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

Obesity-Related Malignant Neoplasm Clinical Trial

— HERO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05040152
• Other study ID #: OSU-21007
• Secondary ID: NCI-2021-03973F9
• Status: Completed
• Phase: N/A
• Start date: November 6, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: April 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 17, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Obesity
• Obesity-Related Malignant Neoplasm

Intervention

Behavioral:
• Dietary Counseling and Surveillance
Receive dietary recommendations

Other:
• Exercise Intervention
Complete home exercises
• Informational Intervention
Receive education brochures
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive telephone-based weight loss intervention

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes body fat percentage	Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100	Up to 15 weeks
Other	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
Other	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
Other	Interleukin (IL)-6 concentration (pg/mL)	Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays	Up to 15 weeks
Other	TNF-alpha concentration (pg/mL)	TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme	Up to 15 weeks
Other	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
Other	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
Other	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
Other	Dietary intake	Self-reported using the National Institutes of Health Daily Food List	Up to 15 weeks
Primary	Feasibility of a 15-week telephone-based weight loss intervention	Will be defined as the percentage of enrolled participants who complete the study.	Up to 15 weeks
Secondary	Changes in body weight (KG)	Changes in body weight (KG)will be measured by a weight scale	Up to 15 weeks
Secondary	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

External Links

•   The Jamesline