Testing a Novel Stress-induced Eating Intervention for Cancer Prevention

Study Overview
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Brief Summary
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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.

Official Title
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Testing a Novel Stress-induced Eating Intervention for Cancer Prevention

Conditions
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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
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* Behavioral: Pavlovian Conditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progressive Muscle Relaxation only<br>Condition 1: 7-dose control - Progressive Muscle Relaxation only | Behavioral: Pavlovian Conditioning<br>* Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit<br>|
| Experimental: Pairs Progressive Muscle Relaxation with fruit<br>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<br>* Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit<br>|

What is the study measuring?
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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 |