Acute Exercise and Addictive BehaviorNCT03356509
Effect of Exercise on Chocolate Addiction
A study testing Exercise in people with Acute Exercise and Addictive Behavior, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Exercise and Addictive Behavior
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 15 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- PMS
- Pregnancy
- Prisoners
- Risk factors for heart disease as determined by physician
- Medication that interferes with capacity to exercise
- Answer "Yes" to PAR-Q
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory of Clinical and Applied Physiology
Coral Gables, Florida, 33146
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Exercise and Addictive Behavior
- Being tested
- Exercise
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise will be performed on a stationary bicycle ergometer.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | They will do a 26-min bout of high intensity interval exercise. Receives: Behavioral: Exercise |
| No exercise | No intervention | They will sit quietly for 26 minutes without access to electronic devices or reading materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional Bias (AB) to chocolate using a modified visual dot probe task (Kemps et al, 2009)
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.
Measured: 15 minutes
Secondary outcomes (3)
Affective Valence measured by The Feeling Scale (Hardy & Rejeski, 1989)
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.
Measured: 1 minute
Affective Activation measured by the Felt Arousal Scale (Svebak & Murgatroyd, 1985)
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.
Measured: 1 minute
Cravings for chocolate using the State Food Cravings Questionnaire (Cepeda-Benito et al, 2000)
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start8 Jan 2018
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exercise and Addictive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arlette Perry, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356509
- Sponsor's protocol ID
- 20170895
- Status last verified
- Sep 2018
- First submitted
- 25 Oct 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a High Intensity Interval Exercise Bout on Addictive Behaviors in Overweight/Obese Adults
- ClinicalTrials.gov ID
- NCT03356509
- Acronym / sponsor ID
- 20170895
- Conditions
- Acute Exercise and Addictive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseThey will do a 26-min bout of high intensity interval exercise. |
| No exercise | No intervention | –They will sit quietly for 26 minutes without access to electronic devices or reading materials. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- PMS
- Pregnancy
- Prisoners
- Risk factors for heart disease as determined by physician
- Medication that interferes with capacity to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise will be performed on a stationary bicycle ergometer. | Behavioural | Exercise |
Primary outcome
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.
3 secondary outcomes
Affective Valence measured by The Feeling Scale (Hardy & Rejeski, 1989)
Time frame: 1 minute
Affective Activation measured by the Felt Arousal Scale (Svebak & Murgatroyd, 1985)
Time frame: 1 minute
Cravings for chocolate using the State Food Cravings Questionnaire (Cepeda-Benito et al, 2000)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Acute Exercise and Addictive Behavior, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attentional Bias (AB) to chocolate using a modified visual dot probe task (Kemps et al, 2009) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.