Obesity-Related Malignant NeoplasmHERONCT05040152
Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio
A study testing Dietary Counseling and Surveillance, Exercise Intervention and Informational Intervention in people with Obesity-Related Malignant Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study determines the feasibility of a telephone-based weight lost intervention in reducing cancer risk and health disparities in rural Ohio. Obesity is the leading preventable cause of cancer, and obesity-related inflammation is linked to elevated cancer risk, independent of obesity itself. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity-Related Malignant Neoplasm
- What is being tested?
- Dietary Counseling and Surveillance, Exercise Intervention and Informational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2021to 17 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) >= 25 kg/m^2
- Age: 20-64.9 years
- Not currently participating in any weight loss intervention or meet the physical activity recommendation (150 min/week of moderate-intensity exercise or 75 min/week of vigorous exercise)
- The ability to walk two blocks
- Ability to speak and read English
Who cannot join
- 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
- Pregnant or nursing women
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Address Obesity to Reduce Cancer Risk and Health Disparities in Rural Ohio
This study determines the feasibility of a telephone-based weight lost intervention in reducing cancer risk and health disparities in rural Ohio. Obesity is the leading preventable cause of cancer, and obesity-related inflammation is linked to elevated cancer risk, independent of obesity itself. Rural populations are a vulnerable population in need of increased access to tailored strategies and benefit from weight loss interventions. This study aims to see whether a telephone-based intervention may help obese people in rural area to reduce body weight, so as to prevent obesity-related cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility and acceptability of a 15-week telephone-based weight loss intervention among overweight/obese rural residents.
II. To estimate the preliminary efficacy of the lifestyle modifications on weight loss, body composition (fat mass, percent body fat), inflammatory biomarkers (IL-6, TNF-alpha, and C-recreative protein [CRP]), and other disease risk factors (lipid profiles).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: 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.
ARM II: Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.
- Conditions
- Obesity-Related Malignant Neoplasm
- Being tested
- Dietary Counseling and Surveillance, Exercise Intervention, Informational Intervention, Questionnaire Administration, Telephone-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Counseling and SurveillanceBehavioural
Receive dietary recommendations
Complete home exercises
Informational InterventionOther
Receive education brochures
Questionnaire AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive telephone-based weight loss intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm I (telephone-based intervention) | Experimental | 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. Receives: Behavioral: Dietary Counseling and Surveillance; Other: Exercise Intervention; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention |
| Arm II (education brochures) | Active comparator | Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. Receives: Other: Informational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a 15-week Telephone-based Weight Loss Intervention
Will be defined as the number of enrolled participants who complete the study.
Measured: Up to 15 weeks
Secondary outcomes (2)
Changes in Body Weight (KG)
Changes in body weight (KG)will be measured by a weight scale
Measured: Up to 15 weeks
Changes in Body Fat Mass
Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100
Measured: Up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start6 Nov 2021
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity-Related Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian C Focht, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040152
- Sponsor's protocol ID
- OSU-21007
- Other IDs
- NCI-2021-03973, F99CA253745
- Acronym
- HERO
- Status last verified
- Jun 2025
- First submitted
- 25 May 2021
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Address Obesity to Reduce Cancer Risk and Health Disparities in Rural Ohio
- ClinicalTrials.gov ID
- NCT05040152
- Acronym / sponsor ID
- HERO / OSU-21007
- Conditions
- Obesity-Related Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study determines the feasibility of a telephone-based weight lost intervention in reducing cancer risk and health disparities in rural Ohio. Obesity is the leading preventable cause of cancer, and obesity-related inflammation is linked to elevated cancer risk, independent of obesity itself. Rural populations are a vulnerable population in need of increased access to tailored strategies and benefit from weight loss interventions. This study aims to see whether a telephone-based intervention may help obese people in rural area to reduce body weight, so as to prevent obesity-related cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility and acceptability of a 15-week telephone-based weight loss intervention among overweight/obese rural residents.
II. To estimate the preliminary efficacy of the lifestyle modifications on weight loss, body composition (fat mass, percent body fat), inflammatory biomarkers (IL-6, TNF-alpha, and C-recreative protein [CRP]), and other disease risk factors (lipid profiles).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: 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.
ARM II: Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (telephone-based intervention) | Experimental | Behavioral: Dietary Counseling and Surveillance, Other: Exercise Intervention, Other: Questionnaire Administration, Behavioral: Telephone-Based InterventionParticipants 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. |
| Arm II (education brochures) | Active comparator | Other: Informational Intervention, Other: Questionnaire AdministrationParticipants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) >= 25 kg/m^2
- Age: 20-64.9 years
- Not currently participating in any weight loss intervention or meet the physical activity recommendation (150 min/week of moderate-intensity exercise or 75 min/week of vigorous exercise)
- The ability to walk two blocks
- Ability to speak and read English
Key exclusion criteria (3 listed)
- 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
- Pregnant or nursing women
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Counseling and SurveillanceReceive dietary recommendations | Behavioural | Arm I (telephone-based intervention) |
| Exercise InterventionComplete home exercises | Other | Arm I (telephone-based intervention) |
| Informational InterventionReceive education brochures | Other | Arm II (education brochures) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (telephone-based intervention), Arm II (education brochures) |
| Telephone-Based InterventionReceive telephone-based weight loss intervention | Behavioural | Arm I (telephone-based intervention) |
Primary outcome
Feasibility of a 15-week Telephone-based Weight Loss Intervention
Time frame: Up to 15 weeks
Will be defined as the number of enrolled participants who complete the study.
2 secondary outcomes
Changes in Body Weight (KG)
Time frame: Up to 15 weeks
Changes in Body Fat Mass
Time frame: Up to 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian C Focht, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Counseling and Surveillance, Exercise Intervention and Informational Intervention in people with Obesity-Related Malignant Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a 15-week Telephone-based Weight Loss Intervention (time frame: Up to 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.