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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Healthy Lifestyle
* Behavioral: Positive Parenting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Lifestyles<br>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<br>* A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.<br>|
| Active Comparator: Positive Parenting<br>The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills. | Behavioral: Positive Parenting<br>* A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, healthy eating, weight, families, Community Health Worker, childhood obesity, built environment