Down SyndromeHomeGrownNCT07296861
HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome
A study testing The HomeGrown and Waitlist in people with Down Syndrome and Child Obesity, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this project is to evaluate an adapted health promotion program, HomeGrown, designed to improve the health of young children with Down syndrome by supporting families in making healthy home environmental changes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Child Obesity
- What is being tested?
- The HomeGrown and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult:
- Ability to provide informed consent
- 18 years or older
- Primary caregiver of a child with Down syndrome aged 2 to 6 years old
- Have access to WI-FI or smartphone
- Be able to read and speak English
Show all 10Show fewer
- Children:
- Be 2-6 years old.
- Are diagnosed with Down syndrome
- Are not reliant on tube feeding
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Health Promotion and Disease Prevention
Chapel Hill, North Carolina, 27599-7426
About this study
The goal of this project is to evaluate an adapted health promotion program, HomeGrown, designed to improve the health of young children with Down syndrome by supporting families in making healthy home environmental changes. There is a significant need for evidence-based programs that address healthy eating and physical activity within this population, as most existing interventions have been developed for typically developing children. By tailoring the program to the unique needs of families of young children with Down syndrome, this project aims to advance inclusion and equity in health behavior promotion.
This R61/R33 study will assess the feasibility (R61 Phase) and subsequent efficacy (R33 Phase) of the HomeGrown program in improving family practices related to nutrition and physical activity. During the R61 feasibility phase, 38 primary caregivers of children aged 2-6 years with Down syndrome will be enrolled in a 6-month randomized controlled trial. Families will be randomized 1:1 to either the HomeGrown intervention or a waitlist control group (6-month delayed start), stratified by the child's biological sex (male/female) and age (2-3 vs. 4-6 years). All measures will be collected at baseline and at 6-month follow-up.
Read more
The R61 feasibility phase will address three specific aims:
Accrual: Achieve an enrollment rate of 10 families per month, supporting feasibility for the R33 efficacy phase.
Engagement: Demonstrate that families use at least 70% of available HomeGrown intervention components, measured using the digital behavior change interventions engagement scale.
Data Collection \& Retention: Achieve at least 80% retention with completion of all outcome assessments.
By addressing key gaps in nutrition and physical activity research for young children with Down syndrome, this study has the potential to improve health outcomes for an underserved population and inform future clinical and community health promotion efforts.
- Conditions
- Down Syndrome, Child Obesity
- Being tested
- The HomeGrown, Waitlist
- Keywords
- home environmental
- Medical subject headings
- Down Syndrome, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The HomeGrownBehavioural
The implementation model for supporting home environment changes focuses on engaging families in Homegrown, giving them access to interactive online tools and resources that guide behavior change, and providing monthly support check-in calls as they work to adopt evidence-based healthy eating and physical activity practices at home. Families will participate in the 6-month program with support from a trained health educator. The HomeGrown program begins with a family orientation session, followed by access to the HomeGrown web application.
Participants will have access to HomeGrown intervention which is a 6-month program that helps families improve healthy eating and physical activity at home. Families start with an orientation session, then use the HomeGrown web application with interactive tools and resources. Monthly check-in calls with a trained health educator provide guidance and support throughout the program.
WaitlistOther
Participants will have a 1-hour training with the interventionist to learn how to use a website (not HomeGrown). Access to HomeGrown will be provided after the 6-month study is completed.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- HomeGrown program | Experimental | Participants will receive interventions. Receives: Behavioral: The HomeGrown |
| Arm 2 Waitlist control | Active comparator | Participants will receive interventions after study completion, 6-month delayed start. Receives: Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual Rate
Percent of eligible participants who agreed to join study.
Measured: Baseline
Participant Engagement
Digital behavior change engagement scale will be measured as number of participants completed digital intervention.
Measured: 6 months
Participant Retention
Percent of participants who completed 6-month measures.
Measured: 6 months
Secondary outcomes (2)
Child Physical Activity
GT3X+ accelerometers (ActiGraph, Pensacola, FL) are small wearable devices that measure movement and physical activity levels. worn on children's waist for 7 consecutive days. Reminders about wearing and returning the device will be sent via email/text throughout each assessment period. Video instructions will also be available through the web application. Accelerometer data will be used to calculate the number of minutes participants spend in each physical activity level (sedentary, light, moderate, vigorous, and total non-sedentary).
Measured: 6 months
Child Diet Quality
Caregivers will complete 24-hour dietary recalls to report their child's food and beverage intake using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool. Caregivers will receive a standardized email with login details, instructions, and a prompt to complete the recall, followed by a reminder text on their assigned recall days. If a recall is still not completed, data collectors will make a final attempt to complete it with the caregiver by phone.
