Testing a Novel Stress-induced Eating Intervention for Cancer Prevention

Subjects will be enrolled in a stress-induced eating intervention with 5, 7, or 9 treatments or control. Treatment will comprise imagining a stressful event, engaging in a stress relief activity (Progressive Muscle Relaxation), and consuming a fruit once per day. There will be one lab visit at baseline in which participants undergo an acute laboratory stressor (i.e., speech and math tasks) and consume food from a buffet. There will be another lab visit at two weeks post-intervention. In the second (and final) lab visit, participants will repeat the acute laboratory stressor (i.e., speech and math tasks) and buffet, and additionally complete questionnaires about their experience in the study.

Study Overview

• Status: Withdrawn
• Conditions: 7-dose Control - Progressive Muscle Relaxation Only; 5-dose - Pairs Progressive Muscle Relaxation With Fruit 5 Consecutive Days; 7-dose - Pairs Progressive Muscle Relaxation With Fruit 7 Consecutive Days; 9-dose - Pairs Progressive Muscle Relaxation With Fruit 9 Consecutive Days
• Intervention / Treatment: Behavioral: Pavlovian Conditioning

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: A. Janet Tomiyama, PhD; Phone Number: 310-206-6875; Email: tomiyama@psych.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age 18 or older
• fluent in English
• access to an internet-connected device
• reporting a neutral taste and moderate novelty for at least one fruit
• reporting household size-adjusted income less than or equal to 200% of the federal poverty threshold
• perceived stress scale score of 21.82 (1 SD above the national mean)
• BMI 25
• scoring 3.23 on the Dutch Eating Behavior-Emotional Eating Questionnaire

Exclusion Criteria:

• on a diet that would compel them to refrain from eating food in the laboratory buffet
• allergy to any foods presented in the buffet
• selecting a fruit as one or more of top three choices of foods that would make them feel better if stressed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Progressive Muscle Relaxation only; Condition 1: 7-dose control - Progressive Muscle Relaxation only	Behavioral: Pavlovian Conditioning; Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit
Experimental: Pairs Progressive Muscle Relaxation with fruit; Condition 2: 5-dose - Pairs Progressive Muscle Relaxation with fruit 5 consecutive days; Condition 3: 7-dose - Pairs Progressive Muscle Relaxation with fruit 7 consecutive days; Condition 4: 9-dose - Pairs Progressive Muscle Relaxation with fruit 9 consecutive days	Behavioral: Pavlovian Conditioning; Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthy Eating Index	The Healthy Eating Index was developed by the USDA to capture diet quality. The total score is able to capture both the healthiness of fruits and the unhealthiness of classic comfort foods that are high in calories, fat, and sugar.	14 days after last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calorie intake	Calorie intake will be recorded across all the foods that the participants choose to eat in the outcome assessment buffet.	14 days after last dose
Acceptability/Credibility	The Credibility/Expectancy Questionnaire is a validated measure to access issues of intervention acceptability, credibility, and expectancy.	14 days after last dose

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2019
• Primary Completion (Estimated): May 1, 2021
• Study Completion (Estimated): May 1, 2021

Study Registration Dates

• First Submitted: March 11, 2018
• First Submitted That Met QC Criteria: March 11, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 16-000893

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No