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

NCT05040152 | Completed Results DMC

• 3 other identifiers: OSU-21007NCI-2021-03973F99CA253745
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity-Related Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in Body Weight (KG)

  Up to 15 weeks

• Changes in Body Fat Mass

  Up to 15 weeks

Other Outcomes (9)

• Changes Body Fat Percentage

  Up to 15 weeks

• Lipid Profiles

  Up to 15 weeks

• C-reactive Protein (CRP) Concentration (ng/L)

  Up to 15 weeks

Study Arms (2)

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.

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.

Other: Informational Intervention; Other: Questionnaire Administration

Interventions

Dietary Counseling and Surveillance BEHAVIORAL

Receive dietary recommendations

Arm I (telephone-based intervention)

Exercise Intervention OTHER

Complete home exercises

Arm I (telephone-based intervention)

Informational Intervention OTHER

Receive education brochures

Arm II (education brochures)

Questionnaire Administration OTHER

Ancillary studies

Arm I (telephone-based intervention); Arm II (education brochures)

Telephone-Based Intervention BEHAVIORAL

Receive telephone-based weight loss intervention

Arm I (telephone-based intervention)

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Xiaochen Zhang
• Organization: The Ohio State University Comprehensive Cancer Center

xiaochen.zhang@osumc.edu

614-293-9600

Study Officials

• Brian C Focht, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: September 10, 2021
• Study Start: November 6, 2021
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)