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Trial · NCT04692909

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in BMIChange in BMI between baseline and the end of the treatment (day 15) and follow-up (a month after day 15)Unit of measure: BMI in kg/m\^2 (weight in kilograms, height in meters)
PrimaryChange in BMIChange in BMI between baseline and follow-up (a month after day 15)Unit of measure: BMI in kg/m\^2 (weight in kilograms, height in meters)
SecondaryChange in food addiction symptoms on the Yale Food Addiction Scale (YFAS)The change in the number of symptoms on day 15 compared to baseline will be assessed.The YFAS includes 1-7 symptoms, while participants are recruited to the study if they have 3 symptoms or more. The greater the symptoms, the more food addiction the participants experience.
SecondaryChange in food addiction symptoms on the Yale Food Addiction Scale (YFAS)The change in the number of symptoms on day 16 (a month after day 15) compared to baseline will be assessed.The YFAS includes 1-7 symptoms, while participants are recruited to the study if they have 3 symptoms or more. The greater the symptoms, the more food addiction the participants experience.
SecondaryCognitive regulation of eatingThe change in reaction time on the Food Stroop task between day 15 and baseline.
Cognitive regulation of eating will be assessed with a computerized Food Stroop task. A change in reaction time (milliseconds) in response to high-calorie food, low-calorie food, and non-food items will be assessed.
SecondaryCognitive regulation of eatingThe change in reaction time on the Food Stroop task between day 16 (a month after day 15) and baseline.
Cognitive regulation of eating will be assessed with a computerized Food Stroop task. A change in reaction time (milliseconds) in response to high-calorie food, low-calorie food, and non-food items will be assessed.
SecondaryDepressive symptomsA change in BDI score from baseline to day 15.
Depressive symptoms will be assessed with the 21-question multiple-choice self-report inventory, the Beck Depression Inventory (BDI). The highest possible total for the whole test would be sixty-three and the lowest possible score for the test would be zero.
SecondaryDepressive symptomsA change in BDI score from baseline to day 16.
Depressive symptoms will be assessed with the 21-question multiple-choice self-report inventory, the Beck Depression Inventory (BDI). The highest possible total for the whole test would be sixty-three and the lowest possible score for the test would be zero.
SecondaryEating behavior [cognitive restraint (CR), emotional eating (EE), uncontrollable eating (UE)] will be assessed with the Three Factor Eating Questionnaire (TFEQ).The change in these parameters will be assessed between baseline and day 15.The TFEQ measures CR, EE, and UE. A change (decrease or increase) in the symptoms of each of the scales will be assessed at the end of the intervention and at follow up.
SecondaryEating behavior [cognitive restraint (CR), emotional eating (EE), uncontrollable eating (UE)] will be assessed with the Three Factor Eating Questionnaire (TFEQ).The change in these parameters will be assessed between day 16 (a month after day 15) and baseline.The TFEQ measures CR, EE, and UE. A change (decrease or increase) in the symptoms of each of the scales will be assessed at the end of the intervention and at follow up.
SecondaryEating behavior [restrictive eating (RE), emotional eating (EME), external eating (EXE)] will be assessed with the Dutch Eating Behavior Questionnaire (DEBQ)The change in these parameters will be assessed between baseline and day 15.The DEBQ measures RE, EME and EXE, A change (decrease or increase) in the symptoms of each of the scales will be assessed at the end of the intervention and at follow up.
SecondaryEating behavior [restrictive eating (RE), emotional eating (EME), external eating (EXE)]The change in these parameters will be assessed between day 16 (a month after day 15) and baseline.The DEBQ measures RE, EME and EXE, A change (decrease or increase) in the
SecondaryBinge eating frequencyThe change in binge eating frequency between baseline and day 15.Binge eating will be assessed with the Eating disorder examination-questionnaire with Instructions (EDE-Q-I). This questionnaire assesses binge eating frequency over the past 28 days.
SecondaryBinge eating frequencyThe change in binge eating frequency between baseline and day 16.Binge eating will be assessed with the Eating disorder examination-questionnaire with Instructions (EDE-Q-I). This questionnaire assesses binge eating frequency over the past 28 days.
SecondaryQuality of lifeThe change in the SF-36 score between baseline and day 15.Health Status Scale Short-form 36 (SF-36)
SecondaryQuality of lifeThe change in the SF-36 score between baseline and day 16.Health Status Scale Short-form 36 (SF-36)
SecondaryGeneral moodThe change in the overall score (positive affect minus negative affect) between baseline and day 15.Positive Affect Negative Affect Schedule (PANAS).
SecondaryGeneral moodThe change in the overall score (positive affect minus negative affect) between baseline and day 16.Positive Affect Negative Affect Schedule (PANAS).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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