Evidence of an Intervention on Childhood BMI z ScoreNCT01397123
The Impact of an Intervention Taught by Trained Teachers on Childhood BMI z Score
A study testing Training teachers on healthier lifestyles in people with Evidence of an Intervention on Childhood BMI z Score, run by University of Minho at 1 site in Portugal.
Trial summary
The purpose of this study is to assess the effects of a six months nutrition intervention, delivered and taught by classroom teachers with in-service nutrition training, on the prevention of overweight and obesity among children in grades 1 to 4. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Evidence of an Intervention on Childhood BMI z Score
- What is being tested?
- Training teachers on healthier lifestyles
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2007to Jun 2009
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from the schools involved in the study with informed consent provided by parents.
Who cannot join
- Age more than 12
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Santos Simões group of schools
Guimarães, Braga District, 4810
About this study
The purpose of this study is to assess the effects of a six months nutrition intervention, delivered and taught by classroom teachers with in-service nutrition training, on the prevention of overweight and obesity among children in grades 1 to 4.
In this randomized controlled trial, 464 children from seven elementary schools were allocated to a six months nutrition educational intervention by their own teachers or to standard care. Intervened teachers had 12 sessions of three hours each with the researchers throughout six months, according to the following topics: nutrition and healthy eating (sessions 1 to 4); the importance of drinking water (session 5); strategies to encourage fruits and vegetables consumption and to decrease high energy-density foods intake (sessions 6 to 8); strategies to increase physical activity (sessions 9 and 10); and healthy cooking activities (sessions 11 and 12). After each session, teachers were encouraged to develop activities in class that focused on the learned topics. Sociodemographic, anthropometric, dietary, and physical activity assessments were performed at baseline and the end of intervention.
Read more
We expect that fewer intervened children become overweight and the consumption of fruit and vegetables will be higher. In addition, we expect a less consumption of low-nutrition high dense foods.
We also expect to provide further support to decrease overweight epidemic, involving classroom teachers in a training intervention and making them dedicated interventionists.
Read the detailed description
The prevalence of obesity continues to increase (Ogden et al., 2006) and is growing concerns in Portugal and in the world. As successful treatments have been elusive, the prevention should be considered a high priority. So, present efforts are being dedicated to develop and implement overweight and obesity prevention interventions (Gortmaker, et al, 1999; James, Tomas \& Kerr, 2004), in the hope that multilevel approach, if occur early in childhood, may improve eating habits and physical activity and therefore, contribute to prevent or reverse this epidemic state.
In each school, previously trained persons performed anthropometric evaluation, using standardized procedures (WHO Expert Commitee 1995). Anthropometric measurements were performed in children with light indoor clothing and barefooted. Weight was measured in an electronic scale, with an error of ±100g (Seca, Model 703, Germany), and height was measured using a stadiometer, with the head in the Frankfort plane. BMI was computed as mass, Kg/height, m2. The prevalence of underweight, normal weight, overweight and obesity was calculated according to the International Obesity Task Force (IOTF) criteria, making a correspondence between the traditional adult cut-off and specific values for children according to gender and age (Cole et al. 2000). A z-score (the number of standard deviations (SD) from the reference population) was calculated for each child using the LMS method and the calculation was determined using the LMS growth add-in for excel (Pan and Cole 2009).
Dietary intake was gathered by 24h dietary recalls obtained by nutritionists and/or trained interviewers. We assessed a single recall before and another after the intervention. The respondents had no prior notification of when the recalls would occur. Training of interviewers included practice using photos and food models to quantify portion sizes, experience in probing information from children without suggesting responses as well as the type of food consumed in detail of fat content, brand name, constituents of mixed dishes and so on. The 24h dietary recall is the most commonly used dietary assessment method because it is easy to administer, can be performed in large-scale studies (Kranz and Sie-Riz 2002, Gomez-Martínez et al. 2009), and can be used to assess adequacy of energy and macronutrient intakes. During the 24h dietary recall, each child was asked to recall all food and beverages consumed during the past 24h. Daily routines were used as prompts (waking up, going to bed, time between classes, and before or after school) to enhance recall. Portion sizes of foods and beverages consumed were also estimated using food models, photos and other props (cups, glasses, food wrappers or containers) as an aid in determining serving sizes. Energy and nutritional intake were estimated using an adapted Portuguese version of the nutritional analysis software Food Processor Plus (ESHA Research Inc., Salem, OR, USA). The 24-hour dietary recall interviews captured the time and name of each eating occasion, the foods and beverages reported at each eating occasion, and the source from which item was obtained.
In order to assess the level of physical activity of children, parents were asked five questions with four answer choices (4-point scale) ranging from 0 (very seldom) to 4 (very often): a) Outside the school does your child take part in organized sport? b) Outside school does your child take part in non-organized sport? c) Outside school, how many times a week does your child take part in sport or physical activity for at least 20 minutes? d) Outside school hours, how many hours a week does your child usually take part in physical activity so much that he gets out of breath or sweat? e) Does your child take part in competitive sport? (Mota and Esculcas 2002). The total sum of the points was computed reaching a maximum of 20 points. To express the activity levels, a Physical Activity Index was obtained, which divided the sample into four activity classes: sedentary group (0-5); low activity group (6-10); moderately active group (11-15); and vigorously active group (16-20), on the basis of their reported physical activity (Mota and Esculcas 2002).
Social, demographic and family characteristics were assessed by questionnaire. The survey sent to parents contained questions about gender and age of children, education of the parents (recorded in five categories: 0, 1-4, 5-9, 10-12, and more than 12 years of formal education). This information was further grouped for analysis into three categories: up to 9 years, 10-12 years, and more than 12 years of education.
The research team proposed, in January 2008, the accreditation of the sessions that were developed with the teachers to the Minister of Education, Scientific-Pedagogic Council for In-service Training (Conselho Científico Pedagógico da Formação Contínua, Ministério da Educação). This proposal was approved in September 2008 in the form of "training workshop" with 72 hours duration, distributed by active learning strategies (36 hours) and work contact with the children (36 hours). Teachers of the intervention group had 12 sessions of three hours each with the researchers throughout six months, which included the following topics: nutrition and healthy eating for the children and the families (sessions 1 to 4); the importance of the water (session 5); strategies to encourage fruits and vegetables consumption and to decrease high energy density foods intake (sessions 6 to 8); to increase physical activity and to reduce screen time exposure (sessions 9 and 10); and healthy cooking (sessions 11 and 12). After each session, teachers resend the learned contents to develop creative and engaging classroom activities about the addressed topic. All the questions that arose during the implementation of classroom activities were addressed and resolved shortly with the researchers. Teachers were allowed to develop and refine the activities and learning strategies that were proposed by researchers. At the end of this period, the teachers delivered a critical report of activities focused on the work contact with children.
The data analysis was performed using SPSS ®, Version 18.0 (SPSS Inc; Chicago, IL).
- Being tested
- Training teachers on healthier lifestyles
- Keywords
- BMI z-score, children, overweight, school-based intervention, trained teachers, fruit, vegetables, Low nutrition energy dense foods
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training teachers on healthier lifestylesOther
During 2007/2008 seven out of eighty public elementary public schools from Guimarães (Portugal) were invited to participate in this study. The number of schools involved was according to constraints of personnel for the assessment and intervention. Schools were the unit of randomization and three were assigned into intervention, and four into control group. Data was collected prior to intervention and immediately after, during the year 2009 (post-intervention). Prior to participation on data collection, parents provided informed consent, and children provided oral assent.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Other: Training teachers on healthier lifestyles |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z score
Measured: the first 3 months after the intervention
Secondary outcomes (1)
dietary intake
Measured: within the first 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startSep 2007
- Primary completionJun 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Evidence of an Intervention on Childhood BMI z ScoreStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Porto
- Investigators
- Pedro Moreira, PhD, Study director, Universidade do PortoBeatriz Pereira, PhD, Study director, University of MinhoRafaela V Rosario, Principal investigator, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397123
- Sponsor's protocol ID
- 1845
- Other IDs
- 7613/2008
- Status last verified
- Jul 2011
- First submitted
- 28 Jun 2011
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. doi: 10.1136/bmj.320.7244.1240.
