NCT03028233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2019

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

4.6 years

First QC Date

January 10, 2017

Last Update Submit

May 1, 2019

Conditions

Obesity

Keywords

physical activityhealthy eatingweightfamiliesCommunity Health Workerchildhood obesitybuilt environment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Child Dietary Behaviors: Overall

    2 years

  • Child Dietary Behaviors for snacks

    2 years

  • Child Dietary Behaviors for Beverages

    2 years

  • Parent Dietary Behaviors: Overall

    2 years

  • Parent Dietary Behaviors for Snacks

    2 years

  • +9 more secondary outcomes

Study Arms (2)

Healthy Lifestyles

EXPERIMENTAL

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

Positive Parenting

ACTIVE COMPARATOR

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

Behavioral: Positive Parenting

Interventions

Healthy LifestyleBEHAVIORAL

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

Healthy Lifestyles
Positive ParentingBEHAVIORAL

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

Positive Parenting

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Has an inability or unwillingness to give informed consent or assent
  • Is a prisoner
  • The child has been told by a doctor that they cannot walk or eat fruits and vegetables.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • 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.

    PMID: 31171975DERIVED

MeSH Terms

Conditions

ObesityMotor ActivityBody WeightPediatric Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Milagros C Rosal, PhD

    UMass Medical School

    PRINCIPAL INVESTIGATOR

  • Wenjun Li, PhD

    UMass Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 23, 2017

Study Start

September 1, 2014

Primary Completion

April 22, 2019

Study Completion

April 22, 2019

Last Updated

May 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)