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

Not Applicable

Completed

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

• Registration Number: NCT05040152
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

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 Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-10
• Study Start: 2021-11-06
• Primary Completion: 2022-05-17
• Study Completion: 2022-05-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (telephone-based intervention)	Dietary Counseling and Surveillance	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 (education brochures)	Questionnaire Administration	Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.
Arm II (education brochures)	Informational Intervention	Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.
Arm I (telephone-based intervention)	Questionnaire Administration	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 I (telephone-based intervention)	Exercise 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.
Arm I (telephone-based intervention)	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of a 15-week telephone-based weight loss intervention	Up to 15 weeks	Will be defined as the percentage of enrolled participants who complete the study.

Secondary Outcome Measures

Name	Time	Method
Changes in body weight (KG)	Up to 15 weeks	Changes in body weight (KG)will be measured by a weight scale
Changes in body fat mass	Up to 15 weeks	Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States