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Food Insecurity, Obesity, and Impulsive Food Choice (FIOI)

Primary Purpose

Feeding Behavior, Obesity, Impulsivity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Eating
Nutrition DVD
Sponsored by
Idaho State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding Behavior focused on measuring Mindfulness, Obesity, Food insecurity, Delay discounting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Idaho State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mindful Eating

Nutrition Digital Video Disc (DVD)

Control

Arm Description

Participants in this arm will receive a 50 min mindful eating training with four pieces of food. They will practice mindful eating at home with two meals for a one-week duration.

Participants will watch a 50 min DVD on nutrition and receive four pieces of food. They will receive prompts twice a week to give one-word answers to questions about food.

Participants will receive four pieces of food. They will not receive any prompts during the one week.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
October 5, 2016
Last Updated
March 3, 2020
Sponsor
Idaho State University
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1. Study Identification

Unique Protocol Identification Number
NCT02930642
Brief Title
Food Insecurity, Obesity, and Impulsive Food Choice
Acronym
FIOI
Official Title
Food Insecurity, Obesity, and Impulsive Food Choice
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idaho State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Behavior, Obesity, Impulsivity
Keywords
Mindfulness, Obesity, Food insecurity, Delay discounting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindful Eating
Arm Type
Experimental
Arm Description
Participants in this arm will receive a 50 min mindful eating training with four pieces of food. They will practice mindful eating at home with two meals for a one-week duration.
Arm Title
Nutrition Digital Video Disc (DVD)
Arm Type
Active Comparator
Arm Description
Participants will watch a 50 min DVD on nutrition and receive four pieces of food. They will receive prompts twice a week to give one-word answers to questions about food.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive four pieces of food. They will not receive any prompts during the one week.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Eating
Other Intervention Name(s)
Raisin exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nutrition DVD
Intervention Description
Participants watch a 50 minute video on nutrition to control for verbal aspects of food.
Primary Outcome Measure Information:
Title
Number of impulsive choices as assessed by the Food Choice Questionnaire
Description
Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical food-related outcomes
Time Frame
Two to three weeks
Title
Number of impulsive choices as assessed by the Monetary Choice Questionnaire
Description
Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes
Time Frame
Two to three weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Rasmussen, PhD
Organizational Affiliation
Idaho State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Idaho State University
City
Pocatello
State/Province
Idaho
ZIP/Postal Code
83209-8112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
26235925
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.
Results Reference
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PubMed Identifier
19744547
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.
Results Reference
background
PubMed Identifier
23685325
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.
Results Reference
background
PubMed Identifier
25796210
Citation
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.
Results Reference
background
PubMed Identifier
23219294
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.
Results Reference
background
PubMed Identifier
11385061
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. doi: 10.1093/jn/131.6.1738.
Results Reference
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Food Insecurity, Obesity, and Impulsive Food Choice

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