Interventions in Nutrition Education and Skills

NCT02924051 | Completed Results DMC

• 1 other identifier: 14-0020-P2H
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Average Saturated Fatty Acid Intake/Day

  Baseline, 12 months

• Frequency of Fast Food Consumption

  Baseline and 12 months

Study Arms (2)

Motivational Interview (MI)

EXPERIMENTAL

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

Cooking Skills/Nutritional Education

ACTIVE COMPARATOR

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

Interventions

Motivational Interviewing BEHAVIORAL

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

Motivational Interview (MI)

Cooking skills and nutritional education BEHAVIORAL

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

Cooking Skills/Nutritional Education

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People who live in one of six rural Kentucky food desert counties

You may not qualify if:

• \<16 years old
• Unable to read/write English
• Any GI malabsorption disorder that prevents high fiber consumption

Sponsors & Collaborators

• Frances Hardin-Fanning, PhD, RN: lead

MeSH Terms

Conditions

Obesity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Frances Hardin-Fanning
• Organization: University of Kentucky

fdbowe2@uky.edu

(859) 257-4866

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Control/Intervention Groups (3 sites in each group)

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 22, 2019
• Results First Posted: July 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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.
• 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.