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

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.

Study Overview

• Status: Completed
• Conditions: Obesity-Related Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Dietary Counseling and Surveillance; Other: Exercise Intervention; Behavioral: Telephone-Based Intervention; Other: Informational Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (telephone-based intervention); 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.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Dietary Counseling and Surveillance; Receive dietary recommendations; Other: Exercise Intervention; Complete home exercises; Behavioral: Telephone-Based Intervention; Receive telephone-based weight loss intervention
Active Comparator: Arm II (education brochures); Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.	Other: Questionnaire Administration; Ancillary studies; Other: Informational Intervention; Receive education brochures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of a 15-week Telephone-based Weight Loss Intervention	Will be defined as the number of enrolled participants who complete the study.	Up to 15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Body Weight (KG)	Changes in body weight (KG)will be measured by a weight scale	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	Up to 15 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise-Related Self-Efficacy Exercise-Related	Assessed by using Exercise Self-Efficacy, Barrier Self-Efficacy, and Multi-dimensional Self-Efficacy scales	Up to 15 weeks
Changes Body Fat Percentage	Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100	Up to 15 weeks
Lipid Profiles	Total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be obtained by fasting capillary blood sampling from fingerstick and analyzed using Cholestech LDX	Up to 15 weeks
C-reactive Protein (CRP) Concentration (ng/L)	C-reactive protein (CRP) concentration (ng/L) will be quantified with an automated chemistry analyzer	Up to 15 weeks
Interleukin (IL)-6 Concentration (pg/mL)	Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays	Up to 15 weeks
TNF-alpha Concentration (pg/mL)	TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme	Up to 15 weeks
Physical Fitness	Participants will be asked to complete two valid and reliable timed performance-related mobility tasks, including 400-meter walk and lift and carry task	Up to 15 weeks
Physical Activity	Self-reported using Leisure-Time Exercise Questionnaires118. Objectively measured physical activity will be recorded using the LIFECORDER Plus Accelerometer for 7 days in the 1st and 15th week	Up to 15 weeks
Dietary Intake	Self-reported using the National Institutes of Health Daily Food List	Up to 15 weeks

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Brian C Focht, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2021
• Primary Completion (Actual): May 17, 2022
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Neoplasms; Obesity
• Other Study ID Numbers: OSU-21007; NCI-2021-03973 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); F99CA253745 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No