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NCT Number: NCT05040152

Weight Loss Intervention for the Reduction of 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.

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Key information

Conditions

Obesity-Related Malignant Neoplasm

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Counseling and Surveillance

Behavioral

Receive dietary recommendations

Exercise intervention

Other

Complete home exercises

Informational intervention

Other

Receive education brochures

Questionnaire Administration

Other

Ancillary studies

Telephone-Based Intervention

Behavioral

Receive telephone-based weight loss intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in Body Weight (KG)

    Time frame: Up to 15 weeks

    Changes in body weight (KG)will be measured by a weight scale

  2. Changes in Body Fat Mass

    Time frame: Up to 15 weeks

    Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100

Other outcomes

  1. Changes Body Fat Percentage

    Time frame: Up to 15 weeks

    Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100

  2. Lipid Profiles

    Time frame: Up to 15 weeks

    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

  3. C-reactive Protein (CRP) Concentration (ng/L)

    Time frame: Up to 15 weeks

    C-reactive protein (CRP) concentration (ng/L) will be quantified with an automated chemistry analyzer

  4. Interleukin (IL)-6 Concentration (pg/mL)

    Time frame: Up to 15 weeks

    Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays

  5. TNF-alpha Concentration (pg/mL)

    Time frame: Up to 15 weeks

    TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme

  6. Physical Fitness

    Time frame: Up to 15 weeks

    Participants will be asked to complete two valid and reliable timed performance-related mobility tasks, including 400-meter walk and lift and carry task

  7. Physical Activity

    Time frame: Up to 15 weeks

    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

  8. Exercise-Related Self-Efficacy Exercise-Related

    Time frame: Up to 15 weeks

    Assessed by using Exercise Self-Efficacy, Barrier Self-Efficacy, and Multi-dimensional Self-Efficacy scales

  9. Dietary Intake

    Time frame: Up to 15 weeks

    Self-reported using the National Institutes of Health Daily Food List

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Address Obesity to Reduce Cancer Risk and Health Disparities in Rural Ohio

Acronym: HERO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2021
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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