Effect of Mindful Eating on Body Mass Index in Obese Adolescents
This study is currently recruiting participants.
Verified February 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Seema Kumar, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01764113
First received: January 7, 2013
Last updated: February 28, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adolescent Obesity |
Behavioral: Mindful Eating Behavioral: Standard dietary counselling |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Mindful Eating on Body Mass Index and Cardiovascular Risk Markers in Obese Adolescents: A Pilot Randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Body Mass Index [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]Body Mass Index would be calculated at baseline, at 3 months and at 6 months
Secondary Outcome Measures:
- Quality of Life [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]Well validated questionnaires of quality of life would be assessed at baseline, at 3 months and at 6 months.
Other Outcome Measures:
- Fasting glucose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mindful Eating
Subjects and at least one of their parents will receive mindful eating based behavioral modification program
|
Behavioral: Mindful Eating
Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions
|
|
Active Comparator: Standard Dietary Couseling
Subjects and their parents will receive standard nutritional counseling provided by a registered dietician
|
Behavioral: Standard dietary counselling |
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.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- BMI at or greater than the 95th percentile for age and gender
Exclusion Criteria
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764113
Locations
| United States, Minnesota | |
| Mayo Clinic in Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Seema Kumar, MD 507-284-3300 kumar.seema@mayo.edu | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | Seema Kumar, MD | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | Seema Kumar, Assistant Professor of Pediatrics, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01764113 History of Changes |
| Other Study ID Numbers: | 12-004401 |
| Study First Received: | January 7, 2013 |
| Last Updated: | February 28, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Obesity Adolescence Mindful Eating |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013