Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Mean Change from Baseline in Self-Report State Food Craving Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 24-hr follow-up |
|
Primary |
Mean Change from Baseline in Self-Report State Food Craving Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 2-week follow-up |
|
Primary |
Mean Change from Baseline in Self-Report State Food Craving Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 1-month follow-up |
|
Primary |
Mean Change from Baseline in Self-Report State Food Craving Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 3-month follow-up |
|
Primary |
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 |
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. |
current; assess differences between groups at 24-hr follow-up |
|
Primary |
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 |
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. |
current; assess differences between groups at 2-week follow-up |
|
Primary |
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 |
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. |
current; assess differences between groups at 1-month follow-up |
|
Primary |
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 |
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. |
current; assess differences between groups at 3-month follow-up |
|
Primary |
Mean Change from Baseline in Heart Rate Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 24-hr follow-up |
|
Primary |
Mean Change from Baseline in Heart Rate Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 2-week follow-up |
|
Primary |
Mean Change from Baseline in Heart Rate Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 1-month follow-up |
|
Primary |
Mean Change from Baseline in Heart Rate Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 3-month follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Heart Rate Response to High Calorie Food Cues 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. |
current; assess differences between groups at 24-hr follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Heart Rate Response to High Calorie Food Cues 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. |
current; assess differences between groups at 2-week follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Heart Rate Response to High Calorie Food Cues 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. |
current; assess differences between groups at 1-month follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Heart Rate Response to High Calorie Food Cues 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. |
current; assess differences between groups at 3-month follow-up |
|
Primary |
Mean Change from Baseline in Skin Conductance Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 24-hr follow-up |
|
Primary |
Mean Change from Baseline in Skin Conductance Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 2-week follow-up |
|
Primary |
Mean Change from Baseline in Skin Conductance Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 1-month follow-up |
|
Primary |
Mean Change from Baseline in Skin Conductance Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 3-month follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Skin Conductance Response to High Calorie Food Cues 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. |
current; assess differences between groups at 24-hr follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Skin Conductance Response to High Calorie Food Cues 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. |
current; assess differences between groups at 2-week follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Skin Conductance Response to High Calorie Food Cues 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. |
current; assess differences between groups at 1-month follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Skin Conductance Response to High Calorie Food Cues 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. |
current; assess differences between groups at 3-month follow-up |
|
Primary |
Mean Change from Baseline in Salivation Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 24-hr follow-up |
|
Primary |
Mean Change from Baseline in Salivation Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 2-week follow-up |
|
Primary |
Mean Change from Baseline in Salivation Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 1-month follow-up |
|
Primary |
Mean Change from Baseline in Salivation Response to High Calorie Food Cues 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. |
current; assess change from baseline vs. 3-month follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Salivation Response to High Calorie Food Cues 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. |
current; assess differences between groups at 24-hr follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Salivation Response to High Calorie Food Cues 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. |
current; assess differences between groups at 2-week follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Salivation Response to High Calorie Food Cues 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. |
current; assess differences between groups at 1-month follow-up |
|
Primary |
Differences between R-E Training Group and Extinction Control Group in Salivation Response to High Calorie Food Cues 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. |
current; assess differences between groups at 3-month follow-up |
|
Secondary |
Mean Change from Baseline in Consumption of High Calorie Foods/Drinks 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. |
current; assess change from baseline vs. 2-week follow-up |
|
Secondary |
Mean Change from Baseline in Consumption of High Calorie Foods/Drinks 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. |
current; assess change from baseline vs. 1-month follow-up |
|
Secondary |
Mean Change from Baseline in Consumption of High Calorie Foods/Drinks 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. |
current; assess change from baseline vs. 3-month follow-up |
|
Secondary |
Differences between R-E Training Group and Extinction Control Group in Consumption of High Calorie Foods/Drinks 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. |
current; assess differences between groups at 2-week follow-up |
|
Secondary |
Differences between R-E Training Group and Extinction Control Group in Consumption of High Calorie Foods/Drinks 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. |
current; assess differences between groups at 1-month follow-up |
|
Secondary |
Differences between R-E Training Group and Extinction Control Group in Consumption of High Calorie Foods/Drinks 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. |
current; assess differences between groups at 3-month follow-up |
|
Secondary |
Mean Change from Baseline in Body Weight at 2-week Follow-up |
Participants will be weighed while in street clothes and without shoes using a calibrated digital scale. |
current; assess change from baseline vs. 2-week follow-up |
|
Secondary |
Mean Change from Baseline in Body Weight at 1-month Follow-up |
Participants will be weighed while in street clothes and without shoes using a calibrated digital scale. |
current; assess change from baseline vs. 1-month follow-up |
|
Secondary |
Mean Change from Baseline in Body Weight at 3-month Follow-up |
Participants will be weighed while in street clothes and without shoes using a calibrated digital scale. |
current; assess change from baseline vs. 3-month follow-up |
|
Secondary |
Differences between R-E Training Group and Extinction Control Group in Body Weight at 2-week Follow-up |
Participants will be weighed while in street clothes and without shoes using a calibrated digital scale. |
current; assess differences between groups at 2-week follow-up |
|
Secondary |
Differences between R-E Training Group and Extinction Control Group in Body Weight at 1-month Follow-up |
Participants will be weighed while in street clothes and without shoes using a calibrated digital scale. |
current; assess differences between groups at 1-month follow-up |
|
Secondary |
Differences between R-E Training Group and Extinction Control Group in Body Weight at 3-month Follow-up |
Participants will be weighed while in street clothes and without shoes using a calibrated digital scale. |
current; assess differences between groups at 3-month follow-up |
|