Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio (HERO)
Primary Purpose
Obesity-Related Malignant Neoplasm
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dietary Counseling and Surveillance
Exercise Intervention
Informational Intervention
Questionnaire Administration
Telephone-Based Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Obesity-Related Malignant Neoplasm
Eligibility Criteria
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
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (telephone-based intervention)
Arm II (education brochures)
Arm 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.
Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.
Outcomes
Primary Outcome Measures
Feasibility of a 15-week telephone-based weight loss intervention
Will be defined as the percentage of enrolled participants who complete the study.
Secondary Outcome Measures
Changes in body weight (KG)
Changes in body weight (KG)will be measured by a weight scale
Changes in body fat mass
Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100
Full Information
NCT ID
NCT05040152
First Posted
May 25, 2021
Last Updated
September 14, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05040152
Brief Title
Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio
Acronym
HERO
Official Title
Address Obesity to Reduce Cancer Risk and Health Disparities in Rural Ohio
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 6, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity-Related Malignant Neoplasm
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (telephone-based intervention)
Arm Type
Experimental
Arm 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.
Arm Title
Arm II (education brochures)
Arm Type
Active Comparator
Arm Description
Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Counseling and Surveillance
Intervention Description
Receive dietary recommendations
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Complete home exercises
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive education brochures
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive telephone-based weight loss intervention
Primary Outcome Measure Information:
Title
Feasibility of a 15-week telephone-based weight loss intervention
Description
Will be defined as the percentage of enrolled participants who complete the study.
Time Frame
Up to 15 weeks
Secondary Outcome Measure Information:
Title
Changes in body weight (KG)
Description
Changes in body weight (KG)will be measured by a weight scale
Time Frame
Up to 15 weeks
Title
Changes in body fat mass
Description
Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100
Time Frame
Up to 15 weeks
Other Pre-specified Outcome Measures:
Title
Changes body fat percentage
Description
Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100
Time Frame
Up to 15 weeks
Title
Lipid profiles
Description
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
Time Frame
Up to 15 weeks
Title
C-reactive protein (CRP) concentration (ng/L)
Description
C-reactive protein (CRP) concentration (ng/L) will be quantified with an automated chemistry analyzer
Time Frame
Up to 15 weeks
Title
Interleukin (IL)-6 concentration (pg/mL)
Description
Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays
Time Frame
Up to 15 weeks
Title
TNF-alpha concentration (pg/mL)
Description
TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme
Time Frame
Up to 15 weeks
Title
Physical fitness
Description
Participants will be asked to complete two valid and reliable timed performance-related mobility tasks, including 400-meter walk and lift and carry task
Time Frame
Up to 15 weeks
Title
Physical activity
Description
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
Time Frame
Up to 15 weeks
Title
Exercise-Related Self-Efficacy Exercise-Related
Description
Assessed by using Exercise Self-Efficacy, Barrier Self-Efficacy, and Multi-dimensional Self-Efficacy scales
Time Frame
Up to 15 weeks
Title
Dietary intake
Description
Self-reported using the National Institutes of Health Daily Food List
Time Frame
Up to 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian C Focht, PhD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
Learn more about this trial
Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio
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