Clinical trial NCT03028233: Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
Official title: Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: physical activity
healthy eating
weight
families
Community Health Worker
childhood obesity
built environment
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Oak Hill Community Development Corporation
name: Worcester Public Schools
First posted: 2017-01-23
Enrollment: 244
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: child BMI z-score
timeFrame: 2 years
Secondary outcomes:
measure: Child Dietary Behaviors: Overall
timeFrame: 2 years
measure: Child Dietary Behaviors for snacks
timeFrame: 2 years
measure: Child Dietary Behaviors for Beverages
timeFrame: 2 years
measure: Parent Dietary Behaviors: Overall
timeFrame: 2 years
measure: Parent Dietary Behaviors for Snacks
timeFrame: 2 years
measure: Parent Dietary Behaviors for Beverages
timeFrame: 2 years
measure: Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
timeFrame: 2 years
measure: Child Physical Activity and Sedentariness: C-PAQ and PAQ-C
timeFrame: 2 years
measure: Child Physical Activity and Sedentariness: ActiGraph GT1M
timeFrame: 2 years
measure: Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
timeFrame: 2 years
measure: Parent physical activity and sedentariness: C-PAQ and PAQ-C
timeFrame: 2 years
measure: Parent physical activity and sedentariness: ActiGraph GT1M
timeFrame: 2 years
measure: Parent BMI
timeFrame: 2 years
measure: Child utilization of built environment resources
timeFrame: 2 years
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Milagros C Rosal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMass Medical School
name: Wenjun Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.