NCT03356509

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 8, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

October 25, 2017

Last Update Submit

September 14, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 minutes

Secondary Outcomes (3)

  • Affective Valence measured by The Feeling Scale (Hardy & Rejeski, 1989)

    1 minute

  • Affective Activation measured by the Felt Arousal Scale (Svebak & Murgatroyd, 1985)

    1 minute

  • Cravings for chocolate using the State Food Cravings Questionnaire (Cepeda-Benito et al, 2000)

    5 minutes

Study Arms (2)

Exercise

EXPERIMENTAL

They will do a 26-min bout of high intensity interval exercise.

Behavioral: Exercise

No exercise

NO INTERVENTION

They will sit quietly for 26 minutes without access to electronic devices or reading materials.

Interventions

ExerciseBEHAVIORAL

Exercise will be performed on a stationary bicycle ergometer.

Exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • PMS
  • Pregnancy
  • Prisoners
  • Risk factors for heart disease as determined by physician
  • Medication that interferes with capacity to exercise
  • Answer "Yes" to PAR-Q

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Clinical and Applied Physiology

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 29, 2017

Study Start

January 8, 2018

Primary Completion

September 15, 2018

Study Completion

September 15, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations