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

March 16, 2015 updated by: Yunsheng Ma, University of Massachusetts, Worcester
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in components of the metabolic syndrome, inflammatory markers, LDL cholesterol, insulin levels, HbA1c, and diet
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Yunsheng Ma, MD, Ph.D., University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-13075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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