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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-06

Study Completion Date

2022-05-17

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.

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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.

Conditions

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Obesity-Related Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm I (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.

Group Type EXPERIMENTAL

Dietary Counseling and Surveillance

Intervention Type BEHAVIORAL

Receive dietary recommendations

Exercise Intervention

Intervention Type OTHER

Complete home exercises

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Receive telephone-based weight loss intervention

Arm II (education brochures)

Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines.

Group Type ACTIVE_COMPARATOR

Informational Intervention

Intervention Type OTHER

Receive education brochures

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Dietary Counseling and Surveillance

Receive dietary recommendations

Intervention Type BEHAVIORAL

Exercise Intervention

Complete home exercises

Intervention Type OTHER

Informational Intervention

Receive education brochures

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Telephone-Based Intervention

Receive telephone-based weight loss intervention

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes