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

Sponsor

University of Massachusetts, Worcester (Other)

Overall Status

Completed

CT.gov ID

NCT03028233

Collaborator

Oak Hill Community Development Corporation (Other), Worcester Public Schools (Other)

244

Enrollment

Location

Arms

55.7

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Healthy Lifestyle Behavioral: Positive Parenting	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

244 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Apr 22, 2019

Actual Study Completion Date :

Apr 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
Active Comparator: Positive Parenting The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.	Behavioral: Positive Parenting A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.

Arm

Intervention/Treatment

Experimental: Healthy Lifestyles

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.

Active Comparator: Positive Parenting

The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.

Behavioral: Positive Parenting

A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.

Outcome Measures

Primary Outcome Measures

child BMI z-score [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.

Secondary Outcome Measures

Child Dietary Behaviors: Overall [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.