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Weight GainSNAPNCT01183689

Study of Novel Approaches for Prevention

A study testing Small Behavior Changes and Large Behavior Changes in people with Weight Gain, run by Wake Forest University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Weight Gain
What is being tested?
Small Behavior Changes and Large Behavior Changes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
599 participants
Where
2 sitesUnited States
Study dates
Aug 2010to 30 Sep 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1. BMI of 21 - 30 kg/m2

Who cannot join

  • Untreated hypertension, hyperlipidemia, or type 2 diabetes, unless permission is provided by their health care provider.
  • Heart disease, heart problems or report being prescribed drugs for blood pressure or a major heart condition, unless permission is provided by their health care provider.
  • Type 1 diabetes or treatment of type 2 diabetes with insulin or oral medication that may cause hypoglycemia.
  • Health problems which may influence the ability to walk for physical activity (e.g. lower limb amputation) or other reasons why a person should not do physical activity, unless permission is provided from their health care provider.
  • Health problems that may be associated with unintentional weight change or affect the safety of a weight loss program, including report of a heart attack or stroke, chest pain during periods of activity or rest, loss of consciousness, active tuberculosis, HIV, chronic hepatitis B or C, inflammatory bowel disease requiring treatment within the past year, thyroid disease, renal disease, liver disease, hospitalization for asthma in the past year, or cancer within the past 5 years (except for non-melanoma skin cancers or early stage cervical cancer) or chronic use of steroid medication.
  • Report of a past diagnosis of or treatment for a Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa) or meet criteria for anorexia or bulimia nervosa during screening for this trial
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  • Report of a past diagnosis of or current symptoms of alcohol or substance dependence.
  • Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months.
  • History of schizophrenia, manic depression, or bipolar disorder.
  • Hospitalization for depression or other psychiatric disorder within the past 12 months.
  • Having lost and maintained a weight loss of 10 pounds or more within the past 6 months or are currently participating in a weight loss program, trying to gain weight, using steroids for muscle mass or weight gain, taking weight loss medication, or have had surgery for weight loss.
  • Participation in another weight loss or physical activity study that would interfere with this study.
  • Another member of the household (or roommate) is a participant or staff member on this trial.
  • Reason to suspect that the participant would not adhere to the study intervention or assessment schedule (i.e., can't come to group on a regular basis; will be away for more than two weeks during initial intervention phase or planning to move from the area within next year).
  • Not able to speak and understand English.
  • Residence or place of work further than 30 miles from the intervention site.
  • Perceived inability to attend the 2 year data collection visit.
  • Does not have Internet access on a regular basis.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of North Carolina

    Chapel Hill, North Carolina, 27559

  • The Miriam Hospital

    Providence, Rhode Island, 02903

Other trials in United States

About this study

The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Two different self-regulation interventions for weight gain prevention will be compared in this trial; one intervention will focus on making small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger changes in eating and exercise that occur periodically, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gains. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average three-year follow-up differs across the three groups, with the hypotheses that weight gain will be greater in the Control group than in either intervention and greater in the Small Changes than Large Changes group.

SNAP-E (Extension) will determine whether the effects of the intervention can be maintained over an additional 3 years (i.e. through a total of 6 years).

Read the detailed description

Young adults, aged 20-35 years, experience the greatest rate of weight gain, averaging 1-2 lbs/yr. Over time, this weight gain is associated with a worsening in cardiovascular disease risk factors and an increase in the prevalence of metabolic syndrome. Given the difficulties in producing sustained weight loss later in life, preventing weight gain from occurring during this critical period is key to curbing the obesity epidemic. The Study of Novel Approaches for Prevention (SNAP) is a 2-center randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Approximately 600 participants will be recruited over two years and randomly assigned to a control condition (N=200), self-regulation with small changes (N=200) or self-regulation with large changes (N=200). The Small Changes group will be taught to make small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs whereas the Large Changes group will emphasize periodic, larger changes in eating and exercise, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gain. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average planned follow-up of three years differs across the three groups, with a priori hypotheses that weight gain will be greater in the Control group than in either intervention and greater in the Small Changes than Large Changes group. Secondary aims are to compare the three groups on a) the proportion of participants in the three groups who gain less than 1 pound over the planned follow-up, b) the mean difference in weight gain from baseline to 24-month follow-up, c) the changes in behaviors and psychosocial measures (diet, physical activity, dietary restraint, frequency of self-weighing,depression, and occurrence of abnormal eating behaviors), and d) the changes in cardiovascular disease risk factors (blood pressure, lipids, insulin sensitivity, and waist circumference). The trial will also examine the association among changes in behaviors, weight, and cardiovascular disease risk factors and examine variables that may moderate the effects of the intervention (including gender, ethnicity, initial BMI, age) and potential mediators of the effects of the intervention (including changes in diet, activity, and self-regulatory behaviors). SNAP is member of the Early Adult Reduction in Weight Through Lifestyle Interventions (EARLY) consortium of clinical trials funded by the National Heart, Lung, and Blood Institute.

Conditions
Weight Gain
Being tested
Small Behavior Changes, Large Behavior Changes
Medical subject headings
Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Small Behavior ChangesBehavioural

    Also called Small Behavior Changes plus self-regulation

    The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.

    Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.

    Exercise: At the start of the program, participants will be given a pedometer and asked to record their current or baseline number of steps. They will then be given the goal of increasing their daily steps by 2000 steps per day over this baseline level.

  • Large Behavior ChangesBehavioural

    Also called Large Behavior Changes plus self-regulation

    The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.

    Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.

    Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes per day) using activities similar in intensity to brisk walking.

Study groups in NCT01183689
Study groupRoleWhat they receive
Control GroupNo intervention"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.
Small behavior changesExperimentalParticipants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).
Receives: Behavioral: Small Behavior Changes
Large behavior changesExperimentalParticipants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).
Receives: Behavioral: Large Behavior Changes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Changes From Baseline Over Follow-up.

    Mean weight change from baseline across an average planned follow-up of three years. These mean changes will be compared among the three arms of the trial.

    Measured: 3 years

Secondary outcomes (20)

  1. Weight Gain 1 Pound or More at Any Time Over Follow-up

    Average over time (average follow-up of 3 years) of the percent of participants within each arm of the trial who gain 1 pound or more at each visit. These percentages will be compared among the three arms generalized estimating equations. Note that weight changes in units of pounds were used to define this outcome so that it may be more clear to participants. Elsewhere in the protocol, weight is reported in kilograms. Percentages at each visit are the percent who gained 1 pound or more from baseline among all who were weighed at that visit. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status.

    Measured: 3 years

  2. Mean Weight Changes

    Mean differences in weight changes among intervention groups at 24 months post-randomization

    Measured: 2 years

  3. Mean Changes in Systolic Blood Pressure

    Compare changes in systolic blood pressure across the three intervention groups

    Measured: Measured at 2 Years

  4. Mean Changes From Baseline in Diastolic Blood Pressure

    Change from baseline to 2 years in diastolic blood pressure

    Measured: 2 years

  5. Mean Changes From Baseline to 2 Years in Total Cholesterol

    Mean changes from baseline to 2 years in total cholesterol among participants with Year 2 measurements (mg/dl)

    Measured: 2 years

  6. Obesity

    Percentage of those participants whose body mass index at baseline was less than 30 kg/m2 who subsequently transitioned to a body mass index of 30 kg/m2 or more (i.e. met criteria for obesity) sometime during 3 years of follow-up (i.e. at least one visit). Percentages will be compared among the three arms of the trial and summarized with odds ratios Participants were assigned values of 0 or 1 at each exam depending on their obesity level. Inference is based on generalized estimating equations.

    Measured: 3 years

  7. Dietary Restraint: Mean Change From Baseline to 2 Years

    The Eating Inventory (Stunkard, 1988) is a 51-item self-report instrument, was used to assess the subscale of dietary restraint (e.g., degree of conscious control exerted over eating behaviors; range from 0-21 with higher scores reflecting greater levels of restraint).

    Reference: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.

    Measured: 2 years

  8. Disinhibition

    The Eating Inventory (TFEQ(Stunkard, 1988), a 51-item self-report instrument, was used to assess the subscale of disinhibition (e.g., susceptibility to loss of control over eating; range 0-16, with higher scores reflecting greater levels of disinhibition).

    REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.

    Measured: Changes at 2 years

  9. Flexible Dietary Control

    Flexible control is characterized by a balanced approach to eating (e.g., taking smaller portions to control weight, engaging in healthy compensation) and is associated with better weight management outcomes (Westenhoefer, Stunkard, \& Pudel, 1999). Scores range from 0 to 12 with higher scores reflecting greater levels of flexible control.

    REF: Westenhoefer, J., Stunkard, A. J., \& Pudel, V. (1999). Validation of the flexible and rigid control dimensions of dietary restraint. Int J Eat Disord, 26(1), 53-64.

    Measured: Changes from baseline to 2 years

  10. Rigid Dietary Control

    Rigid control is characterized by an all-or-nothing inflexibility around dietary rules (e.g., strict calorie counting, with guilt following if calorie-dense foods are consumed) that is associated with poor weight outcomes and more binge eating (Westenhoefer, Stunkard, \& Pudel, 1999). Scores range from 0 to 16 with higher scores reflecting greater rigid control.

    REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.

    Measured: Changes from baseline to 2 years

  11. General Health Index

    The General Health Index, a one-item question from the CDC's Health-Related Quality of Life measure (Measuring Healthy Days, 2000) required participants to report whether in general their health is excellent (1), very good (2), good (3), fair (4), or poor (5). Lower scores denotes better outcomes.

    Ref: Measuring Healthy Days. (2000). Atlanta, Georgia: Centers for Disease Control and Prevention

    Measured: Changes from baseline to 2 years

  12. Mean Changes in High Density Lipoprotein Cholesterol (HDL-C)

    Mean changes in HDL-C from baseline to year 2 in (mg/dl) for compared among the 3 arms using analysis of variance

    Measured: 2 years

  13. Mean Changes in Low Density Lipoprotein Cholesterol (LDL-C)

    Mean changes between baseline and 2 years in low density lipoprotein cholesterol: LDL-c (mg/dl)

    Measured: 2 years

  14. Mean Change in Fasting Glucose From Baseline to 2 Years

    Mean change in fasting glucose from baseline to 2 years in mg/dl for all participants with year 2 measures

    Measured: 2 years

  15. Mean Change in Fasting Insulin From Baseline to 2 Years

    Mean change in fasting insulin (uU/ml) from baseline to 2 years

    Measured: 2 years

  16. Depression Symptomatology

    Mean changes in the Center for Epidemiologic Studies Depression (CES-C) Scale. Reference: Turvey, C. L., Wallace, R. B., \& Herzog, R. (1999). A revised CES-D measure of depressive symptoms and a DSM-based measure of major depressive episodes in the elderly. Int Psychogeriatr, 11(2), 139-148. 20 item questionnaire with a possible range of scores is zero to 60, and higher scores indicating the presence of more symptomatology.

    Measured: 2 years

  17. Insulin Resistance

    We calculated homeostatic model assessment insulin resistance (HOMA-IR): fasting glucose in (mg/dl) * fasting insulin in (uU/mL).

    Measured: Change from baseline to 2 years

  18. Total Energy Dietary Intake Per Day (Kcals)

    Dietary intake was assessed using the 2005 Block Food Frequency Questionnaire (Block FFQ) at baseline and 2 years. This validated, quantitative 110-food item questionnaire is designed to assess relative intake of energy.

    REF: Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol 1990; 43:1327-1335.

    Measured: Changes from baseline to 2 years in kilocalories

  19. Change in Waist Circumference (cm)

    Waist circumference will be measured using a Gulik tape measure and following a standardized protocol. Two measures of waist circumference will be taken; if the difference exceeds 1.0 cm, a third measure will be taken. Changes are measured from baseline to year 2.

    Measured: Change from baseline to 2 years

  20. Self-weighing

    Number of days per week the participant reports weighing themselves. This is divided into two groups: 1) more than once per week and 2) no more than once per week

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completion31 Dec 2014
  4. Study completion30 Sep 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
599 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01183689
Sponsor's protocol ID
IRB00010097
Other IDs
5U01HL090875
Acronym
SNAP
Status last verified
Jan 2020
First submitted
13 Aug 2010
Last updated
14 Jan 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified data can be obtained by request, conditional on a data use agreement.

Publications

  • Hayes JF, LaRose JG, Gorin AA, Lewis CE, Bahnson J, Phelan S, Wing RR; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Weight gain prevention interventions in the Study of Novel Approaches to Weight Gain Prevention (SNAP) trial promote ideal cardiovascular health in young adults. Obesity (Silver Spring). 2023 Jun;31(6):1530-1537. doi: 10.1002/oby.23753. Epub 2023 May 8.

    PubMed 37157110

  • Corso LML, Wing RR, Tate DF, Espeland MA, Blanchard BE, McCaffery JM. Uric acid as a predictor of weight gain and cardiometabolic health in the Study of Novel Approaches to Weight Gain Prevention (SNAP) study. Int J Obes (Lond). 2022 Aug;46(8):1556-1559. doi: 10.1038/s41366-022-01131-1. Epub 2022 May 2.

    PubMed 35501471

  • Wing RR, Espeland MA, Tate DF, Perdue LH, Bahnson J, Polzien K, Robichaud EF, LaRose JG, Gorin AA, Lewis CE, Jelalian E; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Weight Gain Over 6 Years in Young Adults: The Study of Novel Approaches to Weight Gain Prevention Randomized Trial. Obesity (Silver Spring). 2020 Jan;28(1):80-88. doi: 10.1002/oby.22661.

    PubMed 31858732

  • LaRose JG, Neiberg RH, Evans EW, Tate DF, Espeland MA, Gorin AA, Perdue L, Hatley K, Lewis CE, Robichaud E, Wing RR; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Dietary outcomes within the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial. Int J Behav Nutr Phys Act. 2019 Jan 31;16(1):14. doi: 10.1186/s12966-019-0771-z.

    PubMed 30704533

  • Olson KL, Neiberg RH, Tate DF, Garcia KR, Gorin AA, Lewis CE, Unick J, Wing RR. Weight and Shape Concern Impacts Weight Gain Prevention in the SNAP Trial: Implications for Tailoring Intervention Delivery. Obesity (Silver Spring). 2018 Aug;26(8):1270-1276. doi: 10.1002/oby.22212. Epub 2018 Jun 28.

    PubMed 29956495

  • McCaffery JM, Ordovas JM, Huggins GS, Lai CQ, Espeland MA, Tate DF, Wing RR. Weight gain prevention buffers the impact of CETP rs3764261 on high density lipoprotein cholesterol in young adulthood: The Study of Novel Approaches to Weight Gain Prevention (SNAP). Nutr Metab Cardiovasc Dis. 2018 Aug;28(8):816-821. doi: 10.1016/j.numecd.2018.02.018. Epub 2018 Mar 6.

    PubMed 29699816

  • Unick JL, Lang W, Williams SE, Bond DS, Egan CM, Espeland MA, Wing RR, Tate DF; SNAP Research Group. Objectively-assessed physical activity and weight change in young adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2017 Dec 4;14(1):165. doi: 10.1186/s12966-017-0620-x.

    PubMed 29202850

  • Wing RR, Tate DF, Garcia KR, Bahnson J, Lewis CE, Espeland MA; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Improvements in Cardiovascular Risk Factors in Young Adults in a Randomized Trial of Approaches to Weight Gain Prevention. Obesity (Silver Spring). 2017 Oct;25(10):1660-1666. doi: 10.1002/oby.21917. Epub 2017 Aug 7.

    PubMed 28782918

  • Unick JL, Lang W, Tate DF, Bond DS, Espeland MA, Wing RR. Objective Estimates of Physical Activity and Sedentary Time among Young Adults. J Obes. 2017;2017:9257564. doi: 10.1155/2017/9257564. Epub 2017 Jan 2.

    PubMed 28116151

  • Crane MM, LaRose JG, Espeland MA, Wing RR, Tate DF. Recruitment of young adults for weight gain prevention: randomized comparison of direct mail strategies. Trials. 2016 Jun 8;17(1):282. doi: 10.1186/s13063-016-1411-4.

    PubMed 27278474

  • Wing RR, Tate DF, Espeland MA, Lewis CE, LaRose JG, Gorin AA, Bahnson J, Perdue LH, Hatley KE, Ferguson E, Garcia KR, Lang W; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Innovative Self-Regulation Strategies to Reduce Weight Gain in Young Adults: The Study of Novel Approaches to Weight Gain Prevention (SNAP) Randomized Clinical Trial. JAMA Intern Med. 2016 Jun 1;176(6):755-62. doi: 10.1001/jamainternmed.2016.1236.

    PubMed 27136493

  • Wing RR, Tate D, LaRose JG, Gorin AA, Erickson K, Robichaud EF, Perdue L, Bahnson J, Espeland MA. Frequent self-weighing as part of a constellation of healthy weight control practices in young adults. Obesity (Silver Spring). 2015 May;23(5):943-9. doi: 10.1002/oby.21064. Epub 2015 Apr 10.

    PubMed 25865175

  • Tate DF, LaRose JG, Griffin LP, Erickson KE, Robichaud EF, Perdue L, Espeland MA, Wing RR. Recruitment of young adults into a randomized controlled trial of weight gain prevention: message development, methods, and cost. Trials. 2014 Aug 16;15:326. doi: 10.1186/1745-6215-15-326.

    PubMed 25128185

  • Wing RR, Tate D, Espeland M, Gorin A, LaRose JG, Robichaud EF, Erickson K, Perdue L, Bahnson J, Lewis CE. Weight gain prevention in young adults: design of the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial. BMC Public Health. 2013 Apr 4;13:300. doi: 10.1186/1471-2458-13-300.

    PubMed 23556505

Questions about this trial

What is this clinical trial studying?

A study testing Small Behavior Changes and Large Behavior Changes in people with Weight Gain, run by Wake Forest University at 2 sites 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 1 inclusion and 18 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 7 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Weight Changes From Baseline Over Follow-up. (time frame: 3 years). 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 NCT01183689, which also lists 14 linked publications.

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 14 Jan 2020.

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