Childhood ObesityCHECKNCT03195790
Creating Healthy Environments for Chicago Kids
A study testing Family-based pediatric obesity treatment in people with Childhood Obesity, run by Rush University Medical Center at 1 site in United States.
Trial summary
Pediatric obesity interventions for low-income populations are increasingly delivered in children's homes, which may make treatment more accessible to families and enhance the potency of the intervention in several ways. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Family-based pediatric obesity treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2017to 19 Sep 2022
- 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
- Family includes at least one child who is 6 to 12 years old, and is overweight or obese (has a body mass index at or above the 85th percentile for age and sex)
- Child's household has an income-to-poverty ratio ≤ 2.0
Who cannot join
- Child or caregiver(s) are not fluent in English
- Unwilling to attend and complete either home-based or clinic-based treatment, or to complete any aspect of the study assessment battery
- Medical contraindication or barrier to weight loss treatment
- Caregiver has a major medical or psychiatric condition likely to interfere with treatment
- Plans to relocate outside the Chicago area in the next 12 months, or living in temporary or group housing with other families
- Resides more than 15 miles from the Illinois Medical District (study site)
- Conditions in or around the home that jeopardize staff/interventionist safety
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Value and Mechanisms of Home Visitation in Obesity Interventions for Low-income Children
Pediatric obesity interventions for low-income populations are increasingly delivered in children's homes, which may make treatment more accessible to families and enhance the potency of the intervention in several ways. This randomized trial will directly test whether delivering family-based behavioral interventions for pediatric overweight/obesity in the home setting improves weight loss outcomes in low-income children relative to medical center-based treatment. The trial will also quantify the cost-effectiveness of home visitation, and explore the mechanisms accounting for observed treatment effects
Read the detailed description
The goal of this project is to systematically evaluate the incremental weight loss benefit and cost-effectiveness of delivering standard family-based treatment for pediatric overweight/obesity in the home setting vs. traditional medical settings. In a randomized controlled trial involving low-income households, 266 children ages 6-12 years will be allocated to 12 months of family-based treatment delivered either in their home or at an urban academic medical center. Both arms will receive the same intervention content and dosage, and differ only in the location of in-person treatment sessions. Aim 1 is to test the hypothesis that home-based treatment produces a greater reduction in child adiposity, reflected in 12-month change in BMI z-score. Aim 2 is to compare the cost-effectiveness of home-based treatment to medical center-based treatment, and calculate the added cost of the incremental weight loss benefit associated with home visitation. These data will inform efforts to disseminate home-based interventions for low-income populations by public health agencies and third-party payers. Aim 3 is to explore specific mechanisms through which home visitation may improve weight loss outcomes.
- Conditions
- Childhood Obesity
- Being tested
- Family-based pediatric obesity treatment
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based pediatric obesity treatmentBehavioural
Families with at least one overweight/obese child between ages 6 and 11 years will receive 12-months of family-based pediatric obesity treatment that emphasizes healthy changes to the home environment and family routines. The intervention targets dietary intake, physical activity, and consistent sleep.
| Study group | Role | What they receive |
|---|---|---|
| Medical center treatment arm | Active comparator | Family-based pediatric obesity treatment delivered at an urban medical center. Receives: Behavioral: Family-based pediatric obesity treatment |
| Home treatment arm | Experimental | Family-based pediatric obesity treatment delivered in the family's home. Receives: Behavioral: Family-based pediatric obesity treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child adiposity
Change from baseline in child body mass index z-score (zBMI)
Measured: 12 months
Secondary outcomes (2)
Clinically significant weight loss
Proportion of children achieving adiposity reduction of at least 0.25 zBMI
Measured: 12 months
Cost-effectiveness
Incremental cost-effectiveness ratio of home-based vs medical center treatment, calculated from societal perspective.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start8 Aug 2017
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195790
- Sponsor's protocol ID
- 15120306
- Other IDs
- R01DK111358
- Acronym
- CHECK
- Status last verified
- Oct 2024
- First submitted
- 20 Jun 2017
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This plan is to be determined.
Publications
Appelhans BM, French SA, Bradley LE, Lui K, Janssen I, Richardson D. CHECK: A randomized trial evaluating the efficacy and cost-effectiveness of home visitation in pediatric weight loss treatment. Contemp Clin Trials. 2020 Jan;88:105891. doi: 10.1016/j.cct.2019.105891. Epub 2019 Nov 15.
PubMed 31740429
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value and Mechanisms of Home Visitation in Obesity Interventions for Low-income Children
- ClinicalTrials.gov ID
- NCT03195790
- Acronym / sponsor ID
- CHECK / 15120306
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 22 Jun 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.
Pediatric obesity interventions for low-income populations are increasingly delivered in children's homes, which may make treatment more accessible to families and enhance the potency of the intervention in several ways. This randomized trial will directly test whether delivering family-based behavioral interventions for pediatric overweight/obesity in the home setting improves weight loss outcomes in low-income children relative to medical center-based treatment. The trial will also quantify the cost-effectiveness of home visitation, and explore the mechanisms accounting for observed treatment effects
Detailed description
The goal of this project is to systematically evaluate the incremental weight loss benefit and cost-effectiveness of delivering standard family-based treatment for pediatric overweight/obesity in the home setting vs. traditional medical settings. In a randomized controlled trial involving low-income households, 266 children ages 6-12 years will be allocated to 12 months of family-based treatment delivered either in their home or at an urban academic medical center. Both arms will receive the same intervention content and dosage, and differ only in the location of in-person treatment sessions. Aim 1 is to test the hypothesis that home-based treatment produces a greater reduction in child adiposity, reflected in 12-month change in BMI z-score. Aim 2 is to compare the cost-effectiveness of home-based treatment to medical center-based treatment, and calculate the added cost of the incremental weight loss benefit associated with home visitation. These data will inform efforts to disseminate home-based interventions for low-income populations by public health agencies and third-party payers. Aim 3 is to explore specific mechanisms through which home visitation may improve weight loss outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Medical center treatment arm | Active comparator | Behavioral: Family-based pediatric obesity treatmentFamily-based pediatric obesity treatment delivered at an urban medical center. |
| Home treatment arm | Experimental | Behavioral: Family-based pediatric obesity treatmentFamily-based pediatric obesity treatment delivered in the family's home. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Family includes at least one child who is 6 to 12 years old, and is overweight or obese (has a body mass index at or above the 85th percentile for age and sex)
- Child's household has an income-to-poverty ratio ≤ 2.0
Key exclusion criteria (7 listed)
- Child or caregiver(s) are not fluent in English
- Unwilling to attend and complete either home-based or clinic-based treatment, or to complete any aspect of the study assessment battery
- Medical contraindication or barrier to weight loss treatment
- Caregiver has a major medical or psychiatric condition likely to interfere with treatment
- Plans to relocate outside the Chicago area in the next 12 months, or living in temporary or group housing with other families
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-based pediatric obesity treatmentFamilies with at least one overweight/obese child between ages 6 and 11 years will receive 12-months of family-based pediatric obesity treatment that emphasizes healthy changes to the home environment and family routines. The intervention targets dietary intake, physical activity, and consistent sleep. | Behavioural | Home treatment arm, Medical center treatment arm |
Primary outcome
Child adiposity
Time frame: 12 months
Change from baseline in child body mass index z-score (zBMI)
2 secondary outcomes
Clinically significant weight loss
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
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 4 Nov 2024.
- Derived from this study: PubMed 31740429Appelhans BM, French SA, Bradley LE, Lui K, Janssen I, Richardson D. CHECK: A randomized trial evaluating the efficacy and cost-effectiveness of home visitation in pediatric weight loss treatment. Contemp Clin Trials. 2020 Jan;88:105891. doi: 10.1016/j.cct.2019.105891. Epub 2019 Nov 15.
- Individual participant dataSharing planned: Undecided. This plan is to be determined.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based pediatric obesity treatment in people with Childhood Obesity, run by Rush University Medical 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 2 inclusion and 7 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 4 Nov 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?
Child adiposity (time frame: 12 months). 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 NCT03195790, which also lists 1 linked publication.
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 4 Nov 2024.