- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03334669
Family-centered Obesity Prevention: Communities for Healthy Living (CHL) (CHL)
Empowerment as a Mechanism for Change in Childhood Obesity Prevention
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Chestnut Hill, Massachusetts, United States, 02467
- Boston College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Sites randomized to the intervention group will receive the following:
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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.
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.
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.
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No Intervention: Control
Control sites will not receive any intervention components (i.e., standard practice).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Change in child BMI-z score
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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
|
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/
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Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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 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
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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
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
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Change in child physical activity assessed by parent report of average minutes per day child spent in structured free play and organized physical activities
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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 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
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Change in child daily sleep duration assessed by parent report (calculated from average bedtime and wake time)
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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
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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
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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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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
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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
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Change in child BMIz (and modified BMIz) over the summer period
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Summer weight gain was assessed over 3 summer periods using BMI data collected at the beginning and end of each academic year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kirsten Davison, PhD, Boston College
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-3559
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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