A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome
NCT ID: NCT00911885
Last Updated: 2015-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
240 participants
INTERVENTIONAL
2009-04-30
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome
NCT02023515
Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study
NCT01008878
Promoting Employee Health Through The Worksite Food Environment
NCT02660086
Workplace-Sponsored Diet and Exercise Program to Reduce Obesity
NCT00123526
Preventing Obesity in the Worksite: A Multi-Message, Multi-"Step" Approach
NCT01585480
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High Fiber Diet
A single dietary change condition that focuses exclusively on increasing fiber.
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.
AHA Diet
The AHA Diet is the current recommendation for patients with the metabolic syndrome.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
21 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
University of Massachusetts, Worcester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yunsheng Ma
Associate Professor, University of Massachusetts
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yunsheng Ma, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-13075
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.