The Role of Emotional Arousal in Food Preference and Taste
The Purpose of This Study is to Investigate the Role of Stress in Food Craving and Food Consumption by Examining Stress Response Using Subjective, Physiological and Neurobiological Measurements
2 other identifiers
interventional
160
1 country
1
Brief Summary
The purpose of this study is to examine the role of stress in food craving and food consumption in obesity. Using experimentally validated guided imagery procedure, the investigators propose to examine the stress response using subjective, physiological and neurobiological measurements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Aug 2013
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 30, 2014
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedFebruary 11, 2022
February 1, 2022
5.8 years
January 30, 2014
February 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Baseline
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
Immediately After Image
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory at plus 5 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
5 minutes
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory at plus 15 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
15 minutes
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory at plus 30 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
30 minutes
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory at plus 45 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
45 minutes
Food Craving based on the Food Craving Inventory
An abbreviated assessment base don the Food Craving Inventory at plus 60 minutes. The Food Craving Inventory is a self-report questionnaire of specific food cravings. The questionnaire consists of 25 items measuring the frequency of cravings for specific foods and consists of 4 factors or subscales measuring cravings for High Fats, Carbohydrates/Starches, Sweets, and Fast Food Fats and also generates a total score. The brief version of the inventory uses 2 items from each of the 4 subscales.
60 minutes
Secondary Outcomes (1)
food snack intake
30 minutes
Study Arms (3)
Normal Weight
ACTIVE COMPARATORBMI18.5-24.9 (normal range)
Overweight
EXPERIMENTALbody mass index between 25.0 - 29.9 (overweight range)
Obese
EXPERIMENTALbody mass index between 30 and 35 (obese range)
Interventions
The stress imagery script will be based on subjects' description of a recent personal stressful event that they had experienced as "most stressful". "Most stressful" is determined by having the subjects rate the perceived stress experienced by them on a 10-point Likert scale where "1=not at all stressful" and "10=the most stress they felt recently in their life". Only situations rated as 8 or above on this scale are accepted as appropriate for script development. Examples of acceptable stressful situations include breakup with significant other, a verbal argument with a significant other or family member or unemployment-related stress, such as being fired or laid off from work.
A food cue script will be developed from the subjects' experience of eating their most favorite foods. Examples include ordering pizza, cooking a favorite meal, or going out to a restaurant.
A neutral-relaxing script will be developed from the subjects' commonly experienced neutral-relaxing situations, such as a trip to the beach or park.
Eligibility Criteria
You may qualify if:
- Between ages 18-45 years
- Able to read and write
- Normal/lean BMI group: BMI 18.5-24.9 as calculated based on height and weight.
- Overweight BMI group: BMI 25.0 - 29.9 as calculated based on height and weight Obese BMI group: BMI 30-35 as calculated based on height and weight.
- Do not meet criteria for any current Axis I DSM-IV psychiatric diagnoses and provide negative urine toxicology screens during initial appointments and at admission for laboratory sessions.
You may not qualify if:
- Meet current criteria for dependence on any psychoactive substance, including nicotine and caffeine
- Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse
- Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded
- Women on oral contraceptives, peri and post menopausal women, and those with hysterectomies
- Pregnant and lactating women will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale University
New Haven, Connecticut, 06492, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajita Sinha, PhD
Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2014
First Posted
March 30, 2015
Study Start
August 1, 2013
Primary Completion
June 1, 2019
Study Completion
August 1, 2019
Last Updated
February 11, 2022
Record last verified: 2022-02