Plain English Summary
Background and study aims
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.
Who can participate?
People who live in one of six rural Kentucky food desert counties (a food desert is an urban area in which it is difficult to buy affordable or good-quality fresh food).
What does the study involve?
Participants in three of the counties will receive an education/skills intervention paired with a form of coaching called motivational interviewing 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. We will measure the impact of motivational interviewing on fresh fruit and vegetable consumption, saturated fat consumption and number of meals cooked at home.
What are the possible benefits and risks of participating?
People in the study will learn how to cook healthy meals for their families. They will also learn how to read food labels, make recipe substitutions and become more aware of the healthy foods available in their community. There are no known risks to participating in this study.
Where is the study run from?
University of Kentucky College of Nursing (USA).
When is the study starting and how long is it expected to run for?
From January 2014 to March 2016.
Who is funding the study?
National Institute of Nursing Research (USA).
Who is the main contact?
Dr Frances Hardin-Fanning
fdbowe2@uky.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Frances Hardin-Fanning
ORCID ID
http://orcid.org/0000-0002-4325-6423
Contact details
751 Rose Street
Lexington
40536
United States of America
+1 (0)859 257 4866
fdbowe2@uky.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02924051
Protocol/serial number
5K23NR014883-02
Study information
Scientific title
The impact of motivational interviewing during a nutrition education and skills intervention in Central Appalachia
Acronym
REACH
Study hypothesis
Primary aim: To develop and test the effectiveness of a culturally appropriate, individualized dietary behavior change intervention that includes motivational interviewing aimed at increasing consumption of foods known to decrease CVD risk.
Hypothesis: Intervention group participants who receive motivational interviewing sessions will exhibit a greater increase in the consumption of healthy foods compared to participants in the control group.
Secondary aim: To determine whether health literacy, financial status and/or risk of food insecurity moderate the effects of the intervention on consumption of CVD risk-reducing foods.
Ethics approval
University of Kentucky Medical Institutional Review Board, 04/03/2014, #14-0020-P2H
Study design
Longitudinal pilot study
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Condition
Adherence to a healthy diet
Intervention
Adherence to a healthy diet is difficult in rural Central Appalachian food deserts and strategies to improve dietary habits in this region must consider the impact of austere environment and cultural food norms. This longitudinal pilot study is being conducted in six eastern Kentucky rural Appalachian food desert counties with similar demographics to determine the impact of motivational interviewing on consumption of foods associated with better health outcomes.
The education/skills intervention paired with motivational interviewing is being delivered in three contiguous rural Kentucky food desert counties. 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). Counties were determined in collaboration with the UK College of Agriculture Cooperative Extension faculty. All participants in the intervention and control groups received an AHA cookbook, cooking classes taught by Family and Consumer Science agents at their cooperative extension office, and food preparation tools along with instructions on how to read nutrition labels. Intervention participants are contacted monthly by a trained registered nurse who assists them in developing an individualized plan of successful behavior change and they are receiving monitoring and feedback, using MI techniques.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Fresh fruit and vegetable consumption measured at baseline, 6 months and 12 months (study completion) using the BLOCK Fruit/Vegetable/Fiber Screener
2. Saturated fat intake measured at baseline and 12 months using the National Cancer Institute Diet History Questionnaire II
3. Frequency of home cooked meals and perception of food environment measured at baseline, 6 months and 12 months using the Leise Food Environment Questionnaire
4. Household Food Security using the USDA Household Food Security Survey Module at baseline and 12 months
5. Grocery buying habits measured via participants' grocery receipts at baseline, 3 months, 6 months and 12 months
Secondary outcome measures
Grocery buying habits measured via participants' grocery receipts at baseline, 3 months, 6 months and 12 months
Overall trial start date
15/01/2014
Overall trial end date
14/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. >16 years old
2. Live in one of six rural food desert counties in Kentucky
3. Able to read and comprehend English
Participant type
Healthy volunteer
Age group
Mixed
Gender
Both
Target number of participants
Twenty five participants from each of six counties (n=150)
Participant exclusion criteria
1. <16 years old
2. Not or resident of any study county
3. Unable to read and comprehend English
Recruitment start date
15/01/2015
Recruitment end date
01/03/2015
Locations
Countries of recruitment
United States of America
Trial participating centre
University of Kentucky College of Nursing
751 Rose Street
Lexington
40536
United States of America
Funders
Funder type
Government
Funder name
National Institute of Nursing Research
Alternative name(s)
NINR
Funding Body Type
government organisation
Funding Body Subtype
Research institutes and centers
Location
United States of America
Results and Publications
Publication and dissemination plan
We plan to publish the results in peer-reviewed nursing and nutrition journals. We also plan to present the results at national nursing research conferences.
Intention to publish date
31/12/2020
Participant level data
Stored in repository
Basic results (scientific)
Publication list