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Weight Loss Intervention for Obesity (HERO Trial)

N/A

Waitlist Available

Led By Brian C Focht, PhD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

The ability to walk two blocks

Age: 20-64.9 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 weeks

Awards & highlights

HERO Trial Summary

This trial will test whether a weight-loss intervention delivered over the phone can help obese people in rural areas reduce their risk of cancer.

Who is the study for?

This trial is for adults aged 20-65 in rural Ohio with a BMI of 25 or higher who aren't currently trying to lose weight or meeting exercise recommendations. It's not for pregnant/nursing women, those unable to consent, people with prior cancer diagnoses (except non-melanoma skin cancer), or severe medical conditions.Check my eligibility

What is being tested?

The study tests if a telephone-based program can help reduce obesity and lower cancer risk by providing exercise guidance, dietary counseling, health information, and regular check-ins via questionnaires and phone calls.See study design

What are the potential side effects?

Since the intervention involves lifestyle changes like diet modification and increased physical activity rather than medication, side effects may include typical exercise-related discomforts such as muscle soreness.

HERO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can walk two blocks without assistance.

Select...

I am between 20 and 64 years old.

HERO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 weeks 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 a 15-week telephone-based weight loss intervention

Secondary outcome measures

Changes in body fat mass

Changes in body weight (KG)

Other outcome measures

C-reactive protein (CRP) concentration (ng/L)

Changes body fat percentage

Dietary intake

+6 more

HERO Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (telephone-based intervention)Experimental Treatment4 Interventions

Participants receive weekly telephone-based weight loss intervention for 15 weeks, including dietary recommendations tailored to their current weight and weight loss target, home-based aerobic and resistance exercise, and weekly telephone counseling session over 30-45 minutes.

Group II: Arm II (education brochures)Active Control2 Interventions

Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Counseling and Surveillance

2021

N/A

~40

Telephone-Based Intervention

2017

Completed Phase 2

~3400

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,127 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,627 Total Patients Enrolled

Brian C Focht, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

3 Previous Clinical Trials

541 Total Patients Enrolled

Media Library

Dietary Counseling and Surveillance Clinical Trial Eligibility Overview. Trial Name: NCT05040152 — N/A

Cancer Research Study Groups: Arm I (telephone-based intervention), Arm II (education brochures)

Cancer Clinical Trial 2023: Dietary Counseling and Surveillance Highlights & Side Effects. Trial Name: NCT05040152 — N/A

Dietary Counseling and Surveillance 2023 Treatment Timeline for Medical Study. Trial Name: NCT05040152 — N/A

Frequently Asked Questions

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

For whom is enrollment in this clinical experiment open?

"This study is seeking 40 individuals suffering from obesity, aged between 20 and 64. To qualify for the trial, participants must not be undergoing any other weight loss treatments or have an activity level equal to 150 moderate minutes of exercise/week or 75 vigorous minutes a week; additionally they should possess a BMI >25 kg/m^2, two blocks of walking capacity and fall in the aforementioned age range."

Answered by AI

Is the study open to elderly individuals?

"This trial is restricted to participants between the ages of 20 and 64. There are 499 medical trials aimed at younger patients, whereas 2787 studies cater to those older than 65 years old."

Answered by AI

Has the FDA greenlit Exercise Intervention for therapeutic use?

"Due to the limited amount of data present for Exercise Intervention, its safety is estimated at a score of 1. This is typical of Phase 1 trials, where there exists few supporting studies on both efficacy and safety."

Answered by AI

Are there any vacancies remaining for enrolment in this research project?

"According to information archived on clinicaltrials.gov, enrollment for this particular trial has been closed since June 3rd 2022; however, there are still over 3300 other studies looking for participants at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio

Brian Focht 2021. "Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05040152.