NCT02930642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

October 5, 2016

Last Update Submit

March 3, 2020

Conditions

Keywords

MindfulnessObesityFood insecurityDelay discounting

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Mindful Eating

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.

Behavioral: Mindful Eating

Nutrition Digital Video Disc (DVD)

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.

Other: Nutrition DVD

Control

NO INTERVENTION

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

Interventions

Mindful EatingBEHAVIORAL

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.

Also known as: Raisin exercise
Mindful Eating

Participants watch a 50 minute video on nutrition to control for verbal aspects of food.

Nutrition Digital Video Disc (DVD)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Diagnosed with an eating disorder
  • HIV
  • Hemophilia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Idaho State University

Pocatello, Idaho, 83209-8112, United States

Location

Related Publications (6)

  • 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.

    PMID: 26235925BACKGROUND
  • 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.

    PMID: 19744547BACKGROUND
  • 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.

    PMID: 23685325BACKGROUND
  • 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.

    PMID: 25796210BACKGROUND
  • 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.

    PMID: 23219294BACKGROUND
  • 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.

    PMID: 11385061BACKGROUND

MeSH Terms

Conditions

Feeding BehaviorObesityImpulsive Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Erin Rasmussen, PhD

    Idaho State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2016

First Posted

October 12, 2016

Study Start

May 31, 2017

Primary Completion

March 3, 2020

Study Completion

March 3, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Locations