Family-centered Obesity Prevention: Communities for Healthy Living (CHL) (CHL)
Primary Purpose
Pediatric Obesity, Obesity
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parents Connect for Healthy Living (PConnect)
Enhanced Nutrition Support
Media Resources
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric Obesity focused on measuring Childhood obesity, Preschool, Head Start, Family Interventions, Community Based Participatory Research (CBPR), Empowerment Theory, Family Ecological Theory, Step Wedge Design, Low Income
Eligibility 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
Sites / Locations
- Boston College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Sites randomized to the intervention group will receive the following: Parents Connect for Healthy Living (PConnect) Enhanced Nutrition Support Media Resources
Control sites will not receive any intervention components (i.e., standard practice).
Outcomes
Primary Outcome Measures
Change in Child BMI-z score
Change in child BMI-z score
Modified change in BMI z-score
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
Change in child fruit and vegetable intake
Change in child fruit and vegetable intake assessed by parent report of child weekly frequency of intake
Change in child sugar-sweetened beverage intake
Change in child sugar-sweetened beverage consumption assessed by parent report of child weekly frequency of intake
Change in child physical activity
Change in child physical activity assessed by parent report of average minutes per day child spent in structured free play and organized physical activities
Change in child sleep duration
Change in child daily sleep duration assessed by parent report (calculated from average bedtime and wake time)
Change in child screen-time
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)
Summer weight gain
Change in child BMIz (and modified BMIz) over the summer period
Full Information
NCT ID
NCT03334669
First Posted
October 10, 2017
Last Updated
October 29, 2020
Sponsor
Boston College
Collaborators
Action for Boston Community Development, Community Action Agency of Somerville, Harvard School of Public Health (HSPH), University at Albany, Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03334669
Brief Title
Family-centered Obesity Prevention: Communities for Healthy Living (CHL)
Acronym
CHL
Official Title
Empowerment as a Mechanism for Change in Childhood Obesity Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Suspended
Why Stopped
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).
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston College
Collaborators
Action for Boston Community Development, Community Action Agency of Somerville, Harvard School of Public Health (HSPH), University at Albany, Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Obesity
Keywords
Childhood obesity, Preschool, Head Start, Family Interventions, Community Based Participatory Research (CBPR), Empowerment Theory, Family Ecological Theory, Step Wedge Design, Low Income
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
4280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Sites randomized to the intervention group will receive the following:
Parents Connect for Healthy Living (PConnect)
Enhanced Nutrition Support
Media Resources
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control sites will not receive any intervention components (i.e., standard practice).
Intervention Type
Behavioral
Intervention Name(s)
Parents Connect for Healthy Living (PConnect)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Nutrition Support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Media Resources
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Child BMI-z score
Description
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
Title
Modified change in BMI z-score
Description
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/
Time Frame
Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2)
Secondary Outcome Measure Information:
Title
Change in child fruit and vegetable intake
Description
Change in child fruit and vegetable intake assessed by parent report of child weekly frequency of 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
Title
Change in child sugar-sweetened beverage intake
Description
Change in child sugar-sweetened beverage consumption assessed by parent report of child weekly frequency of 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
Title
Change in child physical activity
Description
Change in child physical activity assessed by parent report of average minutes per day child spent in structured free play and organized physical activities
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
Title
Change in child sleep duration
Description
Change in child daily sleep duration assessed by parent report (calculated from average bedtime and wake 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
Title
Change in child screen-time
Description
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)
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
Title
Summer weight gain
Description
Change in child BMIz (and modified BMIz) over the summer period
Time Frame
Summer weight gain was assessed over 3 summer periods using BMI data collected at the beginning and end of each academic year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Davison, PhD
Organizational Affiliation
Boston College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston College
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30630109
Citation
Beckerman JP, Aftosmes-Tobio A, Kitos N, Jurkowski JM, Lansburg K, Kazik C, Gavarkovs A, Vigilante A, Kalyoncu B, Figueroa R, Klabunde R, Barouch R, Haneuse S, Taveras E, Davison KK; CHL study team. Electronic address: chlheadstart@gmail.com. Communities for healthy living (CHL) - A family-centered childhood obesity prevention program integrated into Head Start services: Study protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2019 Mar;78:34-45. doi: 10.1016/j.cct.2019.01.002. Epub 2019 Jan 7.
Results Reference
background
PubMed Identifier
32703293
Citation
Beckerman-Hsu JP, Aftosmes-Tobio A, Gavarkovs A, Kitos N, Figueroa R, Kalyoncu ZB, Lansburg K, Yu X, Kazik C, Vigilante A, Leonard J, Torrico M, Jurkowski JM, Davison KK. Communities for Healthy Living (CHL) A Community-based Intervention to Prevent Obesity in Low-Income Preschool Children: Process Evaluation Protocol. Trials. 2020 Jul 23;21(1):674. doi: 10.1186/s13063-020-04571-0.
Results Reference
background
PubMed Identifier
33482774
Citation
Beckerman-Hsu JP, Gago C, Aftosmes-Tobio A, Jurkowski JM, Lansburg K, Leonard J, Torrico M, Haneuse S, Subramanian SV, Kenney EL, Davison KK. Acceptability and appropriateness of a novel parent-staff co-leadership model for childhood obesity prevention in Head Start: a qualitative interview study. BMC Public Health. 2021 Jan 22;21(1):201. doi: 10.1186/s12889-021-10159-3.
Results Reference
derived
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Family-centered Obesity Prevention: Communities for Healthy Living (CHL)
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