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Lifestyle Modification Intervention for Obesity

N/A
Waitlist Available
Led By Evan 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
Ages 18-75 years
Resides in the U.S.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
Awards & highlights

Study Summary

This trial will compare a weight loss program with a balanced calorie deficit diet to a weight loss program with an ad libitum whole food plant-based diet to see which is more effective.

Eligible Conditions
  • Obesity

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The video appointment must be available for 15-minute once-weekly.
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You are willing to follow a whole food plant-based diet or a traditional calorie-reduced diet for the study duration.
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Individuals must provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-months).
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, mid-treatment (6- and 12-weeks) and post-treatment (6-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
Subjective Appetite as assessed by visual analogue scale (VAS)
Other outcome measures
Weight decreased
Depressive Symptoms as assessed by the Beck Depression Inventory-II (BDI-II)
Dietary acceptability as assessed by a diet acceptability questionnaire
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Lifestyle Modification with an Ad Libitum Whole Food Plant-Based Eating PlanExperimental Treatment2 Interventions
Lifestyle modification intervention with an ad libitum whole food plant-based diet (i.e., participants will eat, ad libitum, fruits, vegetables, starches, legumes, and whole grains, and will avoid eating processed foods, refined oils, and animal products)
Group II: Lifestyle Modification with a Balanced Calorie Deficit DietExperimental Treatment2 Interventions
Lifestyle modification intervention with a balanced calorie deficit diet (i.e., participants will be prescribed a calorie goal and will track their dietary intake in order to meet this goal).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Balanced Calorie Deficit Eating Plan
2022
N/A
~60
Ad Libitum Whole Food Plant-Based Eating Plan
2022
N/A
~60
Lifestyle Modification Intervention
2022
N/A
~60

Find a Location

Who is running the clinical trial?

Drexel UniversityLead Sponsor
147 Previous Clinical Trials
47,325 Total Patients Enrolled
29 Trials studying Obesity
6,482 Patients Enrolled for Obesity
Evan Forman, PhDPrincipal InvestigatorDrexel University

Frequently Asked Questions

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

How many participants is the clinical trial currently accommodating?

"Affirmative. The information hosted on clinicaltrials.gov implies that this medical trial is actively seeking participants, with its first listing stemming from May 1st 2022 and the most recent change being made April 29th 2022. Roughly 52 patients are expected to be recruited across a single site."

Answered by AI

Are there vacancies available for enrolment in this experiment?

"Absolutely. The relevant information located on clinicaltrials.gov reveals that this medical research is actively recruiting patients, having been posted online in May 1st 2022 and updated most recently on April 29th of the same year. This study requires a total of 52 participants to be sourced from one active trial site."

Answered by AI

Would I be a suitable candidate for enrollment in this experiment?

"This trial is recruiting 52 participants within the age range of 18 and 75 that have been diagnosed with obesity. The prerequisites for enrolment include: providing consent to contact their medical doctor if required, having a BMI that falls between 27-50 kg/m2, living in America, being competent in English language skills (speaking, writing & understanding), expressing an inclination to shed weight; further agreeing to obey either a whole food plant-based diet or traditional calorie reduced plan over the duration of this study as well as consistently attending video meetings which only last 15 minutes each week from 8am - 7pm EST and possessing regular access to online connection"

Answered by AI

Does the research include participants aged 70 and above?

"This clinical trial is enlisting participants aged 18-75 years."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~19 spots leftby Mar 2025