NCT00943254

Brief Summary

This study is being done to gain knowledge on how effective different approaches of providing a diagnosis and varying educational tools that include DVDs and multimedia or printed instruction sheets on your readiness to increase the subject's level of exercise, lose more weight, eat a healthier diet; and to assess the subject's awareness of their risk of heart disease and their readiness to participate in a comprehensive lifestyle modification program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 15, 2010

Status Verified

October 1, 2010

Enrollment Period

2.8 years

First QC Date

July 20, 2009

Last Update Submit

October 13, 2010

Conditions

Metabolic Cardiovascular Syndrome

Keywords

Metabolic Cardiovascular Syndrome

Outcome Measures

Primary Outcomes (2)

  • Lifestyle Change: Readiness to Exercise, level of physical activity

    6 weeks

  • Stages of Change for Exercise and for Fruits and vegetables

    6 weeks

Study Arms (3)

Arm 1

EXPERIMENTAL

Patients randomized to this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based and DVD materials

Other: High-Tech Education

Arm 2

EXPERIMENTAL

Patients in this arm receive the diagnosis of "metabolic syndrome" and subsequent education using paper-based material

Other: Low-Tech Education

Arm 3

NO INTERVENTION

Patients randomized to control receive the diagnosis of individual cardiovascular risk factors with paper-based educational material

Interventions

High-Tech EducationOTHER

Patients will be told that they have the metabolic syndrome and will subsequently watch two 10-minute videos on the metabolic syndrome and on getting started with exercise. They also receive all the paper-based educational material as in arm 2

Arm 1
Low-Tech EducationOTHER

Patients will be told that they have the metabolic syndrome and will subsequently receive paper-based educational material on the metabolic syndrome,pre-diabetes, and hypertension. They also receive pamphlets on dietary management of high cholesterol and triglycerides, and the importance of exercise and weight loss.

Arm 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any 3 of the following 5:
  • History of hypertension or either systolic blood pressure \>125 or diastolic blood pressure \>85 mmHg or documented history and receiving treatment for it
  • Abdominal circumference ≥40 inches in men or ≥35 inches in women
  • Fasting triglycerides ≥ 150mg/dL or receiving treatment for it
  • Fasting blood glucose ≥ 100mg/dL but \<126mg/dL
  • HDL cholesterol \<40mg/dL in men or \<50mg/dL in women or receiving treatment for it

You may not qualify if:

  • Documented diagnosis of metabolic syndrome in the clinical record, if previously seen at Mayo.
  • History of coronary artery disease
  • Diabetes mellitus, or using an oral hypoglycemic pill for glucose intolerance
  • Congestive heart failure
  • Familial hypercholesterolemia including familial hypertriglyceridemia,
  • Fasting LDL-cholesterol \>160 mg/dL
  • Fasting triglycerides \> 390 mg/dL
  • Have systolic blood pressure \>160 and diastolic blood pressure \>100mg/dL
  • History of hypertension with changes in their blood pressure medicines within the last 60 days before enrollment.
  • History of dyslipidemia and changes on their lipid lowering agents such as statins, ezetimibe, fibrates or niacin within the last 60 days before enrollment.
  • Secondary causes of obesity such as hypothyroidism, Cushing syndrome, or eating disorders
  • Pregnant women or women planning to get pregnant during the duration of the study
  • Advanced liver disease
  • Renal insufficiency
  • Having any other major chronic medical condition
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Jumean MF, Korenfeld Y, Somers VK, Vickers KS, Thomas RJ, Lopez-Jimenez F. Impact of diagnosing metabolic syndrome on risk perception. Am J Health Behav. 2012 Jul;36(4):522-32. doi: 10.5993/AJHB.36.4.9.

    PMID: 22488402DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Randal J Thomas, MD, MS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 22, 2009

Study Start

October 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 15, 2010

Record last verified: 2010-10

Locations

US(1)