Pediatric ObesityCHLNCT03334669
Family-centered Obesity Prevention: Communities for Healthy Living (CHL)
A study testing Parents Connect for Healthy Living (PConnect), Enhanced Nutrition Support and Media Resources in people with Pediatric Obesity and Obesity, run by Boston College at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Obesity
- What is being tested?
- Parents Connect for Healthy Living (PConnect), Enhanced Nutrition Support and Media Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,999 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Enrolled in a participating Head Start program
- Age 33 months to 5 years (i.e., meets Head Start age eligibility criteria)
- Enrolled in a participating Head Start program
- Age 33 months to 5 years
Who cannot join
- Those not meeting inclusion criteria
- Secondary Outcome Measures
- Children not enrolled at a participating Head Start program
- Children less than 29 months or older than 59 months by Sept 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empowerment as a Mechanism for Change in Childhood Obesity Prevention
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.
Read the 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.
- Conditions
- Pediatric Obesity, Obesity
- Being tested
- Parents Connect for Healthy Living (PConnect), Enhanced Nutrition Support, Media Resources
- Keywords
- Childhood obesity, Preschool, Head Start, Family Interventions, Community Based Participatory Research (CBPR), Empowerment Theory, Family Ecological Theory, Step Wedge Design, Low Income
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents Connect for Healthy Living (PConnect)Behavioural
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 SupportBehavioural
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 ResourcesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child BMI-z score
Change in child BMI-z score
Measured: 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/
Measured: 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
Change in child fruit and vegetable intake assessed by parent report of child weekly frequency of intake
Measured: 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
Change in child sugar-sweetened beverage consumption assessed by parent report of child weekly frequency of intake
Measured: 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
Change in child physical activity assessed by parent report of average minutes per day child spent in structured free play and organized physical activities
Measured: 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
Change in child daily sleep duration assessed by parent report (calculated from average bedtime and wake time)
Measured: 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
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)
Measured: 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
Summer weight gain
Change in child BMIz (and modified BMIz) over the summer period
Measured: Summer weight gain was assessed over 3 summer periods using BMI data collected at the beginning and end of each academic year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Oct 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: 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).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 4,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- Action for Boston Community Development, Community Action Agency of Somerville, Harvard School of Public Health (HSPH), University at Albany, Massachusetts General Hospital
- Responsible party
- Principal investigator, Kirsten, Boston College
- Investigators
- Kirsten Davison, PhD, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334669
- Sponsor's protocol ID
- 15-3559
- Acronym
- CHL
- Status last verified
- Sep 2025
- First submitted
- 10 Oct 2017
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33152514Beckerman 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.
PubMed 30630109Beckerman-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.
PubMed 32703293Beckerman-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.
PubMed 33734963Beckerman-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.
PubMed 33482774Gago 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.
PubMed 35123371Grafft 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.
PubMed 36318233Gago 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.
PubMed 40292486Gago 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.
PubMed 36631869
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowerment as a Mechanism for Change in Childhood Obesity Prevention
- ClinicalTrials.gov ID
- NCT03334669
- Acronym / sponsor ID
- CHL / 15-3559
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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).
- Enrolment
- 4,999 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- Action for Boston Community Development, Community Action Agency of Somerville, Harvard School of Public Health (HSPH), University at Albany, Massachusetts General Hospital
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Parents Connect for Healthy Living (PConnect), Behavioral: Enhanced Nutrition Support, Behavioral: Media ResourcesSites randomized to the intervention group will receive the following: 1. Parents Connect for Healthy Living (PConnect) 2. Enhanced Nutrition Support 3. Media Resources |
| Control | No intervention | –Control sites will not receive any intervention components (i.e., standard practice). |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled in a participating Head Start program
- Age 33 months to 5 years (i.e., meets Head Start age eligibility criteria)
- Enrolled in a participating Head Start program
- Age 33 months to 5 years
Key exclusion criteria (4 listed)
- Those not meeting inclusion criteria
- Secondary Outcome Measures
- Children not enrolled at a participating Head Start program
- Children less than 29 months or older than 59 months by Sept 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
| Enhanced Nutrition SupportEnhanced 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. | Behavioural | Intervention |
| Media ResourcesMedia 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. | Behavioural | Intervention |
Primary outcome
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/
6 secondary outcomes
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 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 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 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 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
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
Results and safety
The study was stopped early (reason given: 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).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Background: PubMed 33152514Davison 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.
- Background: PubMed 30630109Beckerman 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.
- Background: PubMed 32703293Beckerman-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.
- Results publication: PubMed 33734963Beckerman-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.
- Results publication: PubMed 33482774Beckerman-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.
- Results publication: PubMed 35123371Gago 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.
- Results publication: PubMed 36318233Grafft 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.
- Results publication: PubMed 40292486Gago 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.
- Results publication: PubMed 36631869Gago 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Davison, PhD principal investigator
Boston College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents Connect for Healthy Living (PConnect), Enhanced Nutrition Support and Media Resources in people with Pediatric Obesity and Obesity, run by Boston College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03334669, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.