OverweightNCT02114190
Family-Based Mindful Eating Intervention for Overweight Adolescents
A study testing Adolescent Mindful Eating Group and Parent Integrated Group in people with Overweight and Adolescent Behavior, run by Oregon Research Institute at 1 site in United States.
Trial summary
With currently 35% of U.S. adolescents being overweight and one in six having metabolic syndrome, adolescent obesity is one of the major global health challenges of the 21st century. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Overweight, Adolescent Behavior, Family Research
- What is being tested?
- Adolescent Mindful Eating Group and Parent Integrated Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Mar 2017
- 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescent ages 14-17 years old living at home with at least one parent/guardian,
- BMI ≥ 85th percentile,
- assent from adolescent,
- consent from a parent/guardian,
- willingness of one parent/guardian living with adolescent to participate in the study,
- English speaking.
Who cannot join
- Adolescent BMI ≥ 40 (requires additional medical attention the intervention is unable to provide),
- previously diagnosed type 1 or type 2 diabetes,
- blood pressure in the range of stage 2 hypertension which requires medication
- treatment which interferes with outcomes related to blood pressure and glucose,
- medications that significantly interfere with weight gain such as oral steroid use greater than two consecutive weeks
- antipsychotic medications,
Show all 10Show fewer
- participation in a standardized weight loss program within the previous 6 months,
- inability to provide informed assent,
- no parent/guardian consent,
- insufficient reading ability to comprehend the self-administered assessment instruments (approximately 5th grade reading level).
Trial locations and contacts
1 site in 1 country.
United States1 site
ORI Center for Family and Adolescent Research
Albuquerque, New Mexico, 87102
About this study
Official title: Adaptation and Evaluation of a Family-Based Mindful Eating Intervention for Overweight Adolescents
With currently 35% of U.S. adolescents being overweight and one in six having metabolic syndrome, adolescent obesity is one of the major global health challenges of the 21st century. Few enduring treatment strategies have been identified in adolescent populations and the majority of standard weight loss programs fail to adequately address the impact of psychological factors on eating behavior and the beneficial contribution of parental involvement in adolescent behavior change. A critical need exists to expand treatment development efforts beyond traditional education and cognitive-behavioral programs and to explore alternative treatment models for adolescent obesity. Meditation-based mindful eating programs may represent a unique and novel scientific approach to the current adolescent obesity epidemic as they address key psychological variables affecting weight. Furthermore, the recent expansion of mindfulness programs to include family relationships shows the immense potential for broadening the customarily individual focus of this intervention to include broader factors thought to influence adolescent health outcomes. Thus, we propose to develop a mindful eating approach to eating behavior and weight loss specifically tailored for adolescents and their families. The first phase of our three phase development process will be devoted to adapting an adolescent protocol (Mindful Eating-A) based on an established mindful eating program currently being used with adult populations. We will then develop a 'family enhanced Mindful Eating-A' (Mindful Eating-A+F) protocol that integrates a family systems perspective. The goal of Mindful Eating-A+F is to expand the focus of Mindful Eating-A to include family factors that influence adolescent eating behaviors. The second design phase will consist of an initial test of both intervention components to provide feedback on usefulness and acceptability (N = 10 families). The final phase will examine the overall efficacy of the optimized Mindful Eating-A+F, relative to the Mindful Eating-A intervention with 30 overweight adolescents (BMI > 85th percentile) ages 14-17 and at least one parent. Within this examination, post-treatment and 3-month follow-up comparisons across the two treatment approaches will be made and effect sizes within and between treatments will be assessed.
Read the detailed description
Adolescent obesity is one of the major global health challenges of the 21st century. Currently, 35% of adolescents are overweight (BMI > 85th percentile), and one in six are diagnosed with metabolic syndrome. While the adoption and maintenance of healthful dietary practices has been identified as a high priority topic for future research, few enduring treatment strategies have been identified. The cause of adolescent obesity is multi-factorial; psychological and family factors largely contribute to this epidemic along with biological and environmental influences. However, the majority of standard weight loss programs fail to adequately address the impact of psychological factors on eating behavior and the beneficial contribution of parental involvement in making dietary change in overweight adolescent populations.
