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

NCT ID: NCT03028233

Last Updated: 2019-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-04-22

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.

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Healthy Lifestyle

Intervention Type BEHAVIORAL

A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.

Positive Parenting

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

Group Type ACTIVE_COMPARATOR

Positive Parenting

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Positive Parenting

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

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oak Hill Community Development Corporation

UNKNOWN

Sponsor Role collaborator

Worcester Public Schools

UNKNOWN

Sponsor Role collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Milagros Rosal

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Milagros C Rosal, PhD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Wenjun Li, PhD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Locations

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UMass Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31171975 (View on PubMed)

Other Identifiers

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U48DP005031

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H00005048

Identifier Type: -

Identifier Source: org_study_id

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