Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Lifestyle
Positive Parenting
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring physical activity, healthy eating, weight, families, Community Health Worker, childhood obesity, built environment
Eligibility Criteria
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.
Sites / Locations
- UMass Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Healthy Lifestyles
Positive Parenting
Arm 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.
The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
Outcomes
Primary Outcome Measures
child BMI z-score
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.
Secondary Outcome Measures
Child Dietary Behaviors: Overall
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
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
This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
Parent Dietary Behaviors: Overall
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
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
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
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
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT03028233
First Posted
January 10, 2017
Last Updated
May 1, 2019
Sponsor
University of Massachusetts, Worcester
Collaborators
Oak Hill Community Development Corporation, Worcester Public Schools
1. Study Identification
Unique Protocol Identification Number
NCT03028233
Brief Title
Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
Official Title
Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 22, 2019 (Actual)
Study Completion Date
April 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Oak Hill Community Development Corporation, Worcester Public Schools
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
physical activity, healthy eating, weight, families, Community Health Worker, childhood obesity, built environment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Lifestyles
Arm Type
Experimental
Arm 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.
Arm Title
Positive Parenting
Arm Type
Active Comparator
Arm Description
The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyle
Intervention Description
A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.
Intervention Type
Behavioral
Intervention Name(s)
Positive Parenting
Intervention Description
A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.
Primary Outcome Measure Information:
Title
child BMI z-score
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Child Dietary Behaviors: Overall
Description
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)
Time Frame
2 years
Title
Child Dietary Behaviors for snacks
Description
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)
Time Frame
2 years
Title
Child Dietary Behaviors for Beverages
Description
This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
Time Frame
2 years
Title
Parent Dietary Behaviors: Overall
Description
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)
Time Frame
2 years
Title
Parent Dietary Behaviors for Snacks
Description
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)
Time Frame
2 years
Title
Parent Dietary Behaviors for Beverages
Description
This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
Time Frame
2 years
Title
Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
Description
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)
Time Frame
2 years
Title
Child Physical Activity and Sedentariness: C-PAQ and PAQ-C
Description
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
Time Frame
2 years
Title
Child Physical Activity and Sedentariness: ActiGraph GT1M
Description
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.
Time Frame
2 years
Title
Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
Description
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)
Time Frame
2 years
Title
Parent physical activity and sedentariness: C-PAQ and PAQ-C
Description
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
Time Frame
2 years
Title
Parent physical activity and sedentariness: ActiGraph GT1M
Description
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
Time Frame
2 years
Title
Parent BMI
Description
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.
Time Frame
2 years
Title
Child utilization of built environment resources
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milagros C Rosal, PhD
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenjun Li, PhD
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31171975
Citation
Borg A, Haughton CF, Sawyer M, Lemon SC, Kane K, Pbert L, Li W, Rosal MC. Design and methods of the Healthy Kids & Families study: a parent-focused community health worker-delivered childhood obesity prevention intervention. BMC Obes. 2019 Jun 3;6:19. doi: 10.1186/s40608-019-0240-x. eCollection 2019.
Results Reference
derived
Learn more about this trial
Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
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