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Mindfulness-Based Weight Control (MBWC) for Obesity (HEARTS Trial)

N/A
Waitlist Available
Led By Amy F Sato, PhD
Research Sponsored by Kent State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Awards & highlights

HEARTS Trial Summary

This trial is testing a weight-loss program that combines mindfulness training with behavioral weight control for low-income adolescents. They will compare weight and emotional eating changes between the two groups.

Eligible Conditions
  • Obesity
  • Stress
  • Eating Disorders

HEARTS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Adolescent Body Mass Index (BMI)
Change in Adolescent Chronic Stress
Change in Adolescent Emotional Eating
+3 more
Secondary outcome measures
Change in Adolescent Eating Behaviors
Change in Adolescent Eating Pathology and Symptomology
Change in Adolescent Emotion Regulation
+4 more

HEARTS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Weight ControlExperimental Treatment1 Intervention
All participants will be randomly assigned to a 12-session group-based Mindfulness-Based Weight Control (MBWC) intervention or a Standard Behavioral Weight Control (SBWC) intervention. Participants assigned to the MBWC intervention will receive mindfulness curriculum informed by Mindfulness-Based Stress Reduction plus the standard behavioral weight control components. Group sessions will be approximately 60 minutes each week. Outside of group sessions, participants will be asked to engage in dietary self-monitoring (MBWC and SBWC groups) and practice mindfulness skills (MBWC only).
Group II: Standard Behavioral Weight ControlActive Control1 Intervention
All participants will be randomly assigned to a 12-week group-based Mindfulness-Based Behavioral Weight Control (MBWC) intervention or a Standard Behavioral Weight Control (SBWC) intervention. Participants assigned to the SBWC intervention will receive the SBWC without mindfulness components. Each of the 12 group sessions will be approximately 60 minutes. Outside of group sessions, participants will be asked to practice dietary self-monitoring at home during the week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Weight Control (MBWC)
2019
N/A
~140

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER
1,504 Previous Clinical Trials
4,187,523 Total Patients Enrolled
65 Trials studying Obesity
58,054 Patients Enrolled for Obesity
Kent State UniversityLead Sponsor
41 Previous Clinical Trials
6,454 Total Patients Enrolled
3 Trials studying Obesity
321 Patients Enrolled for Obesity
University of MichiganOTHER
1,794 Previous Clinical Trials
6,373,777 Total Patients Enrolled
34 Trials studying Obesity
9,965 Patients Enrolled for Obesity

Frequently Asked Questions

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

Does the study permit those aged sixty and above to participate?

"This study is open to minors aged 13-18 years old, while there are 81 studies that cater to those under 18 and 292 for senior citizens over 65."

Answered by AI

Is there currently an opportunity to register for this research endeavor?

"According to clinicaltrials.gov, this trial is currently enrolling individuals and was initially published on the 2nd of July 2019 with its most recent update being made at the end of January 2022."

Answered by AI

How many participants are involved in the research endeavor?

"Affirmative. Per the data located on clinicaltrials.gov, this medical experiment is presently enrolling volunteers. It was initially posted on July 2nd 2019 and last updated January 31st 2022, with a total of 240 participants being sought at one clinical site."

Answered by AI

Am I eligible to join this research experiment?

"Candidates requiring relief from psychological distress and aged between 13-18 are eligible to join this clinical study. The team is expecting to enrol a total of 240 participants."

Answered by AI

What is the primary aim of this clinical investigation?

"The primary objective of this 14-week research project is to measure the change in adolescent perceived stress. Additionally, secondary objectives include evaluating changes related to eating pathology and symptomology (as measured by Youth Eating disorder Examination-Questionnaire Global Score), emotion regulation strategies (utilizing Emotion Regulation Questionnaire for Children and Adolescents scores) as well as self-esteem levels (measured with Rosenberg Self Esteem Scale total score)."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
Kent State University
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Kent State University: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Healthy Eating, Activity and Reduction of Teen Stress
Amy Sato 2019. "Healthy Eating, Activity and Reduction of Teen Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04038684.
~24 spots leftby Apr 2025
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