Testing a Novel Stress-induced Eating Intervention for Cancer Prevention

Not Applicable

Withdrawn

• Conditions: 7-dose - Pairs Progressive Muscle Relaxation With Fruit 7 Consecutive Days; 9-dose - Pairs Progressive Muscle Relaxation With Fruit 9 Consecutive Days; 7-dose Control - Progressive Muscle Relaxation Only; 5-dose - Pairs Progressive Muscle Relaxation With Fruit 5 Consecutive Days
• Interventions: Behavioral: Pavlovian Conditioning

• Registration Number: NCT03468257
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-03-11
• Study First Posted: 2018-03-16
• Study Start: 2019-07
• Primary Completion: 2021-05
• Study Completion: 2021-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progressive Muscle Relaxation only	Pavlovian Conditioning	Condition 1: 7-dose control - Progressive Muscle Relaxation only
Pairs Progressive Muscle Relaxation with fruit	Pavlovian Conditioning	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

Primary Outcome Measures

Name	Time	Method
Healthy Eating Index	14 days after last dose	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.

Secondary Outcome Measures

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