Patients attend 6 online nutrition and PA education classes, cooking sessions, and participate in physical activities over 120 minutes each. Patients also receive text messages, electronic newsletters and have access to an interactive nutrition website.

Attend nutrition and PA classes, and cooking sessions

Health Education

Physical Activity

Health Promotion and Education: Text Messages

Health Promotion and Education: Web Site

Quality-of-Life Assessment

Questionnaire Administration

Rachel Ceballos

This clinical trial studies how to improve the diet quality and physical activity level of Latino cancer survivors living in rural areas. The recommendation to eat a high-quality diet and engage in moderate-to-vigorous physical exercise may reduce cancer risk, improve cancer survival rate, and reduce associated conditions. However, it is not well understood how best to teach cancer survivors, especially Latino cancer survivors living in rural areas, to achieve and maintain diet and physical activity. Understanding how to build a culturally appropriate education that is effective may improve the diet quality and physical activity level of Latino cancer survivors.

OUTLINE:

Patients attend 6 online nutrition and physical activity (PA) education classes, cooking sessions, and participate in physical activities over 120 minutes each. Patients also receive text messages, electronic newsletters and have access to an interactive nutrition website.

After completion of study, patients are followed up periodically.

eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors

Adaptation and Evaluation of an Online and eHealth Diet and Physical Activity Program to Improve Cardiometabolic Health in Rural Latino Adults "Mi Vida Saludable en el Valle"

Number of participants that completed the follow-up (3 month) data collection. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Number of participants who responded to 1 or more text messages. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Number of times participant received all 6 grocery deliveries. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

For the purpose of this feasibility study, participants who completed at least 3 of the 6 online sessions were assessed. Participants attend 6 online nutrition and PA education classes, cooking sessions, and participate in physical activities over 120 minutes each. Patients also receive text messages, electronic newsletters and have access to an interactive nutrition website Health Education: Attend nutrition and PA classes, and cooking sessions Physical Activity: Participate in physical activities This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Acceptability of the cooking sessions was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Acceptability of recipes was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Acceptability of the nutrition and physical activity sessions was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Acceptability of the nutrition text messages was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Acceptability of physical activity text messages was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Acceptability of the website was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery.This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Acceptability of the FITBit was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery.This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Acceptability of monthly check-in calls was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Acceptability of contact with study staff was assessed during the exit interview. The exit interview asked participants to respond to a series of 15-questions assessing the helpfulness of each intervention component (e.g., online session, FITBit, e-communications, etc). Response options include a 6-item Likert scale (1=not at all helpful to 5=very helpful). A space for written-qualitative responses was also provided to allow the participant to provide information about the context and recommendations related to the intervention components/delivery. This feasibility study has primary outcomes that are descriptive in nature and do not include statistical analyses. The outcome measure data table provide the feasibility results for the project.

Nutrition preferences were measured using 17-questions adapted from a battery developed and validated by the study team. The battery is titled "The Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Questionnaires for Latinas" (preparing manuscript for submission). Participants were asked to rate their like or dislike for 11 specific fruits or vegetables (e.g., green cabbage, kale, turkey or veggie burgers, foods made with oil instead of butter or lard). For each fruit or vegetable listed they were asked to rate on a 5 point likert scale with 1=strongly dislike to 5=strongly like or respond with "never tried it"=0. Scores are averaged across the 17 items. Higher scores are considered a better outcome.

Nutrition Self-efficacy was measured using 11-questions from a battery developed and validated by the study team. The battery is titled "The Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Questionnaires for Latinas" (preparing manuscript for submission). Participants were asked to rate thow confident they are in their ability to engage in healthy dietary behaviors for one month. For each behavior listed they were asked to rate on a 5 point likert scale with 1=not at all confident to 5=extremely confident. Scores are averaged across the 11 items. Higher scores are considered a better outcome.

Nutrition knowledge was a single question. The value reflects a change in the percent of women who correctly answered the targeted number of daily serving intake of fruits and vegetables at baseline compared to 3-month follow-up. The correct answer was 5-9 servings per day.

Physical Activity preferences were measured using 8-questions from a battery developed and validated by the study team. The battery is titled "The Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Questionnaires for Latinas" (preparing manuscript for submission). Participants were asked to rate their like or dislike for 8 specific types of physical activity (e.g., doing housework with vigorous effort, dancing in a group setting, playing with children with vigorous effort). For each activity listed they were asked to rate on a 5 point likert scale with 1=strongly dislike to 5=strongly like or respond with "never tried it"=0. Scores are averaged across the 8 items. Higher scores are considered a better outcome.

Physical Activity Self-Efficacy: Self-efficacy was measured using 5-questions from a battery developed and validated by the study team. The battery is titled "The Preferences and Self-Efficacy of Diet and Physical Activity Behaviors Questionnaires for Latinas" (preparing manuscript for submission). Participants were asked to rate how confident they are in their ability to engage in healthy physical activity behaviors given certain conditions (e.g., when you can't notice any improvements in your fitness, when you have many other demands on your time, when you feel a little stiff or sore) for one month. For each behavior listed they were asked to rate on a 5 point likert scale with 1=not at all confident to 5=extremely confident. Scores are averaged across the 5 items. Higher scores are considered a better outcome.

Self-reported physical activity reflects change in time spent sitting (minutes/day). NOTE: The outcomes are reported as a change score (value at 3 months minus value at baseline)

Self-reported physical activity: walking (MET-minutes/week). NOTE: METs=metabolic equivalent of task. Walking in this case is defined as a light activity equivalent to \< 3 METs. The outcomes are reported as a change score (value at 3 months minus value at baseline).

Self-reported physical activity includes moderate to vigorous physical activity (MET-minutes/week).

NOTE: METs=metabolic equivalent of task. Moderate to Vigorous Physical Activity is considered activities estimated at 3 or more METs. The outcomes are reported as a change score (value at 3 months minus value at baseline)

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Associate Professor

This is a single arm feasibility study to assess a culturally tailored eHealth diet and physical activity education and communication program for rural Latino adults with a history of hypertension, diabetes, cardiovascular disease, cancer, and/or obesity in the Lower Yakima Valley in Washington State.

eHealth Diet and Physical Activity Program

This is a single arm feasibility study to assess a culturally tailored eHealth diet and physical activity program for rural Latino adults with a history of hypertension, diabetes, cardiovascular disease, cancer, and/or obesity in the Lower Yakima Valley.

Single Arm

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race

Race/Ethnicity, Customized

United States

Because this is a feasibility study, retention was measured. The overall number of baseline participants was 20 and 19 were included in the final analyses. This is due to a loss to follow up of 1 participant and reflects a 95% retention rate.

Region of Enrollment

Indicates if participant is born in the U.S. vs foreign-born

Place of Birth

Years of education

Body Mass Index

Married or Living with Partner

Living Alone

Married or Living With Partner

Number of Household Members

Use of Electronic Benefit Transfer/Supplemental Nutrition Assistance Program

Employed (FT or PT)

Unemployed

Employment Status

Only Spanish

More Spanish than English

Both Spanish and English Equally

More English than Spanish

Languages Spoken at Home

Diabetes

Hypertension

Cholesterol

Liver Disease

Gastrointestinal Problems

Cancer

Clinical Diagnosis

Heather Greenlee

Patients attend 6 online nutrition and PA education classes, cooking sessions, and participate in physical activities over 120 minutes each. Patients also receive text messages, electronic newsletters and have access to an interactive nutrition website.

Health Education: Attend nutrition and PA classes, and cooking sessions

Physical Activity: Participate in physical activities

Health Promotion and Education: Text Messages: Receive motivational text messages

Health Promotion and Education: Web Site: Given access to nutrition website

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication

Feasibility: Retention

Feasibility: Adherence for Text Messages

Feasibility: Adherence of Grocery Deliveries

Feasibility: Adherence for Online Sessions

Feasibility: Acceptability of Cooking Sessions

Feasibility: Acceptability of Recipes

Feasibility: Acceptability Nutrition and Physical Activity Sessions

Feasibility: Acceptability of Nutrition Text Messages

Feasibility: Acceptability of Physical Activity Text Messages

Feasibility: Acceptability of Website

Feasibility: Acceptability of FITBit

Feasibility: Acceptability of Monthly check-in Calls

Feasibility: Acceptability of Contact With Study Staff

Baseline

3 month follow-up

Nutrition Preferences: Fruit and Vegetables

Nutrition Self-Efficacy

Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors	NCT04081298	Hematopoietic a... Malignant Solid...	Health Educatio... Physical Activi... Health Promotio... Health Promotio... Quality-of-Life... Questionnaire A...	18 Years -	Fred Hutchinson Cancer Center
eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors	NCT04081298	Hematopoietic a... Malignant Solid...	Health Educatio... Physical Activi... Health Promotio... Health Promotio... Quality-of-Life... Questionnaire A...	18 Years -	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for health promotion and education: web site