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Behavioral Intervention

JOIN for ME Program for Childhood Obesity

N/A

Waitlist Available

Led By Elissa Jelalian, PhD

Research Sponsored by The Miriam Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

speak English or Spanish

be 6 to 12 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)

Awards & highlights

Study Summary

This trial is testing the effectiveness of an obesity treatment program in low income settings. The program will be delivered in English or Spanish, and the primary outcomes include change in child and parent weight status and health-related quality of life.

Who is the study for?

This trial is for children aged 6-12 with obesity (BMI > 85th percentile) and their caregivers. Participants must speak English or Spanish, agree to the study's terms, and have a caregiver willing to join in sessions. It excludes those in other weight loss programs, with major psychiatric disorders including eating disorders, medical conditions affecting diet/activity, or developmental delays impacting intervention engagement.Check my eligibility

What is being tested?

The JOIN for ME program targets childhood obesity in low-income communities through housing authorities and patient-centered medical homes. The effectiveness of this community-based program will be measured by changes in child/parent weight and quality of life after participation. Some families start immediately while others wait four months before joining.See study design

What are the potential side effects?

Since JOIN for ME is a lifestyle intervention program rather than a medication, it does not have side effects like drugs do. However, participants may experience changes related to new diet and exercise routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can speak English or Spanish.

Select...

I am between 6 and 12 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intensive treatment 1 (4 months), post-maintenance treatment 2 (10 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Outcome - Change in child health-related quality of life (HRQL)

Patient Outcome - Change in child weight status

Patient Outcome - Change in parent health-related quality of life (HRQL)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Delayed treatmentExperimental Treatment1 Intervention

Participants will start the intervention 4-months post enrollment.

Group II: Active treatmentExperimental Treatment1 Intervention

Participants will start the intervention immediately upon study enrollment.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Miriam HospitalLead Sponsor

238 Previous Clinical Trials

37,364 Total Patients Enrolled

Brown UniversityOTHER

456 Previous Clinical Trials

562,970 Total Patients Enrolled

University of North Carolina, Chapel HillOTHER

1,504 Previous Clinical Trials

4,187,551 Total Patients Enrolled

Media Library

JOIN for ME (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04647760 — N/A

Childhood Obesity Research Study Groups: Active treatment, Delayed treatment

Childhood Obesity Clinical Trial 2023: JOIN for ME Highlights & Side Effects. Trial Name: NCT04647760 — N/A

JOIN for ME (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04647760 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental therapy open to individuals beyond the age of fifty?

"The requirements for taking part in this clinical trial state that only those between 6 and 12 years old may join, inclusive."

Answered by AI

Are there any opportunities for individuals to take part in this research?

"The information on clinicaltrials.gov suggests that recruitment for this trial is still ongoing, having first been posted in late January 2021 and last amended in October of the same year."

Answered by AI

How many participants are accepted in this clinical research project?

"Affirmative. Clinicaltrials.gov evidences that this clinical experiment, which was initially announced on January 25th 2021, is currently recruiting participants. 128 patients must be recruited at a single location for the study to commence."

Answered by AI

What criteria must a person satisfy to be considered for enrolment in this medical experiment?

"For successful enrolment, applicants must be between the ages of 6 and 12 with a BMI higher than 85th percentile. In addition to providing consent for participation in this study, participants are also required to appoint an adult that can accompany them during sessions and accommodate any delay in treatment onset if necessary. 128 children currently suffering from pediatric obesity meet these criteria."

Answered by AI

Recent research and studies

join for MeJournal

Protocol for the Rhode Island CORD 3.0 Study: Adapting, Testing, and Packaging the <i>join for Me</i> Family-based Childhood Obesity Program in Low-income Communities

Jelalian, Elissa, Whitney Evans, Katherine E. Darling, Ronald Seifer, Patrick Vivier, Jeanne Goldberg, Catherine Wright, et al.. 2021. “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”. Childhood Obesity. Mary Ann Liebert Inc. doi:10.1089/chi.2021.0179.

join for MeJournal

Implementation of the <i>join for Me</i> Program for Families from Low-income Backgrounds: The Use of Theory-driven Formative Evaluation: Rhode Island CORD 3.0

Darling, Katherine E., Jacqueline F. Hayes, E. Whitney Evans, Ronald Seifer, A. Rani Elwy, and Elissa Jelalian. 2021. “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”. Childhood Obesity. Mary Ann Liebert Inc. doi:10.1089/chi.2021.0172.

clinicaltrials.govStudy

Packaging and Disseminating the JOIN for ME Program in Low-Income Settings

Elissa Jelalian 2021. "Packaging and Disseminating the JOIN for ME Program in Low-Income Settings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04647760.