Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/07/2015
Date assigned
03/08/2015
Last edited
07/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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 measures

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

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

Sponsor information

Organisation

University of Kentucky Office of Research Integrity

Sponsor details

315 Kinkead Hall
Lexington
40536
United States of America

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute of Nursing Research

Alternative name(s)

NINR

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

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

30/12/2016

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes