Overweight and ObesityNCT04042493
Connect for Health Pediatric Weight Management Program
A study testing Connect for Health in people with Overweight and Obesity and Severe Obesity, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The overall aim of this study is to disseminate the evidence-based Connect for Health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the US who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Overweight and Obesity, Severe Obesity
- What is being tested?
- Connect for Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,304 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Nov 2019to 31 Jul 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children receiving primary care at the participating health centers across the three health systems
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Denver Health and Hospital Authority
Denver, Colorado, 80204
Greenville Health System / Prisma Health
Greenville, South Carolina, 29605
About this study
Official title: Dissemination and Implementation of Effective Childhood Obesity Treatment Innovations
The overall aim of this study is to disseminate the evidence-based Connect for Health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the US who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program implementation and dissemination.
- Conditions
- Overweight and Obesity, Severe Obesity
- Being tested
- Connect for Health
- Keywords
- Overweight, Obesity, Pediatric, Implementation, Dissemination
- Medical subject headings
- Overweight, Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connect for HealthBehavioural
The program includes (1) electronic health record (EHR)-based clinical decision support tools to guide pediatric providers in child weight management; (2) clinician and medical staff training in obesity management best practices, (3) family educational materials focused on evidence-based behavioral targets; and (4) social- and community-informed text messages for parents to support behavior change.
| Study group | Role | What they receive |
|---|---|---|
| Connect for Health Program | Experimental | Not described Receives: Behavioral: Connect for Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child Body Mass Index
Age- and sex-specific Body Mass Index z-score
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start19 Nov 2019
- Primary completion30 Apr 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The Connect for Health program is a package of practice-level care enhancements to systematically improve the quality of clinical care provided for childhood obesity and offer support directly to parents to improve the children's growth trajectories.
- Masking
- None (open label)
- Enrolment
- 19,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health and Hospital Authority, Prisma Health-Upstate
- Responsible party
- Principal investigator, Elsie Taveras, MD, Massachusetts General Hospital
- Investigators
- Elsie Taveras, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042493
- Sponsor's protocol ID
- 2018P002972
- Other IDs
- DI-2017C3-9005
- Status last verified
- Mar 2023
- First submitted
- 31 Jul 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simione M, Aschbrenner K, Farrar-Muir H, Luo M, Granadeno J, Caballero-Gonzalez A, Price SN, Torres C, Boudreau AA, Fiechtner L, Hambidge SJ, Sease K, Taveras EM. Adapting Connect for Health pediatric weight management program for telehealth in response to the COVID-19 pandemic. Implement Sci Commun. 2023 Nov 16;4(1):139. doi: 10.1186/s43058-023-00523-2.
PubMed 37974245Simione M, Farrar-Muir H, Mini FN, Perkins ME, Luo M, Frost H, Orav EJ, Metlay J, Zai AH, Kistin CJ, Sease K, Hambidge SJ, Taveras EM; Connect for Health Collaborative. Implementation of the Connect for Health pediatric weight management program: study protocol and baseline characteristics. J Comp Eff Res. 2021 Aug;10(11):881-892. doi: 10.2217/cer-2021-0076. Epub 2021 May 24.
PubMed 34024120Simione M, Frost HM, Cournoyer R, Mini FN, Cassidy J, Craddock C, Moreland J, Wallace J, Metlay J, Kistin CJ, Sease K, Hambidge SJ, Taveras EM. Engaging stakeholders in the adaptation of the Connect for Health pediatric weight management program for national implementation. Implement Sci Commun. 2020 Jun 17;1:55. doi: 10.1186/s43058-020-00047-z. eCollection 2020.
PubMed 32885211
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination and Implementation of Effective Childhood Obesity Treatment Innovations
- ClinicalTrials.gov ID
- NCT04042493
- Acronym / sponsor ID
- 2018P002972
- Conditions
- Overweight and Obesity, Severe Obesity
- Keywords
- Overweight, Obesity, Pediatric, Implementation, Dissemination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19,304 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Denver Health and Hospital Authority, Prisma Health-Upstate
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 2 Aug 2019 (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 overall aim of this study is to disseminate the evidence-based Connect for Health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the US who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program implementation and dissemination.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Connect for Health program is a package of practice-level care enhancements to systematically improve the quality of clinical care provided for childhood obesity and offer support directly to parents to improve the children's growth trajectories.
| Arm | Type | Receives |
|---|---|---|
| Connect for Health Program | Experimental | Behavioral: Connect for Health |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children receiving primary care at the participating health centers across the three health systems
Key exclusion criteria (0 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 |
|---|---|---|
| Connect for HealthThe program includes (1) electronic health record (EHR)-based clinical decision support tools to guide pediatric providers in child weight management; (2) clinician and medical staff training in obesity management best practices, (3) family educational materials focused on evidence-based behavioral targets; and (4) social- and community-informed text messages for parents to support behavior change. | Behavioural | Connect for Health Program |
Primary outcome
Change in child Body Mass Index
Time frame: One year
Age- and sex-specific Body Mass Index z-score
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 22 Mar 2023.
- Derived from this study: PubMed 37974245Simione M, Aschbrenner K, Farrar-Muir H, Luo M, Granadeno J, Caballero-Gonzalez A, Price SN, Torres C, Boudreau AA, Fiechtner L, Hambidge SJ, Sease K, Taveras EM. Adapting Connect for Health pediatric weight management program for telehealth in response to the COVID-19 pandemic. Implement Sci Commun. 2023 Nov 16;4(1):139. doi: 10.1186/s43058-023-00523-2.
- Derived from this study: PubMed 34024120Simione M, Farrar-Muir H, Mini FN, Perkins ME, Luo M, Frost H, Orav EJ, Metlay J, Zai AH, Kistin CJ, Sease K, Hambidge SJ, Taveras EM; Connect for Health Collaborative. Implementation of the Connect for Health pediatric weight management program: study protocol and baseline characteristics. J Comp Eff Res. 2021 Aug;10(11):881-892. doi: 10.2217/cer-2021-0076. Epub 2021 May 24.
- Derived from this study: PubMed 32885211Simione M, Frost HM, Cournoyer R, Mini FN, Cassidy J, Craddock C, Moreland J, Wallace J, Metlay J, Kistin CJ, Sease K, Hambidge SJ, Taveras EM. Engaging stakeholders in the adaptation of the Connect for Health pediatric weight management program for national implementation. Implement Sci Commun. 2020 Jun 17;1:55. doi: 10.1186/s43058-020-00047-z. eCollection 2020.
- 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.
Elsie Taveras, MD, MPH principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connect for Health in people with Overweight and Obesity and Severe Obesity, run by Massachusetts General Hospital 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 0 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 22 Mar 2023. 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?
Change in child Body Mass Index (time frame: 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 NCT04042493, which also lists 3 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 22 Mar 2023.