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
|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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||4280 participants|
|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)|
|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|
Sites randomized to the intervention group will receive the following:
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).
- 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
- 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/
- 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
- 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
- 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
- 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)
- 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)
- 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
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
|United States, Massachusetts|
|Chestnut Hill, Massachusetts, United States, 02467|
|Principal Investigator:||Kirsten Davison, PhD||Boston College|