Overview

This trial is active, not recruiting.

Conditions feeding behavior, obesity, impulsivity
Treatments mindful eating, nutrition dvd
Phase phase 1
Sponsor Idaho State University
Start date June 2016
End date May 2019
Trial size 120 participants
Trial identifier NCT02930642, IdahoSU001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
mindful eating Raisin exercise
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.
(Active Comparator)
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.
nutrition dvd
Participants watch a 50 minute video on nutrition to control for verbal aspects of food.
(No Intervention)
Participants will receive four pieces of food. They will not receive any prompts during the one week.

Primary Outcomes

Measure
Number of impulsive choices as assessed by the Food Choice Questionnaire
time frame: Two to three weeks
Number of impulsive choices as assessed by the Monetary Choice Questionnaire
time frame: Two to three weeks

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Food Insecurity, Obesity, and Impulsive Food Choice
Principal investigator Erin Rasmussen, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Idaho State University.