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Mindfulness-Based Weight Loss Therapy for Obesity (Activate Trial)

N/A

Waitlist Available

Led By Evan M Forman, PhD

Research Sponsored by Drexel University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months).

Awards & highlights

Activate Trial Summary

This trial will test whether adding three components of mindfulness and acceptance based behavioral therapy (MABT) to remotely delivered weight loss counseling helps people lose weight, and identify which subsets of people are most responsive to each component.

Who is the study for?

Adults aged 18-70 with a BMI of 27-50 kg/m2 who are willing to lose weight, be physically active, and attend group sessions can join. They must complete food diaries and baseline tasks, and allow the team to consult their doctor if needed. Those unable to exercise, pregnant or breastfeeding women, people planning other weight loss treatments or changes in medications that affect weight cannot participate.Check my eligibility

What is being tested?

The trial is testing three core components of Mindfulness and Acceptance based Behavioral Therapies (MABTs) for obesity: Awareness, Acceptance, Values Clarity. These will be added to remote counseling for weight loss using a factorial design to see which parts work best alone or together.See study design

What are the potential side effects?

Since this trial involves behavioral therapy rather than medication, there aren't typical side effects like you'd expect from drugs. Participants may experience emotional discomfort as they confront personal habits related to eating and lifestyle.

Activate Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, mid-treatment (6 months), post-treatment (12 months), and at 6-, 12-, and 24-month follow-up (i.e., at 0, 6, 12, 18, 24 and 36 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

Weight change

Secondary outcome measures

Change in quality of life

Dietary intake

Physical activity

Activate Trial Design

8Treatment groups

Experimental Treatment

Group I: Standard Behavioral Weight Loss TreatmentExperimental Treatment1 Intervention

Group II: Behavioral + Values + AwarenessExperimental Treatment3 Interventions

Group III: Behavioral + ValuesExperimental Treatment2 Interventions

Group IV: Behavioral + Mindful AwarenessExperimental Treatment2 Interventions

Group V: Behavioral + Mindful AcceptanceExperimental Treatment2 Interventions

Group VI: Behavioral + Acceptance + Values + AwarenessExperimental Treatment4 Interventions

Group VII: Behavioral + Acceptance + ValuesExperimental Treatment3 Interventions

Group VIII: Behavioral + Acceptance + AwarenessExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Treatment

2019

Completed Phase 4

~190

Values

2019

N/A

~90

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Drexel UniversityLead Sponsor

150 Previous Clinical Trials

47,430 Total Patients Enrolled

30 Trials studying Obesity

6,332 Patients Enrolled for Obesity

Evan M Forman, PhDPrincipal InvestigatorDrexel University Center for Weight, Eating and Lifestyle Science

1 Previous Clinical Trials

336 Total Patients Enrolled

1 Trials studying Obesity

336 Patients Enrolled for Obesity

Media Library

Obesity Clinical Trial 2023: Mindfulness and Acceptance Based Behavioral Treatment Highlights & Side Effects. Trial Name: NCT04337619 — N/A

Obesity Patient Testimony for trial: Trial Name: NCT04337619 — N/A

Frequently Asked Questions

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

Are elderly patients welcome in this research project?

"The age requirements for this particular trial are that applicants must be aged between 18 and 70. Out of the 740 clinical trials available for people over 65, this is one of 243 trials specifically designed for those under the age of 18."

Answered by AI

Might I be able to help out with this clinical trial?

"Researchers are looking for 285 participants that fit the following description: between 18-70 years old, obese BMI , overweight or obese BMI (27-50 kg/m2), willing to make healthy lifestyle changes, and able to attend group sessions."

Answered by AI

Are new participants being taken in for this experiment?

"As of now, this particular clinical trial is not enrolling patients. The last time the listing was updated on the website was March 10th, 2022. Although this specific study is no longer looking for volunteers, there are 1182 other trials that are currently active and recruiting participants."

Answered by AI

Who else is applying?

What state do they live in?

Oregon

New Jersey

Pennsylvania

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

What site did they apply to?

Drexel University Center for Weight, Eating and Lifestyle Science

How many prior treatments have patients received?

Why did patients apply to this trial?

I have tried everything and nothing works. This study sounds interesting - I’ve done some mindfulness stuff in therapy, but not in terms of weight loss.

PatientReceived no prior treatments

I don’t know how to diet because I was 110 pounds I was 38 when I had my second child and I progressively have gained weight since I was laid off January 2021 I have probably put on about 20 to 30 pounds and want to feel better about myself have some confidence and look good.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss

Evan Forman 2019. "Project Activate: Mindfulness and Acceptance Based Behavioral Treatment for Weight Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04337619.

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