Clinical trial NCT05040152: Weight Loss Intervention for the Reduction of Cancer Risk and Health Disparities in Rural Ohio
Official title: Address Obesity to Reduce Cancer Risk and Health Disparities in Rural Ohio
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity-Related Malignant Neoplasm
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility of a 15-week Telephone-based Weight Loss Intervention
timeFrame: Up to 15 weeks
Secondary outcomes:
measure: Changes in Body Weight (KG)
timeFrame: Up to 15 weeks
measure: Changes in Body Fat Mass
timeFrame: Up to 15 weeks
Other outcomes:
measure: Changes Body Fat Percentage
timeFrame: Up to 15 weeks
measure: Lipid Profiles
timeFrame: Up to 15 weeks
measure: C-reactive Protein (CRP) Concentration (ng/L)
timeFrame: Up to 15 weeks
measure: Interleukin (IL)-6 Concentration (pg/mL)
timeFrame: Up to 15 weeks
measure: TNF-alpha Concentration (pg/mL)
timeFrame: Up to 15 weeks
measure: Physical Fitness
timeFrame: Up to 15 weeks
measure: Physical Activity
timeFrame: Up to 15 weeks
measure: Exercise-Related Self-Efficacy Exercise-Related
timeFrame: Up to 15 weeks
measure: Dietary Intake
timeFrame: Up to 15 weeks
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Brian C Focht, PhD
role: PRINCIPAL_INVESTIGATOR
References: