A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome (CANDO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yunsheng Ma, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00911885
First received: June 1, 2009
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Behavioral: Dietary Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in components of the metabolic syndrome, inflammatory markers, LDL cholesterol, insulin levels, HbA1c, and diet [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: April 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Fiber Diet
A single dietary change condition that focuses exclusively on increasing fiber.
Behavioral: Dietary Intervention
The efficacy of the two dietary change interventions will be compared in a randomized controlled trial, with 120 patients per group. The two approaches are 1) the American Heart Association (AHA) Dietary Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. Patients in both conditions will receive intensive dietary instruction for 3 months, followed by a 9 month maintenance phase. Both conditions will receive dietary instructions via individual and group sessions led by registered dietitians.
Active Comparator: AHA Diet
The AHA Diet is the current recommendation for patients with the metabolic syndrome.
Behavioral: Dietary Intervention
The efficacy of the two dietary change interventions will be compared in a randomized controlled trial, with 120 patients per group. The two approaches are 1) the American Heart Association (AHA) Dietary Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. Patients in both conditions will receive intensive dietary instruction for 3 months, followed by a 9 month maintenance phase. Both conditions will receive dietary instructions via individual and group sessions led by registered dietitians.

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 will be compared in a randomized controlled trial, with 120 patients per group. The two approaches are 1) the American Heart Association (AHA) Dietary Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. Patients in both conditions will receive intensive dietary instruction for 3 months, followed by a 9 month maintenance phase. Both conditions will receive dietary instructions via individual and group sessions led by registered dietitians. Assessments, including diet, anthropometrics, blood pressure, fasting blood glucose, glycosylated hemoglobin (HbA1c), blood lipids, insulin, inflammatory markers, medication use, depression, quality of life, and physical activity will be conducted at baseline and at 6-, and 12-months after randomization. A 3-month post-intensive intervention assessment will measure short-term changes in body weight, diet, and metabolic syndrome indicators.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet diagnostic criteria for the metabolic syndrome;
  2. 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;
  3. Age 21 to 70 years old;
  4. Telephone in the home or easy access to one;
  5. Can provide informed consent;
  6. Physician's approval to participate in the study;
  7. Non-smoking status (given nicotine's effect on weight suppression, on HDL, and smoking cessation's effect weight gain); and
  8. Ability to speak and read English.

Exclusion Criteria:

  1. Has clinically diagnosed diabetes, or a fasting blood sugar of ≥ 126 mg/dl;
  2. Had an acute coronary events within the previous 6 months;
  3. Pregnant or lactating;
  4. Women with polycystic ovary syndrome;133
  5. Plans to move out of the area within the 12-month study period;
  6. Diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, active diverticulitis, renal disease);
  7. Has major depression or suicidality;
  8. Is following a low-carbohydrate, high-fat dietary regimen such as the Atkins' Diet.134 Is participating in any current weight loss program;
  9. Has had bariatric surgery or is currently using weight loss medication; and
  10. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911885

Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Yunsheng Ma, MD, Ph.D. University of Massachusetts, Worcester
  More Information

Additional Information:
Publications:
Responsible Party: Yunsheng Ma, Associate Professor, University of Massachusetts, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00911885     History of Changes
Other Study ID Numbers: H-13075
Study First Received: June 1, 2009
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Weight
Diet
Lipids

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 26, 2014