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).
CHL
Empowerment as a Mechanism for Change in Childhood Obesity Prevention
Sponsor study identifier
interventional
4,999
1 country
1
Study Start
October 1, 2017
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2017
Actual (reported)October 10, 2017
Actual (reported)November 7, 2017
Actual (reported)December 31, 2019
Actual (reported)December 31, 2019
Actual (reported)Change in Child BMI-z score
Change in child BMI-z score
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
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/
Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2)
Change in child fruit and vegetable intake
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
Sites randomized to the intervention group will receive the following: 1. Parents Connect for Healthy Living (PConnect) 2. Enhanced Nutrition Support 3. Media Resources
Control sites will not receive any intervention components (i.e., standard practice).
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.
Boston College
Chestnut Hill, Massachusetts, 02467, United States
Davison KK, Haneuse S. Modifications to Communities for Healthy Living trial design resulting from COVID-19. Contemp Clin Trials. 2020 Dec;99:106205. doi: 10.1016/j.cct.2020.106205. Epub 2020 Nov 2. No abstract available.
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.
Kirsten Davison, PhD
Boston College
4,999 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2017
PsylliumRx Dietary Fiber Study
Change in child sugar-sweetened beverage intake
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
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
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 screen-time
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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, Aftosmes-Tobio A, Lansburg K, Leonard J, Torrico M, Kenney EL, Subramanian SV, Haneuse S, Davison KK. Summer Weight Gain Among Preschool-Aged Children With Obesity: An Observational Study in Head Start. Prev Chronic Dis. 2021 Mar 18;18:E25. doi: 10.5888/pcd18.200532.
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.
Gago CM, Jurkowski J, Beckerman-Hsu JP, Aftosmes-Tobio A, Figueroa R, Oddleifson C, Mattei J, Kenney EL, Haneuse S, Davison KK. Exploring a theory of change: Are increases in parental empowerment associated with healthier weight-related parenting practices? Soc Sci Med. 2022 Mar;296:114761. doi: 10.1016/j.socscimed.2022.114761. Epub 2022 Jan 31.
Grafft N, Aftosmes-Tobio A, Gago C, Lansburg K, Beckerman-Hsu J, Trefry B, Kumanyika S, Davison K. Adaptation and implementation outcomes of a parenting program for low-income, ethnically diverse families delivered virtually versus in-person. Transl Behav Med. 2022 Nov 21;12(11):1065-1075. doi: 10.1093/tbm/ibac077.
Gago CM, Aftosmes-Tobio A, Grafft N, Davison KK. "It Should Be a Priority": Lessons Learned by Head Start Leaders, Staff, and Parent Facilitators Delivering a Multi-Site Parent-Centered Child Obesity Prevention Intervention. Nutrients. 2025 Mar 18;17(6):1063. doi: 10.3390/nu17061063.
Gago C, Aftosmes-Tobio A, Beckerman-Hsu JP, Oddleifson C, Garcia EA, Lansburg K, Figueroa R, Yu X, Kitos N, Torrico M, Leonard J, Jurkowski JK, Mattei J, Kenney EL, Haneuse S, Davison KK. Evaluation of a cluster-randomized controlled trial: Communities for Healthy Living, family-centered obesity prevention program for Head Start parents and children. Int J Behav Nutr Phys Act. 2023 Jan 11;20(1):4. doi: 10.1186/s12966-022-01400-2.
First Posted
November 7, 2017
Study Start
October 1, 2017
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)Last Updated
September 29, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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