Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Conditions
Keywords
Cancer Survivor
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHealth Education
Attend nutrition and PA classes, and cooking sessions
OTHERPhysical Activity
Participate in physical activities
OTHERHealth Promotion and Education: Text Messages
Receive motivational text messages
OTHERHealth Promotion and Education: Web Site
Given access to nutrition website
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must self-identify as being at least 18 years of age or older * Participants must self-identify as Latino * Participants must be a resident of the Lower Yakima Valley (LYV) and anticipate remaining in the LYV for at least 1 year * Participants must speak Spanish or English and fully understand Spanish for online group sessions * Participants must self-identify as having a medical history of hypertension * Participants must self-identify as having a medical history of diabetes * Participants must self-identify as having a medical history of cardiovascular disease * Participants must self-identify as having a medical history of obesity, as defined by a body mass index (BMI) of \> 30 kg/m\^2 * Participants must self-identify as having a medical history of cancer (excluding non-melanoma skin cancer). All other cancer types will be included provided * There is no evidence of recurrent or metastatic disease * The patient has not received a bone marrow, stem cell, or cord blood transplant * For cancer survivors, participants must self-identify as being at least 60 days post final chemotherapy, biologic therapy, or radiation therapy treatment and/or surgery. Current use of hormonal therapy is permitted (e.g., tamoxifen and aromatase inhibitors) * Participants must be willing and able to receive text messages via cellphone for 3-6 months * Participants must be willing and able to attend six 120-minute online group sessions * Participants must be willing to complete the surveys, and diet/PA assessments * Participants who report having been told by a health professional they have diabetes or cardiovascular disease must provide a clearance from their physician for participation * Participants must consume \< 5 servings of fruits and vegetables per day and/or engage in \< 150 minutes per week of moderate to vigorous physical activity, as assessed by brief questionnaires * Participants must have an Eastern Cooperative Oncology Group (ECOG) scale of performance status score of 0 or 1 for performance status. These scales and criteria are commonly used by doctors and trained research staff to assess a person's daily living abilities. These scales and criteria are commonly used by doctors and trained research staff to assess a person's daily living abilities. Scores of 0 and 1 corresponds to being fully active, able to carry on all pre-disease performance without restriction; and restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, respectively * Ability to understand and the willingness to sign an online informed consent document \* Depending on preference, the consent will be provided in English or Spanish
Exclusion criteria
* Participants must not be active smokers within the past 30 days. Active smoking is defined as any smoking, even a puff. Participants who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for participants to stop smoking than it is to change their dietary patterns. If identified as a smoker, the individual will be referred the Centers for Disease Control and Prevention (CDC) Quit Now phone line which supports smoking cessation, or the National Institutes of Health (NIH) quit support website SmokeFree.gov which are both available in English and Spanish * Women must not be pregnant at time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Acceptability of Contact With Study Staff | At 3 months | 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. |
| Feasibility: Acceptability of Cooking Sessions | At 3 months | 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. |
| Feasibility: Acceptability of Recipes | At 3 months | 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. |
| Feasibility: Acceptability Nutrition and Physical Activity Sessions | At 3 months | 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. |
| Feasibility: Acceptability of Nutrition Text Messages | At 3 months | 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. |
| Feasibility: Acceptability of Physical Activity Text Messages | At 3 months | 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. |
| Feasibility: Acceptability of Website | At 3 months | 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. |
| Feasibility: Acceptability of FITBit | At 3 months | 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. |
| Feasibility: Acceptability of Monthly check-in Calls | At 3 months | 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. |
| Feasibility: Retention | At 3-months | 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. |
| Feasibility: Adherence for Text Messages | At 3 months | 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. |
| Feasibility: Adherence of Grocery Deliveries | At 3 months | 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. |
| Feasibility: Adherence for Online Sessions | At 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutrition Self-Efficacy | Baseline and 3 months | 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 | Change in correct nutrition knowledge response from baseline to 3 month follow-up | 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 | Baseline and 3 months | 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 | Baseline and 3 months | 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: Time Sitting | Baseline and 3 month follow-up | 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 | Baseline and 3 month-follow-up | 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: Moderate to Vigorous Physical Activity | Baseline and 3-month follow-up | 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) |
| Nutrition Preferences: Fruit and Vegetables | Baseline and 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
The study was paused April 2020 due to the pandemic. Because we had not reached the number needed to begin our first intervention cohort and pandemic protocols halted our in-person study design, the project was paused. We revised the study design and began recruitment again with a new online version of the protocol, recruitment protocols, and participant eligibility on 9/16/2021. The revised protocol concluded on 2/25/2022.
Pre-assignment details
As this was a single arm study, participants were not assigned to any arm or group.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 13 |
| Body Mass Index | 33.6 kg/m-squared STANDARD_DEVIATION 7.2 |
| Clinical Diagnosis Cancer | 2 Participants |
| Clinical Diagnosis Cholesterol | 3 Participants |
| Clinical Diagnosis Diabetes | 8 Participants |
| Clinical Diagnosis Gastrointestinal Problems | 3 Participants |
| Clinical Diagnosis Hypertension | 6 Participants |
| Clinical Diagnosis Liver Disease | 2 Participants |
| Employment Status Employed (FT or PT) | 11 Participants |
| Employment Status Unemployed | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Languages Spoken at Home Both Spanish and English Equally | 4 Participants |
| Languages Spoken at Home More English than Spanish | 8 Participants |
| Languages Spoken at Home More Spanish than English | 2 Participants |
| Languages Spoken at Home Only Spanish | 6 Participants |
| Married or Living With Partner Living Alone | 10 Participants |
| Married or Living With Partner Married or Living with Partner | 10 Participants |
| Number of Household Members | 3.9 Household Members STANDARD_DEVIATION 2.1 |
| Place of Birth Foreign born | 8 Participants |
| Place of Birth U.S born | 12 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants |
| Race/Ethnicity, Customized Race Other | 7 Participants |
| Race/Ethnicity, Customized Race White | 12 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 1 Participants |
| Use of Electronic Benefit Transfer/Supplemental Nutrition Assistance Program | 3 Participants |
| Years of education | 12.3 years STANDARD_DEVIATION 3.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Feasibility: Acceptability Nutrition and Physical Activity Sessions
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.
Time frame: At 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability Nutrition and Physical Activity Sessions | Nutrition and physical activity sessions were somewhat or very helpful | 19 Participants |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability Nutrition and Physical Activity Sessions | Nutrition and physical activity sessions were not very helpful or not at all helpful | 0 Participants |
Primary
Feasibility: Acceptability of Contact With Study Staff
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.
Time frame: At 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Contact With Study Staff | Contact with study staff was somewhat or very helpful | 18 Participants |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Contact With Study Staff | Contact with study staff was not very helpful or not at all helpful | 1 Participants |
Primary
Feasibility: Acceptability of Cooking Sessions
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.
Time frame: At 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Cooking Sessions | Cooking sessions were somewhat or very helpful | 18 Participants |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Cooking Sessions | Cooking sessions were somewhat or not very helpful or not at all helpful | 1 Participants |
Primary
Feasibility: Acceptability of FITBit
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.
Time frame: At 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of FITBit | Fitbits were somewhat or very helpful | 16 Participants |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of FITBit | Fitbits were not very helpful or not at all helpful | 3 Participants |
Primary
Feasibility: Acceptability of Monthly check-in Calls
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.
Time frame: At 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Monthly check-in Calls | Monthly checking in calls were somewhat or very helpful | 18 Participants |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Monthly check-in Calls | Monthly checking in calls were not very helpful or not at all helpful | 1 Participants |
Primary
Feasibility: Acceptability of Nutrition Text Messages
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.
Time frame: At 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Nutrition Text Messages | nutrition text messages were somewhat or very helpful | 18 Participants |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Nutrition Text Messages | nutrition text messages were not very helpful or not at all helpful | 1 Participants |
Primary
Feasibility: Acceptability of Physical Activity Text Messages
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.
Time frame: At 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Physical Activity Text Messages | physical activity text messages were somewhat or very helpful | 18 Participants |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Physical Activity Text Messages | physical activity text messages were not very helpful or not at all helpful | 1 Participants |
Primary
Feasibility: Acceptability of Recipes
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.
Time frame: At 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Recipes | Recipes were somewhat or very helpful | 19 Participants |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Recipes | Recipes were somewhat or not at all helpful | 0 Participants |
Primary
Feasibility: Acceptability of Website
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.
Time frame: At 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Website | Website was somewhat or very helpful | 12 Participants |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Acceptability of Website | Website was not very helpful or not at all helpful | 7 Participants |
Primary
Feasibility: Adherence for Online Sessions
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.
Time frame: At 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Adherence for Online Sessions | 13 Participants |
Primary
Feasibility: Adherence for Text Messages
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.
Time frame: At 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Adherence for Text Messages | 10 Participants |
Primary
Feasibility: Adherence of Grocery Deliveries
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.
Time frame: At 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Adherence of Grocery Deliveries | 19 Participants |
Primary
Feasibility: Retention
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.
Time frame: At 3-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Feasibility: Retention | 19 Participants |
Secondary
Nutrition Knowledge
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.
Time frame: Change in correct nutrition knowledge response from baseline to 3 month follow-up
Population: McNemar's test for binary measures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Nutrition Knowledge | 21 change in % of correct responses |
Comparison: Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)p-value: 0.1McNemar
Secondary
Nutrition Preferences: Fruit and Vegetables
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.
Time frame: Baseline and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Nutrition Preferences: Fruit and Vegetables | Baseline | 3.80 score on a scale | Standard Deviation 0.89 |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Nutrition Preferences: Fruit and Vegetables | 3 month follow-up | 4.04 score on a scale | Standard Deviation 0.41 |
p-value: 0.24Paired sample t-test
Secondary
Nutrition Self-Efficacy
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.
Time frame: Baseline and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Nutrition Self-Efficacy | Baseline | 3.20 score on a scale | Standard Deviation 0.76 |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Nutrition Self-Efficacy | 3 month follow-up | 3.34 score on a scale | Standard Deviation 0.69 |
p-value: 0.43paired t-test
Secondary
Physical Activity Preferences
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.
Time frame: Baseline and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Physical Activity Preferences | 3 month follow-up | 3.66 score on a scale | Standard Deviation 0.55 |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Physical Activity Preferences | Baseline | 3.47 score on a scale | Standard Deviation 0.7 |
p-value: 0.2paired-sample t-test
Secondary
Physical Activity Self-Efficacy
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.
Time frame: Baseline and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Physical Activity Self-Efficacy | Baseline | 3.12 score on a scale | Standard Deviation 0.69 |
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Physical Activity Self-Efficacy | 3 month follow-up | 3.18 score on a scale | Standard Deviation 0.64 |
p-value: 0.71paired sample t-test
Secondary
Self-Reported Physical Activity: Moderate to Vigorous Physical Activity
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)
Time frame: Baseline and 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Self-Reported Physical Activity: Moderate to Vigorous Physical Activity | -1024 change in mean (MET-minutes/week) | Standard Deviation 4709 |
p-value: 0.36paired-sample t-test
Secondary
Self-Reported Physical Activity: Time Sitting
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)
Time frame: Baseline and 3 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Self-Reported Physical Activity: Time Sitting | -3.6 change in mean (minutes/day) | Standard Deviation 128.7 |
Comparison: Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)p-value: 0.94paired-sample t-test
Secondary
Self-Reported Physical Activity: Walking
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).
Time frame: Baseline and 3 month-follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Services: Single Arm Feasibility Online Diet and Physical Activity and eHealth Communication | Self-Reported Physical Activity: Walking | 490 change in mean (MET-minutes/week) | Standard Deviation 907 |
p-value: 0.03paired-sample t-test