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Clinical Trials/NCT03028233
NCT03028233
Completed
N/A

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

University of Massachusetts, Worcester1 site in 1 country244 target enrollmentSeptember 2014
ConditionsObesity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Massachusetts, Worcester
Enrollment
244
Locations
1
Primary Endpoint
child BMI z-score
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
April 22, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Milagros Rosal

Professor

University of Massachusetts, Worcester

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Child Dietary Behaviors: Overall(2 years)
  • Child Physical Activity and Sedentariness: ActiGraph GT1M(2 years)
  • Parent Dietary Behaviors for Beverages(2 years)
  • Child Dietary Behaviors for Beverages(2 years)
  • Parent Dietary Behaviors: Overall(2 years)
  • Child Physical Activity and Sedentariness: C-PAQ and PAQ-C(2 years)
  • Parent physical activity and sedentariness: C-PAQ and PAQ-C(2 years)
  • Child Dietary Behaviors for snacks(2 years)
  • Parent Dietary Behaviors for Snacks(2 years)
  • Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey(2 years)
  • Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey(2 years)
  • Parent physical activity and sedentariness: ActiGraph GT1M(2 years)
  • Parent BMI(2 years)
  • Child utilization of built environment resources(2 years)

Study Sites (1)

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