Testing a Novel Stress-induced Eating Intervention for Cancer Prevention

NCT ID: NCT03468257

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2021-05-31

Brief Summary

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Progressive Muscle Relaxation only

Condition 1: 7-dose control - Progressive Muscle Relaxation only

Group Type: ACTIVE_COMPARATOR

Pavlovian Conditioning

Intervention Type: BEHAVIORAL

Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit

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

Group Type: EXPERIMENTAL

Pavlovian Conditioning

Intervention Type: BEHAVIORAL

Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit

Interventions

Pavlovian Conditioning

Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

A. Janet Tomiyama

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

16-000893

Identifier Type: -

Identifier Source: org_study_id