Interventions in Nutrition Education and Skills

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Motivational Interviewing; Behavioral: Cooking skills and nutritional education

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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interview (MI); 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	Behavioral: Motivational Interviewing; Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.
Active Comparator: Cooking Skills/Nutritional Education; 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.	Behavioral: Cooking skills and nutritional education; Participants in this group will develop an understanding of healthy food options and healthy food preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Frances Hardin-Fanning, PhD, RN

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 22, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 14-0020-P2H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data being compiled
• IPD Sharing Time Frame: Will be available upon request June 30, 2018 (following publication/presentation of primary/secondary outcome results). Data will be available for 6 years.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR