Testing a Novel Stress-induced Eating Intervention for Cancer Prevention

5-dose - Pairs Progressive Muscle Relaxation With Fruit 5 Consecutive Days Clinical Trial

Official title:

Testing a Novel Stress-induced Eating Intervention for Cancer Prevention

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03468257
• Other study ID #: 16-000893
• Status: Withdrawn
• Phase: N/A
• Start date: July 2019
• Est. completion date: May 2021

Study information

• Verified date: March 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 5-dose - Pairs Progressive Muscle Relaxation With Fruit 5 Consecutive Days
• 7-dose - Pairs Progressive Muscle Relaxation With Fruit 7 Consecutive Days
• 7-dose Control - Progressive Muscle Relaxation Only
• 9-dose - Pairs Progressive Muscle Relaxation With Fruit 9 Consecutive Days

Intervention

Behavioral:
• Pavlovian Conditioning
Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Acceptability/Credibility	The Credibility/Expectancy Questionnaire is a validated measure to access issues of intervention acceptability, credibility, and expectancy.	14 days after last dose