NCT01764113

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

January 7, 2013

Last Update Submit

January 21, 2014

Conditions

Adolescent Obesity

Keywords

ObesityAdolescenceMindful Eating

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    Body Mass Index would be calculated at baseline, at 3 months and at 6 months

    Baseline and 6 months

Secondary Outcomes (1)

  • Quality of Life

    Baseline and 6 months

Other Outcomes (1)

  • Fasting glucose

    6 months

Study Arms (2)

Mindful Eating

EXPERIMENTAL

Subjects and at least one of their parents will receive mindful eating based behavioral modification program

Behavioral: Mindful Eating

Standard Dietary Couseling

ACTIVE COMPARATOR

Subjects and their parents will receive standard nutritional counseling provided by a registered dietician

Behavioral: Standard dietary counselling

Interventions

Mindful EatingBEHAVIORAL

Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions

Mindful Eating
Standard dietary counsellingBEHAVIORAL
Standard Dietary Couseling

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • BMI at or greater than the 95th percentile for age and gender

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seema Kumar, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 9, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

US(1)