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

NCT04077385 | Withdrawn DMC

• 2 other identifiers: STUDY181001371K23DK117994-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity; Craving; Eating Behavior

Outcome Measures

Primary Outcomes (32)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (12)

• Mean Change from Baseline in Consumption of High Calorie Foods/Drinks at 2-week Follow-up

  current; assess change from baseline vs. 2-week follow-up

• Mean Change from Baseline in Consumption of High Calorie Foods/Drinks at 1-month Follow-up

  current; assess change from baseline vs. 1-month follow-up

• Mean Change from Baseline in Consumption of High Calorie Foods/Drinks at 3-month Follow-up

  current; assess change from baseline vs. 3-month follow-up

• Differences between R-E Training Group and Extinction Control Group in Consumption of High Calorie Foods/Drinks at 2-week Follow-up

  current; assess differences between groups at 2-week follow-up

• Differences between R-E Training Group and Extinction Control Group in Consumption of High Calorie Foods/Drinks at 1-month Follow-up

  current; assess differences between groups at 1-month follow-up

Study Arms (2)

Retrieval Extinction (R-E) Training Group

EXPERIMENTAL

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

Extinction Control Group

ACTIVE COMPARATOR

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

Interventions

Retrieval-extinction (R-E) Training BEHAVIORAL

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 of high calorie snack foods such as a single M\&M or potato chip.

Retrieval Extinction (R-E) Training Group

Extinction Training BEHAVIORAL

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 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.

Extinction Control Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-59 years
• 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, or other illegal 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

You may not qualify if:

• Engaged in a weight loss treatment/program or involved in another research study providing treatment/intervention for weight loss
• Participation in a food cue-reactivity pilot study that used procedures similar to those of the current study (e.g., food cue-reactivity task, bogus taste test)
• Diabetes diagnosis
• Initiation of thyroid-related medications or, for women, initiation of new birth control medication, an implant, or intrauterine device in the past 3 months
• Regular use of benzodiazepines (i.e., \>5 times in the past 30 days)
• Use of weight- or appetite-affecting medication
• Currently receiving treatment for an eating disorder
• Bariatric surgery in the past 3 years
• Food allergies or restrictions over the next 4 months preventing consumption of foods presented during lab tasks
• Has a pacemaker implant
• For women: currently pregnant or planning to become pregnant in the next 4 months
• For women: currently breastfeeding with \>50% of baby's/child's nutrition coming from breast milk

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Lisa J Germeroth, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 4, 2019
• Study Start: October 2, 2020
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)