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BMC Medical Research Methodology
Published in: BMC Medical Research Methodology 1/2009

Open Access 01-12-2009 | Study protocol

Design and methods for testing a simple dietary message to improve weight loss and dietary quality

Authors: Philip A Merriam, Yunsheng Ma, Barbara C Olendzki, Kristin L Schneider, Wenjun Li, Ira S Ockene, Sherry L Pagoto

Published in: BMC Medical Research Methodology | Issue 1/2009

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Abstract

Background

The current food pyramid guidelines have been criticized because of their complexity and the knowledge required for users to understand the recommendations. Simplification of a dietary message to focus on a single key aspect of dietary quality, e.g., fiber intake, may make the message much easier to comprehend and adhere, such that respondents can achieve greater weight loss, better dietary quality and overall metabolic health.

Methods and design

This is a randomized controlled clinical trial with two equal sized arms. In total, 240 obese adults who meet diagnostic criteria for the metabolic syndrome will be randomized to one of the two conditions: 1) a high fiber diet and 2) the American Heart Association (AHA) diet. In the high fiber diet condition, patients will be given instruction only on achieving daily dietary fiber intake of 30 g or more. In the AHA diet condition, patients will be instructed to make the several dietary changes recommended by the AHA 2006 guidelines. The trial examines participant weight loss and dietary quality as well as changes in components of the metabolic syndrome, inflammatory biomarkers, low-density lipoprotein cholesterol levels, insulin levels, and glycosolated hemoglobin. Potential mediators, i.e., diet adherence and perceived ease of the diet, and the intervention effect on weight change will also be examined.

Discussions

The purpose of this paper is to outline the study design and methods for testing the simple message of increasing dietary fiber. If the simple dietary approach is found efficacious for weight loss; and, improves dietary quality, metabolic health, and adherence, it might then be used to develop a simple public health message.

