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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity-Related Malignant Neoplasm

Intervention / Treatment
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* Behavioral: Dietary Counseling and Surveillance
* Other: Exercise Intervention
* Other: Informational Intervention
* Other: Questionnaire Administration
* Behavioral: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (telephone-based intervention)<br>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<br>* Receive dietary recommendations<br>Other: Exercise Intervention<br>* Complete home exercises<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Behavioral: Telephone-Based Intervention<br>* Receive telephone-based weight loss intervention<br>|
| Active Comparator: Arm II (education brochures)<br>Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. | Other: Informational Intervention<br>* Receive education brochures<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight (KG) | Changes in body weight (KG)will be measured by a weight scale | Up to 15 weeks | 
| 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 |