PubMed 10797032Kranz S, Siega-Riz AM. Sociodemographic determinants of added sugar intake in preschoolers 2 to 5 years old. J Pediatr. 2002 Jun;140(6):667-72. doi: 10.1067/mpd.2002.124307.
PubMed 12072868Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PubMed 16595758Goldberg GR, Black AE, Jebb SA, Cole TJ, Murgatroyd PR, Coward WA, Prentice AM. Critical evaluation of energy intake data using fundamental principles of energy physiology: 1. Derivation of cut-off limits to identify under-recording. Eur J Clin Nutr. 1991 Dec;45(12):569-81.
PubMed 1810719Gomez-Martinez S, Martin A, Romeo J, Castillo M, Mesena M, Baraza JC, Jimenez-Pavon D, Redondo C, Zamora S, Marcos A. Is soft drink consumption associated with body composition? A cross-sectional study in Spanish adolescents. Nutr Hosp. 2009 Jan-Feb;24(1):97-102.
PubMed 19266121Mota J, Esculcas C. Leisure-time physical activity behavior: structured and unstructured choices according to sex, age, and level of physical activity. Int J Behav Med. 2002;9(2):111-21. doi: 10.1207/s15327558ijbm0902_03.
PubMed 12174530Schofield WN. Predicting basal metabolic rate, new standards and review of previous work. Hum Nutr Clin Nutr. 1985;39 Suppl 1:5-41.
PubMed 4044297Rosario R, Araujo A, Padrao P, Lopes O, Moreira A, Pereira B, Moreira P. Health Promotion Intervention to Improve Diet Quality in Children. Health Promot Pract. 2017 Mar;18(2):253-262. doi: 10.1177/1524839916634096. Epub 2016 Jul 9.
PubMed 27095035
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Intervention Taught by Trained Teachers on Childhood BMI z Score
- ClinicalTrials.gov ID
- NCT01397123
- Acronym / sponsor ID
- 1845
- Keywords
- BMI z-score, children, overweight, school-based intervention, trained teachers, fruit, vegetables, Low nutrition energy dense foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Collaborators
- Universidade do Porto
- Study start
- Sep 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Jul 2011 (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 purpose of this study is to assess the effects of a six months nutrition intervention, delivered and taught by classroom teachers with in-service nutrition training, on the prevention of overweight and obesity among children in grades 1 to 4.
In this randomized controlled trial, 464 children from seven elementary schools were allocated to a six months nutrition educational intervention by their own teachers or to standard care. Intervened teachers had 12 sessions of three hours each with the researchers throughout six months, according to the following topics: nutrition and healthy eating (sessions 1 to 4); the importance of drinking water (session 5); strategies to encourage fruits and vegetables consumption and to decrease high energy-density foods intake (sessions 6 to 8); strategies to increase physical activity (sessions 9 and 10); and healthy cooking activities (sessions 11 and 12). After each session, teachers were encouraged to develop activities in class that focused on the learned topics. Sociodemographic, anthropometric, dietary, and physical activity assessments were performed at baseline and the end of intervention.
We expect that fewer intervened children become overweight and the consumption of fruit and vegetables will be higher. In addition, we expect a less consumption of low-nutrition high dense foods.
We also expect to provide further support to decrease overweight epidemic, involving classroom teachers in a training intervention and making them dedicated interventionists.
Detailed description
The prevalence of obesity continues to increase (Ogden et al., 2006) and is growing concerns in Portugal and in the world. As successful treatments have been elusive, the prevention should be considered a high priority. So, present efforts are being dedicated to develop and implement overweight and obesity prevention interventions (Gortmaker, et al, 1999; James, Tomas \& Kerr, 2004), in the hope that multilevel approach, if occur early in childhood, may improve eating habits and physical activity and therefore, contribute to prevent or reverse this epidemic state.
In each school, previously trained persons performed anthropometric evaluation, using standardized procedures (WHO Expert Commitee 1995). Anthropometric measurements were performed in children with light indoor clothing and barefooted. Weight was measured in an electronic scale, with an error of ±100g (Seca, Model 703, Germany), and height was measured using a stadiometer, with the head in the Frankfort plane. BMI was computed as mass, Kg/height, m2. The prevalence of underweight, normal weight, overweight and obesity was calculated according to the International Obesity Task Force (IOTF) criteria, making a correspondence between the traditional adult cut-off and specific values for children according to gender and age (Cole et al. 2000). A z-score (the number of standard deviations (SD) from the reference population) was calculated for each child using the LMS method and the calculation was determined using the LMS growth add-in for excel (Pan and Cole 2009).
Dietary intake was gathered by 24h dietary recalls obtained by nutritionists and/or trained interviewers. We assessed a single recall before and another after the intervention. The respondents had no prior notification of when the recalls would occur. Training of interviewers included practice using photos and food models to quantify portion sizes, experience in probing information from children without suggesting responses as well as the type of food consumed in detail of fat content, brand name, constituents of mixed dishes and so on. The 24h dietary recall is the most commonly used dietary assessment method because it is easy to administer, can be performed in large-scale studies (Kranz and Sie-Riz 2002, Gomez-Martínez et al. 2009), and can be used to assess adequacy of energy and macronutrient intakes. During the 24h dietary recall, each child was asked to recall all food and beverages consumed during the past 24h. Daily routines were used as prompts (waking up, going to bed, time between classes, and before or after school) to enhance recall. Portion sizes of foods and beverages consumed were also estimated using food models, photos and other props (cups, glasses, food wrappers or containers) as an aid in determining serving sizes. Energy and nutritional intake were estimated using an adapted Portuguese version of the nutritional analysis software Food Processor Plus (ESHA Research Inc., Salem, OR, USA). The 24-hour dietary recall interviews captured the time and name of each eating occasion, the foods and beverages reported at each eating occasion, and the source from which item was obtained.
In order to assess the level of physical activity of children, parents were asked five questions with four answer choices (4-point scale) ranging from 0 (very seldom) to 4 (very often): a) Outside the school does your child take part in organized sport? b) Outside school does your child take part in non-organized sport? c) Outside school, how many times a week does your child take part in sport or physical activity for at least 20 minutes? d) Outside school hours, how many hours a week does your child usually take part in physical activity so much that he gets out of breath or sweat? e) Does your child take part in competitive sport? (Mota and Esculcas 2002). The total sum of the points was computed reaching a maximum of 20 points. To express the activity levels, a Physical Activity Index was obtained, which divided the sample into four activity classes: sedentary group (0-5); low activity group (6-10); moderately active group (11-15); and vigorously active group (16-20), on the basis of their reported physical activity (Mota and Esculcas 2002).
Social, demographic and family characteristics were assessed by questionnaire. The survey sent to parents contained questions about gender and age of children, education of the parents (recorded in five categories: 0, 1-4, 5-9, 10-12, and more than 12 years of formal education). This information was further grouped for analysis into three categories: up to 9 years, 10-12 years, and more than 12 years of education.
The research team proposed, in January 2008, the accreditation of the sessions that were developed with the teachers to the Minister of Education, Scientific-Pedagogic Council for In-service Training (Conselho Científico Pedagógico da Formação Contínua, Ministério da Educação). This proposal was approved in September 2008 in the form of "training workshop" with 72 hours duration, distributed by active learning strategies (36 hours) and work contact with the children (36 hours). Teachers of the intervention group had 12 sessions of three hours each with the researchers throughout six months, which included the following topics: nutrition and healthy eating for the children and the families (sessions 1 to 4); the importance of the water (session 5); strategies to encourage fruits and vegetables consumption and to decrease high energy density foods intake (sessions 6 to 8); to increase physical activity and to reduce screen time exposure (sessions 9 and 10); and healthy cooking (sessions 11 and 12). After each session, teachers resend the learned contents to develop creative and engaging classroom activities about the addressed topic. All the questions that arose during the implementation of classroom activities were addressed and resolved shortly with the researchers. Teachers were allowed to develop and refine the activities and learning strategies that were proposed by researchers. At the end of this period, the teachers delivered a critical report of activities focused on the work contact with children.
The data analysis was performed using SPSS ®, Version 18.0 (SPSS Inc; Chicago, IL).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Other: Training teachers on healthier lifestyles |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children from the schools involved in the study with informed consent provided by parents.
Key exclusion criteria (1 listed)
- Age more than 12
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 |
|---|---|---|
| Training teachers on healthier lifestylesDuring 2007/2008 seven out of eighty public elementary public schools from Guimarães (Portugal) were invited to participate in this study. The number of schools involved was according to constraints of personnel for the assessment and intervention. Schools were the unit of randomization and three were assigned into intervention, and four into control group. Data was collected prior to intervention and immediately after, during the year 2009 (post-intervention). Prior to participation on data collection, parents provided informed consent, and children provided oral assent. | Other | Lifestyle counseling |
Primary outcome
BMI z score
Time frame: the first 3 months after the intervention
1 secondary outcome
dietary intake
Time frame: within the first 3 months after the intervention
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 Jul 2011.
- Background: PubMed 10797032Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. doi: 10.1136/bmj.320.7244.1240.
- Background: PubMed 12072868Kranz S, Siega-Riz AM. Sociodemographic determinants of added sugar intake in preschoolers 2 to 5 years old. J Pediatr. 2002 Jun;140(6):667-72. doi: 10.1067/mpd.2002.124307.
- Background: PubMed 16595758Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Background: PubMed 1810719Goldberg GR, Black AE, Jebb SA, Cole TJ, Murgatroyd PR, Coward WA, Prentice AM. Critical evaluation of energy intake data using fundamental principles of energy physiology: 1. Derivation of cut-off limits to identify under-recording. Eur J Clin Nutr. 1991 Dec;45(12):569-81.
- Background: PubMed 19266121Gomez-Martinez S, Martin A, Romeo J, Castillo M, Mesena M, Baraza JC, Jimenez-Pavon D, Redondo C, Zamora S, Marcos A. Is soft drink consumption associated with body composition? A cross-sectional study in Spanish adolescents. Nutr Hosp. 2009 Jan-Feb;24(1):97-102.
- Background: PubMed 12174530Mota J, Esculcas C. Leisure-time physical activity behavior: structured and unstructured choices according to sex, age, and level of physical activity. Int J Behav Med. 2002;9(2):111-21. doi: 10.1207/s15327558ijbm0902_03.
- Background: PubMed 4044297Schofield WN. Predicting basal metabolic rate, new standards and review of previous work. Hum Nutr Clin Nutr. 1985;39 Suppl 1:5-41.
- Derived from this study: PubMed 27095035Rosario R, Araujo A, Padrao P, Lopes O, Moreira A, Pereira B, Moreira P. Health Promotion Intervention to Improve Diet Quality in Children. Health Promot Pract. 2017 Mar;18(2):253-262. doi: 10.1177/1524839916634096. Epub 2016 Jul 9.
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.
Pedro Moreira, PhD study director
Universidade do Porto
Beatriz Pereira, PhD study director
University of Minho
Rafaela V Rosario principal investigator
University of Minho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training teachers on healthier lifestyles in people with Evidence of an Intervention on Childhood BMI z Score, run by University of Minho at 1 site in Portugal.
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 1 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 Jul 2011. 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 Portugal. 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?
BMI z score (time frame: the first 3 months after the intervention). 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 NCT01397123, which also lists 8 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 19 Jul 2011.