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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Florida
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise
They will do a 26-min bout of high intensity interval exercise.
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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