Obesity-Related Malignant Neoplasm
Conditions
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.
Interventions
BEHAVIORALDietary Counseling and Surveillance
Receive dietary recommendations
OTHERExercise Intervention
Complete home exercises
OTHERInformational Intervention
Receive education brochures
OTHERQuestionnaire Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Receive telephone-based weight loss intervention
Sponsors
National Cancer Institute (NCI)
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a 15-week Telephone-based Weight Loss Intervention | Up to 15 weeks | Will be defined as the number of enrolled participants who complete the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Body Weight (KG) | Up to 15 weeks | Changes in body weight (KG)will be measured by a weight scale |
| Changes in Body Fat Mass | Up to 15 weeks | Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes Body Fat Percentage | Up to 15 weeks | Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100 |
| Lipid Profiles | Up to 15 weeks | 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 |
| C-reactive Protein (CRP) Concentration (ng/L) | Up to 15 weeks | C-reactive protein (CRP) concentration (ng/L) will be quantified with an automated chemistry analyzer |
| Physical Activity | Up to 15 weeks | 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 |
| TNF-alpha Concentration (pg/mL) | Up to 15 weeks | TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme |
| Physical Fitness | Up to 15 weeks | Participants will be asked to complete two valid and reliable timed performance-related mobility tasks, including 400-meter walk and lift and carry task |
| Interleukin (IL)-6 Concentration (pg/mL) | Up to 15 weeks | Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays |
| Exercise-Related Self-Efficacy Exercise-Related | Up to 15 weeks | Assessed by using Exercise Self-Efficacy, Barrier Self-Efficacy, and Multi-dimensional Self-Efficacy scales |
| Dietary Intake | Up to 15 weeks | Self-reported using the National Institutes of Health Daily Food List |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 27 |
| 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 | 13 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Arm I (Telephone-based Intervention) | Arm II (Education Brochures) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 13 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 13 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 13 Participants | 40 Participants |
| Region of Enrollment United States | 27 participants | 13 participants | 40 participants |
| Sex: Female, Male Female | 24 Participants | 12 Participants | 36 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 13 |
| other Total, other adverse events | 0 / 27 | 0 / 13 |
| serious Total, serious adverse events | 0 / 27 | 0 / 13 |
Outcome results
Primary
Feasibility of a 15-week Telephone-based Weight Loss Intervention
Will be defined as the number of enrolled participants who complete the study.
Time frame: Up to 15 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Telephone-based Intervention) | Feasibility of a 15-week Telephone-based Weight Loss Intervention | 22 Participants |
| Arm II (Education Brochures) | Feasibility of a 15-week Telephone-based Weight Loss Intervention | 11 Participants |
Secondary
Changes in Body Fat Mass
Changes in body fat mass will be measured using a 3-Dimension (3D) Body Scanner, Styku S100
Time frame: Up to 15 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Telephone-based Intervention) | Changes in Body Fat Mass | 0.23 lb | Standard Error 3.46 |
| Arm II (Education Brochures) | Changes in Body Fat Mass | 0.11 lb | Standard Error 2.38 |
Secondary
Changes in Body Weight (KG)
Changes in body weight (KG)will be measured by a weight scale
Time frame: Up to 15 weeks
Population: The number of participants analyzed is the number that the 15 week intervention and the 15 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Telephone-based Intervention) | Changes in Body Weight (KG) | -4.93 kg | Standard Error 1.12 |
| Arm II (Education Brochures) | Changes in Body Weight (KG) | -2.09 kg | Standard Error 1.58 |
Other Pre-specified
Changes Body Fat Percentage
Changes body fat percentage will be measured using a 3-Dimension (3D) Body Scanner, Styku S100
Time frame: Up to 15 weeks
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
Time frame: Up to 15 weeks
Other Pre-specified
Dietary Intake
Self-reported using the National Institutes of Health Daily Food List
Time frame: Up to 15 weeks
Other Pre-specified
Exercise-Related Self-Efficacy Exercise-Related
Assessed by using Exercise Self-Efficacy, Barrier Self-Efficacy, and Multi-dimensional Self-Efficacy scales
Time frame: Up to 15 weeks
Other Pre-specified
Interleukin (IL)-6 Concentration (pg/mL)
Interleukin (IL)-6 concentration (pg/mL) will be quantified with sandwich enzyme immunoassay assays
Time frame: Up to 15 weeks
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
Time frame: Up to 15 weeks
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
Time frame: Up to 15 weeks
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
Time frame: Up to 15 weeks
Other Pre-specified
TNF-alpha Concentration (pg/mL)
TNF-alpha concentration (pg/mL) will be quantified with sandwich enzyme
Time frame: Up to 15 weeks