Meditation-based programs may improve the efficacy of more established weight-loss interventions for adolescents by addressing key psychological variables affecting weight. Mindfulness-Based Stress Reduction (MBSR) is a well-established, systematic patient-centered educational approach that uses training in mindfulness meditation to increase awareness of and the ability to respond skillfully to experiences that contribute to emotional distress and maladaptive behavior. The efficacy of MBSR in reducing psychological distress and symptoms of stress in adults has been consistently shown in controlled studies. Significant improvements in physiological measures related to metabolic syndrome including blood pressure, cholesterol, and glycemic control have also been demonstrated. Similar meditation programs have been successfully implemented with adolescents to address problems such as hypertension, depression, and eating behaviors. Furthermore, the recent expansion of mindfulness programs to include family relationships shows the immense potential for broadening the customarily individual focus of meditation-based interventions to include broader factors thought to influence adolescent health outcomes. This is important given that greater involvement of the family is thought to increase the effectiveness of interventions aimed at adolescent weight control, weight maintenance and weight loss.
Recently, researchers have begun to modify the MBSR program specifically for populations attempting to make dietary health changes. One newly modified program for adults is Mindful Eating \& Living (MEAL), a brief 6-session program designed to teach skills which can lead to increased awareness of eating, emotions, and judgment. Preliminary data from our own research with adults shows significant changes in eating behaviors and other obesity related problems, including reduced psychological distress, regulation of intake patterns, disordered eating, improved metabolic regulation, and weight loss.
Although theoretically compelling, mindful eating interventions have never been examined with an overweight adolescent population. Thus, an unprecedented opportunity exists to develop a systematic program of research investigating a mindfulness approach to eating behavior and weight loss specifically tailored for adolescents and their families. This is critical given that adolescence is a period with special developmental considerations, and it is not clear that weight loss programs developed for children or adults are effective with adolescents. Interventions aimed at adolescent eating behaviors have met with mixed success, and it has been theorized that this may be due, in part, to an inadequate understanding of the factors (e.g. psychological and family-based) associated with eating behaviors among adolescents that need to be addressed in interventions. To address these gaps, this study proposes to systematically adapt, pilot, refine, and evaluate a developmentally appropriate Mindful Eating intervention for overweight adolescents based on the current protocol format taught in the adult MEAL program. We have designed a three-phase iterative development process that includes: 1) community key informant and consultant input; 2) beta-testing and further refinement of the program; and 3) formal pilot testing. Study aims include:
Aim 1: Adapt a mindful eating intervention protocol (Mindful Eating -A) for an overweight adolescent population (BMI ≥ 85th percentile), ages 14-17. The intervention will be tailored to the unique developmental challenges of adolescence, suitable for use in applied community settings, and demonstrate feasibility and acceptability.
Aim 2: Develop a 'family enhanced mindful eating -A' (Mindful Eating -A+F) intervention protocol that integrates a family systems perspective into Mindful Eating -A. The goal is to expand the focus of Mindful Eating -A to include family factors that influence adolescent eating behaviors. These include food-related parenting styles, food organization behaviors, family support, and the parents' own eating-related behaviors. Mindful Eating -A+F will demonstrate feasibility, and acceptability, and will be suitable for use in applied community settings.
Aim 3: To examine the overall efficacy of the optimized Mindful Eating -A+F, relative to the Mindful Eating -A intervention. Within this examination, post-treatment and 3-month follow-up comparisons across the two treatment approaches will be made. Effect sizes within and between treatments will be assessed. We expect that Mindful Eating -A+F will show stronger and more enduring effects than Mindful Eating -A alone on adolescent outcomes. Primary outcomes include adolescent weight, BMI, and eating behaviors. Secondary outcomes include adolescent's markers of metabolic syndrome, psychological distress, family barriers, and mindfulness.
- Conditions
- Overweight, Adolescent Behavior, Family Research, Weight Loss
- Being tested
- Adolescent Mindful Eating Group, Parent Integrated Group
- Keywords
- Overweight Adolescents, Mindful Eating and Living, Family Systems, Body-Mass Index, Mindfulness
- Medical subject headings
- Overweight, Adolescent Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Mindful Eating GroupBehavioural
Adolescents will learn mindfulness and meditation, how to be mindful when eating, mindful yoga, how to recognize hunger cures, understand emotional eating, trigger foods and how to apply mindful eating in social situations.
Parent Integrated GroupBehavioural
Adolescents will receive learn same techniques as adolescents in Adolescent Mindful Eating Group. The group component of the parent intervention is designed for parents only and will be run parallel to the adolescent group. The goal of these sessions is to teach parents skills to support adolescent by developing effective parenting styles, parenting skills, strategies around eating behavior change, productive problem solving, and the role of all other family members with regard to the treatment process. The last five sessions will be dedicated to teaching a slightly reduced MEAL adult protocol to allow parents to learn mindfulness skills as it applies to their own eating behaviors and affective reactivity.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Mindful Eating Group | Experimental | Adolescents will participate in a 8 week mindful eating programs tailored for adolescents. Receives: Behavioral: Adolescent Mindful Eating Group |
| Parent Intergrated Group | Experimental | This intervention incorporates a family systems perspective into mindful eating interventions for adolescents. This intervention will consist of 11 sessions in an 8 week period, with sessions 2,7, and 11 incorporating family sessions. The purpose of the family sessions are to increase overall family motivation for behavior change, involve family members in identifying specific targets of change and establishing agreed upon strategies. Receives: Behavioral: Parent Integrated Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time: adolescent weight
Measurement of participant's weight
Measured: Week 0, Week 8, Week 20
Secondary outcomes (6)
Change over time: markers of metabolic syndrome.
Measurement of metabolic syndrome (insulin resistance, blood pressure, and dyslipidemia)
Measured: Week 0, Week 8, Week 20
Change over time: adolescent Body Mass Index
Measurement of participant's Body Mass Index
Measured: Week 0, Week 8, Week 20
Change over time: adolescent's eating behavior
Measurement of participant's eating behaviors
Measured: Week 0, Week 8, Week 20
Change over time: markers of psychological distress
Measurement of psychological distress
Measured: Week 0, Week 8, Week 20
Change over time: family barriers to healthy eating
Measurement of family barriers to healthy eating
Measured: Week 0, Week 8, Week 20
Change over time: practice of mindfulness
Measurement of participant's practice of mindfulness
Measured: Week 0, Week 8, Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanne Dalen, Ph.D, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114190
- Sponsor's protocol ID
- 1R34AT007843-01
- Status last verified
- Aug 2017
- First submitted
- 1 Apr 2014
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Evaluation of a Family-Based Mindful Eating Intervention for Overweight Adolescents
- ClinicalTrials.gov ID
- NCT02114190
- Acronym / sponsor ID
- 1R34AT007843-01
- Conditions
- Overweight, Adolescent Behavior, Family Research, Weight Loss
- Keywords
- Overweight Adolescents, Mindful Eating and Living, Family Systems, Body-Mass Index, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Apr 2014 (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.
With currently 35% of U.S. adolescents being overweight and one in six having metabolic syndrome, adolescent obesity is one of the major global health challenges of the 21st century. Few enduring treatment strategies have been identified in adolescent populations and the majority of standard weight loss programs fail to adequately address the impact of psychological factors on eating behavior and the beneficial contribution of parental involvement in adolescent behavior change. A critical need exists to expand treatment development efforts beyond traditional education and cognitive-behavioral programs and to explore alternative treatment models for adolescent obesity. Meditation-based mindful eating programs may represent a unique and novel scientific approach to the current adolescent obesity epidemic as they address key psychological variables affecting weight. Furthermore, the recent expansion of mindfulness programs to include family relationships shows the immense potential for broadening the customarily individual focus of this intervention to include broader factors thought to influence adolescent health outcomes. Thus, we propose to develop a mindful eating approach to eating behavior and weight loss specifically tailored for adolescents and their families. The first phase of our three phase development process will be devoted to adapting an adolescent protocol (Mindful Eating-A) based on an established mindful eating program currently being used with adult populations. We will then develop a 'family enhanced Mindful Eating-A' (Mindful Eating-A+F) protocol that integrates a family systems perspective. The goal of Mindful Eating-A+F is to expand the focus of Mindful Eating-A to include family factors that influence adolescent eating behaviors. The second design phase will consist of an initial test of both intervention components to provide feedback on usefulness and acceptability (N = 10 families). The final phase will examine the overall efficacy of the optimized Mindful Eating-A+F, relative to the Mindful Eating-A intervention with 30 overweight adolescents (BMI > 85th percentile) ages 14-17 and at least one parent. Within this examination, post-treatment and 3-month follow-up comparisons across the two treatment approaches will be made and effect sizes within and between treatments will be assessed.
Detailed description
Adolescent obesity is one of the major global health challenges of the 21st century. Currently, 35% of adolescents are overweight (BMI > 85th percentile), and one in six are diagnosed with metabolic syndrome. While the adoption and maintenance of healthful dietary practices has been identified as a high priority topic for future research, few enduring treatment strategies have been identified. The cause of adolescent obesity is multi-factorial; psychological and family factors largely contribute to this epidemic along with biological and environmental influences. However, the majority of standard weight loss programs fail to adequately address the impact of psychological factors on eating behavior and the beneficial contribution of parental involvement in making dietary change in overweight adolescent populations.
Meditation-based programs may improve the efficacy of more established weight-loss interventions for adolescents by addressing key psychological variables affecting weight. Mindfulness-Based Stress Reduction (MBSR) is a well-established, systematic patient-centered educational approach that uses training in mindfulness meditation to increase awareness of and the ability to respond skillfully to experiences that contribute to emotional distress and maladaptive behavior. The efficacy of MBSR in reducing psychological distress and symptoms of stress in adults has been consistently shown in controlled studies. Significant improvements in physiological measures related to metabolic syndrome including blood pressure, cholesterol, and glycemic control have also been demonstrated. Similar meditation programs have been successfully implemented with adolescents to address problems such as hypertension, depression, and eating behaviors. Furthermore, the recent expansion of mindfulness programs to include family relationships shows the immense potential for broadening the customarily individual focus of meditation-based interventions to include broader factors thought to influence adolescent health outcomes. This is important given that greater involvement of the family is thought to increase the effectiveness of interventions aimed at adolescent weight control, weight maintenance and weight loss.
Recently, researchers have begun to modify the MBSR program specifically for populations attempting to make dietary health changes. One newly modified program for adults is Mindful Eating \& Living (MEAL), a brief 6-session program designed to teach skills which can lead to increased awareness of eating, emotions, and judgment. Preliminary data from our own research with adults shows significant changes in eating behaviors and other obesity related problems, including reduced psychological distress, regulation of intake patterns, disordered eating, improved metabolic regulation, and weight loss.
Although theoretically compelling, mindful eating interventions have never been examined with an overweight adolescent population. Thus, an unprecedented opportunity exists to develop a systematic program of research investigating a mindfulness approach to eating behavior and weight loss specifically tailored for adolescents and their families. This is critical given that adolescence is a period with special developmental considerations, and it is not clear that weight loss programs developed for children or adults are effective with adolescents. Interventions aimed at adolescent eating behaviors have met with mixed success, and it has been theorized that this may be due, in part, to an inadequate understanding of the factors (e.g. psychological and family-based) associated with eating behaviors among adolescents that need to be addressed in interventions. To address these gaps, this study proposes to systematically adapt, pilot, refine, and evaluate a developmentally appropriate Mindful Eating intervention for overweight adolescents based on the current protocol format taught in the adult MEAL program. We have designed a three-phase iterative development process that includes: 1) community key informant and consultant input; 2) beta-testing and further refinement of the program; and 3) formal pilot testing. Study aims include:
Aim 1: Adapt a mindful eating intervention protocol (Mindful Eating -A) for an overweight adolescent population (BMI ≥ 85th percentile), ages 14-17. The intervention will be tailored to the unique developmental challenges of adolescence, suitable for use in applied community settings, and demonstrate feasibility and acceptability.
Aim 2: Develop a 'family enhanced mindful eating -A' (Mindful Eating -A+F) intervention protocol that integrates a family systems perspective into Mindful Eating -A. The goal is to expand the focus of Mindful Eating -A to include family factors that influence adolescent eating behaviors. These include food-related parenting styles, food organization behaviors, family support, and the parents' own eating-related behaviors. Mindful Eating -A+F will demonstrate feasibility, and acceptability, and will be suitable for use in applied community settings.
Aim 3: To examine the overall efficacy of the optimized Mindful Eating -A+F, relative to the Mindful Eating -A intervention. Within this examination, post-treatment and 3-month follow-up comparisons across the two treatment approaches will be made. Effect sizes within and between treatments will be assessed. We expect that Mindful Eating -A+F will show stronger and more enduring effects than Mindful Eating -A alone on adolescent outcomes. Primary outcomes include adolescent weight, BMI, and eating behaviors. Secondary outcomes include adolescent's markers of metabolic syndrome, psychological distress, family barriers, and mindfulness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent Mindful Eating Group | Experimental | Behavioral: Adolescent Mindful Eating GroupAdolescents will participate in a 8 week mindful eating programs tailored for adolescents. |
| Parent Intergrated Group | Experimental | Behavioral: Parent Integrated GroupThis intervention incorporates a family systems perspective into mindful eating interventions for adolescents. This intervention will consist of 11 sessions in an 8 week period, with sessions 2,7, and 11 incorporating family sessions. The purpose of the family sessions are to increase overall family motivation for behavior change, involve family members in identifying specific targets of change and establishing agreed upon strategies. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Adolescent ages 14-17 years old living at home with at least one parent/guardian,
- BMI ≥ 85th percentile,
- assent from adolescent,
- consent from a parent/guardian,
- willingness of one parent/guardian living with adolescent to participate in the study,
Key exclusion criteria (10 listed)
- Adolescent BMI ≥ 40 (requires additional medical attention the intervention is unable to provide),
- previously diagnosed type 1 or type 2 diabetes,
- blood pressure in the range of stage 2 hypertension which requires medication
- treatment which interferes with outcomes related to blood pressure and glucose,
- medications that significantly interfere with weight gain such as oral steroid use greater than two consecutive weeks
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 |
|---|---|---|
| Adolescent Mindful Eating GroupAdolescents will learn mindfulness and meditation, how to be mindful when eating, mindful yoga, how to recognize hunger cures, understand emotional eating, trigger foods and how to apply mindful eating in social situations. | Behavioural | Adolescent Mindful Eating Group |
| Parent Integrated GroupAdolescents will receive learn same techniques as adolescents in Adolescent Mindful Eating Group. The group component of the parent intervention is designed for parents only and will be run parallel to the adolescent group. The goal of these sessions is to teach parents skills to support adolescent by developing effective parenting styles, parenting skills, strategies around eating behavior change, productive problem solving, and the role of all other family members with regard to the treatment process. The last five sessions will be dedicated to teaching a slightly reduced MEAL adult protocol to allow parents to learn mindfulness skills as it applies to their own eating behaviors and affective reactivity. | Behavioural | Parent Intergrated Group |
Primary outcome
Change over time: adolescent weight
Time frame: Week 0, Week 8, Week 20
Measurement of participant's weight
6 secondary outcomes
Change over time: markers of metabolic syndrome.
Time frame: Week 0, Week 8, Week 20
Change over time: adolescent Body Mass Index
Time frame: Week 0, Week 8, Week 20
Change over time: adolescent's eating behavior
Time frame: Week 0, Week 8, Week 20
Change over time: markers of psychological distress
Time frame: Week 0, Week 8, Week 20
Change over time: family barriers to healthy eating
Time frame: Week 0, Week 8, Week 20
Change over time: practice of mindfulness
Time frame: Week 0, Week 8, Week 20
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 22 Aug 2017.
Related trials for Overweight
RecruitingPhase 2
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
Healthy Volunteers, Overweight
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
Active, not recruitingPhase 2
A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity
Overweight, Obesity
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity
Obesity, Overweight and/or Obesity
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.
Jeanne Dalen, Ph.D principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescent Mindful Eating Group and Parent Integrated Group in people with Overweight and Adolescent Behavior, run by Oregon Research Institute 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 6 inclusion and 10 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change over time: adolescent weight (time frame: Week 0, Week 8, Week 20). 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 22 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.