NCT01375504

Brief Summary

This study is designed to assess the effect of a mindfulness training program with special focus on diet and nutrition vs. dietary counseling in 40 obese adults (BMI range 30-40) and their partner/spouses (irrespective of their BMI), in a 6-month pilot randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable obesity

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

First Submitted

Initial submission to the registry

June 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

June 13, 2011

Last Update Submit

April 18, 2012

Conditions

Obesity

Keywords

ObesityBody Mass IndexMindfulness TrainingAttention and Interpretation Therapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to a healthier lifestyle.

    Improvement in general health.

    6 Months

Secondary Outcomes (4)

  • Change from baseline in vital signs.

    6 Months

  • Change from baseline in laboratory values.

    6 Months

  • Change from baseline in stress management.

    6 Months

  • Change in baseline on different aspects of eating.

    6 Months

Study Arms (2)

Dietary Counseling

ACTIVE COMPARATOR

The control group will receive two sessions of dietary counseling (with instruction to follow a weight loss program) provided by a clinical dietician, consistent with current routine care for adults with obesity.

Behavioral: Dietary Counseling

Mindfulness Training Program

OTHER

The mindfulness training program will be administered over three 90-minute sessions by a physician and clinical dietician with expertise in mind-body medicine and nutrition.

Behavioral: Mindfulness Training Program

Interventions

Dietary CounselingBEHAVIORAL

The control group will receive two sessions of dietary counseling (with instruction to follow a weight loss program) provided by a clinical dietician, consistent with current routine care for adults with obesity.

Dietary Counseling
Mindfulness Training ProgramBEHAVIORAL

The mindfulness program will be administered over three 90-minute sessions by a physician and clinical dietician with expertise in mind-body medicine and nutrition.

Mindfulness Training Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese adults (BMI ≥ 30)
  • Currently working at Mayo Clinic Rochester
  • Able to provide informed consent
  • Stable weight (within + 10 pounds) during the three months prior to enrolling in the study

You may not qualify if:

  • Currently (in the past six months) attending a weight loss program
  • Underlying genetic or endocrine cause for weight gain
  • Current cancer
  • Medications known to affect weight (corticosteroids, antidepressants, anti psychotics, mood stabilizers, and anti-epileptic medications)
  • Musculoskeletal conditions affecting the ability to adequately perform general physical activity
  • Active smoking
  • Substance abuse
  • Quitting smoking within 6 months of enrolling in the study
  • Have clinically significant acute unstable neurological, psychiatric, hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
  • Have an established practice of meditation for three or more months
  • Not willing to complete study outcome measures.
  • PARTNER/SPOUSE
  • Able to provide informed consent
  • Have clinically significant acute unstable neurological,Psychiatric, hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
  • Have an established practice of meditation for three or more months

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

Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Amit Sood, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 17, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

US(1)