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

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ClinicalTrials.gov Identifier: NCT03334669
Recruitment Status : Suspended (The primary trial was halted due to covid-19 in the last 6 months of the trial; as a result, the intervention was not fully implemented and the final outcomes were not measured. Outcomes will be assessed with the data available (BL, Y1, Y2).)
First Posted : November 7, 2017
Last Update Posted : October 30, 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)
Actual Enrollment : 4280 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. NOTE: Due to COVID-19 shutdown the final group of Head Start programs did receive the full intervention. The investigators elected to assess intervention impact with one year less data than expected. Due to low power, sensitivity analyses will examine the roles of dose, fidelity, baseline child overweight/obesity.
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
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 31, 2021

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; NOTE: The PConnect program was not implemented in 2019-2020 due to the coronavirus pandemic. In 2020-2021, PConnect was implemented virtually; these are pilot data and not part of the main trial.

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 has overweight or obesity. NOTE: Enhanced nutrition support was not implemented in spring 2020 due to the pandemic. In 2020-2021, it was moved to a virtual format in what will be a pilot virtual trial.

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. NOTE: Due to the pandemic, media resources were not shared in spring 2020. They were implemented in virtual format in 2020-2021 in a pilot virtual trial.

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 (BL, Y1, Y2) rather than 4 years as planned ]
    Change in child BMI-z score

  2. Modified change in BMI z-score [ Time Frame: Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) ]
    BMI of a child is expressed relative to the median BMI in units of ½ of the distance between 0 and +2 z- scores. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5703793/


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 (BL, Y1, Y2) rather than 4 years as planned ]
    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 (BL, Y1, Y2) rather than 4 years as planned ]
    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 (BL, Y1, Y2) rather than 4 years as planned ]
    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 (BL, Y1, Y2) rather than 4 years as planned ]
    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 (BL, Y1, Y2) rather than 4 years as planned ]
    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)

  6. Summer weight gain [ Time Frame: Summer weight gain was assessed over 3 summer periods using BMI data collected at the beginning and end of each academic year ]
    Change in child BMIz (and modified BMIz) over the summer period



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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 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

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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: October 30, 2020
Last Verified: October 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