Status:
COMPLETED
A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
Identifying a simple dietary recommendation for weight loss and metabolic health may demonstrate potential for a simple public health message to impact coronary heart disease (CHD) prevention and meta...
Detailed Description
The investigators will recruit 240 overweight and obese adults from a primary care setting who meet diagnostic criteria for metabolic syndrome. The efficacy of the two dietary change interventions wil...
Eligibility Criteria
Inclusion
- Meet diagnostic criteria for the metabolic syndrome;
- Interested in losing weight and have a BMI 30-40.22 BMI\>40 kg/m2 indicates severe obesity and is associated with functional limitations that are likely to prevent participation in the study;
- Age 21 to 70 years old;
- Telephone in the home or easy access to one;
- Can provide informed consent;
- Physician's approval to participate in the study;
- Non-smoking status (given nicotine's effect on weight suppression, on HDL, and smoking cessation's effect weight gain); and
- Ability to speak and read English.
Exclusion
- Has clinically diagnosed diabetes, or a fasting blood sugar of ≥ 126 mg/dl;
- Had an acute coronary events within the previous 6 months;
- Pregnant or lactating;
- Women with polycystic ovary syndrome;133
- Plans to move out of the area within the 12-month study period;
- Diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, active diverticulitis, renal disease);
- Has major depression or suicidality;
- Is following a low-carbohydrate, high-fat dietary regimen such as the Atkins' Diet.134 Is participating in any current weight loss program;
- Has had bariatric surgery or is currently using weight loss medication; and
- Has an eating disorder (anorexia nervosa, bulimia nervosa or binge eating). Patients on lipid-lowering medications will not be excluded, but should be on a stable dose for 6 months.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00911885
Start Date
April 1 2009
End Date
March 1 2015
Last Update
March 18 2015
Active Locations (1)
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1
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655