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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
Must not have
Unable to give informed consent
Prior cancer diagnosis (except non-melanoma skin cancer) or severe medical conditions such as unstable cardiovascular disease or digestive disorders that would preclude physical activity and dietary intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 weeks
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk two blocks without assistance.
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I am between 20 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand and agree to the study's procedures and risks.
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I don't have a history of serious cancer (other than non-melanoma skin cancer) or severe health issues that limit my physical activity or diet.

Timeline

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

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

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
325 Previous Clinical Trials
290,564 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,361 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
~11 spots leftby Jul 2025
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