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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03468257
Other study ID # 16-000893
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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