A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome

Completed · Not applicable

Conditions studied: Metabolic Syndrome

In brief

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 metabolic syndrome. In a randomized clinical trial, the investigators propose to compare the efficacy of two intervention approaches to dietary change for CHD prevention among persons with metabolic syndrome. The two approaches are 1) the AHA Dietary Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. The investigators hypothesize that a message promoting high fiber intake may be the simple message that has potential to produce broad impact.

Key facts

Study ID

NCT00911885

Run by

University of Massachusetts, Worcester

People needed

240

Starts

2009-04-01

Expected to finish

2015-03-01

Last updated by the study team

2015-03-18

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Massachusetts Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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