2 years ]
    This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
  • Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey [ Time Frame: 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)
  • Child Physical Activity and Sedentariness: C-PAQ and PAQ-C [ Time Frame: 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
  • Child Physical Activity and Sedentariness: ActiGraph GT1M [ Time Frame: 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.
  • Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey [ Time Frame: 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)
  • Parent physical activity and sedentariness: C-PAQ and PAQ-C [ Time Frame: 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
  • Parent physical activity and sedentariness: ActiGraph GT1M [ Time Frame: 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
  • Parent BMI [ Time Frame: 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.
  • Child utilization of built environment resources [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
  • child dietary behaviors [ Time Frame: 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)
  • Child Dietary Behaviors for snacks [ Time Frame: 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)
  • Child Dietary Behaviors for Beverages [ Time Frame: 2 years ]
    This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
  • parent dietary behaviors [ Time Frame: 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)
  • Parent Dietary Behaviors for Snacks [ Time Frame: 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)
  • Parent Dietary Behaviors for Beverages [ Time Frame: 2 years ]
    This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
  • child physical activity and sedentariness [ Time Frame: 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)
  • child physical activity and sedentariness [ Time Frame: 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
  • child physical activity and sedentariness [ Time Frame: 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.
  • parent physical activity and sedentariness [ Time Frame: 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)
  • parent physical activity and sedentariness [ Time Frame: 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
  • parent physical activity and sedentariness [ Time Frame: 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
  • Parent BMI [ Time Frame: 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.
  • Child utilization of built environment resources [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
Official Title  ICMJE Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: Healthy Lifestyle
    A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.
  • Behavioral: Positive Parenting
    A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Healthy Lifestyle
  • Active Comparator: Positive Parenting
    The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
    Intervention: Behavioral: Positive Parenting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 20, 2018)
244
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2017)
480
Estimated Study Completion Date  ICMJE March 29, 2019
Estimated Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03028233
Other Study ID Numbers  ICMJE H00005048
U48DP005031 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Milagros Rosal, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE
  • Oak Hill Community Development Corporation
  • Worcester Public Schools
Investigators  ICMJE
Principal Investigator: Milagros C Rosal, PhD UMass Medical School
Principal Investigator: Wenjun Li, PhD UMass Medical School
PRS Account University of Massachusetts, Worcester
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP