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

Obesity Clinical Trial

— CHL  

Official title:

Empowerment as a Mechanism for Change in Childhood Obesity Prevention

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03334669
• Other study ID #: 15-3559
• Status: Suspended
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: October 2020
• Source: Boston College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 4280
• Est. completion date: July 31, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Boston College	Chestnut Hill	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Boston College	Action for Boston Community Development, Community Action Agency of Somerville, Harvard School of Public Health, Massachusetts General Hospital, University at Albany

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Secondary	Change in child fruit and vegetable intake	Change in child fruit and vegetable intake assessed by parent report of child weekly frequency of 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
Secondary	Change in child sugar-sweetened beverage intake	Change in child sugar-sweetened beverage consumption assessed by parent report of child weekly frequency of 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
Secondary	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	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
Secondary	Change in child sleep duration	Change in child daily sleep duration assessed by parent report (calculated from average bedtime and wake 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
Secondary	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)	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
Secondary	Summer weight gain	Change in child BMIz (and modified BMIz) over the summer period	Summer weight gain was assessed over 3 summer periods using BMI data collected at the beginning and end of each academic year