ObesityHC3NCT05106426
Healthy Caregivers-Healthy Children
A study testing Healthy Caregivers- Healthy children and Jump Start in people with Obesity and Child, Only, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the study is to further develop and examine the Health Caregivers Healthy Children (HC2) program, which encourages obesity prevention through promoting healthy eating and physical activity. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Child, Only
- What is being tested?
- Healthy Caregivers- Healthy children and Jump Start
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 Feb 2024
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1) Children with feeding tubes or those that bring their own meals due to dietary restrictions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Caregivers-Healthy Children Phase 3: Children With Special Needs
The purpose of the study is to further develop and examine the Health Caregivers Healthy Children (HC2) program, which encourages obesity prevention through promoting healthy eating and physical activity.
- Conditions
- Obesity, Child, Only
- Being tested
- Healthy Caregivers- Healthy children, Jump Start
- Keywords
- obesity prevention, childhood, special needs
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Caregivers- Healthy childrenBehavioural
The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom or in-person.
Jump StartBehavioural
The Jump Start intervention is a behavioral health and safety program that provides behavior management and safety programs administered weekly via Zoom or in-person.
| Study group | Role | What they receive |
|---|---|---|
| HC2 intervention Group | Experimental | Participants in this group will receive the Healthy Caregivers-Healthy Children (HC2) intervention for 24 months Receives: Behavioral: Healthy Caregivers- Healthy children |
| Jump Start Control Group | Active comparator | Participants in this group will receive the Jump Start intervention for 24 months Receives: Behavioral: Jump Start |
| Parents/Caregivers of Participants receiving HC2 intervention | No intervention | Parents/caregivers of participants receiving the HC2 program will not be receiving any intervention. |
| No Intervention: Parents/Caregivers of participants receiving Jump Start Intervention | No intervention | Parents/caregivers of participants receiving the Jump Start program will not be receiving any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index Percentile
Body mass index will be collected on children enrolled using participant's height and weight using a percentile score from 0-100
Measured: Baseline, Up to 3 years
Change in Environment and Policy Assessment and Observation tool) and the Healthy Environment Rating Scale
Environment and Policy Assessment and Observation Tool has a total score ranging from 0-100 with the higher score indicating greater quality of nutrition
Measured: Baseline, Up to 3 years
Secondary outcomes (4)
Change in Healthy Caregivers-Healthy Children (HC2) Survey
Teacher and parents complete this survey on the number of reported nutrition and physical activity practices
Measured: Baseline, Up to 3 years
Change in Health Environment Rating Scale
The Healthy Environment Rating Scale has a total score ranging from 0-100 with the higher score indicating increased healthy practices
Measured: Baseline, Up to 3 years
Change in Parent Stress Index
Parents will complete this survey of stress. The Parent Stress Index ranges from 0-100 with higher scores indicating higher levels of stress.
Measured: Baseline, Up to 3 years
Change in Childcare Worker Job Stress Index
The Childcare Worker Job Stress Index is a total score that ranges from 22 to 110 with higher scores indicating higher levels of stress.
Measured: Baseline, Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Nov 2021
- Primary completion1 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Responsible party
- Principal investigator, Ruby Natale, University of Miami
- Investigators
- Ruby Natale, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106426
- Sponsor's protocol ID
- 20210902
- Acronym
- HC3
- Status last verified
- Sep 2024
- First submitted
- 22 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Caregivers-Healthy Children Phase 3: Children With Special Needs
- ClinicalTrials.gov ID
- NCT05106426
- Acronym / sponsor ID
- HC3 / 20210902
- Conditions
- Obesity, Child, Only
- Keywords
- obesity prevention, childhood, special needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 3 Nov 2021 (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 purpose of the study is to further develop and examine the Health Caregivers Healthy Children (HC2) program, which encourages obesity prevention through promoting healthy eating and physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HC2 intervention Group | Experimental | Behavioral: Healthy Caregivers- Healthy childrenParticipants in this group will receive the Healthy Caregivers-Healthy Children (HC2) intervention for 24 months |
| Jump Start Control Group | Active comparator | Behavioral: Jump StartParticipants in this group will receive the Jump Start intervention for 24 months |
| Parents/Caregivers of Participants receiving HC2 intervention | No intervention | –Parents/caregivers of participants receiving the HC2 program will not be receiving any intervention. |
| No Intervention: Parents/Caregivers of participants receiving Jump Start Intervention | No intervention | –Parents/caregivers of participants receiving the Jump Start program will not be receiving any intervention. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1) Children with feeding tubes or those that bring their own meals due to dietary restrictions
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 |
|---|---|---|
| Healthy Caregivers- Healthy childrenThe HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom or in-person. | Behavioural | HC2 intervention Group |
| Jump StartThe Jump Start intervention is a behavioral health and safety program that provides behavior management and safety programs administered weekly via Zoom or in-person. | Behavioural | Jump Start Control Group |
Primary outcome
Change in Body Mass Index Percentile
Time frame: Baseline, Up to 3 years
Body mass index will be collected on children enrolled using participant's height and weight using a percentile score from 0-100
Change in Environment and Policy Assessment and Observation tool) and the Healthy Environment Rating Scale
Time frame: Baseline, Up to 3 years
Environment and Policy Assessment and Observation Tool has a total score ranging from 0-100 with the higher score indicating greater quality of nutrition
4 secondary outcomes
Change in Healthy Caregivers-Healthy Children (HC2) Survey
Time frame: Baseline, Up to 3 years
Change in Health Environment Rating Scale
Time frame: Baseline, Up to 3 years
Change in Parent Stress Index
Time frame: Baseline, Up to 3 years
Change in Childcare Worker Job Stress Index
Time frame: Baseline, Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Ruby Natale principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Caregivers- Healthy children and Jump Start in people with Obesity and Child, Only, run by University of Miami 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 0 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Body Mass Index Percentile (time frame: Baseline, Up to 3 years). 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?
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 19 Sep 2024.