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Behavioral Intervention

Intervention/Treatment for Obesity (OVERCOME-IT Trial)

N/A

Waitlist Available

Led By Amber W Kinsey, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 4

Awards & highlights

OVERCOME-IT Trial Summary

This trial aims to gather initial information on whether a new resistance training program, which is conducted remotely, is practical, well-received, and has positive effects.

Who is the study for?

This trial is for Black or African American women aged 30-64 who are not regularly doing resistance training and have conditions like overweight, obesity, prediabetes, diabetes, or hypertension. Participants must live near the University, be willing to exercise at home using an internet-connected device and get medical clearance if needed.Check my eligibility

What is being tested?

The study tests a new remotely delivered resistance training program designed for cardiometabolic health improvement. It aims to see how feasible and effective this home-based workout regimen can be for participants.See study design

What are the potential side effects?

Since the intervention involves physical exercise, potential side effects may include muscle soreness, fatigue, joint pain or injury. However, these are common with any new exercise routine and typically decrease over time as the body adapts.

OVERCOME-IT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 4 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Feasibility of recruitment

Feasibility of retention

Intervention adherence

Secondary outcome measures

Change in HbA1C

Change in blood pressure

Change in body composition

+3 more

Side effects data

From 2010 Phase 2 trial • 167 Patients • NCT00112151

66%

Other noncardiovascular serious adverse events

13%

Other nonserious adverse events

11%

Persistently elevated PSA

Total serious cardiovascular adverse events

Persistently elevated HCT >= 54%

Elevated AUA

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Lower-range T

Higher-range T

OVERCOME-IT Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention/TreatmentExperimental Treatment1 Intervention

A home-based resistance training condition that is delivered through a web-based platform.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Resistance Training

2019

Completed Phase 2

~1190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,426 Total Patients Enrolled

73 Trials studying Obesity

474,278 Patients Enrolled for Obesity

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,216,323 Total Patients Enrolled

41 Trials studying Obesity

254,780 Patients Enrolled for Obesity

Amber W Kinsey, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

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

Does this research include individuals aged 55 and above?

"This research is seeking individuals aged 30 years and older but less than 64 years."

Answered by AI

What are the specific criteria for individuals to qualify as participants in this research project?

"Enrollment in this study requires individuals with obesity aged between 30 and 64. The trial aims to recruit a total of 36 participants."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"The data on clinicaltrials.gov indicates that this particular study is not actively seeking participants. Originally uploaded on September 1, 2024 and most recently updated on April 10, 2024. While recruitment for this trial is currently closed, there are a total of 1116 other trials open for enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women

Amber W. Kinsey, PhD 2024. "Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06360536.