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

NCT03334669 | Terminated

• 1 other identifier: 15-3559
• Study Type: interventional
• Target: 4,999
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (6)

• 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

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Sites randomized to the intervention group will receive the following: 1. Parents Connect for Healthy Living (PConnect) 2. Enhanced Nutrition Support 3. Media Resources

Behavioral: Parents Connect for Healthy Living (PConnect); Behavioral: Enhanced Nutrition Support; Behavioral: Media Resources

Control

NO INTERVENTION

Control sites will not receive any intervention components (i.e., standard practice).

Interventions

Parents Connect for Healthy Living (PConnect) BEHAVIORAL

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

Enhanced Nutrition Support BEHAVIORAL

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

Media Resources BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in a participating Head Start program
• Age 33 months to 5 years (i.e., meets Head Start age eligibility criteria)

You may not qualify if:

• Secondary Outcome Measures
• Enrolled in a participating Head Start program
• Age 33 months to 5 years
• Children not enrolled at a participating Head Start program
• Children less than 29 months or older than 59 months by Sept 1

Sponsors & Collaborators

• Boston College: lead
• Action for Boston Community Development: collaborator
• Community Action Agency of Somerville: collaborator
• Harvard School of Public Health (HSPH): collaborator
• University at Albany: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Boston College

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (12)

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  PMID: 7605818 BACKGROUND

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  PMID: 7986969 BACKGROUND

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  PMID: 7825243 BACKGROUND

• Shaw NA. The effects of electroconvulsive shock on the thalamic auditory potential. Biol Psychiatry. 1996 Oct 15;40(8):807-10. doi: 10.1016/0006-3223(96)00252-1. No abstract available.

  PMID: 8894077 BACKGROUND

• Ries JC, Schreiner D, Steininger H, Girod SC. p53 mutation and detection of p53 protein expression in oral leukoplakia and oral squamous cell carcinoma. Anticancer Res. 1998 May-Jun;18(3B):2031-6.

  PMID: 9677462 BACKGROUND

• Kesselring A. [Opening address. Family caregivers: what challenges for the future?]. Krankenpfl Soins Infirm. 2001 Jul;94(7):18-21. No abstract available. German.

  PMID: 11944454 BACKGROUND

• Delahaye L, Mothe-Satney I, Myers MG, White MF, Van Obberghen E. Interaction of insulin receptor substrate-1 (IRS-1) with phosphatidylinositol 3-kinase: effect of substitution of serine for alanine in potential IRS-1 serine phosphorylation sites. Endocrinology. 1998 Dec;139(12):4911-9. doi: 10.1210/endo.139.12.6379.

  PMID: 9832428 BACKGROUND

• 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.

  PMID: 30630109 BACKGROUND

• 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.

  PMID: 32703293 BACKGROUND

• 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.

  PMID: 36631869 DERIVED

• 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.

  PMID: 36318233 DERIVED

• 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.

  PMID: 33482774 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kirsten Davison, PhD

  Boston College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Donahue and DiFelice Professor of Social Work

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: November 7, 2017
• Study Start: October 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)