Clinical TrialFCU4HealthNCT03013309
Raising Healthy Children: A Hybrid Trial of the Family Check-Up 4 Health in Primary Care
A study testing Family Check-Up 4 Health and Treatment as usual in people with Clinical Trial, run by Arizona State University at 3 sites in United States.
Trial summary
This study is a hybrid implementation-effectiveness trial of the Family Check-Up 4 Health (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients will be recruited based on their BMI as documented in the Electronic Health Record (EHR) and randomized to receive the FCU4Health or… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Clinical Trial
- What is being tested?
- Family Check-Up 4 Health and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 May 2017to 30 Jun 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI at or above 85% tile for age and gender
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Terros Health
Phoenix, Arizona, 85012
Valle del Sol
Phoenix, Arizona, 85014
Phoenix Children's Hospital
Phoenix, Arizona, 85016
About this study
Official title: An Individually Tailored, Family-Centered Intervention for Childhood Obesity: Connecting Services in Pediatric Primary Healthcare, the Home and the Community
This study is a hybrid implementation-effectiveness trial of the Family Check-Up 4 Health (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients will be recruited based on their BMI as documented in the Electronic Health Record (EHR) and randomized to receive the FCU4Health or Treatment as Usual.
Read the detailed description
The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training program. Parents and children complete a comprehensive assessment, including questionnaire and observation data. The FCU4Health coordinator reviews the assessment results with the parents, using MI strategies to create a tailored plan to address family needs. This plan may include referrals to community resources or parenting modules that focus on family management.
- Conditions
- Clinical Trial
- Being tested
- Family Check-Up 4 Health, Treatment as usual
- Keywords
- Hybrid, Implementation, Effectiveness, Parent training, Fidelity, Cost-Effectiveness, Primary Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check-Up 4 HealthBehavioural
Also called FCU4Health
A parent-training intervention to improve child health and prevent/manage obesity
Treatment as usualOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receives the Family Check-Up 4 Health Receives: Behavioral: Family Check-Up 4 Health |
| Control | Experimental | Receives Treatment as Usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
BMI
Measured: The investigators will examine trajectories based on 4 assessments over one year
Secondary outcomes (3)
Body Composition
% Body fat
Measured: The investigators will examine trajectories based on 4 assessments over one year
EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)
Quality of life
Measured: The investigators will examine trajectories based on 4 assessments over one year
PedsQL
Quality of life
Measured: The investigators will examine trajectories based on 4 assessments over one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start9 May 2017
- Primary completion30 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Clinical TrialStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cady Berkel, Ph.D., Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013309
- Sponsor's protocol ID
- 1U18DP006255-01
- Acronym
- FCU4Health
- Status last verified
- Aug 2024
- First submitted
- 4 Jan 2017
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berkel C, Knox DC, Flemotomos N, Martinez VR, Atkins DC, Narayanan SS, Rodriguez LA, Gallo CG, Smith JD. A machine learning approach to improve implementation monitoring of family-based preventive interventions in primary care. Implement Res Pract. 2023 Jul 25;4:26334895231187906. doi: 10.1177/26334895231187906. eCollection 2023 Jan-Dec.
PubMed 37790171Harris A, Jordan N, Carroll AJ, Graham AK, Wilson C, Wilson FA, Berkel C, Smith JD. A budget impact analysis of cost to implement a whole child health focused, family-based intervention in primary care for children with elevated BMI. Implement Sci Commun. 2023 Jun 5;4(1):59. doi: 10.1186/s43058-023-00429-z.
PubMed 37277878Smith JD, Carroll AJ, Fu E, Berkel C. Baseline Targeted Moderation in a Trial of the Family Check-Up 4 Health: Potential Explanations for Finding Few Practical Effects. Prev Sci. 2023 Feb;24(2):226-236. doi: 10.1007/s11121-021-01266-z. Epub 2021 Jun 22.
PubMed 34159507Berkel C, Fu E, Carroll AJ, Wilson C, Tovar-Huffman A, Mauricio A, Rudo-Stern J, Grimm KJ, Dishion TJ, Smith JD. Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in Primary Care. Prev Sci. 2021 May;22(4):464-474. doi: 10.1007/s11121-021-01213-y. Epub 2021 Mar 14.
PubMed 33715136Smith JD, Berkel C, Jordan N, Atkins DC, Narayanan SS, Gallo C, Grimm KJ, Dishion TJ, Mauricio AM, Rudo-Stern J, Meachum MK, Winslow E, Bruening MM. An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study). Implement Sci. 2018 Jan 15;13(1):11. doi: 10.1186/s13012-017-0697-2.
