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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02930642
Other study ID # IdahoSU001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2017
Est. completion date March 3, 2020

Study information

Verified date March 2020
Source Idaho State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine the relations among food insecurity status, obesity, and impulsive food choice patterns and to test the extent to which a mindful eating strategy reduces impulsive choice for food. The central hypothesis is that food-insecure individuals will demonstrate more impulsive food choice patterns and demonstrate a greater likelihood of obesity than individuals who are food secure. Two specific aims are proposed:

Specific aim #1: Determine the relation between food insecurity, obesity, and impulsive food choice patterns in women. The working hypothesis is that food-insecure individuals, especially those that are obese, will exhibit more impulsive food choice patterns than food-secure individuals.

Specific aim #2: Determine the efficacy of an extended mindfulness-based eating strategy on impulsive choice patterns among food insecure women. The working hypothesis is that mindful eating will reduce impulsive food choice patterns relative to baseline and control conditions, and will persist to follow-up. The investigators expect mindful eating to reduce impulsive choice compared to control conditions, despite food security status.


Description:

The investigators will recruit women from a variety of community locations, including grocery stores, public schools, churches, local food pantries, and from governmental food assistance programs, such as Women, Infants, and Children and the Supplemental Nutrition Assistance Program. Participants will be recruited heavily from settings where low to moderate food security is prevalent, but not severe food security. Food insecurity status will be determined by completion of the 18-item United State Department of Agriculture (USDA) Food Security Module, and will be scored based on standardized scoring techniques. Participants will provide informed consent, be weighed and measured, and complete several questionnaires that measure diet quality, time since last pay check or food benefits as well as other information, such as age, education, ethnicity, employment status, income, marital status, intelligence, nicotine dependence, and alcohol and drug use. Participants will complete baseline delay and probability discounting tasks for food and money as measures of impulsivity.

Then, food insecure women only will be randomly assigned to one of three arms: mindful eating, a nutrition movie, or a control. Participants in the mindful eating group will be given four foods and receive a 50 min mindful eating workshop. Individuals in the nutrition movie condition also will be given the same four foods, but will view a 50 minute nutrition video. The third group (no treatment control) will receive the four foods, but no treatment. A Time 2 measures of discounting will be administered immediately after the treatments.

Then, for the next week after Session 2, participants in the mindful eating group will be asked to practice mindful eating throughout the week. Research assistants will send text message prompts to participants reminding them to record when they practice mindful eating during meals twice per day for one week. Those in the Nutrition movie will receive the same number of prompts during a one week period as the mindful eating group, but they will give give one-word answers to questions about nutrition. Those in the control group will do nothing during the week.

After one week of mindful eating (or controls), all participants will be asked to return to the laboratory and complete a third set of discounting tasks.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date March 3, 2020
Est. primary completion date March 3, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must be female

- Must be an adult

- Must score 3-5 (with children) or 3-7 (without children) on the USDA Food Security Module

- Must be English speaking

Exclusion Criteria:

- Pregnancy

- Diagnosed with an eating disorder

- HIV

- Hemophilia

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindful Eating
Mindful eating is a behavioral strategy in which food is eaten slowly, with deliberate and focused attention on the features of food, the process of eating, and physiological responses to eating. Objectivity is key.
Other:
Nutrition DVD
Participants watch a 50 minute video on nutrition to control for verbal aspects of food.

Locations

Country Name City State
United States Idaho State University Pocatello Idaho

Sponsors (1)

Lead Sponsor Collaborator
Idaho State University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Hendrickson KL, Rasmussen EB, Lawyer SR. Measurement and validation of measures for impulsive food choice across obese and healthy-weight individuals. Appetite. 2015 Jul;90:254-63. doi: 10.1016/j.appet.2015.03.015. Epub 2015 Mar 18. — View Citation

Hendrickson KL, Rasmussen EB. Effects of mindful eating training on delay and probability discounting for food and money in obese and healthy-weight individuals. Behav Res Ther. 2013 Jul;51(7):399-409. doi: 10.1016/j.brat.2013.04.002. Epub 2013 Apr 27. — View Citation

Lawyer SR, Boomhower SR, Rasmussen EB. Differential associations between obesity and behavioral measures of impulsivity. Appetite. 2015 Dec;95:375-82. doi: 10.1016/j.appet.2015.07.031. Epub 2015 Jul 31. — View Citation

Rasmussen EB, Lawyer SR, Reilly W. Percent body fat is related to delay and probability discounting for food in humans. Behav Processes. 2010 Jan;83(1):23-30. doi: 10.1016/j.beproc.2009.09.001. Epub 2009 Sep 8. — View Citation

Robaina KA, Martin KS. Food insecurity, poor diet quality, and obesity among food pantry participants in Hartford, CT. J Nutr Educ Behav. 2013 Mar;45(2):159-64. doi: 10.1016/j.jneb.2012.07.001. Epub 2012 Dec 5. — View Citation

Townsend MS, Peerson J, Love B, Achterberg C, Murphy SP. Food insecurity is positively related to overweight in women. J Nutr. 2001 Jun;131(6):1738-45. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of impulsive choices as assessed by the Food Choice Questionnaire Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical food-related outcomes Two to three weeks
Primary Number of impulsive choices as assessed by the Monetary Choice Questionnaire Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes Two to three weeks
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