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

The Ohio State University

Status: Completed

Conditions: Obesity-Related Malignant Neoplasm

Treatments: Other: Exercise Intervention; Behavioral: Telephone-Based Intervention; Other: Informational Intervention; Behavioral: Dietary Counseling and Surveillance; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05040152

NCI-2021-03973 (Registry Identifier)

F99CA253745 (U.S. NIH Grant/Contract)

OSU-21007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Arm I (telephone-based intervention)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Behavioral: Dietary Counseling and Surveillance

Behavioral: Telephone-Based Intervention

Other: Exercise Intervention

Arm II (education brochures)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Informational Intervention