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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
Must not have
Inability to engage in physical activity (defined as walking a city block without stopping)
History of bariatric surgery; weight loss of > 5% in the previous 3 months
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
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot walk a city block without stopping.
Select...
I have had weight loss surgery and lost more than 5% of my weight in the last 3 months.

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).
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Weight change
Secondary study objectives
Change in quality of life
Dietary intake
Physical activity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~470
Values
2019
N/A
~90

Find a Location

Who is running the clinical trial?

Drexel UniversityLead Sponsor
154 Previous Clinical Trials
47,921 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
~0 spots leftby Oct 2024
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