Pediatric ObesityPhase 2TEEN JOINNCT02426346
A Scalable Weight Control Intervention for Adolescents
A Phase 2 study testing Group-based physical activity, Group-based incentives and Parent-based incentives in people with Pediatric Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Community-based programs are needed to improve dissemination of efficacious treatment for adolescent obesity. The current study aims to modify a community-based program, delivered through the YMCA, to increase its effectiveness with adolescents. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Group-based physical activity, Group-based incentives and Parent-based incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2017
- Phase
- Phase 2
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 13 to 17 years
- BMI > 85th percentile and absolute BMI < 50
- have at least one parent available to provide consent and participate in sessions
- speak English
- agree to study participation and random assignment
Who cannot join
- currently involved in another weight loss program
- have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity
- developmentally delayed such that the intervention materials will not be appropriate
- in treatment for a major psychiatric disorder, including an eating disorder, or are diagnosed with a major psychiatric disorder at the time of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Weight Management and Diabetes Research Center, The Miriam Hospital/Alpert Medical School of Brown University
Providence, Rhode Island, 02903
Kim Mailloux, BS, 401-793-8320, kkent1@lifespan.org
About this study
Official title: TEEN JOIN: A Scalable Weight Control Intervention for Adolescents
Community-based programs are needed to improve dissemination of efficacious treatment for adolescent obesity. The current study aims to modify a community-based program, delivered through the YMCA, to increase its effectiveness with adolescents. Adolescents will be randomized to either a 16-week standard program (JOIN) or a targeted intervention tailored for adolescents (TEEN JOIN). Primary outcomes include changes in BMI, objectively measured physical activity, and self-efficacy, assessed at 4 months and 10 months following randomization.
Read the detailed description
In 2010, the U.S. Preventive Services Task Force (USPSTF) provided a Grade recommendation B (i.e. the service is recommended with moderate/high certainty of benefit) for clinicians to screen children ages 6-17 years for obesity and refer identified youth to comprehensive behavioral programs. The challenge in meeting this objective is the lack of community-based obesity treatments to which to refer, particularly for adolescents. The JOIN program, developed as a collaboration between United HealthGroup and Y-USA is a pediatric weight control intervention targeted toward a broad age range of youth from 6-17 years that is: 1) based on well established and evidence based principles; 2) delivered by YMCA facilitators within a community setting: and 3) potentially scalable nationally. Findings from a 6-month pilot study examining the effectiveness of JOIN demonstrated impressive changes in weight status for school age children, but more modest results for adolescents. The primary aim of this study is to modify the JOIN program to increase its effectiveness with adolescents while retaining its potential for scalability.
A total of 120 adolescents (ages 13-17) with BMI > 85th% and < 50 will be randomly assigned to a 16-week targeted program (TEEN JOIN), or the traditional JOIN intervention, followed by biweekly and monthly maintenance sessions. Evaluation of adolescent height, weight, objective physical activity and psychosocial outcomes will be obtained at baseline, 4 months, and 10 months. Additional outcomes will include treatment feasibility, including attendance, completion of diet and physical activity monitoring logs, and exit interviews with adolescents and parents regarding the intervention. The investigators will also obtain preliminary indicators of cost effectiveness. It is hypothesized that adolescents who are randomized to TEEN JOIN will demonstrate greater decrease in BMI at 4 and 10 months than those randomized to JOIN. It is further hypothesized that adolescents randomized to TEEN JOIN will demonstrate greater increases in participation in moderate-vigorous physical activity and greater improvements in self-concept, self-efficacy related to physical activity, and group cohesion than adolescents who receive the standard JOIN condition.
- Conditions
- Pediatric Obesity
- Being tested
- Behavioral weight control, Group-based physical activity, Group-based incentives, Parent-based incentives
- Keywords
- Adolescent; Adolescent obesity; Community-based; Overweight
- Medical subject headings
- Pediatric Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral weight controlBehavioural
Prescription of diet \& physical activity and behavioral strategies for weight control
Group-based physical activityBehavioural
Teens exercise for 60 minutes with their group
Group-based incentivesBehavioural
Adolescents earn reinforcements within group
Parent-based incentivesBehavioural
Adolescents earn reinforcements from their parents (outside of group)
| Study group | Role | What they receive |
|---|---|---|
| JOIN FOR ME | Active comparator | The JOIN for ME curriculum includes 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Weekly meetings are scheduled for 60 minutes and are facilitated by a YMCA coach. Interventions include behavioral weight control and parent-based incentives. Parents attend group at weeks 1, 2 and 16 with their teen. Receives: Behavioral: Behavioral weight control; Behavioral: Parent-based incentives |
| TEEN JOIN | Experimental | Similar to the JOIN FOR ME condition, adolescents in the TEEN JOIN condition attend 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Interventions include behavioral weight control, group-based physical activity, and group-based incentives. Parents attend separate meetings at weeks 1, 2, and 16. Receives: Behavioral: Behavioral weight control; Behavioral: Group-based physical activity; Behavioral: Group-based incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI, kg/m2)
Measured: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Secondary outcomes (2)
Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband
Objectively-measured moderate and vigorous physical activity
Measured: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Self-Efficacy Questionnaire
Adolescents' confidence in their ability to lose weight and engage in physical activity
Measured: Baseline, post-treatment 1 (4 months), post-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 posted24 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elissa Jelalian, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426346
- Sponsor's protocol ID
- 1R34DK10098101A1
- Acronym
- TEEN JOIN
- Status last verified
- Apr 2017
- First submitted
- 21 Apr 2015
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jelalian E, Evans EW, Rancourt D, Ranzenhofer L, Taylor N, Hart C, Seifer R, Klinepier K, Foster GD. JOIN for ME: Testing a Scalable Weight Control Intervention for Adolescents. Child Obes. 2020 Apr;16(3):192-203. doi: 10.1089/chi.2019.0053. Epub 2019 Dec 18.
PubMed 31855057
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEEN JOIN: A Scalable Weight Control Intervention for Adolescents
- ClinicalTrials.gov ID
- NCT02426346
- Acronym / sponsor ID
- TEEN JOIN / 1R34DK10098101A1
- Conditions
- Pediatric Obesity
- Keywords
- Adolescent; Adolescent obesity; Community-based; Overweight
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Apr 2015 (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.
Community-based programs are needed to improve dissemination of efficacious treatment for adolescent obesity. The current study aims to modify a community-based program, delivered through the YMCA, to increase its effectiveness with adolescents. Adolescents will be randomized to either a 16-week standard program (JOIN) or a targeted intervention tailored for adolescents (TEEN JOIN). Primary outcomes include changes in BMI, objectively measured physical activity, and self-efficacy, assessed at 4 months and 10 months following randomization.
Detailed description
In 2010, the U.S. Preventive Services Task Force (USPSTF) provided a Grade recommendation B (i.e. the service is recommended with moderate/high certainty of benefit) for clinicians to screen children ages 6-17 years for obesity and refer identified youth to comprehensive behavioral programs. The challenge in meeting this objective is the lack of community-based obesity treatments to which to refer, particularly for adolescents. The JOIN program, developed as a collaboration between United HealthGroup and Y-USA is a pediatric weight control intervention targeted toward a broad age range of youth from 6-17 years that is: 1) based on well established and evidence based principles; 2) delivered by YMCA facilitators within a community setting: and 3) potentially scalable nationally. Findings from a 6-month pilot study examining the effectiveness of JOIN demonstrated impressive changes in weight status for school age children, but more modest results for adolescents. The primary aim of this study is to modify the JOIN program to increase its effectiveness with adolescents while retaining its potential for scalability.
A total of 120 adolescents (ages 13-17) with BMI > 85th% and < 50 will be randomly assigned to a 16-week targeted program (TEEN JOIN), or the traditional JOIN intervention, followed by biweekly and monthly maintenance sessions. Evaluation of adolescent height, weight, objective physical activity and psychosocial outcomes will be obtained at baseline, 4 months, and 10 months. Additional outcomes will include treatment feasibility, including attendance, completion of diet and physical activity monitoring logs, and exit interviews with adolescents and parents regarding the intervention. The investigators will also obtain preliminary indicators of cost effectiveness. It is hypothesized that adolescents who are randomized to TEEN JOIN will demonstrate greater decrease in BMI at 4 and 10 months than those randomized to JOIN. It is further hypothesized that adolescents randomized to TEEN JOIN will demonstrate greater increases in participation in moderate-vigorous physical activity and greater improvements in self-concept, self-efficacy related to physical activity, and group cohesion than adolescents who receive the standard JOIN condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JOIN FOR ME | Active comparator | Behavioral: Behavioral weight control, Behavioral: Parent-based incentivesThe JOIN for ME curriculum includes 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Weekly meetings are scheduled for 60 minutes and are facilitated by a YMCA coach. Interventions include behavioral weight control and parent-based incentives. Parents attend group at weeks 1, 2 and 16 with their teen. |
| TEEN JOIN | Experimental | Behavioral: Behavioral weight control, Behavioral: Group-based physical activity, Behavioral: Group-based incentivesSimilar to the JOIN FOR ME condition, adolescents in the TEEN JOIN condition attend 16 weekly in person sessions followed by 4 biweekly and 4 monthly maintenance sessions for a 10-month program. Interventions include behavioral weight control, group-based physical activity, and group-based incentives. Parents attend separate meetings at weeks 1, 2, and 16. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 13 to 17 years
- BMI > 85th percentile and absolute BMI < 50
- have at least one parent available to provide consent and participate in sessions
- speak English
- agree to study participation and random assignment
Key exclusion criteria (4 listed)
- currently involved in another weight loss program
- have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity
- developmentally delayed such that the intervention materials will not be appropriate
- in treatment for a major psychiatric disorder, including an eating disorder, or are diagnosed with a major psychiatric disorder at the time of screening.
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 |
|---|---|---|
| Behavioral weight controlPrescription of diet \& physical activity and behavioral strategies for weight control | Behavioural | JOIN FOR ME, TEEN JOIN |
| Group-based physical activityTeens exercise for 60 minutes with their group | Behavioural | TEEN JOIN |
| Group-based incentivesAdolescents earn reinforcements within group | Behavioural | TEEN JOIN |
| Parent-based incentivesAdolescents earn reinforcements from their parents (outside of group) | Behavioural | JOIN FOR ME |
Primary outcome
Change in Body Mass Index (BMI, kg/m2)
Time frame: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
2 secondary outcomes
Objective time spent in moderate and vigorous physical activity measured by the Senswear Mini (MINI) armband
Time frame: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Self-Efficacy Questionnaire
Time frame: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Derived from this study: PubMed 31855057Jelalian E, Evans EW, Rancourt D, Ranzenhofer L, Taylor N, Hart C, Seifer R, Klinepier K, Foster GD. JOIN for ME: Testing a Scalable Weight Control Intervention for Adolescents. Child Obes. 2020 Apr;16(3):192-203. doi: 10.1089/chi.2019.0053. Epub 2019 Dec 18.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group-based physical activity, Group-based incentives and Parent-based incentives 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: status not confirmed, as of the sponsor's last update on 21 Apr 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elissa Jelalian, PhD (401 793 9716, elissa_jelalian@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI, kg/m2) (time frame: Baseline, post-treatment 1 (4 months), post-treatment 2 (10 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 NCT02426346, 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 21 Apr 2017.