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Healthy eating can be difficult for people who live in poor, geographically isolated regions of the United States. In particular, people who live in Appalachia often experience food insecurity (i.e., their access to adequate food is limited by a lack of money and other resources at times during the year) and lack of access to healthy foods. This pilot study evaluates the effectiveness of motivational interviewing in helping individuals who live in these austere regions improve their diets in the context of limited resources and healthy food availability
Participants in three of the counties will receive an education/skills intervention paired with a form of coaching called motivational interviewing (MI) conducted by a trained registered nurse. Three similar counties that do not border any of the intervention counties are serving as controls (these counties receive the same nutrition education/skills intervention without motivational interviewing). All participants will receive cookbooks, cooking classes, food preparation tools, and prepared food dishes to take home to their families. The investigators will measure the impact of motivational interviewing on fresh fruit and vegetable consumption, saturated fat consumption and number of meals cooked at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interview (MI) | Experimental | Intervention group participants receive cooking skills and nutritional education via cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse |
|
| Cooking Skills/Nutritional Education | Active Comparator | Participants in this arm receive cooking skills and nutritional education via cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral | Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months | Block Fruit/Vegetable/Fiber Screener is a tool that ranks usual intake of fruit, vegetables, and fiber. Total fruit/vegetable/fiber score can range from 0-50 with higher numbers reflecting greater frequency of fruit, vegetable and fiber consumption. | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average Saturated Fatty Acid Intake/Day | Using the NCI DHQ II, respondents' frequency of consumption of foods (i.e., meats and oils) and portion size, dietary saturated fat consumption was calculated as average grams/day. Higher grams/day reflect higher consumption of saturated fatty acids. | Baseline, 12 months |
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Inclusion Criteria:
• People who live in one of six rural Kentucky food desert counties
Exclusion Criteria:
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Data being compiled
Will be available upon request June 30, 2018 (following publication/presentation of primary/secondary outcome results). Data will be available for 6 years.
Data, free of identifiers, will be provided in Excel spreadsheets to requesting researchers to the PI via email (fdbowe2@uky.edu) after June 30, 2018. Both the University of Kentucky Medical IRB and Data Safety Monitoring Board will be asked to review the request prior to release. Researchers must state purpose of the request, intent of data analysis, and acknowledge the PI in subsequent publications/presentations by signing the University of Ky College of Nursing Data Use Agreement and Letter of Intent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cooking Skills/Nutrition Education | Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families. |
| FG001 | Cooking Skills/Nutrition Education/Motivational Interviewing | Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse. Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families. |
| BG001 | Intervention | Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse. Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months | Block Fruit/Vegetable/Fiber Screener is a tool that ranks usual intake of fruit, vegetables, and fiber. Total fruit/vegetable/fiber score can range from 0-50 with higher numbers reflecting greater frequency of fruit, vegetable and fiber consumption. | Participants who completed the Block Screener at baseline and post-intervention (12 months) | Posted | Mean | Full Range | units on a scale | Baseline, 12 months |
|
Adverse event data were monitored over the entire 12 month period of the study. No adverse or serious adverse events were reported in this study.
Adverse event monitoring was based on Clinical Trials definitions.
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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 | Control | Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frances Hardin-Fanning | University of Kentucky | (859) 257-4866 | fdbowe2@uky.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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Control/Intervention Groups (3 sites in each group)
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| Cooking skills and nutritional education | Behavioral | Participants in this group will develop an understanding of healthy food options and healthy food preparation. |
|
| Frequency of Fast Food Consumption |
Fast food consumption was measured using a single item on the National Cancer Institute Diety History Questionaire (NCI DHQ II) "How often did you eat beef hamburgers or cheeseburgers from a fast food or other restaurant?" Responses are selected from 11 pre-determined options increasing in frequency from "never" to "2 or more times per day." Values range from 0 to 10; higher values indicate an increased frequency of fast food consumption. |
| Baseline and 12 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse. Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence. |
|
|
|
| Secondary | Average Saturated Fatty Acid Intake/Day | Using the NCI DHQ II, respondents' frequency of consumption of foods (i.e., meats and oils) and portion size, dietary saturated fat consumption was calculated as average grams/day. Higher grams/day reflect higher consumption of saturated fatty acids. | Number of participants completing the NCI DHQ II survey | Posted | Mean | Standard Deviation | grams/day | Baseline, 12 months |
|
|
|
| Secondary | Frequency of Fast Food Consumption | Fast food consumption was measured using a single item on the National Cancer Institute Diety History Questionaire (NCI DHQ II) "How often did you eat beef hamburgers or cheeseburgers from a fast food or other restaurant?" Responses are selected from 11 pre-determined options increasing in frequency from "never" to "2 or more times per day." Values range from 0 to 10; higher values indicate an increased frequency of fast food consumption. | Participants completing the NCI DHQ II question related fast food comsumpsion | Posted | Mean | Standard Error | units on a scale | Baseline and 12 months |
|
|
|
|
| 0 |
| 82 |
| 0 |
| 82 |
| 0 |
| 82 |
| EG001 | Intervention | Intervention group participants received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to their families, along with monthly motivational interviewing conducted by a trained registered nurse. Motivational Interviewing: Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence. | 0 | 106 | 0 | 106 | 0 | 106 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |