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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-03973 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| F99CA253745 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (telephone-based intervention) | Experimental | 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 (education brochures) | Active Comparator | Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Counseling and Surveillance | Behavioral | Receive dietary recommendations |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of a 15-week Telephone-based Weight Loss Intervention | Will be defined as the number of enrolled participants who complete the study. | Up to 15 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes Body Fat Percentage | Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100 | Up to 15 weeks |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian C Focht, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Dietary Counseling and Surveillance: Receive dietary recommendations Exercise Intervention: Complete home exercises Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive telephone-based weight loss intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2021 |
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| Exercise Intervention | Other | Complete home exercises |
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| Informational Intervention | Other | Receive education brochures |
|
| Questionnaire Administration | Other | Ancillary studies |
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| Telephone-Based Intervention | Behavioral | Receive telephone-based weight loss intervention |
|
| Up to 15 weeks |
| Up to 15 weeks |
| 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 |
| Interleukin (IL)-6 Concentration (pg/mL) | Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays | Up to 15 weeks |
| TNF-alpha Concentration (pg/mL) | TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme | Up to 15 weeks |
| 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 |
| 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 |
| 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 |
| Dietary Intake | Self-reported using the National Institutes of Health Daily Food List | Up to 15 weeks |
| FG001 | Arm II (Education Brochures) | Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. Informational Intervention: Receive education brochures Questionnaire Administration: Ancillary studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Dietary Counseling and Surveillance: Receive dietary recommendations Exercise Intervention: Complete home exercises Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive telephone-based weight loss intervention |
| BG001 | Arm II (Education Brochures) | Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. Informational Intervention: Receive education brochures Questionnaire Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of a 15-week Telephone-based Weight Loss Intervention | Will be defined as the number of enrolled participants who complete the study. | Posted | Count of Participants | Participants | Up to 15 weeks |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Changes in Body Weight (KG) | Changes in body weight (KG)will be measured by a weight scale | The number of participants analyzed is the number that the 15 week intervention and the 15 week follow-up | Posted | Mean | Standard Error | kg | Up to 15 weeks |
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| |||||||||||||||||||||||||||||
| Secondary | Changes in Body Fat Mass | Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100 | Posted | Mean | Standard Error | lb | Up to 15 weeks |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Changes Body Fat Percentage | Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100 | Not Posted | Up to 15 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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 | Not Posted | Up to 15 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | C-reactive Protein (CRP) Concentration (ng/L) | C-reactive protein (CRP) concentration (ng/L) will be quantified with an automated chemistry analyzer | Not Posted | Up to 15 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interleukin (IL)-6 Concentration (pg/mL) | Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays | Not Posted | Up to 15 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | TNF-alpha Concentration (pg/mL) | TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme | Not Posted | Up to 15 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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 | Not Posted | Up to 15 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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 | Not Posted | Up to 15 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exercise-Related Self-Efficacy Exercise-Related | Assessed by using Exercise Self-Efficacy, Barrier Self-Efficacy, and Multi-dimensional Self-Efficacy scales | Not Posted | Up to 15 weeks | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Dietary Intake | Self-reported using the National Institutes of Health Daily Food List | Not Posted | Up to 15 weeks | Participants |
Up to 15 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Dietary Counseling and Surveillance: Receive dietary recommendations Exercise Intervention: Complete home exercises Questionnaire Administration: Ancillary studies Telephone-Based Intervention: Receive telephone-based weight loss intervention | 0 | 27 | 0 | 27 | 0 | 27 |
| EG001 | Arm II (Education Brochures) | Participants receive education brochures describing the American Institute for Cancer Research physical activity and dietary guidelines. Informational Intervention: Receive education brochures Questionnaire Administration: Ancillary studies | 0 | 13 | 0 | 13 | 0 | 13 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaochen Zhang | The Ohio State University Comprehensive Cancer Center | 614-293-9600 | xiaochen.zhang@osumc.edu |
| May 30, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2022 | May 30, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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