ObesityNCT02011646
Healthy Body Study
A study testing Healthy Weight in people with Obesity, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Few obesity prevention programs have produced weight gain prevention effects that persist over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in duration, making implementation difficult and costly. Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Healthy Weight
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Sep 2015
- 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 12 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ≥ 12 years old
- Body image concerns
- Sub-threshold Eating disorder symptomatology
- Overweight but not obese (BMI between the 85th and 95th percentile for children/adolescents and BMI between 25 and 30 kg/m2 for adults 21-24)
- Be able to commit to weekly 1-hour sessions for six weeks and 3 separate assessment visits to the MSAHC
Who cannot join
- Current eating disorder (anorexia nervosa, bulimia nervosa or binge eating disorder)
- absence of body image concerns
- normal or obese body weight (< 85th or ≥ 95th BMI percentile)
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Testing a Healthy Weight Intervention in Adolescents
Few obesity prevention programs have produced weight gain prevention effects that persist over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in duration, making implementation difficult and costly. The 2010 US Preventative Services Task Force (USPSTF) recommendations for treating child \& adolescent obesity state that programs should have ≥ 25 hr of comprehensive treatment including dietary, physical activity and behavioral counseling, and that programs with < 25 hr usually do not produce improvements. The implication is that, if centers cannot provide this level of service (as most cannot), it is not worth providing any kind of treatment at all. In extreme exception to this, an intensive 3-hr non-restrictive obesity prevention program involving participant-driven healthy lifestyle improvement plans designed to bring caloric intake and output into balance (Healthy Weight) has been found to significantly reduce increases in BMI and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up. We propose to test an extended 6-hr version of the Healthy Weight intervention in a sample of primarily low SES, minority adolescents and young adults who are overweight and report body dissatisfaction and subthreshold eating disorder symptoms, as these are prevalent risk factors for obesity. We will test the hypothesis that participants assigned to the Healthy Weight vs. control intervention will have significantly lower BMI and % body fat during follow-up. Secondary outcomes will include body dissatisfaction, depressive symptoms, and eating disorder symptoms. 300 adolescents and young adults at high risk for future weight gain by virtue of their age, BMI percentile, body dissatisfaction and eating disorder symptomatology will be randomized to Healthy Weight or weight control educational video. Participants will complete assessments of BMI, body composition, potential mediators, and other outcomes at pretest, posttest and 6--mo follow-ups (in yr 1). Thus, to refute the USPSTF recommendations statement, we propose to show that a 6-hr intervention led by graduate students can produce significant reductions in risk for both obesity and eating disorders, suggesting this inexpensive and brief intervention could and should be rolled out nationwide.
Primary Aim: To test the hypothesis that Healthy Weight will significantly reduce increases in BMI, % body fat, and risk for onset of obesity during follow-up.
Read more
Secondary Aim: To test the hypothesis that Healthy Weight will significantly reduce body dissatisfaction, depressive symptoms, and eating disorder symptoms.
NOTE: THIS STUDY IS ONLY OPEN TO PATIENTS AT THE MOUNT SINAI ADOLESCENT HEALTH CENTER
Read the detailed description
Obesity is associated with increased risk of mortality, atherosclerotic cerebrovascular disease, coronary heart disease, colorectal cancer and death from all causes (Flegal et al., 2005), is credited with over 111,000 deaths annually in the US (Flegal et al., 2005), shortens the lifespan by 5-20 years (Fontaine et al., 2003) and results in $150 billion in annual health-related expenditures (Finkelstein et al., 2009). Despite alarming increases in both adult and childhood obesity in recent decades, obesity rates in adolescents have grown at an even faster rate (Ogden et al., 2012; NCHS, 2012). Adolescent obesity has more than tripled in the past 30 years and continues to rise (Ogden et al., 2012; NCHS, 2012). Obese adolescents are more likely to have high cholesterol and high blood pressure, prediabetes, bone/joint problems, sleep apnea, and social and psychological problems such as stigmatization and poor self-esteem (DHHS, 2010; CDC, 2011). Unfortunately, virtually all obesity treatments result in only transient weight loss (Turk et al., 2009). Evidence suggests that it is nearly impossible for individuals to maintain behavioral weight losses once they have been obese for an extended period of time (Ochner et al., 2013). Although bariatric surgery can result in more persistent weight loss, this invasive procedure is contraindicated for numerous individuals, particularly children (Martin et al., 2010). Thus, a pressing public health priority is to develop simple and effective obesity prevention programs.
In 2010, the U.S. Preventive Services Task Force (USPSTF) issued recommendations for screening and treating childhood and adolescent obesity. They endorsed comprehensive moderate-to high intensity programs including counseling for weight loss, healthy diet, and physical activity as well as instruction and support for the use of behavioral management techniques including self-monitoring, stimulus control, eating management, contingency management, and cognitive behavioral therapy techniques. The USPSTF further defined moderate- to high-intensity programs as > 25 hr of contact and states that "such interventions would not be feasible for implementation in a primary care setting." (USPSTF, 2010, p. 365). Further, they assert that less intensive (< 25 contact hours) programs do not produce significant improvements. "Low-intensity interventions, defined as < 25 contact hours over a 6-month period, did not result in significant improvement in weight status" (USPSTF, 2010, p. 364). The implication is that, since most centers cannot provide this level of service, it is not worthwhile for adolescent health centers to provide any kind of obesity intervention at all. According to the USPSTF's website, "its recommendations are considered the gold standard for clinical preventive services." Such recommendations could discourage the testing and implementation of brief interventions designed to prevent obesity. Thus, to refute USPSTF statement, we propose to show that a 6-hr intervention led by graduate students can produce significant reductions in risk for both obesity and eating disorders, suggesting that this brief and inexpensive intervention could and should be rolled out nationwide.
- Conditions
- Obesity
- Being tested
- Healthy Weight, Controlled Intervention
- Keywords
- diet, body weight, eating, eating disorder, exercise
- Medical subject headings
- Obesity, Body Weight, Feeding and Eating Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy WeightBehavioural
The PI will train 4 group leaders to deliver the intervention. Groups will be offered four times per week and consist of approximately 10 participants. Each group will be led by 2 group leaders and each group leader will lead two sessions per week during the 2.5 mo intervention period. Group leaders will digitally video-record all sessions of the first two groups they deliver so the PI can provide supervision and rate fidelity and competence for a random selection of 6 of these 12 sessions. Group leaders will transmit the video recordings via an encrypted, secure internet connection to Dr. Ochner (who was trained by Dr. Eric Stice, the creator of the intervention) within 3 d for supervision, and competence and fidelity assessments.
Controlled InterventionBehavioural
"The Weight of the World" is a 51 min documentary focusing on the topics of obesity and healthy living. Via information presented by medical professionals and lifestyle experts, this film delves into issues related to preventing and combating obesity. Major topics include the importance of healthy eating and exercise behaviors and the changes that can be made by communities to reshape our lifestyles. Participants will be given a copy of the DVD. They will also be given the choice to stream it free on the web.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Weight | Experimental | intervention four times per week and consist of approximately 10 participants. Receives: Behavioral: Healthy Weight |
| Controlled Intervention | Active comparator | Participants will be given a copy of the DVD. They will also be given the choice to stream it free on the web. Receives: Behavioral: Controlled Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Height will be measured to the nearest millimeter using a direct reading stadiometer. Weight will be assessed to the nearest 0.1 kg using a digital scale (Tanita TBF-300A) with participants wearing light clothing without shoes or coats.
Measured: baseline
Body Mass Index (BMI)
Height will be measured to the nearest millimeter using a direct reading stadiometer. Weight will be assessed to the nearest 0.1 kg using a digital scale (Tanita TBF-300A) with participants wearing light clothing without shoes or coats.
Measured: at 5 min post intervention
Body Mass Index (BMI)
Height will be measured to the nearest millimeter using a direct reading stadiometer. Weight will be assessed to the nearest 0.1 kg using a digital scale (Tanita TBF-300A) with participants wearing light clothing without shoes or coats.
Measured: 6 month follow-up
Body Fat
Body Fat - We will use bioelectrical impedance analysis (BIA) using the Tanita TBF-300A Body Composition Analyzer to assess % body fat to maximize our sensitivity to predict increases in body fat and obesity onset. Two measures will be averaged.
Measured: baseline
Body Fat
Body Fat - We will use bioelectrical impedance analysis (BIA) using the Tanita TBF-300A Body Composition Analyzer to assess % body fat to maximize our sensitivity to predict increases in body fat and obesity onset. Two measures will be averaged.
Measured: at 5 min post intervention
Body Fat
Body Fat - We will use bioelectrical impedance analysis (BIA) using the Tanita TBF-300A Body Composition Analyzer to assess % body fat to maximize our sensitivity to predict increases in body fat and obesity onset. Two measures will be averaged.
Measured: 6 month follow up
Secondary outcomes (6)
Body Dissatisfaction
an adapted form of the Satisfaction and Dissatisfaction with Body Parts Scale to assess body satisfaction (Berscheid et al., 1973). It asks respondents to rate their level of satisfaction with nine body parts on 6-point scales ranging from "extremely satisfied" to "extremely dissatisfied." This scale has shown excellent internal consistency, temporal reliability, predictive validity for eating disorder symptom onset, and sensitivity to intervention effects (Stice et al., 2006; 2008; 2012).
Measured: baseline
Body Dissatisfaction
an adapted form of the Satisfaction and Dissatisfaction with Body Parts Scale to assess body satisfaction (Berscheid et al., 1973). It asks respondents to rate their level of satisfaction with nine body parts on 6-point scales ranging from "extremely satisfied" to "extremely dissatisfied." This scale has shown excellent internal consistency, temporal reliability, predictive validity for eating disorder symptom onset, and sensitivity to intervention effects (Stice et al., 2006; 2008; 2012).
Measured: at 5 min post intervention
Body Dissatisfaction
an adapted form of the Satisfaction and Dissatisfaction with Body Parts Scale to assess body satisfaction (Berscheid et al., 1973). It asks respondents to rate their level of satisfaction with nine body parts on 6-point scales ranging from "extremely satisfied" to "extremely dissatisfied." This scale has shown excellent internal consistency, temporal reliability, predictive validity for eating disorder symptom onset, and sensitivity to intervention effects (Stice et al., 2006; 2008; 2012).
Measured: at 6 months follow up
Eating Disorders
Measured: baseline
Eating Disorders
Measured: at 5 min post intervention
Eating Disorders
Measured: at 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: The PI changed institutions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Ochner, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011646
- Sponsor's protocol ID
- GCO 13-0765
- Status last verified
- Feb 2016
- First submitted
- 10 Dec 2013
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Healthy Weight Intervention in Adolescents
- ClinicalTrials.gov ID
- NCT02011646
- Acronym / sponsor ID
- GCO 13-0765
- Conditions
- Obesity
- Keywords
- diet, body weight, eating, eating disorder, exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI changed institutions
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Dec 2013 (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.
Few obesity prevention programs have produced weight gain prevention effects that persist over long-term follow-up and those that have are extremely lengthy, averaging 52 hr in duration, making implementation difficult and costly. The 2010 US Preventative Services Task Force (USPSTF) recommendations for treating child \& adolescent obesity state that programs should have ≥ 25 hr of comprehensive treatment including dietary, physical activity and behavioral counseling, and that programs with < 25 hr usually do not produce improvements. The implication is that, if centers cannot provide this level of service (as most cannot), it is not worth providing any kind of treatment at all. In extreme exception to this, an intensive 3-hr non-restrictive obesity prevention program involving participant-driven healthy lifestyle improvement plans designed to bring caloric intake and output into balance (Healthy Weight) has been found to significantly reduce increases in BMI and obesity onset relative to alternative interventions and assessment-only controls through 3-yr follow-up. We propose to test an extended 6-hr version of the Healthy Weight intervention in a sample of primarily low SES, minority adolescents and young adults who are overweight and report body dissatisfaction and subthreshold eating disorder symptoms, as these are prevalent risk factors for obesity. We will test the hypothesis that participants assigned to the Healthy Weight vs. control intervention will have significantly lower BMI and % body fat during follow-up. Secondary outcomes will include body dissatisfaction, depressive symptoms, and eating disorder symptoms. 300 adolescents and young adults at high risk for future weight gain by virtue of their age, BMI percentile, body dissatisfaction and eating disorder symptomatology will be randomized to Healthy Weight or weight control educational video. Participants will complete assessments of BMI, body composition, potential mediators, and other outcomes at pretest, posttest and 6--mo follow-ups (in yr 1). Thus, to refute the USPSTF recommendations statement, we propose to show that a 6-hr intervention led by graduate students can produce significant reductions in risk for both obesity and eating disorders, suggesting this inexpensive and brief intervention could and should be rolled out nationwide.
Primary Aim: To test the hypothesis that Healthy Weight will significantly reduce increases in BMI, % body fat, and risk for onset of obesity during follow-up.
Secondary Aim: To test the hypothesis that Healthy Weight will significantly reduce body dissatisfaction, depressive symptoms, and eating disorder symptoms.
NOTE: THIS STUDY IS ONLY OPEN TO PATIENTS AT THE MOUNT SINAI ADOLESCENT HEALTH CENTER
Detailed description
Obesity is associated with increased risk of mortality, atherosclerotic cerebrovascular disease, coronary heart disease, colorectal cancer and death from all causes (Flegal et al., 2005), is credited with over 111,000 deaths annually in the US (Flegal et al., 2005), shortens the lifespan by 5-20 years (Fontaine et al., 2003) and results in $150 billion in annual health-related expenditures (Finkelstein et al., 2009). Despite alarming increases in both adult and childhood obesity in recent decades, obesity rates in adolescents have grown at an even faster rate (Ogden et al., 2012; NCHS, 2012). Adolescent obesity has more than tripled in the past 30 years and continues to rise (Ogden et al., 2012; NCHS, 2012). Obese adolescents are more likely to have high cholesterol and high blood pressure, prediabetes, bone/joint problems, sleep apnea, and social and psychological problems such as stigmatization and poor self-esteem (DHHS, 2010; CDC, 2011). Unfortunately, virtually all obesity treatments result in only transient weight loss (Turk et al., 2009). Evidence suggests that it is nearly impossible for individuals to maintain behavioral weight losses once they have been obese for an extended period of time (Ochner et al., 2013). Although bariatric surgery can result in more persistent weight loss, this invasive procedure is contraindicated for numerous individuals, particularly children (Martin et al., 2010). Thus, a pressing public health priority is to develop simple and effective obesity prevention programs.
In 2010, the U.S. Preventive Services Task Force (USPSTF) issued recommendations for screening and treating childhood and adolescent obesity. They endorsed comprehensive moderate-to high intensity programs including counseling for weight loss, healthy diet, and physical activity as well as instruction and support for the use of behavioral management techniques including self-monitoring, stimulus control, eating management, contingency management, and cognitive behavioral therapy techniques. The USPSTF further defined moderate- to high-intensity programs as > 25 hr of contact and states that "such interventions would not be feasible for implementation in a primary care setting." (USPSTF, 2010, p. 365). Further, they assert that less intensive (< 25 contact hours) programs do not produce significant improvements. "Low-intensity interventions, defined as < 25 contact hours over a 6-month period, did not result in significant improvement in weight status" (USPSTF, 2010, p. 364). The implication is that, since most centers cannot provide this level of service, it is not worthwhile for adolescent health centers to provide any kind of obesity intervention at all. According to the USPSTF's website, "its recommendations are considered the gold standard for clinical preventive services." Such recommendations could discourage the testing and implementation of brief interventions designed to prevent obesity. Thus, to refute USPSTF statement, we propose to show that a 6-hr intervention led by graduate students can produce significant reductions in risk for both obesity and eating disorders, suggesting that this brief and inexpensive intervention could and should be rolled out nationwide.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Weight | Experimental | Behavioral: Healthy Weightintervention four times per week and consist of approximately 10 participants. |
| Controlled Intervention | Active comparator | Behavioral: Controlled InterventionParticipants will be given a copy of the DVD. They will also be given the choice to stream it free on the web. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- ≥ 12 years old
- Body image concerns
- Sub-threshold Eating disorder symptomatology
- Overweight but not obese (BMI between the 85th and 95th percentile for children/adolescents and BMI between 25 and 30 kg/m2 for adults 21-24)
- Be able to commit to weekly 1-hour sessions for six weeks and 3 separate assessment visits to the MSAHC
Key exclusion criteria (3 listed)
- Current eating disorder (anorexia nervosa, bulimia nervosa or binge eating disorder)
- absence of body image concerns
- normal or obese body weight (< 85th or ≥ 95th BMI percentile)
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 |
|---|---|---|
| Healthy WeightThe PI will train 4 group leaders to deliver the intervention. Groups will be offered four times per week and consist of approximately 10 participants. Each group will be led by 2 group leaders and each group leader will lead two sessions per week during the 2.5 mo intervention period. Group leaders will digitally video-record all sessions of the first two groups they deliver so the PI can provide supervision and rate fidelity and competence for a random selection of 6 of these 12 sessions. Group leaders will transmit the video recordings via an encrypted, secure internet connection to Dr. Ochner (who was trained by Dr. Eric Stice, the creator of the intervention) within 3 d for supervision, and competence and fidelity assessments. | Behavioural | Healthy Weight |
| Controlled Intervention"The Weight of the World" is a 51 min documentary focusing on the topics of obesity and healthy living. Via information presented by medical professionals and lifestyle experts, this film delves into issues related to preventing and combating obesity. Major topics include the importance of healthy eating and exercise behaviors and the changes that can be made by communities to reshape our lifestyles. Participants will be given a copy of the DVD. They will also be given the choice to stream it free on the web. | Behavioural | Controlled Intervention |
Primary outcome
Body Mass Index (BMI)
Time frame: baseline
Height will be measured to the nearest millimeter using a direct reading stadiometer. Weight will be assessed to the nearest 0.1 kg using a digital scale (Tanita TBF-300A) with participants wearing light clothing without shoes or coats.
Body Mass Index (BMI)
Time frame: at 5 min post intervention
Height will be measured to the nearest millimeter using a direct reading stadiometer. Weight will be assessed to the nearest 0.1 kg using a digital scale (Tanita TBF-300A) with participants wearing light clothing without shoes or coats.
Body Mass Index (BMI)
Time frame: 6 month follow-up
Height will be measured to the nearest millimeter using a direct reading stadiometer. Weight will be assessed to the nearest 0.1 kg using a digital scale (Tanita TBF-300A) with participants wearing light clothing without shoes or coats.
Body Fat
Time frame: baseline
Body Fat - We will use bioelectrical impedance analysis (BIA) using the Tanita TBF-300A Body Composition Analyzer to assess % body fat to maximize our sensitivity to predict increases in body fat and obesity onset. Two measures will be averaged.
Body Fat
Time frame: at 5 min post intervention
Body Fat - We will use bioelectrical impedance analysis (BIA) using the Tanita TBF-300A Body Composition Analyzer to assess % body fat to maximize our sensitivity to predict increases in body fat and obesity onset. Two measures will be averaged.
Body Fat
Time frame: 6 month follow up
Body Fat - We will use bioelectrical impedance analysis (BIA) using the Tanita TBF-300A Body Composition Analyzer to assess % body fat to maximize our sensitivity to predict increases in body fat and obesity onset. Two measures will be averaged.
6 secondary outcomes
Body Dissatisfaction
Time frame: baseline
Body Dissatisfaction
Time frame: at 5 min post intervention
Body Dissatisfaction
Time frame: at 6 months follow up
Eating Disorders
Time frame: baseline
Eating Disorders
Time frame: at 5 min post intervention
Eating Disorders
Time frame: at 6 months follow up
Results and safety
The study was stopped early (reason given: The PI changed institutions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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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.
Christopher Ochner, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Weight in people with Obesity, run by Icahn School of Medicine at Mount Sinai 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 5 inclusion and 3 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 8 Feb 2016. 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: The PI changed institutions). 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?
Body Mass Index (BMI) (time frame: baseline). The study lists 6 primary outcomes in all. 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 8 Feb 2016.