Obesity, ChildhoodNCT05622981
Pediatric Obesity Management Study
A study testing Age-specific educational materials and monitoring in people with Obesity, Childhood and Behavior, Eating, run by Corewell Health East at 1 site in United States.
Trial summary
Childhood obesity is a critical public health issue. Obesity in childhood is associated with many complications, including high blood pressure, type II diabetes mellitus, abnormal blood lipid values, obstructive sleep apnea, development of fatty liver, anxiety and depression. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Obesity, Childhood, Behavior, Eating
- What is being tested?
- Age-specific educational materials and monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 20 Mar 2024
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients presenting to the Beaumont Pediatric Outpatient Clinic, Royal Oak, Michigan for a health maintenance or acute care visit
- Patient age 2-17 years
- Patients with BMI equal to or greater than the 85th percentile
Who cannot join
- Patients less than 2 years
- Patients greater than 17 years
- Patients with BMI less than 85th percentile
- Patients who are pregnant
- Decisionally-impaired individuals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Obesity Management Pilot Study
Childhood obesity is a critical public health issue. Obesity in childhood is associated with many complications, including high blood pressure, type II diabetes mellitus, abnormal blood lipid values, obstructive sleep apnea, development of fatty liver, anxiety and depression. Addressing pediatric obesity is important not only to avoid these comorbidities in childhood, but also to mitigate long-term negative health outcomes, as overweight and obese youth are likely to remain overweight or obese into adulthood. There are published guidelines, however, there is not a successful standardized approach to the management of this problem. The most studied approach to pediatric obesity is multidisciplinary, high-resource weight management programs that are unable to be conducted in the primary care setting, and the prevalence of pediatric obesity continues to increase. The purpose of this study is to create, implement and evaluate a standardized protocol for the management of pediatric obesity in a low-resource primary care setting, using age-specific educational materials and every 2-week follow-up visits focused on achieving progress toward healthy lifestyle goals. The primary outcome will be the change in subject body mass index (BMI) percentile over 24 weeks of visits to the primary care doctor at a pediatric clinic.
Read the detailed description
All patients who present to the Beaumont Pediatric Outpatient Clinic for a Health Maintenance or Acute Care visit that meet inclusion criteria will be eligible for enrollment in the study. Eligible patients and their caregivers/guardians will be approached during health maintenance or acute care visits in the Beaumont Pediatric Outpatient Clinic by their treating physician. The caregivers/guardians will be giving permission for their child's participation in the study. However, we will also obtain oral assent from patients age 8-13 and written assent from patients age 14-17.
Upon enrollment, blood tests will be ordered including a lipid panel, which measures different fats in the blood, including total cholesterol, high-density lipoprotein (HDL, the "good" cholesterol), low-density lipoprotein (LDL, the "bad" cholesterol), and smaller fats called triglycerides; alanine transaminase (ALT, a measure of liver function); and glycated hemoglobin-adult-1c (Hb A1c, a measure of sugar levels in the blood over the last three months. Each enrolled patient will receive an age-specific binder containing educational handouts. There are 11 educational handouts that have been created, edited and reviewed by the study team, and deemed readable at the first-grade level). Binders will be specific to four different age groups: age 2-4, age 5-8, age 9-11, and age 12+ to ensure the information within the binder is appropriate for the age of the child.
At each visit, starting at the enrollment visit, the patients and their family members will identify a specific goal toward implementing healthy lifestyle changes and will be encouraged to keep track of whether this goal has been achieved using the goal sheets within the binder. Follow-up visits will occur every 2 weeks for 6 months for a total of 12 visits, and a new handout will be given for the binder each time. Blood test values will be repeated as recommended by the 2023 American Academy of Pediatrics Guideline for the Evaluation and Treatment of Children and Adolescents with Obesity to evaluate for comorbidities. There will be follow-up surveys given to parents and children over the age of 12 to identify areas of improvement and barriers to healthy choices. For children 2-11 the parents will be provided the survey.
This study is classified as a single-arm interventional study because all patients are assigned to behavioral intervention per the study protocol, and there is no comparator group. Participant data will be reported based on age ranges specified in the protocol.
- Conditions
- Obesity, Childhood, Behavior, Eating
- Being tested
- Age-specific educational materials and monitoring
- Keywords
- overweight, children, hypertension, elevated body mass index, type II diabetes, dyslipidemia, obstructive sleep apnea, primary care interventions
- Medical subject headings
- Pediatric Obesity, Feeding Behavior, Overweight, Hypertension, Diabetes Mellitus, Type 2, Dyslipidemias, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Age-specific educational materials and monitoringBehavioural
Subjects will receive age-specific behavioral modification and educational materials plus every 2-week monitoring for goals and progress at reducing BMI for 24 weeks in the pediatric primary care clinic.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral intervention for healthy lifestyle goals, four analysis groups divided by age (2-4, 5-8, 9-11, 12-17) Receives: Behavioral: Age-specific educational materials and monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body mass index (BMI) percentile at 24 weeks
BMI will be calculated from height and weight using the formula BMI=(weight in kilograms)/(height in meters)squared, and BMI-for-age percentile determined based on the Centers for Disease Control (CDC) standardized growth charts. BMI percentile at study enrollment (baseline) will be subtracted from BMI percentile measured at the 24-week visit to calculate change in BMI percentile. Negative numbers will indicate a decrease in BMI percentile over time, while positive numbers will indicate an increase in BMI percentile over the study period.
Measured: Baseline to 24 weeks
Secondary outcomes (21)
Change in systolic blood pressure percentile at 24 weeks
Systolic blood pressure will be measured at study enrollment (baseline) and at the 24-week visit, and the blood pressure-for-age percentile determined using 2017 American Academy of Pediatrics (AAP) Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. The change in blood pressure percentile will be calculated by subtracting the systolic blood pressure percentile at baseline from the systolic blood pressure percentile at 24 weeks. Negative numbers will indicate a decrease in systolic blood pressure percentile, while positive numbers will indicate an increase in systolic blood pressure percentile over the study period.
Measured: baseline to 24 weeks
Change in diastolic blood pressure percentile at 24 weeks
Diastolic blood pressure will be measured at study enrollment (baseline) and at the 24-week visit, and the blood pressure-for-age percentile determined using 2017 American Academy of Pediatrics (AAP) Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. The change in blood pressure percentile will be calculated by subtracting the diastolic blood pressure percentile at baseline from the diastolic blood pressure percentile at 24 weeks. Negative numbers will indicate a decrease in diastolic blood pressure percentile, while positive numbers will indicate an increase in diastolic blood pressure percentile over the study period.
Measured: baseline to 24 weeks
Change in serum total cholesterol at 24 weeks
Total cholesterol will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the total cholesterol at baseline from the total cholesterol at 24 weeks. Negative numbers will indicate a decrease in total cholesterol, while positive numbers will indicate an increase in total cholesterol over the study period.
Measured: baseline to 24 weeks
Change in serum high-density lipoprotein (HDL) at 24 weeks
HDL will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the HDL at baseline from the HDL at 24 weeks. Negative numbers will indicate a decrease in HDL, while positive numbers will indicate an increase in HDL over the study period.
Measured: baseline to 24 weeks
Change in serum low-density lipoprotein (LDL) at 24 weeks
LDL will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the LDL at baseline from the LDL at 24 weeks. Negative numbers will indicate a decrease in LDL, while positive numbers will indicate an increase in LDL over the study period.
Measured: baseline to 24 weeks
Change in serum non-high density lipoprotein-cholesterol (non-HDL-c) at 24 weeks
Non-HDL-c will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the non-HDL-c at baseline from the non-HDL-c at 24 weeks. Negative numbers will indicate a decrease in non-HDL-c, while positive numbers will indicate an increase in non-HDL-c over the study period.
Measured: baseline to 24 weeks
Change in serum triglycerides at 24 weeks
Triglycerides will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the triglycerides at baseline from the triglycerides at 24 weeks. Negative numbers will indicate a decrease in triglycerides, while positive numbers will indicate an increase in triglycerides over the study period.
Measured: baseline to 24 weeks
Change in serum glycated hemoglobin-adult1c (HbA1c) at 24 weeks
HbA1c will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the HbA1c at baseline from the HbA1c at 24 weeks. Negative numbers will indicate a decrease in HbA1c, while positive numbers will indicate an increase in HbA1c over the study period.
Measured: baseline to 24 weeks
Change in serum alanine transaminase (ALT) at 24 weeks
ALT will be measured at study enrollment (baseline) and at the 24-week visit, and the difference calculated by subtracting the ALT at baseline from the ALT at 24 weeks. Negative numbers will indicate a decrease in ALT, while positive numbers will indicate an increase in ALT over the study period.
Measured: baseline to 24 weeks
Child feedback regarding health improvement
Proportion of children responding "yes" to the feedback survey question, "I feel better since starting to focus on a healthy lifestyle." This outcome will be collected only for children age 12 and older.
Measured: 24 weeks
Child feedback regarding exercise
Proportion of children responding "yes" to the feedback survey question, "I have been able to do 60 minutes of exercise daily." This outcome will be collected only for children age 12 and older.
Measured: 24 weeks
Child feedback regarding sleep
Proportion of children responding "yes" to the feedback survey question, "I am getting at least 8 hours of sleep every night." This outcome will be collected only for children age 12 and older.
Measured: 24 weeks
Child feedback regarding binder material
Proportion of children responding "yes" to the feedback survey question, "I have learned something new from the binder materials." This outcome will be collected only for children age 12 and older.
Measured: 24 weeks
Parent feedback regarding healthy eating
Parent feedback to the question, "I am learning about healthy eating," on a follow-up survey will be scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program. The median response will be reported.
Measured: 24 weeks
Proportion of parents with positive response in feedback about healthy eating
Proportion of parents responding 4 or 5 ("Agree" or "Strongly agree") to the feedback survey question "I am learning about healthy eating," on a follow-up survey scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program.
Measured: 24 weeks
Parent feedback regarding healthy changes in the child
Parent feedback to the question "I am seeing some healthy changes in my child," on a follow-up survey will be scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program. The median response will be reported.
Measured: 24 weeks
Proportion of parents with positive response in feedback about healthy changes in the child
Proportion of parents responding 4 or 5 ("Agree" or "Strongly agree") to the feedback survey question "I am seeing some healthy changes in my child," on a follow-up survey scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program.
Measured: 24 weeks
Parent feedback regarding utility of binder information
Parent feedback to the question "The information in the binder is helpful," on a follow-up survey will be scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program. The median response will be reported.
Measured: 24 weeks
Proportion of parents with positive response in feedback about utility of binder information
Proportion of parents responding 4 or 5 ("Agree" or "Strongly agree") to the feedback survey question "The information in the binder is helpful," on a follow-up survey scored on a Likert scale from 1-5, where 1 is "Strongly disagree" and indicates dissatisfaction with this aspect of the program, and 5 is "Strongly agree" and indicates satisfaction with this aspect of the program.
Measured: 24 weeks
Parent-identified barriers to behavioral changes
A list of potential barriers to lifestyle changes will be provided to parents in the feedback survey. The proportion of parents identifying each barrier will be reported.
Measured: 24 weeks
Adherence to follow-up scheduling
The proportion of visits attended out of all visits scheduled during the study period will be reported.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start20 Mar 2023
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Why it stopped: limitations in staff and resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, non-blinded, non-randomized, behavioral intervention with no comparator arms.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerry Mychaliska, Corewell Health East
- Investigators
- Kerry Mychaliksa, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622981
- Sponsor's protocol ID
- 2022-057
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Obesity Management Pilot Study
- ClinicalTrials.gov ID
- NCT05622981
- Acronym / sponsor ID
- 2022-057
- Conditions
- Obesity, Childhood, Behavior, Eating
- Keywords
- overweight, children, hypertension, elevated body mass index, type II diabetes, dyslipidemia, obstructive sleep apnea, primary care interventions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: limitations in staff and resources
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 21 Nov 2022 (actual)
- 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.
Childhood obesity is a critical public health issue. Obesity in childhood is associated with many complications, including high blood pressure, type II diabetes mellitus, abnormal blood lipid values, obstructive sleep apnea, development of fatty liver, anxiety and depression. Addressing pediatric obesity is important not only to avoid these comorbidities in childhood, but also to mitigate long-term negative health outcomes, as overweight and obese youth are likely to remain overweight or obese into adulthood. There are published guidelines, however, there is not a successful standardized approach to the management of this problem. The most studied approach to pediatric obesity is multidisciplinary, high-resource weight management programs that are unable to be conducted in the primary care setting, and the prevalence of pediatric obesity continues to increase. The purpose of this study is to create, implement and evaluate a standardized protocol for the management of pediatric obesity in a low-resource primary care setting, using age-specific educational materials and every 2-week follow-up visits focused on achieving progress toward healthy lifestyle goals. The primary outcome will be the change in subject body mass index (BMI) percentile over 24 weeks of visits to the primary care doctor at a pediatric clinic.
Detailed description
All patients who present to the Beaumont Pediatric Outpatient Clinic for a Health Maintenance or Acute Care visit that meet inclusion criteria will be eligible for enrollment in the study. Eligible patients and their caregivers/guardians will be approached during health maintenance or acute care visits in the Beaumont Pediatric Outpatient Clinic by their treating physician. The caregivers/guardians will be giving permission for their child's participation in the study. However, we will also obtain oral assent from patients age 8-13 and written assent from patients age 14-17.
Upon enrollment, blood tests will be ordered including a lipid panel, which measures different fats in the blood, including total cholesterol, high-density lipoprotein (HDL, the "good" cholesterol), low-density lipoprotein (LDL, the "bad" cholesterol), and smaller fats called triglycerides; alanine transaminase (ALT, a measure of liver function); and glycated hemoglobin-adult-1c (Hb A1c, a measure of sugar levels in the blood over the last three months. Each enrolled patient will receive an age-specific binder containing educational handouts. There are 11 educational handouts that have been created, edited and reviewed by the study team, and deemed readable at the first-grade level). Binders will be specific to four different age groups: age 2-4, age 5-8, age 9-11, and age 12+ to ensure the information within the binder is appropriate for the age of the child.
At each visit, starting at the enrollment visit, the patients and their family members will identify a specific goal toward implementing healthy lifestyle changes and will be encouraged to keep track of whether this goal has been achieved using the goal sheets within the binder. Follow-up visits will occur every 2 weeks for 6 months for a total of 12 visits, and a new handout will be given for the binder each time. Blood test values will be repeated as recommended by the 2023 American Academy of Pediatrics Guideline for the Evaluation and Treatment of Children and Adolescents with Obesity to evaluate for comorbidities. There will be follow-up surveys given to parents and children over the age of 12 to identify areas of improvement and barriers to healthy choices. For children 2-11 the parents will be provided the survey.
This study is classified as a single-arm interventional study because all patients are assigned to behavioral intervention per the study protocol, and there is no comparator group. Participant data will be reported based on age ranges specified in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, non-blinded, non-randomized, behavioral intervention with no comparator arms.
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: Age-specific educational materials and monitoringBehavioral intervention for healthy lifestyle goals, four analysis groups divided by age (2-4, 5-8, 9-11, 12-17) |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients presenting to the Beaumont Pediatric Outpatient Clinic, Royal Oak, Michigan for a health maintenance or acute care visit
- Patient age 2-17 years
- Patients with BMI equal to or greater than the 85th percentile
Key exclusion criteria (5 listed)
- Patients less than 2 years
- Patients greater than 17 years
- Patients with BMI less than 85th percentile
- Patients who are pregnant
- Decisionally-impaired individuals
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 |
|---|---|---|
| Age-specific educational materials and monitoringSubjects will receive age-specific behavioral modification and educational materials plus every 2-week monitoring for goals and progress at reducing BMI for 24 weeks in the pediatric primary care clinic. | Behavioural | Behavioral intervention |
Primary outcome
Change from baseline body mass index (BMI) percentile at 24 weeks
Time frame: Baseline to 24 weeks
BMI will be calculated from height and weight using the formula BMI=(weight in kilograms)/(height in meters)squared, and BMI-for-age percentile determined based on the Centers for Disease Control (CDC) standardized growth charts. BMI percentile at study enrollment (baseline) will be subtracted from BMI percentile measured at the 24-week visit to calculate change in BMI percentile. Negative numbers will indicate a decrease in BMI percentile over time, while positive numbers will indicate an increase in BMI percentile over the study period.
21 secondary outcomes
Change in systolic blood pressure percentile at 24 weeks
Time frame: baseline to 24 weeks
Change in diastolic blood pressure percentile at 24 weeks
Time frame: baseline to 24 weeks
Change in serum total cholesterol at 24 weeks
Time frame: baseline to 24 weeks
Change in serum high-density lipoprotein (HDL) at 24 weeks
Time frame: baseline to 24 weeks
Change in serum low-density lipoprotein (LDL) at 24 weeks
Time frame: baseline to 24 weeks
Change in serum non-high density lipoprotein-cholesterol (non-HDL-c) at 24 weeks
Time frame: baseline to 24 weeks
Change in serum triglycerides at 24 weeks
Time frame: baseline to 24 weeks
Change in serum glycated hemoglobin-adult1c (HbA1c) at 24 weeks
Time frame: baseline to 24 weeks
Change in serum alanine transaminase (ALT) at 24 weeks
Time frame: baseline to 24 weeks
Child feedback regarding health improvement
Time frame: 24 weeks
Child feedback regarding exercise
Time frame: 24 weeks
Child feedback regarding sleep
Time frame: 24 weeks
Child feedback regarding binder material
Time frame: 24 weeks
Parent feedback regarding healthy eating
Time frame: 24 weeks
Proportion of parents with positive response in feedback about healthy eating
Time frame: 24 weeks
Parent feedback regarding healthy changes in the child
Time frame: 24 weeks
Proportion of parents with positive response in feedback about healthy changes in the child
Time frame: 24 weeks
Parent feedback regarding utility of binder information
Time frame: 24 weeks
Proportion of parents with positive response in feedback about utility of binder information
Time frame: 24 weeks
Parent-identified barriers to behavioral changes
Time frame: 24 weeks
Adherence to follow-up scheduling
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: limitations in staff and resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Obesity, Childhood
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
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.
Kerry Mychaliksa, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Age-specific educational materials and monitoring in people with Obesity, Childhood and Behavior, Eating, run by Corewell Health East 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Apr 2024. 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 was stopped early (reason given: limitations in staff and resources). Results are not available in the source record.
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 from baseline body mass index (BMI) percentile at 24 weeks (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2024.