- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03356509
Effect of Exercise on Chocolate Addiction
September 14, 2018 updated by: Arlette Perry, University of Miami
The Effect of a High Intensity Interval Exercise Bout on Addictive Behaviors in Overweight/Obese Adults
The study will use stress inducing tasks to determine if there are significant improvements in mood, chocolate cravings, and attentional bias to chocolate in overweight/obese chocolate abusers following rest and a bout of high intensity interval exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this research study is to investigate whether a single high intensity interval exercise (HIIE) bout, following two stress-inducing tasks, reduces addictive behavior to chocolate.
Volunteers must complete the consent form before being able to participate in two days of testing (exercise day and control day) which will be presented in randomized order.
The two days will be separated by a one to 7 day washout period.
Subjects will be required to submit a three day chocolate diary then abstain from chocolate on the 4th day.
They will also be asked to record everything they eat and drink on the day before and the morning of the study and list three types of chocolate they crave most.
Two stress-inducing tasks will be performed on both days followed by completion of either 26 minutes of HIIE or seated resting condition followed by the completion of two mood and craving questionnaires.
They will finally be asked to complete a task that measures the amount of attention they pay to chocolate.
Statistical analyses will be conducted to determine the effect of either exercising or not on addictive behaviors to chocolate.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Coral Gables, Florida, United States, 33146
- Laboratory of Clinical and Applied Physiology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI equal or greater than 25
- Eat at least 3.5 oz of chocolate per day
- Scorer at least 33 out of a possible 36 on the Handedness Questionnaire
- Ability to provide informed consent
- No medical contraindications to exercise
- Premenopausal
Exclusion Criteria:
- PMS
- Pregnancy
- Prisoners
- Risk factors for heart disease as determined by physician
- Medication that interferes with capacity to exercise
- Answer "Yes" to PAR-Q
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
They will do a 26-min bout of high intensity interval exercise.
|
Exercise will be performed on a stationary bicycle ergometer.
|
No Intervention: No exercise
They will sit quietly for 26 minutes without access to electronic devices or reading materials.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attentional Bias (AB) to chocolate using a modified visual dot probe task (Kemps et al, 2009)
Time Frame: 15 minutes
|
AB will be measured using a modified visual dot probe task, which consists of measuring reaction times to neutral images versus chocolate images (Kemps et al, 2009).
Neutral images will consist of non-chocolate related items (i.e. office supplies).
After 5 practice trials, 60 critical trials will be displayed which consist of either chocolate or neutral images (presented side by side).
A black fixation cross will appear behind one of the images, and the subject has to respond as quickly as possible to which image the cross is located behind.
The faster the subject responds to the cross behind the chocolate image, the higher their attentional bias is to chocolate.
AB will be measured on both days following both the exercise and control conditions.
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Affective Valence measured by The Feeling Scale (Hardy & Rejeski, 1989)
Time Frame: 1 minute
|
The Feeling Scale measures affective valence using an 11 point range from -5 to +5 with higher values indicating more pleasure.
It is administered on both days following both the exercise and the control condition.
|
1 minute
|
Affective Activation measured by the Felt Arousal Scale (Svebak & Murgatroyd, 1985)
Time Frame: 1 minute
|
The Felt Arousal Scale measures affective activation using a 6 point range from 1 to 6 with the higher values indicating greater activation and arousal.
It is administered on both days following both the exercise and the control condition.
|
1 minute
|
Cravings for chocolate using the State Food Cravings Questionnaire (Cepeda-Benito et al, 2000)
Time Frame: 5 minutes
|
This questionnaire measures the acute intensity of chocolate cravings using 15 items with 3 items per dimension.
The five state dimensions of food cravings are: an intense desire to consume food, anticipation of positive reinforcement from eating, anticipation of relief from negative states and feelings as a result of eating, lack of control over eating if food is eaten, and craving as a hunger/physiological state.
The dimensions will be evaluated using a 5 point Likert scale with the higher score meaning more intense cravings for chocolate.
The questionnaire will be administered on both days following both the exercise and the control condition.
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2018
Primary Completion (Actual)
September 15, 2018
Study Completion (Actual)
September 15, 2018
Study Registration Dates
First Submitted
October 25, 2017
First Submitted That Met QC Criteria
November 22, 2017
First Posted (Actual)
November 29, 2017
Study Record Updates
Last Update Posted (Actual)
September 18, 2018
Last Update Submitted That Met QC Criteria
September 14, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20170895
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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