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Memory-Updating Technique to Reduce Food Craving and High Calorie Food Intake Among Individuals With Overweight/Obesity

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ClinicalTrials.gov Identifier: NCT04077385
Recruitment Status : Not yet recruiting
First Posted : September 4, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lisa J Germeroth, PhD, University of Pittsburgh

Brief Summary:
This study will evaluate the effects of retrieval-extinction (R-E) training on responding to high calorie foods including self-report craving, physiological responding, and high calorie food intake in adults with overweight/obesity. R-E training aims to update the memories that associate cues (i.e., high calorie food) with reward (i.e., consumption). R-E training involves "retrieving" these cue-reward associative memories through brief presentation of relevant cues, resulting in instability of the memories and providing an opportunity to be updated via reconsolidation. Presenting relevant cues while not allowing consumption (i.e., extinction training) during reconsolidation can modify the unstable cue-reward memories, resulting in lasting reductions of craving and intake. This study will be the first to test the effects of R-E training on craving for and intake of high calorie foods in humans. To examine the effects of R-E training on food craving, physiological response (heart rate, skin conductance, salivation), and food intake, 150 adults with overweight/obesity will complete baseline food cue-reactivity and intake tasks in the lab. Participants will be randomized to observe high calorie food cues (i.e., "retrieval" of food cue-reward memories; R-E training group) or non-food cues (i.e., no retrieval of food cue-reward memories; extinction control group) and engage in 60 min of extinction training for high calorie foods. R-E/extinction control training will occur on two consecutive days and four follow-up food cue-reactivity sessions through 3 months. Weight will be assessed at each session and in-lab food intake at 1- and 3-months. Recent food/drink intake will also be assessed at each session. Some participants (n=75) will complete a pilot portion of the study involving real-world data collection of naturally-occurring food cues, craving, and food intake via smartphone. It is hypothesized that: (1) R-E training (vs. extinction control) will decrease high calorie food cue-reactivity (self-report craving, heart rate, skin conductance, salivation) and intake assessed in the lab, as well as self-report craving and food intake assessed in the real world; and (2) decreased high calorie food cue-reactivity will be a mechanism through which R-E training reduces high calorie food intake at follow-up. The Principal Investigator will explore associations between lab and real-world cue-elicited craving and food intake, and the effect of R-E training on weight.

Condition or disease Intervention/treatment Phase
Overweight Obesity Craving Eating Behavior Behavioral: Retrieval-extinction (R-E) Training Behavioral: Extinction Training Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study uses a two-arm parallel assignment in which participants are randomized to either a high calorie food retrieval + high calorie food extinction (R-E training) group or to a non-food retrieval + high calorie food extinction (extinction control) group.
Masking: None (Open Label)
Masking Description: There will not be masking in the current study for participants as they will know if they are observing either high calorie pictorial food cues or non-food-related pictorial cues during the retrieval portion of the R-E/extinction training days. The investigator will also not be masked given that participants will be observed completing the R-E training task during sessions to ensure compliance, which involves observing participants advance through the task via a mirrored image on a second desktop monitor.
Primary Purpose: Treatment
Official Title: A Novel, Memory-Updating Technique to Attenuate Responding to High Calorie Food Cues, Food Intake, and Body Weight Among Individuals With Overweight/Obesity
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Retrieval Extinction (R-E) Training Group
On the two retrieval-extinction (R-E)/extinction training days, participants randomized to the R-E training group will observe 5-min of high calorie pictorial food cues during "retrieval" which will purportedly retrieve cue-reward associative memories. This will be followed by 60-min of extinction training to high calorie food cues. The R-E training group will only differ from the extinction control group in regards to the 5-min exposure to high calorie food cues prior to the 60-min of extinction training to high calorie food cues.
Behavioral: Retrieval-extinction (R-E) Training
The retrieval-extinction (R-E) training intervention will occur on two consecutive days and consist of (a) retrieval of high calorie food cue-reward associative memories and (b) 60-min extinction training for high calorie foods. During the 5-min of retrieval, participants will observe 30 high calorie food images (e.g., cakes, cookies, muffins, hamburgers, french fries, potato chips, pizza). Images will be presented in E-Prime for 8-s each (2-s delay between images). After the 5-min of retrieval and a 10-min rest period, participants will engage in 60-min of extinction training for high calorie foods consisting of 12, 5-min high calorie food cue sequences: 6 image sequences and 6 real food sequences. The real foods will consist of a small portion (i.e., one piece) of high calorie snack foods such as a single M&M or potato chip.

Active Comparator: Extinction Control Group
On the two retrieval-extinction (R-E)/extinction training days, participants randomized to the extinction control group will observe 5-min of non-food-related cues (e.g., pictures of office supplies, tools) during "retrieval," which will purportedly avoid retrieval of the food cue-reward associative memories that are targeted in the R-E training group. The 5-min of exposure to non-food-related cues will be followed by the same 60-min of extinction training to high calorie food cues that the R-E training group receives.
Behavioral: Extinction Training
The extinction control group will engage in two consecutive days of intervention consisting of (a) retrieval of memories not associated with high calorie foods and (b) 60-min extinction training for high calorie foods. During the 5-min of retrieval, participants will observe 30 non-food-related neutral images (e.g., office supplies, tools). Images will be presented in E-Prime for 8-s each (2-s delay between images). After the 5-min of retrieval and a 10-min rest period, participants will engage in 60-min of extinction training for high calorie foods consisting of 12, 5-min high calorie food cue sequences: 6 image sequences and 6 real food sequences. The real foods will consist of a small portion (i.e., one piece) of high calorie snack foods such as a single M&M or potato chip. The 60-min extinction training is the same as the extinction training received by participants in the R-E training intervention.




Primary Outcome Measures :
  1. Mean Change from Baseline in Self-Report State Food Craving Response to High Calorie Food Cues at 24-hr Follow-up [ Time Frame: current; assess change from baseline vs. 24-hr follow-up ]
    Self-reported state food craving in response to high calorie foods presented during the study will be assessed using the 3-item Intense Desire to Eat subscale of the Food Cravings Questionnaire-State (with modified numerical anchors to increase variability in responding). Participants will report the craving they are experiencing "right now, at this very moment" on a 0 (strongly disagree) to 100 (strongly agree) Likert rating scale. Mean scores will be calculated by averaging across ratings for a possible range of scores between 0 and 100, with higher scores reflecting greater self-reported craving.

  2. Mean Change from Baseline in Self-Report State Food Craving Response to High Calorie Food Cues at 2-week Follow-up [ Time Frame: current; assess change from baseline vs. 2-week follow-up ]
    Self-reported state food craving in response to high calorie foods presented during the study will be assessed using the 3-item Intense Desire to Eat subscale of the Food Cravings Questionnaire-State (with modified numerical anchors to increase variability in responding). Participants will report the craving they are experiencing "right now, at this very moment" on a 0 (strongly disagree) to 100 (strongly agree) Likert rating scale. Mean scores will be calculated by averaging across ratings for a possible range of scores between 0 and 100, with higher scores reflecting greater self-reported craving.

  3. Mean Change from Baseline in Self-Report State Food Craving Response to High Calorie Food Cues at 1-month Follow-up [ Time Frame: current; assess change from baseline vs. 1-month follow-up ]
    Self-reported state food craving in response to high calorie foods presented during the study will be assessed using the 3-item Intense Desire to Eat subscale of the Food Cravings Questionnaire-State (with modified numerical anchors to increase variability in responding). Participants will report the craving they are experiencing "right now, at this very moment" on a 0 (strongly disagree) to 100 (strongly agree) Likert rating scale. Mean scores will be calculated by averaging across ratings for a possible range of scores between 0 and 100, with higher scores reflecting greater self-reported craving.

  4. Mean Change from Baseline in Self-Report State Food Craving Response to High Calorie Food Cues at 3-month Follow-up [ Time Frame: current; assess change from baseline vs. 3-month follow-up ]
    Self-reported state food craving in response to high calorie foods presented during the study will be assessed using the 3-item Intense Desire to Eat subscale of the Food Cravings Questionnaire-State (with modified numerical anchors to increase variability in responding). Participants will report the craving they are experiencing "right now, at this very moment" on a 0 (strongly disagree) to 100 (strongly agree) Likert rating scale. Mean scores will be calculated by averaging across ratings for a possible range of scores between 0 and 100, with higher scores reflecting greater self-reported craving.

  5. Differences between R-E Training Group and Extinction Control Group in Self-Report State Food Craving Response to High Calorie Food Cues at 24-hr Follow-up [ Time Frame: current; assess differences between groups at 24-hr follow-up ]
    Self-reported state food craving in response to high calorie foods presented during the study will be assessed using the 3-item Intense Desire to Eat subscale of the Food Cravings Questionnaire-State (with modified numerical anchors to increase variability in responding). Participants will report the craving they are experiencing "right now, at this very moment" on a 0 (strongly disagree) to 100 (strongly agree) Likert rating scale. Mean scores will be calculated by averaging across ratings for a possible range of scores between 0 and 100, with higher scores reflecting greater self-reported craving.

  6. Differences between R-E Training Group and Extinction Control Group in Self-Report State Food Craving Response to High Calorie Food Cues at 2-week Follow-up [ Time Frame: current; assess differences between groups at 2-week follow-up ]
    Self-reported state food craving in response to high calorie foods presented during the study will be assessed using the 3-item Intense Desire to Eat subscale of the Food Cravings Questionnaire-State (with modified numerical anchors to increase variability in responding). Participants will report the craving they are experiencing "right now, at this very moment" on a 0 (strongly disagree) to 100 (strongly agree) Likert rating scale. Mean scores will be calculated by averaging across ratings for a possible range of scores between 0 and 100, with higher scores reflecting greater self-reported craving.

  7. Differences between R-E Training Group and Extinction Control Group in Self-Report State Food Craving Response to High Calorie Food Cues at 1-month Follow-up [ Time Frame: current; assess differences between groups at 1-month follow-up ]
    Self-reported state food craving in response to high calorie foods presented during the study will be assessed using the 3-item Intense Desire to Eat subscale of the Food Cravings Questionnaire-State (with modified numerical anchors to increase variability in responding). Participants will report the craving they are experiencing "right now, at this very moment" on a 0 (strongly disagree) to 100 (strongly agree) Likert rating scale. Mean scores will be calculated by averaging across ratings for a possible range of scores between 0 and 100, with higher scores reflecting greater self-reported craving.

  8. Differences between R-E Training Group and Extinction Control Group in Self-Report State Food Craving Response to High Calorie Food Cues at 3-month Follow-up [ Time Frame: current; assess differences between groups at 3-month follow-up ]
    Self-reported state food craving in response to high calorie foods presented during the study will be assessed using the 3-item Intense Desire to Eat subscale of the Food Cravings Questionnaire-State (with modified numerical anchors to increase variability in responding). Participants will report the craving they are experiencing "right now, at this very moment" on a 0 (strongly disagree) to 100 (strongly agree) Likert rating scale. Mean scores will be calculated by averaging across ratings for a possible range of scores between 0 and 100, with higher scores reflecting greater self-reported craving.

  9. Mean Change from Baseline in Heart Rate Response to High Calorie Food Cues at 24-hr Follow-up [ Time Frame: current; assess change from baseline vs. 24-hr follow-up ]
    Heart rate data will be collected using electrodes affixed below the ribcage and clavicle. MindWare Technologies hardware will collect continuous heart rate data during the presentation of high calorie food cues. Heart rate will be measured on a continuous scale with higher heart rate reflecting greater reactivity to high calorie food cues.

  10. Mean Change from Baseline in Heart Rate Response to High Calorie Food Cues at 2-week Follow-up [ Time Frame: current; assess change from baseline vs. 2-week follow-up ]
    Heart rate data will be collected using electrodes affixed below the ribcage and clavicle. MindWare Technologies hardware will collect continuous heart rate data during the presentation of high calorie food cues. Heart rate will be measured on a continuous scale with higher heart rate reflecting greater reactivity to high calorie food cues.

  11. Mean Change from Baseline in Heart Rate Response to High Calorie Food Cues at 1-month Follow-up [ Time Frame: current; assess change from baseline vs. 1-month follow-up ]
    Heart rate data will be collected using electrodes affixed below the ribcage and clavicle. MindWare Technologies hardware will collect continuous heart rate data during the presentation of high calorie food cues. Heart rate will be measured on a continuous scale with higher heart rate reflecting greater reactivity to high calorie food cues.

  12. Mean Change from Baseline in Heart Rate Response to High Calorie Food Cues at 3-month Follow-up [ Time Frame: current; assess change from baseline vs. 3-month follow-up ]
    Heart rate data will be collected using electrodes affixed below the ribcage and clavicle. MindWare Technologies hardware will collect continuous heart rate data during the presentation of high calorie food cues. Heart rate will be measured on a continuous scale with higher heart rate reflecting greater reactivity to high calorie food cues.

  13. Differences between R-E Training Group and Extinction Control Group in Heart Rate Response to High Calorie Food Cues at 24-hr Follow-up [ Time Frame: current; assess differences between groups at 24-hr follow-up ]
    Heart rate data will be collected using electrodes affixed below the ribcage and clavicle. MindWare Technologies hardware will collect continuous heart rate data during the presentation of high calorie food cues. Heart rate will be measured on a continuous scale with higher heart rate reflecting greater reactivity to high calorie food cues.

  14. Differences between R-E Training Group and Extinction Control Group in Heart Rate Response to High Calorie Food Cues at 2-week Follow-up [ Time Frame: current; assess differences between groups at 2-week follow-up ]
    Heart rate data will be collected using electrodes affixed below the ribcage and clavicle. MindWare Technologies hardware will collect continuous heart rate data during the presentation of high calorie food cues. Heart rate will be measured on a continuous scale with higher heart rate reflecting greater reactivity to high calorie food cues.

  15. Differences between R-E Training Group and Extinction Control Group in Heart Rate Response to High Calorie Food Cues at 1-month Follow-up [ Time Frame: current; assess differences between groups at 1-month follow-up ]
    Heart rate data will be collected using electrodes affixed below the ribcage and clavicle. MindWare Technologies hardware will collect continuous heart rate data during the presentation of high calorie food cues. Heart rate will be measured on a continuous scale with higher heart rate reflecting greater reactivity to high calorie food cues.

  16. Differences between R-E Training Group and Extinction Control Group in Heart Rate Response to High Calorie Food Cues at 3-month Follow-up [ Time Frame: current; assess differences between groups at 3-month follow-up ]
    Heart rate data will be collected using electrodes affixed below the ribcage and clavicle. MindWare Technologies hardware will collect continuous heart rate data during the presentation of high calorie food cues. Heart rate will be measured on a continuous scale with higher heart rate reflecting greater reactivity to high calorie food cues.

  17. Mean Change from Baseline in Skin Conductance Response to High Calorie Food Cues at 24-hr Follow-up [ Time Frame: current; assess change from baseline vs. 24-hr follow-up ]
    Skin conductance data will be collected using two electrodes placed on the palm of the hand. MindWare Technologies hardware will collect continuous skin conductance data during the presentation of high calorie food cues with greater skin conductance reflecting greater reactivity to high calorie food cues.

  18. Mean Change from Baseline in Skin Conductance Response to High Calorie Food Cues at 2-week Follow-up [ Time Frame: current; assess change from baseline vs. 2-week follow-up ]
    Skin conductance data will be collected using two electrodes placed on the palm of the hand. MindWare Technologies hardware will collect continuous skin conductance data during the presentation of high calorie food cues with greater skin conductance reflecting greater reactivity to high calorie food cues.

  19. Mean Change from Baseline in Skin Conductance Response to High Calorie Food Cues at 1-month Follow-up [ Time Frame: current; assess change from baseline vs. 1-month follow-up ]
    Skin conductance data will be collected using two electrodes placed on the palm of the hand. MindWare Technologies hardware will collect continuous skin conductance data during the presentation of high calorie food cues with greater skin conductance reflecting greater reactivity to high calorie food cues.

  20. Mean Change from Baseline in Skin Conductance Response to High Calorie Food Cues at 3-month Follow-up [ Time Frame: current; assess change from baseline vs. 3-month follow-up ]
    Skin conductance data will be collected using two electrodes placed on the palm of the hand. MindWare Technologies hardware will collect continuous skin conductance data during the presentation of high calorie food cues with greater skin conductance reflecting greater reactivity to high calorie food cues.

  21. Differences between R-E Training Group and Extinction Control Group in Skin Conductance Response to High Calorie Food Cues at 24-hr Follow-up [ Time Frame: current; assess differences between groups at 24-hr follow-up ]
    Skin conductance data will be collected using two electrodes placed on the palm of the hand. MindWare Technologies hardware will collect continuous skin conductance data during the presentation of high calorie food cues with greater skin conductance reflecting greater reactivity to high calorie food cues.

  22. Differences between R-E Training Group and Extinction Control Group in Skin Conductance Response to High Calorie Food Cues at 2-week Follow-up [ Time Frame: current; assess differences between groups at 2-week follow-up ]
    Skin conductance data will be collected using two electrodes placed on the palm of the hand. MindWare Technologies hardware will collect continuous skin conductance data during the presentation of high calorie food cues with greater skin conductance reflecting greater reactivity to high calorie food cues.

  23. Differences between R-E Training Group and Extinction Control Group in Skin Conductance Response to High Calorie Food Cues at 1-month Follow-up [ Time Frame: current; assess differences between groups at 1-month follow-up ]
    Skin conductance data will be collected using two electrodes placed on the palm of the hand. MindWare Technologies hardware will collect continuous skin conductance data during the presentation of high calorie food cues with greater skin conductance reflecting greater reactivity to high calorie food cues.

  24. Differences between R-E Training Group and Extinction Control Group in Skin Conductance Response to High Calorie Food Cues at 3-month Follow-up [ Time Frame: current; assess differences between groups at 3-month follow-up ]
    Skin conductance data will be collected using two electrodes placed on the palm of the hand. MindWare Technologies hardware will collect continuous skin conductance data during the presentation of high calorie food cues with greater skin conductance reflecting greater reactivity to high calorie food cues.

  25. Mean Change from Baseline in Salivation Response to High Calorie Food Cues at 24-hr Follow-up [ Time Frame: current; assess change from baseline vs. 24-hr follow-up ]
    Salivation in response to observing high calorie food cues will be collected using three cotton dental rolls (two placed buccally and one placed beneath the tongue) for 2-min segments according to the Strongin-Hinsie Peck method. The dental rolls will be weighed (in grams) to assess the amount of saliva produced. Greater salivation (indicated by heavier weight of dental rolls) will indicate greater reactivity to high calorie food cues.

  26. Mean Change from Baseline in Salivation Response to High Calorie Food Cues at 2-week Follow-up [ Time Frame: current; assess change from baseline vs. 2-week follow-up ]
    Salivation in response to observing high calorie food cues will be collected using three cotton dental rolls (two placed buccally and one placed beneath the tongue) for 2-min segments according to the Strongin-Hinsie Peck method. The dental rolls will be weighed (in grams) to assess the amount of saliva produced. Greater salivation (indicated by heavier weight of dental rolls) will indicate greater reactivity to high calorie food cues.

  27. Mean Change from Baseline in Salivation Response to High Calorie Food Cues at 1-month Follow-up [ Time Frame: current; assess change from baseline vs. 1-month follow-up ]
    Salivation in response to observing high calorie food cues will be collected using three cotton dental rolls (two placed buccally and one placed beneath the tongue) for 2-min segments according to the Strongin-Hinsie Peck method. The dental rolls will be weighed (in grams) to assess the amount of saliva produced. Greater salivation (indicated by heavier weight of dental rolls) will indicate greater reactivity to high calorie food cues.

  28. Mean Change from Baseline in Salivation Response to High Calorie Food Cues at 3-month Follow-up [ Time Frame: current; assess change from baseline vs. 3-month follow-up ]
    Salivation in response to observing high calorie food cues will be collected using three cotton dental rolls (two placed buccally and one placed beneath the tongue) for 2-min segments according to the Strongin-Hinsie Peck method. The dental rolls will be weighed (in grams) to assess the amount of saliva produced. Greater salivation (indicated by heavier weight of dental rolls) will indicate greater reactivity to high calorie food cues.

  29. Differences between R-E Training Group and Extinction Control Group in Salivation Response to High Calorie Food Cues at 24-hr Follow-up [ Time Frame: current; assess differences between groups at 24-hr follow-up ]
    Salivation in response to observing high calorie food cues will be collected using three cotton dental rolls (two placed buccally and one placed beneath the tongue) for 2-min segments according to the Strongin-Hinsie Peck method. The dental rolls will be weighed (in grams) to assess the amount of saliva produced. Greater salivation (indicated by heavier weight of dental rolls) will indicate greater reactivity to high calorie food cues.

  30. Differences between R-E Training Group and Extinction Control Group in Salivation Response to High Calorie Food Cues at 2-week Follow-up [ Time Frame: current; assess differences between groups at 2-week follow-up ]
    Salivation in response to observing high calorie food cues will be collected using three cotton dental rolls (two placed buccally and one placed beneath the tongue) for 2-min segments according to the Strongin-Hinsie Peck method. The dental rolls will be weighed (in grams) to assess the amount of saliva produced. Greater salivation (indicated by heavier weight of dental rolls) will indicate greater reactivity to high calorie food cues.

  31. Differences between R-E Training Group and Extinction Control Group in Salivation Response to High Calorie Food Cues at 1-month Follow-up [ Time Frame: current; assess differences between groups at 1-month follow-up ]
    Salivation in response to observing high calorie food cues will be collected using three cotton dental rolls (two placed buccally and one placed beneath the tongue) for 2-min segments according to the Strongin-Hinsie Peck method. The dental rolls will be weighed (in grams) to assess the amount of saliva produced. Greater salivation (indicated by heavier weight of dental rolls) will indicate greater reactivity to high calorie food cues.

  32. Differences between R-E Training Group and Extinction Control Group in Salivation Response to High Calorie Food Cues at 3-month Follow-up [ Time Frame: current; assess differences between groups at 3-month follow-up ]
    Salivation in response to observing high calorie food cues will be collected using three cotton dental rolls (two placed buccally and one placed beneath the tongue) for 2-min segments according to the Strongin-Hinsie Peck method. The dental rolls will be weighed (in grams) to assess the amount of saliva produced. Greater salivation (indicated by heavier weight of dental rolls) will indicate greater reactivity to high calorie food cues.


Secondary Outcome Measures :
  1. Mean Change from Baseline in Consumption of High Calorie Foods/Drinks at 24-hr Follow-up [ Time Frame: current; assess change from baseline vs. 24-hr follow-up ]
    Food/drink intake will be assessed using a self-report food frequency questionnaire: the Diet History Questionnaire (DHQ) III. The DHQ III will be modified to: (a) assess high calorie foods and drinks targeted by the intervention, and (b) assess food/drink intake over the past week. Higher scores on the DHQ III will indicate greater intake of high calorie foods/drinks.

  2. Mean Change from Baseline in Consumption of High Calorie Foods/Drinks at 2-week Follow-up [ Time Frame: current; assess change from baseline vs. 2-week follow-up ]
    Food/drink intake will be assessed using a self-report food frequency questionnaire: the Diet History Questionnaire (DHQ) III. The DHQ III will be modified to: (a) assess high calorie foods and drinks targeted by the intervention, and (b) assess food/drink intake over the past week. Higher scores on the DHQ III will indicate greater intake of high calorie foods/drinks.

  3. Mean Change from Baseline in Consumption of High Calorie Foods/Drinks at 1-month Follow-up [ Time Frame: current; assess change from baseline vs. 1-month follow-up ]
    Food/drink intake will be assessed using a self-report food frequency questionnaire: the Diet History Questionnaire (DHQ) III. The DHQ III will be modified to: (a) assess high calorie foods and drinks targeted by the intervention, and (b) assess food/drink intake over the past week. Higher scores on the DHQ III will indicate greater intake of high calorie foods/drinks.

  4. Mean Change from Baseline in Consumption of High Calorie Foods/Drinks at 3-month Follow-up [ Time Frame: current; assess change from baseline vs. 3-month follow-up ]
    Food/drink intake will be assessed using a self-report food frequency questionnaire: the Diet History Questionnaire (DHQ) III. The DHQ III will be modified to: (a) assess high calorie foods and drinks targeted by the intervention, and (b) assess food/drink intake over the past week. Higher scores on the DHQ III will indicate greater intake of high calorie foods/drinks.

  5. Differences between R-E Training Group and Extinction Control Group in Consumption of High Calorie Foods/Drinks at 24-hr Follow-up [ Time Frame: current; assess differences between groups at 24-hr follow-up ]
    Food/drink intake will be assessed using a self-report food frequency questionnaire: the Diet History Questionnaire (DHQ) III. The DHQ III will be modified to: (a) assess high calorie foods and drinks targeted by the intervention, and (b) assess food/drink intake over the past week. Higher scores on the DHQ III will indicate greater intake of high calorie foods/drinks.

  6. Differences between R-E Training Group and Extinction Control Group in Consumption of High Calorie Foods/Drinks at 2-week Follow-up [ Time Frame: current; assess differences between groups at 2-week follow-up ]
    Food/drink intake will be assessed using a self-report food frequency questionnaire: the Diet History Questionnaire (DHQ) III. The DHQ III will be modified to: (a) assess high calorie foods and drinks targeted by the intervention, and (b) assess food/drink intake over the past week. Higher scores on the DHQ III will indicate greater intake of high calorie foods/drinks.

  7. Differences between R-E Training Group and Extinction Control Group in Consumption of High Calorie Foods/Drinks at 1-month Follow-up [ Time Frame: current; assess differences between groups at 1-month follow-up ]
    Food/drink intake will be assessed using a self-report food frequency questionnaire: the Diet History Questionnaire (DHQ) III. The DHQ III will be modified to: (a) assess high calorie foods and drinks targeted by the intervention, and (b) assess food/drink intake over the past week. Higher scores on the DHQ III will indicate greater intake of high calorie foods/drinks.

  8. Differences between R-E Training Group and Extinction Control Group in Consumption of High Calorie Foods/Drinks at 3-month Follow-up [ Time Frame: current; assess differences between groups at 3-month follow-up ]
    Food/drink intake will be assessed using a self-report food frequency questionnaire: the Diet History Questionnaire (DHQ) III. The DHQ III will be modified to: (a) assess high calorie foods and drinks targeted by the intervention, and (b) assess food/drink intake over the past week. Higher scores on the DHQ III will indicate greater intake of high calorie foods/drinks.

  9. Mean Change from Baseline in Body Weight at 24-hr Follow-up [ Time Frame: current; assess change from baseline vs. 24-hr follow-up ]
    Participants will be weighed while in street clothes and without shoes using a calibrated digital scale.

  10. Mean Change from Baseline in Body Weight at 2-week Follow-up [ Time Frame: current; assess change from baseline vs. 2-week follow-up ]
    Participants will be weighed while in street clothes and without shoes using a calibrated digital scale.

  11. Mean Change from Baseline in Body Weight at 1-month Follow-up [ Time Frame: current; assess change from baseline vs. 1-month follow-up ]
    Participants will be weighed while in street clothes and without shoes using a calibrated digital scale.

  12. Mean Change from Baseline in Body Weight at 3-month Follow-up [ Time Frame: current; assess change from baseline vs. 3-month follow-up ]
    Participants will be weighed while in street clothes and without shoes using a calibrated digital scale.

  13. Differences between R-E Training Group and Extinction Control Group in Body Weight at 24-hr Follow-up [ Time Frame: current; assess differences between groups at 24-hr follow-up ]
    Participants will be weighed while in street clothes and without shoes using a calibrated digital scale.

  14. Differences between R-E Training Group and Extinction Control Group in Body Weight at 2-week Follow-up [ Time Frame: current; assess differences between groups at 2-week follow-up ]
    Participants will be weighed while in street clothes and without shoes using a calibrated digital scale.

  15. Differences between R-E Training Group and Extinction Control Group in Body Weight at 1-month Follow-up [ Time Frame: current; assess differences between groups at 1-month follow-up ]
    Participants will be weighed while in street clothes and without shoes using a calibrated digital scale.

  16. Differences between R-E Training Group and Extinction Control Group in Body Weight at 3-month Follow-up [ Time Frame: current; assess differences between groups at 3-month follow-up ]
    Participants will be weighed while in street clothes and without shoes using a calibrated digital scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index ≥25.0, indicating overweight/obesity
  • Interested in losing weight
  • Adequate liking of ≥4 foods to be presented during extinction training
  • Willing to complete the following necessary study procedures: (1) eat study foods during taste test, (2) have heart rate sensors placed on skin, (3) abstain from alcohol, cannabis, benzodiazepines, opiates, and other substances starting at midnight before each session, (4) attend sessions at the same time each day and starting with Session 1 on a Monday or Tuesday, and (5) abstain from consuming high calorie foods/drinks across the first 4 sessions

Exclusion Criteria:

  • Regular use of benzodiazepines (i.e., >5 times in the past 30 days)
  • Initiation of thyroid-related medications or, for women, initiation of new birth control medication, an implant, or intrauterine device in the past 3 months
  • Use of weight- or appetite-affecting medication
  • Engaged in a weight loss treatment/program or involved in another research study providing treatment/intervention for weight loss
  • Diabetes diagnosis
  • Bariatric surgery in the past 3 years
  • Receiving treatment for an eating disorder
  • Food allergies or restrictions over the next 3 months preventing consumption of foods presented during lab tasks
  • For women: currently pregnant or planning to become pregnant in the next 3 months
  • For women: currently breastfeeding with >50% of baby's/child's nutrition coming from breast milk

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077385


Contacts
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Contact: Lisa J Germeroth, PhD 412-647-3089 germerothlj@upmc.edu
Contact: Pearl Ruschak, BS 412-647-3494 ruschakpm@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Lisa J Germeroth, PhD    412-647-3089    germerothlj@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Lisa J Germeroth, PhD University of Pittsburgh

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Responsible Party: Lisa J Germeroth, PhD, Assistant Professor, Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04077385     History of Changes
Other Study ID Numbers: STUDY18100137
1K23DK117994-01 ( U.S. NIH Grant/Contract )
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for primary and secondary outcome measures, along with data dictionaries, will be made available without cost to researchers and analysts in the general scientific community. Data will be provided in statistical formats including Statistical Package for Social Sciences (SPSS) file format and will represent the final research data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The data will become available no later than the acceptance for publication of the main findings from the final data set. Data will be available indefinitely through a data archive.
Access Criteria: Any researcher or analyst in the scientific community will have access to the data via a database and management website such as Mendeley Data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms