Autism Spectrum DisorderNCT02712281
Autism MEAL Plan: Parent Training to Manage Eating Aversions & Limited Variety
A study testing Autism MEAL Plan and Parent Education in people with Autism Spectrum Disorder, run by Emory University at 1 site in United States.
Trial summary
The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a group-based parent training intervention designed to assist parents in increasing the variety of foods eaten in children with Autism Spectrum Disorder (ASD). Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Autism MEAL Plan and Parent Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A diagnosis of autism spectrum disorder (ASD), supported by the Autism Diagnostic Observation Schedule (ADOS) and the Social Communication Questionnaire (SCQ)-Lifetime
- Presents with a history of moderate food selectivity (a diet involving at least 6 food items)
- Accepting at least one fruit or vegetable
- Fewer than two food items in one or more food categories (i.e., fruit, vegetable, protein, starch) as measured by the Food Preference Inventory
- Exhibits disruptive refusal behaviors when presented with non-preferred foods (e.g., crying, active verbal protest, tantrums) often or during every meal as indicated by item 7 on the Brief Autism Mealtime Behavior Inventory (BAMBI)
- Parent, or primary caregiver, endorses a feeding concern as one of the top two problems on the Parent Target Problem
- Parent, or primary caregiver, agrees to participate and is deemed able to attend group sessions
- Parent, or primary caregiver, is able to speak, understand, read and write in English
Who cannot join
- Severe feeding problems (e.g., < 5 preferred foods as measure by the Food Preference Inventory)
- Complex medical issues (e.g., gastrostomy tube or formula dependent) requiring intensive treatment such as day treatment or hospital-based treatment
Trial locations and contacts
1 site in 1 country.
About this study
The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a group-based parent training intervention designed to assist parents in increasing the variety of foods eaten in children with Autism Spectrum Disorder (ASD). The goal of the Autism MEAL Plan is to include specific techniques to manage mealtime behavioral challenges and introduce new foods.
Read the detailed description
The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a structured parent-mediated, group-based intervention to reduce mealtime disruptive behavior, expand dietary diversity and reduce parental stress associated with moderate food selectivity in young children with Autism Spectrum Disorder (ASD).
Children ages 3-8 with a diagnosis of ASD who present with moderate food selectivity and associated problem behavior will be screened for inclusion in the study. Following consent and screening procedures, parents of eligible children will be assigned to a group-based parent training (Autism MEAL plan) or group-based parent education. Each parent will receive 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician.
Data will be collected on parental compliance with the Autism MEAL plan and the food acceptance of the child as well as nutritional intake, and refusal behaviors. Child participants will also be included in parent-child dyad in-vivo feedback sessions. Parents assigned to parent education will be able to cross-over to receive the Autism MEAL Plan following completion of post-study measures.
The first aim of the study is to finalize the Autism MEAL Plan materials (e.g., role-play activities, activity sheets and video examples). This includes standardizing therapist scripts in line with the revised curriculum and creating new video examples that coincide with practice worksheets. Home recording (e.g., personal camera phone) to document and present home meal data will also be added to the curriculum.
The second aim is to evaluate the feasibility of the Autism MEAL Plan versus parent education in 40 children (20 per treatment assignment) with ASD and moderate feeding problems.
The final study aim is to evaluate the preliminary efficacy of the Autism MEAL Plan in expanding food diversity, decreasing disruptive behavior and reducing parental stress compared to Parent Education. Methods of evaluating this aim include direct observation, parent ratings of behavior, food intake and stress, as well as blinded clinician ratings, height, weight and BMI.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Autism MEAL Plan, Parent Education
- Keywords
- Food Selectivity, Autism MEAL Plan, Parent Education
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autism MEAL PlanBehavioural
The Autism MEAL plan includes education on feeding issues and behavior management, and specific strategies to expand dietary diversity. Each parent receives 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician. The first three sessions focus on understanding feeding problems and behavior management strategies in children with ASD.The next seven sessions include child-specific feeding interventions, based on parent-report and home data collection of child meal time behavior. To promote application of new skills, homework accompanies each lesson.
The next seven sessions include child-specific feeding interventions, based on parent-report and home data collection of child meal time behavior. To promote application of new skills, homework accompanies each lesson.
Parent EducationBehavioural
The Parent Education study arm includes 10 sessions focusing on the following topics: understanding Autism Spectrum Disorder (ASD), clinical assessments for ASD, development in children with ASD, medical and genetic comorbidities in ASD, family and sibling issues, treatment alternatives, and education and treatment planning. The Parent Education arm does not include topics related to feeding problems or feeding specific interventions. Each parent receives 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician.
Children randomized to Parent Education will be offered the Autism MEAL Plan after completing the 10-week randomized trial.
| Study group | Role | What they receive |
|---|---|---|
| Autism MEAL Plan | Experimental | Parents of eligible children who are randomized to the Autism Managing Eating Aversions and Limited variety (MEAL) Plan will participate in group-based parent training sessions (4 parents per group). Receives: Behavioral: Autism MEAL Plan |
| Parent Education | Active comparator | Parents of eligible children who are randomized to the Parent Education Arm will receive group-based parent education (PE). Each group includes 4 parents. Receives: Behavioral: Parent Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Global Impression - Improvement scale (CGI-I) score
The Clinical Global Impression - Improvement scale (CGI-I) is a 7-point scale measure of overall change of Parent Target Problems (the child's two most pressing problems at screening, as reported by parents), using scores from the Clinical Global Impressions - Severity scale (CGI-S). Scores range from 1 (Very Much Improved) through 4 (Unchanged) to 7 (Very Much Worse).
Measured: Baseline, end of follow-up (up to 18 weeks)
Secondary outcomes (14)
Change in Parenting Stress Index- Short Form (PSI) score
The Parenting Stress Index- Short Form (PSI) is a 36-item survey commonly used
Measured: Baseline, end of follow-up (up to 18 weeks)
Parent Satisfaction Rating
A 10 item Parent Satisfaction Rating questionnaire will assess acceptance and perceived effectiveness of each treatment arm.
Measured: Week 14
Change in Brief Autism Mealtime Behavior Inventory (BAMBI) scores
The Brief Autism Mealtime Behavior Inventory (BAMBI) is an 18-item parent-rated questionnaire on mealtime behaviors
Measured: Baseline, end of follow-up (up to 18 weeks)
Change in Food Preference Inventory (FPI) scores
A 154-item parent-rating of food selectivity. It includes seven food categories (fruits, vegetables, proteins, starches, dairy, miscellaneous/snack, combination foods. The food selectivity score = the number of foods reported as "never" consumed divided by 154 X 100. We will also derive a food acceptance score = the number of food items endorsed as accepted divided by 154 X 100.
Measured: Baseline, end of follow-up (up to 18 weeks)
Change in nutritional intake
Nutritional intake will be assessed by parents recording the child's daily intake on a food diary for 3 days prior to the Baseline, Week 10, Week 14, and Week 18 visits. A nutritionist (blind to treatment assignment) will tally the child's intake of selected vitamins and nutrients (vitamins A, C, D, and E, zinc, calcium, iron, fiber, fat, protein, carbohydrates, and total energy [kcal]) to determine the overall level of each micro- and macro-nutrient. The total number of nutrient deficiencies will be determined using cut points. The evaluation of change in nutritional status will be assessed by averaging the levels of each nutrient across groups.
Measured: Baseline, end of follow-up (up to 18 weeks)
Change in Aberrant Behavior Checklist (ABC) scores
The Aberrant Behavior Checklist (ABC) is a commonly used 58-item parent-rated measure of overall behavioral problems. Subscale categories of the ABC include: Irritability, Lethargy, Stereotypy, Hyperactivity, and Inappropriate Speech.
Measured: Baseline, end of follow-up (up to 18 weeks)
Change in rapid acceptance during 10 minute meal observation
Children and parents will participate in a 10-minute meal observation at the Baseline, Week 10, Week 14 and Week 18 visits. During the 10-minute meal observation caregivers are instructed to present a small bite of food to the child at 30-second intervals with a preset group of foods (e.g., green beans, peaches, grilled chicken, potatoes). Data are collected on a variety of mealtime behaviors including rapid acceptance of food presented. Outcomes are rated by trained observers using conventions established in the Marcus Autism Center's Feeding Disorders Program.
Measured: Baseline, end of follow-up (up to 18 weeks)
Change in rapid swallowing during 10-minute meal observation
Children and parents will participate in a 10-minute meal observation at the Baseline, Week 10, Week 14 and Week 18 visits. During the 10-minute meal observation caregivers are instructed to present a small bite of food to the child at 30-second intervals with a preset group of foods (e.g., green beans, peaches, grilled chicken, potatoes). Data are collected on a variety of mealtime behaviors including rapid swallowing of food presented. Outcomes are rated by trained observers using conventions established in the Marcus Autism Center's Feeding Disorders Program.
Measured: Baseline, end of follow-up (up to 18 weeks)
Change in disruptions during 10-minute meal observation
Children and parents will participate in a 10-minute meal observation at the Baseline, Week 10, Week 14 and Week 18 visits. During the 10-minute meal observation caregivers are instructed to present a small bite of food to the child at 30-second intervals with a preset group of foods (e.g., green beans, peaches, grilled chicken, potatoes). Data are collected on a variety of mealtime behaviors including disruptions (e.g. head turning, pushing away the spoon) when food is presented. Outcomes are rated by trained observers using conventions established in the Marcus Autism Center's Feeding Disorders Program.
Measured: Baseline, end of follow-up (up to 18 weeks)
Change in crying during 10-minute meal observation
children and parents will participate in a 10-minute meal observation at the Baseline, Week 10, Week 14 and Week 18 visits. During the 10-minute meal observation caregivers are instructed to present a small bite of food to the child at 30-second intervals with a preset group of foods (e.g., green beans, peaches, grilled chicken, potatoes). Data are collected on a variety of mealtime behaviors including crying when food is presented. Outcomes are rated by trained observers using conventions established in the Marcus Autism Center's Feeding Disorders Program.
Measured: Baseline, end of follow-up (up to 18 weeks)
Change in volume of food consumed during 10-minute meal observation
Children and parents will participate in a 10-minute meal observation at the Baseline, Week 10, Week 14 and Week 18 visits. During the 10-minute meal observation caregivers are instructed to present a small bite of food to the child at 30-second intervals with a preset group of foods (e.g., green beans, peaches, grilled chicken, potatoes). The volume of food consumed will be measured to assess changes in intake. Outcomes are rated by trained observers using conventions established in the Marcus Autism Center's Feeding Disorders Program.
Measured: Baseline, end of follow-up (up to 18 weeks)
Weight
Direct measurement of weight using a digital scale recorded in kg.
Measured: Baseline, end of follow-up (up to 18 weeks)
Height
Direct measurement of height using a stadiometer recorded in cm.
Measured: Baseline, end of follow-up (up to 18 weeks)
Body Mass Index
Height and weight measurements will be used to calculate BMI percentile by age for each participant and converted to age- and sex- adjusted Z-scores based on the 2000 CDC growth charts
Measured: Baseline, end of follow-up (up to 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, William Sharp, PhD, Emory University
- Investigators
- William Sharp, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712281
- Sponsor's protocol ID
- IRB00085811
- Status last verified
- Dec 2018
- First submitted
- 9 Mar 2016
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sharp WG, Burrell TL, Berry RC, Stubbs KH, McCracken CE, Gillespie SE, Scahill L. The Autism Managing Eating Aversions and Limited Variety Plan vs Parent Education: A Randomized Clinical Trial. J Pediatr. 2019 Aug;211:185-192.e1. doi: 10.1016/j.jpeds.2019.03.046. Epub 2019 May 3.
PubMed 31056202
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism MEAL Plan: Parent Training to Manage Eating Aversions & Limited Variety
- ClinicalTrials.gov ID
- NCT02712281
- Acronym / sponsor ID
- IRB00085811
- Conditions
- Autism Spectrum Disorder
- Keywords
- Food Selectivity, Autism MEAL Plan, Parent Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- Jul 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a group-based parent training intervention designed to assist parents in increasing the variety of foods eaten in children with Autism Spectrum Disorder (ASD). The goal of the Autism MEAL Plan is to include specific techniques to manage mealtime behavioral challenges and introduce new foods.
Detailed description
The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a structured parent-mediated, group-based intervention to reduce mealtime disruptive behavior, expand dietary diversity and reduce parental stress associated with moderate food selectivity in young children with Autism Spectrum Disorder (ASD).
Children ages 3-8 with a diagnosis of ASD who present with moderate food selectivity and associated problem behavior will be screened for inclusion in the study. Following consent and screening procedures, parents of eligible children will be assigned to a group-based parent training (Autism MEAL plan) or group-based parent education. Each parent will receive 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician.
Data will be collected on parental compliance with the Autism MEAL plan and the food acceptance of the child as well as nutritional intake, and refusal behaviors. Child participants will also be included in parent-child dyad in-vivo feedback sessions. Parents assigned to parent education will be able to cross-over to receive the Autism MEAL Plan following completion of post-study measures.
The first aim of the study is to finalize the Autism MEAL Plan materials (e.g., role-play activities, activity sheets and video examples). This includes standardizing therapist scripts in line with the revised curriculum and creating new video examples that coincide with practice worksheets. Home recording (e.g., personal camera phone) to document and present home meal data will also be added to the curriculum.
The second aim is to evaluate the feasibility of the Autism MEAL Plan versus parent education in 40 children (20 per treatment assignment) with ASD and moderate feeding problems.
The final study aim is to evaluate the preliminary efficacy of the Autism MEAL Plan in expanding food diversity, decreasing disruptive behavior and reducing parental stress compared to Parent Education. Methods of evaluating this aim include direct observation, parent ratings of behavior, food intake and stress, as well as blinded clinician ratings, height, weight and BMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism MEAL Plan | Experimental | Behavioral: Autism MEAL PlanParents of eligible children who are randomized to the Autism Managing Eating Aversions and Limited variety (MEAL) Plan will participate in group-based parent training sessions (4 parents per group). |
| Parent Education | Active comparator | Behavioral: Parent EducationParents of eligible children who are randomized to the Parent Education Arm will receive group-based parent education (PE). Each group includes 4 parents. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- A diagnosis of autism spectrum disorder (ASD), supported by the Autism Diagnostic Observation Schedule (ADOS) and the Social Communication Questionnaire (SCQ)-Lifetime
- Presents with a history of moderate food selectivity (a diet involving at least 6 food items)
- Accepting at least one fruit or vegetable
- Fewer than two food items in one or more food categories (i.e., fruit, vegetable, protein, starch) as measured by the Food Preference Inventory
- Exhibits disruptive refusal behaviors when presented with non-preferred foods (e.g., crying, active verbal protest, tantrums) often or during every meal as indicated by item 7 on the Brief Autism Mealtime Behavior Inventory (BAMBI)
Key exclusion criteria (2 listed)
- Severe feeding problems (e.g., < 5 preferred foods as measure by the Food Preference Inventory)
- Complex medical issues (e.g., gastrostomy tube or formula dependent) requiring intensive treatment such as day treatment or hospital-based treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autism MEAL PlanThe Autism MEAL plan includes education on feeding issues and behavior management, and specific strategies to expand dietary diversity. Each parent receives 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician. The first three sessions focus on understanding feeding problems and behavior management strategies in children with ASD.The next seven sessions include child-specific feeding interventions, based on parent-report and home data collection of child meal time behavior. To promote application of new skills, homework accompanies each lesson. The next seven sessions include child-specific feeding interventions, based on parent-report and home data collection of child meal time behavior. To promote application of new skills, homework accompanies each lesson. | Behavioural | Autism MEAL Plan |
| Parent EducationThe Parent Education study arm includes 10 sessions focusing on the following topics: understanding Autism Spectrum Disorder (ASD), clinical assessments for ASD, development in children with ASD, medical and genetic comorbidities in ASD, family and sibling issues, treatment alternatives, and education and treatment planning. The Parent Education arm does not include topics related to feeding problems or feeding specific interventions. Each parent receives 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician. Children randomized to Parent Education will be offered the Autism MEAL Plan after completing the 10-week randomized trial. | Behavioural | Parent Education |
Primary outcome
Change in Clinical Global Impression - Improvement scale (CGI-I) score
Time frame: Baseline, end of follow-up (up to 18 weeks)
The Clinical Global Impression - Improvement scale (CGI-I) is a 7-point scale measure of overall change of Parent Target Problems (the child's two most pressing problems at screening, as reported by parents), using scores from the Clinical Global Impressions - Severity scale (CGI-S). Scores range from 1 (Very Much Improved) through 4 (Unchanged) to 7 (Very Much Worse).
14 secondary outcomes
Change in Parenting Stress Index- Short Form (PSI) score
Time frame: Baseline, end of follow-up (up to 18 weeks)
Parent Satisfaction Rating
Time frame: Week 14
Change in Brief Autism Mealtime Behavior Inventory (BAMBI) scores
Time frame: Baseline, end of follow-up (up to 18 weeks)
Change in Food Preference Inventory (FPI) scores
Time frame: Baseline, end of follow-up (up to 18 weeks)
Change in nutritional intake
Time frame: Baseline, end of follow-up (up to 18 weeks)
Change in Aberrant Behavior Checklist (ABC) scores
Time frame: Baseline, end of follow-up (up to 18 weeks)
Change in rapid acceptance during 10 minute meal observation
Time frame: Baseline, end of follow-up (up to 18 weeks)
Change in rapid swallowing during 10-minute meal observation
Time frame: Baseline, end of follow-up (up to 18 weeks)
Change in disruptions during 10-minute meal observation
Time frame: Baseline, end of follow-up (up to 18 weeks)
Change in crying during 10-minute meal observation
Time frame: Baseline, end of follow-up (up to 18 weeks)
Change in volume of food consumed during 10-minute meal observation
Time frame: Baseline, end of follow-up (up to 18 weeks)
Weight
Time frame: Baseline, end of follow-up (up to 18 weeks)
Height
Time frame: Baseline, end of follow-up (up to 18 weeks)
Body Mass Index
Time frame: Baseline, end of follow-up (up to 18 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Derived from this study: PubMed 31056202Sharp WG, Burrell TL, Berry RC, Stubbs KH, McCracken CE, Gillespie SE, Scahill L. The Autism Managing Eating Aversions and Limited Variety Plan vs Parent Education: A Randomized Clinical Trial. J Pediatr. 2019 Aug;211:185-192.e1. doi: 10.1016/j.jpeds.2019.03.046. Epub 2019 May 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Sharp, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autism MEAL Plan and Parent Education in people with Autism Spectrum Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Global Impression - Improvement scale (CGI-I) score (time frame: Baseline, end of follow-up (up to 18 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.