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Family-centered Obesity Prevention: Communities for Healthy Living (CHL)

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Boston College

Status

Terminated

Conditions

Obesity
Pediatric Obesity

Treatments

Behavioral: Media Resources
Behavioral: Enhanced Nutrition Support
Behavioral: Parents Connect for Healthy Living (PConnect)

Study type

Interventional

Funder types

Other

Identifiers

NCT03334669
15-3559

Details and patient eligibility

About

The Communities for Healthy Living (CHL) program is a family-focused intervention to promote healthy lifestyle behaviors including diet and physical activity among children (age 3-to 5-years) and their families, enrolled in Head Start.

Full description

This evaluation will test the effectiveness of a family-focused intervention, Communities for Healthy Living (CHL), implemented through Head Start. Over 20% of preschool-aged children in the US experience overweight or obese. Because obesity prevention depends heavily on the adoption of healthy lifestyle behaviors early in life, preventive efforts offer a higher promise for success if they are family-centered. Effective family-centered interventions for obesity prevention in preschool-aged children, however, remain elusive. While a number of interventions have shown positive effects on child Body Mass Index (BMI), results are inconsistent and short term effects are not maintained. What is more, because families at greatest risk of childhood obesity - including low-income, single-parent, and ethnic minority families - are the most difficult to recruit and retain, results are often limited in their applicability to high risk populations.

In response, the researchers have partnered with Head Start to develop and test a new approach to family-centered childhood obesity prevention that addresses family engagement upfront. The CHL program will be refined and rigorously tested for efficacy in collaboration with Head Start programs in the greater Boston area, which collectively serve over 2000 low-income children each year. Building on a previous pilot study, the investigators will broaden the parent-centered Community Based Participatory Research approach and include Head Start staff in the decision making and implementation process, refine intervention components, and expand technical assistance protocols to support Head Start ownership of CHL while ensuring implementation fidelity. In addition, consistent with the overarching theoretical framework (Family Ecological Model), neighborhood-level socioeconomic, food and physical activity environments around family homes and examine their impact on intervention outcomes will be measured to inform future scale up efforts.

Enrollment

4,999 patients

Sex

All

Ages

3+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Primary Outcome Measures

Inclusion:

  • Enrolled in a participating Head Start program
  • Age 33 months to 5 years (i.e., meets Head Start age eligibility criteria)

Exclusion:

  • Those not meeting inclusion criteria

Secondary Outcome Measures

Inclusion:

  • Enrolled in a participating Head Start program
  • Age 33 months to 5 years

Exclusion:

  • Children not enrolled at a participating Head Start program
  • Children less than 29 months or older than 59 months by Sept 1

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

4,999 participants in 2 patient groups

Intervention
Experimental group
Description:
Sites randomized to the intervention group will receive the following: 1. Parents Connect for Healthy Living (PConnect) 2. Enhanced Nutrition Support 3. Media Resources
Treatment:
Behavioral: Parents Connect for Healthy Living (PConnect)
Behavioral: Enhanced Nutrition Support
Behavioral: Media Resources
Control
No Intervention group
Description:
Control sites will not receive any intervention components (i.e., standard practice).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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