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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Healthy Lifestyle; Behavioral: Positive Parenting

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: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 years
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)	2 years
Child Dietary Behaviors for Beverages	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	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	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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Oak Hill Community Development Corporation; Worcester Public Schools
• Investigators: Principal Investigator: Milagros C Rosal, PhD, UMass Medical School; Principal Investigator: Wenjun Li, PhD, UMass Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 22, 2019
• Study Completion (Actual): April 22, 2019

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; childhood obesity; weight; healthy eating; Community Health Worker; built environment; families
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: H00005048; U48DP005031 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No