ISRCTN ISRCTN16745373
DOI https://doi.org/10.1186/ISRCTN16745373
ClinicalTrials.gov number NCT02924051
Secondary identifying numbers 5K23NR014883-02
Submission date
17/07/2015
Registration date
03/08/2015
Last edited
23/05/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Frances Hardin-Fanning
Scientific

751 Rose Street
Lexington
40536
United States of America

ORCiD logoORCID ID 0000-0002-4325-6423
Phone +1 (0)859 257 4866
Email fdbowe2@uky.edu

Study information

Study designLongitudinal pilot study
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Community
Study typePrevention
Scientific titleThe impact of motivational interviewing during a nutrition education and skills intervention in Central Appalachia
Study acronymREACH
Study objectivesPrimary 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(s)University of Kentucky Medical Institutional Review Board, 04/03/2014, #14-0020-P2H
Health condition(s) or problem(s) studiedAdherence to a healthy diet
InterventionAdherence 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 typeBehavioural
Primary outcome measure1. 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 measuresGrocery buying habits measured via participants' grocery receipts at baseline, 3 months, 6 months and 12 months
Overall study start date15/01/2014
Completion date14/03/2016

Eligibility

Participant type(s)Healthy volunteer
Age groupMixed
SexBoth
Target number of participantsTwenty five participants from each of six counties (n=150)
Key inclusion criteria1. >16 years old
2. Live in one of six rural food desert counties in Kentucky
3. Able to read and comprehend English
Key exclusion criteria1. <16 years old
2. Not or resident of any study county
3. Unable to read and comprehend English
Date of first enrolment15/01/2015
Date of final enrolment01/03/2015

Locations

Countries of recruitment

  • United States of America

Study participating centre

University of Kentucky College of Nursing
751 Rose Street
Lexington
40536
United States of America

Sponsor information

University of Kentucky Office of Research Integrity
University/education

315 Kinkead Hall
Lexington
40536
United States of America

ROR logo "ROR" https://ror.org/02k3smh20

Funders

Funder type

Government

National Institute of Nursing Research
Government organisation / National government
Alternative name(s)
National Institute of Nursing Research National Institutes of Health, NINR
Location
United States of America

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planWe plan to publish the results in peer-reviewed nursing and nutrition journals. We also plan to present the results at national nursing research conferences.
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 22/07/2019 23/05/2022 No No

Editorial Notes

23/05/2022: ClinicalTrials.gov results added.
13/09/2019: The intention to publish date has been changed from 30/12/2016 to 31/12/2020.
12/09/2019: The NCT code has been added.