Adolescent ObesityPhase 3NCT01764113
Effect of Mindful Eating on Body Mass Index in Obese Adolescents
A Phase 3 study testing Mindful Eating and Standard dietary counselling in people with Adolescent Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is designed to study the effect of a family based mindfulness training program with special focus on diet and nutrition on weight and cardiovascular risk markers in obese adolescents. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Adolescent Obesity
- What is being tested?
- Mindful Eating and Standard dietary counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BMI at or greater than the 95th percentile for age and gender
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Effect of Mindful Eating on Body Mass Index and Cardiovascular Risk Markers in Obese Adolescents: A Pilot Randomized Clinical Trial
This study is designed to study the effect of a family based mindfulness training program with special focus on diet and nutrition on weight and cardiovascular risk markers in obese adolescents.
Read the detailed description
40 obese adolescents would be randomized into either a mindfulness based behavioral modification program or standard dietary counseling. At least one parent would be expected to attend the counseling sessions. Patients would be followed for a period of 6 months. Anthropometric parameters, questionaiires relating to quality of life and blood tests would be drawn at baseline and and at 6 months.
- Conditions
- Adolescent Obesity
- Being tested
- Mindful Eating, Standard dietary counselling
- Keywords
- Obesity, Adolescence, Mindful Eating
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful EatingBehavioural
Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions
Standard dietary counsellingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindful Eating | Experimental | Subjects and at least one of their parents will receive mindful eating based behavioral modification program Receives: Behavioral: Mindful Eating |
| Standard Dietary Couseling | Active comparator | Subjects and their parents will receive standard nutritional counseling provided by a registered dietician Receives: Behavioral: Standard dietary counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Body Mass Index would be calculated at baseline, at 3 months and at 6 months
Measured: Baseline and 6 months
Secondary outcomes (1)
Quality of Life
Well validated questionnaires of quality of life would be assessed at baseline, at 3 months and at 6 months.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seema Kumar, Mayo Clinic
- Investigators
- Seema Kumar, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764113
- Sponsor's protocol ID
- 12-004401
- Status last verified
- Jan 2014
- First submitted
- 7 Jan 2013
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindful Eating on Body Mass Index and Cardiovascular Risk Markers in Obese Adolescents: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01764113
- Acronym / sponsor ID
- 12-004401
- Conditions
- Adolescent Obesity
- Keywords
- Obesity, Adolescence, Mindful Eating
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Jan 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.
This study is designed to study the effect of a family based mindfulness training program with special focus on diet and nutrition on weight and cardiovascular risk markers in obese adolescents.
Detailed description
40 obese adolescents would be randomized into either a mindfulness based behavioral modification program or standard dietary counseling. At least one parent would be expected to attend the counseling sessions. Patients would be followed for a period of 6 months. Anthropometric parameters, questionaiires relating to quality of life and blood tests would be drawn at baseline and and at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Eating | Experimental | Behavioral: Mindful EatingSubjects and at least one of their parents will receive mindful eating based behavioral modification program |
| Standard Dietary Couseling | Active comparator | Behavioral: Standard dietary counsellingSubjects and their parents will receive standard nutritional counseling provided by a registered dietician |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- BMI at or greater than the 95th percentile for age and gender
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mindful EatingSubjects and their parents will receive mindful eating based behavioral modification program over multiple sessions | Behavioural | Mindful Eating |
| Standard dietary counselling | Behavioural | Standard Dietary Couseling |
Primary outcome
Body Mass Index
Time frame: Baseline and 6 months
Body Mass Index would be calculated at baseline, at 3 months and at 6 months
1 secondary outcome
Quality of Life
Time frame: Baseline and 6 months
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 Jan 2014.
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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.
Seema Kumar, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mindful Eating and Standard dietary counselling in people with Adolescent Obesity, run by Mayo Clinic 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 1 inclusion and 0 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 Jan 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Body Mass Index (time frame: Baseline and 6 months). 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 Jan 2014.