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OpenTrials
Completed

NCT Number: NCT02924051

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and "coaching" to resolve barriers and ambivalence.

Cooking skills and nutritional education

Behavioral

Participants in this group will develop an understanding of healthy food options and healthy food preparation.

Primary outcomes

  1. Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months

    Time frame: 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 outcomes

  1. Average Saturated Fatty Acid Intake/Day

    Time frame: 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.

  2. Frequency of Fast Food Consumption

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Frances Hardin-Fanning, PhD, RN

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 5, 2016
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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