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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334669
Recruitment Status : Enrolling by invitation
First Posted : November 7, 2017
Last Update Posted : January 21, 2020
Sponsor:
Collaborators:
Action for Boston Community Development
Community Action Agency of Somerville
Harvard School of Public Health
University at Albany
Massachusetts General Hospital
Information provided by (Responsible Party):
Kirsten, Boston College

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Obesity Behavioral: Parents Connect for Healthy Living (PConnect) Behavioral: Enhanced Nutrition Support Behavioral: Media Resources Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The stepped wedge design is a pragmatic design that is well suited for interventions that use a service delivery protocol and do not rely on individual recruitment of participants. The intervention is integrated into Head Start service delivery and data compiled for all enrolled children are used to evaluate the intervention.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Empowerment as a Mechanism for Change in Childhood Obesity Prevention
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Intervention

Sites randomized to the intervention group will receive the following:

  1. Parents Connect for Healthy Living (PConnect)
  2. Enhanced Nutrition Support
  3. Media Resources
Behavioral: Parents Connect for Healthy Living (PConnect)
Parents Connect for Healthy Living (PConnect) parent curriculum: This 10-week program (20 hours total) engages Head Start parents in a wide range of topics related to health and empowerment and is designed to foster a safe, open forum through which parents can connect with other parents and mobilize resources to support their family's health;

Behavioral: Enhanced Nutrition Support
Enhanced Nutrition Support: Existing nutrition resources within Head Start (e.g., Biannual child health letters) are expanded and improved to ensure parents are aware of their child's weight status and are linked with age-appropriate weight management services if their child is classified as overweight or obese;

Behavioral: Media Resources
Media Resources: Print and online resources that employ consistent messaging to reach parents and ensure that behavior change messages are accessible to families.

No Intervention: Control
Control sites will not receive any intervention components (i.e., standard practice).



Primary Outcome Measures :
  1. Change in Child BMI-z score [ Time Frame: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years ]
    Change in child BMI-z score


Secondary Outcome Measures :
  1. Change in child fruit and vegetable intake [ Time Frame: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years ]
    Change in child fruit and vegetable intake assessed by parent report of child weekly frequency of intake

  2. Change in child sugar-sweetened beverage intake [ Time Frame: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years ]
    Change in child sugar-sweetened beverage consumption assessed by parent report of child weekly frequency of intake

  3. Change in child physical activity [ Time Frame: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years ]
    Change in child physical activity assessed by parent report of average minutes per day child spent in structured free play and organized physical activities

  4. Change in child sleep duration [ Time Frame: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years ]
    Change in child daily sleep duration assessed by parent report (calculated from average bedtime and wake time)

  5. Change in child screen-time [ Time Frame: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years ]
    Change in child daily hours of screen-time exposure (TV, computer, tablet) assessed by parent completion of the School Physical Activity and Nutrition Survey (SPAN)



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Primary Outcome Measures

Inclusion:

  • Enrolled in Head Start
  • Age 3 to 5 years

Exclusion:

  • Those not meeting inclusion criteria

Secondary Outcome Measures

Inclusion:

  • Enrolled in Head Start
  • Age 33 months to 5 years

Exclusion:

  • Children not enrolled at a participating center
  • Children less than age 33 months or older than 6 years

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): NCT03334669


Locations
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United States, Massachusetts
Boston College
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Boston College
Action for Boston Community Development
Community Action Agency of Somerville
Harvard School of Public Health
University at Albany
Massachusetts General Hospital
Investigators
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Principal Investigator: Kirsten Davison, PhD Boston College
Publications:
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Responsible Party: Kirsten, Donahue and DiFelice Professor of Social Work, Boston College
ClinicalTrials.gov Identifier: NCT03334669    
Other Study ID Numbers: 15-3559
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
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 Kirsten, Boston College:
Childhood obesity
Preschool
Head Start
Family Interventions
Community Based Participatory Research (CBPR)
Empowerment Theory
Family Ecological Theory
Step Wedge Design
Low Income
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms