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

March 3, 2020 updated by: Idaho State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Pocatello, Idaho, United States, 83209-8112
        • Idaho State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindful Eating
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.
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 Names:
  • Raisin exercise
Active Comparator: Nutrition Digital Video Disc (DVD)
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.
Other: Nutrition DVD
Participants watch a 50 minute video on nutrition to control for verbal aspects of food.
No Intervention: Control
Participants will receive four pieces of food. They will not receive any prompts during the one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of impulsive choices as assessed by the Food Choice Questionnaire
Time Frame: Two to three weeks
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
Number of impulsive choices as assessed by the Monetary Choice Questionnaire
Time Frame: Two to three weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idaho State University

Investigators

  • Principal Investigator: Erin Rasmussen, PhD, Idaho State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2017

Primary Completion (Actual)

March 3, 2020

Study Completion (Actual)

March 3, 2020

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IdahoSU001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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