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

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ClinicalTrials.gov Identifier: NCT03028233
Recruitment Status : Active, not recruiting
First Posted : January 23, 2017
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Oak Hill Community Development Corporation
Worcester Public Schools
Information provided by (Responsible Party):
Milagros Rosal, University of Massachusetts, Worcester

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Child Dietary Behaviors: Overall [ Time Frame: 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)

  2. Child Dietary Behaviors for snacks [ Time Frame: 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)

  3. Child Dietary Behaviors for Beverages [ Time Frame: 2 years ]
    This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)

  4. Parent Dietary Behaviors: Overall [ Time Frame: 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)

  5. Parent Dietary Behaviors for Snacks [ Time Frame: 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)

  6. Parent Dietary Behaviors for Beverages [ Time Frame: 2 years ]
    This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)

  7. Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey [ Time Frame: 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)

  8. Child Physical Activity and Sedentariness: C-PAQ and PAQ-C [ Time Frame: 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

  9. Child Physical Activity and Sedentariness: ActiGraph GT1M [ Time Frame: 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.

  10. Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey [ Time Frame: 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)

  11. Parent physical activity and sedentariness: C-PAQ and PAQ-C [ Time Frame: 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

  12. Parent physical activity and sedentariness: ActiGraph GT1M [ Time Frame: 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

  13. Parent BMI [ Time Frame: 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.

  14. Child utilization of built environment resources [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028233


Locations
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United States, Massachusetts
UMass Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Oak Hill Community Development Corporation
Worcester Public Schools
Investigators
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Principal Investigator: Milagros C Rosal, PhD UMass Medical School
Principal Investigator: Wenjun Li, PhD UMass Medical School

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Responsible Party: Milagros Rosal, Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03028233     History of Changes
Other Study ID Numbers: H00005048
U48DP005031 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Milagros Rosal, University of Massachusetts, Worcester:
physical activity
healthy eating
weight
families
Community Health Worker
childhood obesity
built environment

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms