Obesity
Conditions
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALMotivational Interviewing
Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and coaching to resolve barriers and ambivalence.
BEHAVIORALCooking skills and nutritional education
Participants in this group will develop an understanding of healthy food options and healthy food preparation.
Sponsors
Frances Hardin-Fanning, PhD, RN
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Control/Intervention Groups (3 sites in each group)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• People who live in one of six rural Kentucky food desert counties
Exclusion criteria
* \<16 years old * Unable to read/write English * Any GI malabsorption disorder that prevents high fiber consumption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Saturated Fatty Acid Intake/Day | Baseline, 12 months | 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. |
| Frequency of Fast Food Consumption | Baseline and 12 months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Control group received cookbooks, cooking classes, food preparation tools and prepared food dishes to take home to families. | 82 |
| 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. | 106 |
| Total | 188 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 9 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 55.4 years | 54.9 years | 50.3 years |
| 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 | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 79 Participants | 183 Participants | 104 Participants |
| Region of Enrollment United States | 82 participants | 188 participants | 106 participants |
| Sex: Female, Male Female | 77 Participants | 176 Participants | 99 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 106 |
| other Total, other adverse events | 0 / 82 | 0 / 106 |
| serious Total, serious adverse events | 0 / 82 | 0 / 106 |
Outcome results
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.
Time frame: Baseline, 12 months
Population: Participants who completed the Block Screener at baseline and post-intervention (12 months)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cooking Skills/Nutrition Education | Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months | Baseline | 16.6 units on a scale |
| Cooking Skills/Nutrition Education | Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months | 12 months | 18.0 units on a scale |
| Cooking Skills/Nutrition Education/Motivational Interviewing | Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months | Baseline | 15.9 units on a scale |
| Cooking Skills/Nutrition Education/Motivational Interviewing | Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months | 12 months | 16.3 units on a scale |
p-value: 0.26t-test, 2 sided
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.
Time frame: Baseline, 12 months
Population: Number of participants completing the NCI DHQ II survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cooking Skills/Nutrition Education | Average Saturated Fatty Acid Intake/Day | Baseline | 26.8 grams/day | Standard Deviation 15.4 |
| Cooking Skills/Nutrition Education | Average Saturated Fatty Acid Intake/Day | Post-Intervention (12 mos) | 19.2 grams/day | Standard Deviation 9.6 |
| Cooking Skills/Nutrition Education/Motivational Interviewing | Average Saturated Fatty Acid Intake/Day | Baseline | 23.8 grams/day | Standard Deviation 14.3 |
| Cooking Skills/Nutrition Education/Motivational Interviewing | Average Saturated Fatty Acid Intake/Day | Post-Intervention (12 mos) | 21.6 grams/day | Standard Deviation 17.9 |
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.
Time frame: Baseline and 12 months
Population: Participants completing the NCI DHQ II question related fast food comsumpsion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cooking Skills/Nutrition Education | Frequency of Fast Food Consumption | 12 months | 3.78 units on a scale | Standard Error 0.5 |
| Cooking Skills/Nutrition Education | Frequency of Fast Food Consumption | Baseline | 3.56 units on a scale | Standard Error 0.49 |
| Cooking Skills/Nutrition Education/Motivational Interviewing | Frequency of Fast Food Consumption | Baseline | 3.16 units on a scale | Standard Error 0.53 |
| Cooking Skills/Nutrition Education/Motivational Interviewing | Frequency of Fast Food Consumption | 12 months | 3.03 units on a scale | Standard Error 0.46 |
Comparison: Comparison of Cooking Skills/Nutrition Education/MI at baseline and 12 months.p-value: 0.36t-test, 1 sided