Pediatric ObesityNCT04647760
Packaging and Disseminating the JOIN for ME Program in Low-Income Settings
A study testing JOIN for ME in people with Pediatric Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
One in five children in the United States have obesity, and under-served populations are differentially impacted by both obesity and its related health consequences. Thus, community-based programs that improve the dissemination of effective obesity treatments are needed within low income settings. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- JOIN for ME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 10 Sep 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
- Healthy volunteers accepted
- Child
Who may be able to join
- be 6 to 12 years old
- have a BMI > 85th percentile
- have at least one caregiver available to provide consent and participate in sessions
- speak English or Spanish
- agree to study participation and delayed treatment onset if applicable.
Who cannot join
- either the child or the parent is currently involved in another weight loss program
- have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity
- are developmentally delayed such that the intervention materials will not be appropriate
- are in treatment for or diagnosed with a major psychiatric disorder, including an eating disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Management and Diabetes Research Center, The Miriam Hospital/Alpert Medical School of Brown University
Providence, Rhode Island, 02903
About this study
One in five children in the United States have obesity, and under-served populations are differentially impacted by both obesity and its related health consequences. Thus, community-based programs that improve the dissemination of effective obesity treatments are needed within low income settings. The current study aims to test the effectiveness of an evidence-based, community centered program, JOIN for ME, in two types of community settings: housing authorities and patient-centered medical homes. Children between the ages of 6-12 years old and who meet study eligibility criteria will be enrolled in the study and participate in the JOIN for ME weight control intervention. Participants will be assigned to active or delayed treatment conditions (4-month delay) but all participants will receive the JOIN for ME program. The program will be delivered in English or Spanish. Primary outcomes include change in child and parent weight status and health-related quality of life.
Read the detailed description
The U.S. Preventive Services Task Force (USPSTF) recently reissued a Grade B recommendation, initially made in 2010, for clinicians to screen children ages 6-18 years for obesity and refer identified youth to comprehensive, multi-component programs with >26 contact hours that include nutrition and physical activity targets and are supported by behavioral strategies. Re-issue of this recommendation highlights the continued importance of comprehensive family-based obesity treatment programs with broad accessibility. The challenge in meeting this objective is the lack of community-based obesity treatments for children. The majority of children in the U.S. do not receive evidence-based treatment of obesity, with few such programs available to youth from low-income backgrounds.
There are multiple efforts underway to broaden both the empirical support for, and accessibility of, pediatric weight management interventions. One such strategy is implementation within the primary care setting as families are already accustomed to attending visits for medical concerns and because physicians are important drivers of health behavior change. An alternative strategy, also with high impact potential, is embedding interventions in established organizations within the communities in which families live, thereby decreasing logistical barriers (e.g. transportation) and enhancing program credibility.
The JOIN for ME program, developed as a collaboration between United HealthGroup and Y-USA, is an empirically tested, effective pediatric weight control intervention for children ages 6-12 years that is delivered by facilitators within a community setting and potentially scalable nationally. The primary aim of this study is to test the effectiveness of the the JOIN for ME intervention in two different types of community setting, housing authorities and patient-centered medical homes, with the intention to increase equity and access to care for families in low-income settings. To accomplish this aim, formative qualitative work was conducted during 2019-2020 with key community stakeholders and families within the targeted community settings. The formative work resulted in adapting "participant facing" intervention materials and tools as well as the development of systems to connect families with local community resources. These developments will be implemented in intervention delivery as a means of increasing acceptability of the intervention and assessing its potential for broader scale dissemination within community settings. Further, certified Community Health Workers (CHWs) will deliver the proposed intervention given their ability to serve as intermediaries between healthcare systems and the community.
A total of 128 children (ages 6-12) with BMI > 85th% will be enrolled in this study and receive the JOIN for ME weight control intervention. The intervention will be delivered in English or Spanish. Participants will be assigned to active or delayed treatment conditions (4-month delay) based on an a priori set of rules pertaining to recruitment strategies and timeline. Evaluation of primary outcomes, change in child and parent weight status and health-related quality of life (HRQL), will be obtained at baseline, 4 months, and 10 months.
The following hypotheses will be tested:
- Children who receive the JOIN for ME program immediately will demonstrate greater decreases in percent over median BMI and zBMI from baseline to 4 months compared to those in the delayed treatment onset prior to receiving the intervention.
- Children who receive the JOIN for ME program immediately will demonstrate improvements in HRQL from baseline to 4 months compared to those in the delayed treatment onset.
- Conditions
- Pediatric Obesity
- Being tested
- JOIN for ME
- Keywords
- Pediatric, Pediatric obesity, Pediatric overweight, Community-based, Behavioral weight loss
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JOIN for MEBehavioural
JOIN for ME is an empirically tested, effective weight management program for children ages 6-12 years.The curriculum includes 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Weekly meetings are attended by the parent/caregiver and child, and occur at a location within their community setting (public housing or patient-centered medical home). Each session is 60 minutes and led by a certified Community Health Worker, with a private weigh-in for each dyad prior to the start of each session. Key behavioral targets include self-monitoring of dietary intake and physical activity, limiting LESS foods, limiting screen time, and weekly attendance. A family-based incentive structure is incorporated into the program such that parents/caregivers reinforce their children for achieving goals. Due to the COVID-19 pandemic, in-person sessions will be conducted virtually until it is safe to resume in-person group sessions.
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Other | Participants will start the intervention immediately upon study enrollment. Receives: Behavioral: JOIN for ME |
| Delayed treatment | Other | Participants will start the intervention 4-months post enrollment. Receives: Behavioral: JOIN for ME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Outcome - Change in child weight status
Change in Body Mass Index (BMI, kg/m2)-for age-percentile
Measured: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
Patient Outcome - Change in parent weight status
Change in Body Mass Index (BMI, kg/m2)
Measured: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
Patient Outcome - Change in child health-related quality of life (HRQL)
Obesity-specific child self-report measure, Size Me Up
Measured: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
Patient Outcome - Change in parent health-related quality of life (HRQL)
Obesity-specific parent self-report measure, Sizing Them Up
Measured: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start25 Jan 2021
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid-implementation effectiveness design incorporating a delayed-treatment design for treatment group assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, University of North Carolina, Chapel Hill, Tufts University, Brandeis University
- Responsible party
- Principal investigator, Elissa Jelalian, The Miriam Hospital
- Investigators
- Elissa Jelalian, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647760
- Sponsor's protocol ID
- 5U18DP006429-02
- Status last verified
- Jul 2025
- First submitted
- 23 Nov 2020
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified data set will be submitted to a data repository or to an investigator created website, if a central repository is not available. IPD which underlie results in a publication will be included in the repository.
Publications
Darling KE, Hayes JF, Evans EW, Seifer R, Elwy AR, Jelalian E. Implementation of the JOIN for ME Program for Families from Low-Income Backgrounds: The Use of Theory-Driven Formative Evaluation: Rhode Island CORD 3.0. Child Obes. 2021 Sep;17(S1):S22-S29. doi: 10.1089/chi.2021.0172.
PubMed 34569847Jelalian E, Evans W, Darling KE, Seifer R, Vivier P, Goldberg J, Wright C, Tanskey L, Warnick J, Hayes J, Shepard D, Tuttle H, Elwy AR. Protocol for the Rhode Island CORD 3.0 Study: Adapting, Testing, and Packaging the JOIN for ME Family-Based Childhood Obesity Program in Low-Income Communities. Child Obes. 2021 Sep;17(S1):S11-S21. doi: 10.1089/chi.2021.0179.
PubMed 34569839
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Packaging and Disseminating the JOIN for ME Program in Low-Income Settings
- ClinicalTrials.gov ID
- NCT04647760
- Acronym / sponsor ID
- 5U18DP006429-02
- Conditions
- Pediatric Obesity
- Keywords
- Pediatric, Pediatric obesity, Pediatric overweight, Community-based, Behavioral weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Brown University, University of North Carolina, Chapel Hill, Tufts University, Brandeis University
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 1 Dec 2020 (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.
One in five children in the United States have obesity, and under-served populations are differentially impacted by both obesity and its related health consequences. Thus, community-based programs that improve the dissemination of effective obesity treatments are needed within low income settings. The current study aims to test the effectiveness of an evidence-based, community centered program, JOIN for ME, in two types of community settings: housing authorities and patient-centered medical homes. Children between the ages of 6-12 years old and who meet study eligibility criteria will be enrolled in the study and participate in the JOIN for ME weight control intervention. Participants will be assigned to active or delayed treatment conditions (4-month delay) but all participants will receive the JOIN for ME program. The program will be delivered in English or Spanish. Primary outcomes include change in child and parent weight status and health-related quality of life.
Detailed description
The U.S. Preventive Services Task Force (USPSTF) recently reissued a Grade B recommendation, initially made in 2010, for clinicians to screen children ages 6-18 years for obesity and refer identified youth to comprehensive, multi-component programs with >26 contact hours that include nutrition and physical activity targets and are supported by behavioral strategies. Re-issue of this recommendation highlights the continued importance of comprehensive family-based obesity treatment programs with broad accessibility. The challenge in meeting this objective is the lack of community-based obesity treatments for children. The majority of children in the U.S. do not receive evidence-based treatment of obesity, with few such programs available to youth from low-income backgrounds.
There are multiple efforts underway to broaden both the empirical support for, and accessibility of, pediatric weight management interventions. One such strategy is implementation within the primary care setting as families are already accustomed to attending visits for medical concerns and because physicians are important drivers of health behavior change. An alternative strategy, also with high impact potential, is embedding interventions in established organizations within the communities in which families live, thereby decreasing logistical barriers (e.g. transportation) and enhancing program credibility.
The JOIN for ME program, developed as a collaboration between United HealthGroup and Y-USA, is an empirically tested, effective pediatric weight control intervention for children ages 6-12 years that is delivered by facilitators within a community setting and potentially scalable nationally. The primary aim of this study is to test the effectiveness of the the JOIN for ME intervention in two different types of community setting, housing authorities and patient-centered medical homes, with the intention to increase equity and access to care for families in low-income settings. To accomplish this aim, formative qualitative work was conducted during 2019-2020 with key community stakeholders and families within the targeted community settings. The formative work resulted in adapting "participant facing" intervention materials and tools as well as the development of systems to connect families with local community resources. These developments will be implemented in intervention delivery as a means of increasing acceptability of the intervention and assessing its potential for broader scale dissemination within community settings. Further, certified Community Health Workers (CHWs) will deliver the proposed intervention given their ability to serve as intermediaries between healthcare systems and the community.
A total of 128 children (ages 6-12) with BMI > 85th% will be enrolled in this study and receive the JOIN for ME weight control intervention. The intervention will be delivered in English or Spanish. Participants will be assigned to active or delayed treatment conditions (4-month delay) based on an a priori set of rules pertaining to recruitment strategies and timeline. Evaluation of primary outcomes, change in child and parent weight status and health-related quality of life (HRQL), will be obtained at baseline, 4 months, and 10 months.
The following hypotheses will be tested:
- Children who receive the JOIN for ME program immediately will demonstrate greater decreases in percent over median BMI and zBMI from baseline to 4 months compared to those in the delayed treatment onset prior to receiving the intervention.
- Children who receive the JOIN for ME program immediately will demonstrate improvements in HRQL from baseline to 4 months compared to those in the delayed treatment onset.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Hybrid-implementation effectiveness design incorporating a delayed-treatment design for treatment group assignment
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Other | Behavioral: JOIN for MEParticipants will start the intervention immediately upon study enrollment. |
| Delayed treatment | Other | Behavioral: JOIN for MEParticipants will start the intervention 4-months post enrollment. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- be 6 to 12 years old
- have a BMI > 85th percentile
- have at least one caregiver available to provide consent and participate in sessions
- speak English or Spanish
- agree to study participation and delayed treatment onset if applicable.
Key exclusion criteria (4 listed)
- either the child or the parent is currently involved in another weight loss program
- have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity
- are developmentally delayed such that the intervention materials will not be appropriate
- are in treatment for or diagnosed with a major psychiatric disorder, including an eating disorder
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 |
|---|---|---|
| JOIN for MEJOIN for ME is an empirically tested, effective weight management program for children ages 6-12 years.The curriculum includes 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Weekly meetings are attended by the parent/caregiver and child, and occur at a location within their community setting (public housing or patient-centered medical home). Each session is 60 minutes and led by a certified Community Health Worker, with a private weigh-in for each dyad prior to the start of each session. Key behavioral targets include self-monitoring of dietary intake and physical activity, limiting LESS foods, limiting screen time, and weekly attendance. A family-based incentive structure is incorporated into the program such that parents/caregivers reinforce their children for achieving goals. Due to the COVID-19 pandemic, in-person sessions will be conducted virtually until it is safe to resume in-person group sessions. | Behavioural | Active treatment, Delayed treatment |
Primary outcome
Patient Outcome - Change in child weight status
Time frame: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
Change in Body Mass Index (BMI, kg/m2)-for age-percentile
Patient Outcome - Change in parent weight status
Time frame: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
Change in Body Mass Index (BMI, kg/m2)
Patient Outcome - Change in child health-related quality of life (HRQL)
Time frame: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
Obesity-specific child self-report measure, Size Me Up
Patient Outcome - Change in parent health-related quality of life (HRQL)
Time frame: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)
Obesity-specific parent self-report measure, Sizing Them Up
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 16 Jul 2025.
- Derived from this study: PubMed 34569847Darling KE, Hayes JF, Evans EW, Seifer R, Elwy AR, Jelalian E. Implementation of the JOIN for ME Program for Families from Low-Income Backgrounds: The Use of Theory-Driven Formative Evaluation: Rhode Island CORD 3.0. Child Obes. 2021 Sep;17(S1):S22-S29. doi: 10.1089/chi.2021.0172.
- Derived from this study: PubMed 34569839Jelalian E, Evans W, Darling KE, Seifer R, Vivier P, Goldberg J, Wright C, Tanskey L, Warnick J, Hayes J, Shepard D, Tuttle H, Elwy AR. Protocol for the Rhode Island CORD 3.0 Study: Adapting, Testing, and Packaging the JOIN for ME Family-Based Childhood Obesity Program in Low-Income Communities. Child Obes. 2021 Sep;17(S1):S11-S21. doi: 10.1089/chi.2021.0179.
- Individual participant dataSharing planned: Yes. A de-identified data set will be submitted to a data repository or to an investigator created website, if a central repository is not available. IPD which underlie results in a publication will be included in the repository.
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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.
Elissa Jelalian, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JOIN for ME in people with Pediatric Obesity, run by The Miriam Hospital 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 5 inclusion and 4 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 16 Jul 2025. 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?
Patient Outcome - Change in child weight status (time frame: Baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)). The study lists 4 primary outcomes in all. 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 NCT04647760, which also lists 2 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 16 Jul 2025.