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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Weight, Diet, Lipids

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Massachusetts Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Fiber Diet

AHA Diet

Arm Description

A single dietary change condition that focuses exclusively on increasing fiber.

The AHA Diet is the current recommendation for patients with the metabolic syndrome.

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Changes in components of the metabolic syndrome, inflammatory markers, LDL cholesterol, insulin levels, HbA1c, and diet

Full Information

First Posted
June 1, 2009
Last Updated
March 16, 2015
Sponsor
University of Massachusetts, Worcester
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00911885
Brief Title
A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome
Acronym
CANDO
Official Title
A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Weight, Diet, Lipids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Fiber Diet
Arm Type
Experimental
Arm Description
A single dietary change condition that focuses exclusively on increasing fiber.
Arm Title
AHA Diet
Arm Type
Active Comparator
Arm Description
The AHA Diet is the current recommendation for patients with the metabolic syndrome.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in components of the metabolic syndrome, inflammatory markers, LDL cholesterol, insulin levels, HbA1c, and diet
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunsheng Ma, MD, Ph.D.
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19359142
Citation
Olendzki BC, Ma Y, Schneider KL, Merriam P, Culver AL, Ockene IS, Pagoto S. A simple dietary message to improve dietary quality: Results from a pilot investigation. Nutrition. 2009 Jul-Aug;25(7-8):736-44. doi: 10.1016/j.nut.2009.01.009. Epub 2009 Apr 9.
Results Reference
background
PubMed Identifier
17904938
Citation
Ma Y, Pagoto SL, Griffith JA, Merriam PA, Ockene IS, Hafner AR, Olendzki BC. A dietary quality comparison of popular weight-loss plans. J Am Diet Assoc. 2007 Oct;107(10):1786-91. doi: 10.1016/j.jada.2007.07.013.
Results Reference
background
PubMed Identifier
18237571
Citation
Ma Y, Li W, Olendzki BC, Pagoto SL, Merriam PA, Chiriboga DE, Griffith JA, Bodenlos J, Wang Y, Ockene IS. Dietary quality 1 year after diagnosis of coronary heart disease. J Am Diet Assoc. 2008 Feb;108(2):240-6; discussion 246-7. doi: 10.1016/j.jada.2007.10.047.
Results Reference
background
PubMed Identifier
20042092
Citation
Merriam PA, Ma Y, Olendzki BC, Schneider KL, Li W, Ockene IS, Pagoto SL. Design and methods for testing a simple dietary message to improve weight loss and dietary quality. BMC Med Res Methodol. 2009 Dec 30;9:87. doi: 10.1186/1471-2288-9-87.
Results Reference
background
PubMed Identifier
20625282
Citation
Ma Y, Olendzki BC, Pagoto SL, Merriam PA, Ockene IS. What are patients actually eating: the dietary practices of cardiovascular disease patients. Curr Opin Cardiol. 2010 Sep;25(5):518-21. doi: 10.1097/HCO.0b013e32833cd538.
Results Reference
background
PubMed Identifier
25300734
Citation
Wedick NM, Ma Y, Olendzki BC, Procter-Gray E, Cheng J, Kane KJ, Ockene IS, Pagoto SL, Land TG, Li W. Access to healthy food stores modifies effect of a dietary intervention. Am J Prev Med. 2015 Mar;48(3):309-17. doi: 10.1016/j.amepre.2014.08.020. Epub 2014 Oct 7.
Results Reference
background
PubMed Identifier
25686165
Citation
Ma Y, Olendzki BC, Wang J, Persuitte GM, Li W, Fang H, Merriam PA, Wedick NM, Ockene IS, Culver AL, Schneider KL, Olendzki GF, Carmody J, Ge T, Zhang Z, Pagoto SL. Single-component versus multicomponent dietary goals for the metabolic syndrome: a randomized trial. Ann Intern Med. 2015 Feb 17;162(4):248-57. doi: 10.7326/M14-0611.
Results Reference
background
PubMed Identifier
24345027
Citation
Wang J, Olendzki BC, Wedick NM, Persuitte GM, Culver AL, Li W, Merriam PA, Carmody J, Fang H, Zhang Z, Olendzki GF, Zheng L, Ma Y. Challenges in sodium intake reduction and meal consumption patterns among participants with metabolic syndrome in a dietary trial. Nutr J. 2013 Dec 18;12:163. doi: 10.1186/1475-2891-12-163.
Results Reference
background
PubMed Identifier
24084051
Citation
Wang J, Persuitte G, Olendzki BC, Wedick NM, Zhang Z, Merriam PA, Fang H, Carmody J, Olendzki GF, Ma Y. Dietary magnesium intake improves insulin resistance among non-diabetic individuals with metabolic syndrome participating in a dietary trial. Nutrients. 2013 Sep 27;5(10):3910-9. doi: 10.3390/nu5103910.
Results Reference
background
PubMed Identifier
22709766
Citation
Merriam PA, Persuitte G, Olendzki BC, Schneider K, Pagoto SL, Palken JL, Ockene IS, Ma Y. Dietary intervention targeting increased fiber consumption for metabolic syndrome. J Acad Nutr Diet. 2012 May;112(5):621-3. doi: 10.1016/j.jand.2012.01.024. Epub 2012 Apr 25. No abstract available.
Results Reference
background
PubMed Identifier
28353070
Citation
Zhang L, Pagoto S, May C, Olendzki B, L Tucker K, Ruiz C, Cao Y, Ma Y. Effect of AHA dietary counselling on added sugar intake among participants with metabolic syndrome. Eur J Nutr. 2018 Apr;57(3):1073-1082. doi: 10.1007/s00394-017-1390-6. Epub 2017 Mar 28.
Results Reference
derived

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A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome

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