PubMed 29334983
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Individually Tailored, Family-Centered Intervention for Childhood Obesity: Connecting Services in Pediatric Primary Healthcare, the Home and the Community
- ClinicalTrials.gov ID
- NCT03013309
- Acronym / sponsor ID
- FCU4Health / 1U18DP006255-01
- Conditions
- Clinical Trial
- Keywords
- Hybrid, Implementation, Effectiveness, Parent training, Fidelity, Cost-Effectiveness, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Northwestern University, University of Washington, University of Southern California
- Study start
- 9 May 2017 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
This study is a hybrid implementation-effectiveness trial of the Family Check-Up 4 Health (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients will be recruited based on their BMI as documented in the Electronic Health Record (EHR) and randomized to receive the FCU4Health or Treatment as Usual.
Detailed description
The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training program. Parents and children complete a comprehensive assessment, including questionnaire and observation data. The FCU4Health coordinator reviews the assessment results with the parents, using MI strategies to create a tailored plan to address family needs. This plan may include referrals to community resources or parenting modules that focus on family management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Family Check-Up 4 HealthReceives the Family Check-Up 4 Health |
| Control | Experimental | Other: Treatment as usualReceives Treatment as Usual |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- BMI at or above 85% tile for age and gender
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 |
|---|---|---|
| Family Check-Up 4 HealthAlso: FCU4HealthA parent-training intervention to improve child health and prevent/manage obesity | Behavioural | Intervention |
| Treatment as usualTreatment as usual | Other | Control |
Primary outcome
BMI
Time frame: The investigators will examine trajectories based on 4 assessments over one year
BMI
3 secondary outcomes
Body Composition
Time frame: The investigators will examine trajectories based on 4 assessments over one year
EuroQol-5D-5Level-Youth (EQ-5D-5L-Y)
Time frame: The investigators will examine trajectories based on 4 assessments over one year
PedsQL
Time frame: The investigators will examine trajectories based on 4 assessments over one year
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 5 Aug 2024.
- Derived from this study: PubMed 37790171Berkel C, Knox DC, Flemotomos N, Martinez VR, Atkins DC, Narayanan SS, Rodriguez LA, Gallo CG, Smith JD. A machine learning approach to improve implementation monitoring of family-based preventive interventions in primary care. Implement Res Pract. 2023 Jul 25;4:26334895231187906. doi: 10.1177/26334895231187906. eCollection 2023 Jan-Dec.
- Derived from this study: PubMed 37277878Harris A, Jordan N, Carroll AJ, Graham AK, Wilson C, Wilson FA, Berkel C, Smith JD. A budget impact analysis of cost to implement a whole child health focused, family-based intervention in primary care for children with elevated BMI. Implement Sci Commun. 2023 Jun 5;4(1):59. doi: 10.1186/s43058-023-00429-z.
- Derived from this study: PubMed 34159507Smith JD, Carroll AJ, Fu E, Berkel C. Baseline Targeted Moderation in a Trial of the Family Check-Up 4 Health: Potential Explanations for Finding Few Practical Effects. Prev Sci. 2023 Feb;24(2):226-236. doi: 10.1007/s11121-021-01266-z. Epub 2021 Jun 22.
- Derived from this study: PubMed 33715136Berkel C, Fu E, Carroll AJ, Wilson C, Tovar-Huffman A, Mauricio A, Rudo-Stern J, Grimm KJ, Dishion TJ, Smith JD. Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in Primary Care. Prev Sci. 2021 May;22(4):464-474. doi: 10.1007/s11121-021-01213-y. Epub 2021 Mar 14.
- Derived from this study: PubMed 29334983Smith JD, Berkel C, Jordan N, Atkins DC, Narayanan SS, Gallo C, Grimm KJ, Dishion TJ, Mauricio AM, Rudo-Stern J, Meachum MK, Winslow E, Bruening MM. An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study). Implement Sci. 2018 Jan 15;13(1):11. doi: 10.1186/s13012-017-0697-2.
- 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.
Cady Berkel, Ph.D. principal investigator
Arizona State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check-Up 4 Health and Treatment as usual in people with Clinical Trial, run by Arizona State University at 3 sites 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 1 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 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
BMI (time frame: The investigators will examine trajectories based on 4 assessments over one year). 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 NCT03013309, which also lists 5 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 5 Aug 2024.