Using the ASA24 output, Healthy Eating Index-Toddlers-2020 (HEI-2020) scores will be calculated. The HEI-2020 reflects how closely a child's diet aligns with dietary guidelines, with scores ranging from 0 to 100; higher scores indicate better diet quality.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start16 Apr 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Willis, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296861
- Sponsor's protocol ID
- 25-2418
- Other IDs
- R01DK128174
- Acronym
- HomeGrown
- Status last verified
- Sep 2026
- First submitted
- 18 Dec 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual, de-identified data will be shared in compliance with NIH data sharing policies. They will be shared via the funding institute's required INCLUDE Data Coordinating Center as well as UNC Dataserve.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07296861
- Acronym / sponsor ID
- HomeGrown / 25-2418
- Conditions
- Down Syndrome, Child Obesity
- Keywords
- home environmental
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Dec 2025 (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 goal of this project is to evaluate an adapted health promotion program, HomeGrown, designed to improve the health of young children with Down syndrome by supporting families in making healthy home environmental changes. There is a significant need for evidence-based programs that address healthy eating and physical activity within this population, as most existing interventions have been developed for typically developing children. By tailoring the program to the unique needs of families of young children with Down syndrome, this project aims to advance inclusion and equity in health behavior promotion.
This R61/R33 study will assess the feasibility (R61 Phase) and subsequent efficacy (R33 Phase) of the HomeGrown program in improving family practices related to nutrition and physical activity. During the R61 feasibility phase, 38 primary caregivers of children aged 2-6 years with Down syndrome will be enrolled in a 6-month randomized controlled trial. Families will be randomized 1:1 to either the HomeGrown intervention or a waitlist control group (6-month delayed start), stratified by the child's biological sex (male/female) and age (2-3 vs. 4-6 years). All measures will be collected at baseline and at 6-month follow-up.
The R61 feasibility phase will address three specific aims:
Accrual: Achieve an enrollment rate of 10 families per month, supporting feasibility for the R33 efficacy phase.
Engagement: Demonstrate that families use at least 70% of available HomeGrown intervention components, measured using the digital behavior change interventions engagement scale.
Data Collection \& Retention: Achieve at least 80% retention with completion of all outcome assessments.
By addressing key gaps in nutrition and physical activity research for young children with Down syndrome, this study has the potential to improve health outcomes for an underserved population and inform future clinical and community health promotion efforts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1- HomeGrown program | Experimental | Behavioral: The HomeGrownParticipants will receive interventions. |
| Arm 2 Waitlist control | Active comparator | Other: WaitlistParticipants will receive interventions after study completion, 6-month delayed start. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to provide informed consent
- 18 years or older
- Primary caregiver of a child with Down syndrome aged 2 to 6 years old
- Have access to WI-FI or smartphone
- Be able to read and speak English
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| The HomeGrownThe implementation model for supporting home environment changes focuses on engaging families in Homegrown, giving them access to interactive online tools and resources that guide behavior change, and providing monthly support check-in calls as they work to adopt evidence-based healthy eating and physical activity practices at home. Families will participate in the 6-month program with support from a trained health educator. The HomeGrown program begins with a family orientation session, followed by access to the HomeGrown web application. Participants will have access to HomeGrown intervention which is a 6-month program that helps families improve healthy eating and physical activity at home. Families start with an orientation session, then use the HomeGrown web application with interactive tools and resources. Monthly check-in calls with a trained health educator provide guidance and support throughout the program. | Behavioural | Arm 1- HomeGrown program |
| WaitlistParticipants will have a 1-hour training with the interventionist to learn how to use a website (not HomeGrown). Access to HomeGrown will be provided after the 6-month study is completed. | Other | Arm 2 Waitlist control |
Primary outcome
Accrual Rate
Time frame: Baseline
Percent of eligible participants who agreed to join study.
Participant Engagement
Time frame: 6 months
Digital behavior change engagement scale will be measured as number of participants completed digital intervention.
Participant Retention
Time frame: 6 months
Percent of participants who completed 6-month measures.
2 secondary outcomes
Child Physical Activity
Time frame: 6 months
Child Diet Quality
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual, de-identified data will be shared in compliance with NIH data sharing policies. They will be shared via the funding institute's required INCLUDE Data Coordinating Center as well as UNC Dataserve.
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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.
Eric Willis, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The HomeGrown and Waitlist in people with Down Syndrome and Child Obesity, run by UNC Lineberger Comprehensive Cancer Center 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 10 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Accrual Rate (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.