Trial registration

NCT00911885
Literature
1.
Millen BE, Pencina MJ, Kimokoti RW, Zhu L, Meigs JB, Ordovas JM, D'Agostino RB: Nutritional risk and the metabolic syndrome in women: opportunities for preventive intervention from the Framingham Nutrition Study. The American journal of clinical nutrition. 2006, 84: 434-41.PubMed
2.
McCullough ML, Feskanich D, Stampfer MJ, Giovannucci EL, Rimm EB, Hu FB, Spiegelman D, Hunter DJ, Colditz GA, Willett WC: Diet quality and major chronic disease risk in men and women: moving toward improved dietary guidance. The American journal of clinical nutrition. 2002, 76: 1261-71.PubMed
3.
Toft U, Kristoffersen LH, Lau C, Borch-Johnsen K, Jorgensen T: The Dietary Quality Score: validation and association with cardiovascular risk factors: the Inter99 study. Eur J Clin Nutr. 2007, 61: 270-8. 10.1038/sj.ejcn.1602503.CrossRefPubMed
4.
Ford ES, Giles WH, Mokdad AH: Increasing prevalence of the metabolic syndrome among u.s. Adults. Diabetes care. 2004, 27: 2444-9. 10.2337/diacare.27.10.2444.CrossRefPubMed
5.
Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001, 285: 2486-97. 10.1001/jama.285.19.2486.
6.
Sahyoun NR, Pratt CA, Anderson A: Evaluation of nutrition education interventions for older adults: a proposed framework. J Am Diet Assoc. 2004, 104: 58-69. 10.1016/j.jada.2003.10.013.CrossRefPubMed
7.
Tsai AG, Wadden TA: Systematic review: an evaluation of major commercial weight loss programs in the United States. Ann Intern Med. 2005, 142: 56-66.CrossRefPubMed
8.
Kelly CN, Stanner SA: Diet and cardiovascular disease in the UK: are the messages getting across?. Proc Nutr Soc. 2003, 62: 583-9. 10.1079/PNS2003272.CrossRefPubMed
9.
Keenan DP, Abusabha R: The fifth edition of the Dietary Guidelines for Americans: lessons learned along the way. J Am Diet Assoc. 2001, 101: 631-4. 10.1016/S0002-8223(01)00160-2.CrossRefPubMed
10.
Howarth NC, Saltzman E, Roberts SB: Dietary fiber and weight regulation. Nutr Rev. 2001, 59: 129-39.CrossRefPubMed
11.
12.
Lairon D: Dietary fiber and control of body weight. Nutr Metab Cardiovasc Dis. 2007, 17: 1-5. 10.1016/j.numecd.2006.07.006.CrossRefPubMed
13.
Galisteo M, Duarte J, Zarzuelo A: Effects of dietary fibers on disturbances clustered in the metabolic syndrome. J Nutr Biochem. 2008, 19: 71-84. 10.1016/j.jnutbio.2007.02.009.CrossRefPubMed
14.
Weickert MO, Pfeiffer AF: Metabolic effects of dietary fiber consumption and prevention of diabetes. The Journal of nutrition. 2008, 138: 439-42.PubMed
15.
Holt S, Brand J, Soveny C, Hansky J: Relationship of satiety to postprandial glycaemic, insulin and cholecystokinin responses. Appetite. 1992, 18: 129-41. 10.1016/0195-6663(92)90190-H.CrossRefPubMed
16.
Warren JM, Henry CJ, Simonite V: Low glycemic index breakfasts and reduced food intake in preadolescent children. Pediatrics. 2003, 112: e414-10.1542/peds.112.5.e414.CrossRefPubMed
17.
Jenkins DJ, Wolever TM, Rao AV, Hegele RA, Mitchell SJ, Ransom TP, Boctor DL, Spadafora PJ, Jenkins AL, Mehling C, Relle LK, Connelly PW, Story JA, Furumoto EJ, Corey P, Wursch P: Effect on blood lipids of very high intakes of fiber in diets low in saturated fat and cholesterol. N Engl J Med. 1993, 329: 21-6. 10.1056/NEJM199307013290104.CrossRefPubMed
18.
Pereira MA, Ludwig DS: Dietary fiber and body-weight regulation. Observations and mechanisms. Pediatr Clin North Am. 2001, 48: 969-80. 10.1016/S0031-3955(05)70351-5.CrossRefPubMed
19.
Raben A, Christensen NJ, Madsen J, Holst JJ, Astrup A: Decreased postprandial thermogenesis and fat oxidation but increased fullness after a high-fiber meal compared with a low-fiber meal. The American journal of clinical nutrition. 1994, 59: 1386-94.PubMed
20.
Pi-Sunyer X: Do glycemic index, glycemic load, and fiber play a role in insulin sensitivity, disposition index, and type 2 diabetes?. Diabetes care. 2005, 28: 2978-9. 10.2337/diacare.28.12.2978.CrossRefPubMed
21.
Lau C, Faerch K, Glumer C, Tetens I, Pedersen O, Carstensen B, Jorgensen T, Borch-Johnsen K: Dietary glycemic index, glycemic load, fiber, simple sugars, and insulin resistance: the Inter99 study. Diabetes care. 2005, 28: 1397-403. 10.2337/diacare.28.6.1397.CrossRefPubMed
22.
Liese AD, Schulz M, Fang F, Wolever TM, D'Agostino RB, Sparks KC, Mayer-Davis EJ: Dietary glycemic index and glycemic load, carbohydrate and fiber intake, and measures of insulin sensitivity, secretion, and adiposity in the Insulin Resistance Atherosclerosis Study. Diabetes care. 2005, 28: 2832-8. 10.2337/diacare.28.12.2832.CrossRefPubMed
23.
Hanai H, Ikuma M, Sato Y, Iida T, Hosoda Y, Matsushita I, Nogaki A, Yamada M, Kaneko E: Long-term effects of water-soluble corn bran hemicellulose on glucose tolerance in obese and non-obese patients: improved insulin sensitivity and glucose metabolism in obese subjects. Biosci Biotechnol Biochem. 1997, 61: 1358-61. 10.1271/bbb.61.1358.CrossRefPubMed
24.
Sierra M, Garcia JJ, Fernandez N, Diez MJ, Calle AP, Sahagun AM: Effects of ispaghula husk and guar gum on postprandial glucose and insulin concentrations in healthy subjects. Eur J Clin Nutr. 2001, 55: 235-43. 10.1038/sj.ejcn.1601147.CrossRefPubMed
25.
Davy BM, Melby CL: The effect of fiber-rich carbohydrates on features of Syndrome X. J Am Diet Assoc. 2003, 103: 86-96. 10.1053/jada.2003.50005.CrossRefPubMed
26.
Burke V, Hodgson JM, Beilin LJ, Giangiulioi N, Rogers P, Puddey IB: Dietary protein and soluble fiber reduce ambulatory blood pressure in treated hypertensives. Hypertension. 2001, 38: 821-6. 10.1161/hy1001.092614.CrossRefPubMed
27.
Appel LJ, Moore TJK, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N: A clinical trial of the effects of dietary patterns of blood pressure. N Engl J Med. 1997, 336: 1117-24. 10.1056/NEJM199704173361601.CrossRefPubMed
28.
Ferrannini E, Buzzigoli G, Bonadonna R, Giorico MA, Oleggini M, Graziadei L, Pedrinelli R, Brandi L, Bevilacqua S: Insulin resistance in essential hypertension. N Engl J Med. 1987, 317: 350-7.CrossRefPubMed
29.
Ajani UA, Ford ES, Mokdad AH: Dietary fiber and C-reactive protein: findings from national health and nutrition examination survey data. The Journal of nutrition. 2004, 134: 1181-5.PubMed
30.
King DE, Egan BM, Geesey ME: Relation of dietary fat and fiber to elevation of C-reactive protein. Am J Cardiol. 2003, 92: 1335-9. 10.1016/j.amjcard.2003.08.020.CrossRefPubMed
31.
Ma Y, Griffith J, Chasan-Taber L, Olendzki B, Jackson E, Stanek E, Li W, Pagoto S, Hafner A, Ockene I: Association between dietary fiber and serum C-reactive protein. The American journal of clinical nutrition. 2006, 83: 760-6.PubMedPubMedCentral
32.
Ma Y, Hébert J, Li W, Bertone-Johnson E, Olendzki B, Ockene I, Pagoto S, Rosal M, Ockene J, Tinker L, Griffith J, Liu S: Association between dietary fiber and markers of systemic inflammation in the Women's Health Initiative Observational Study. Nutrition. 2008, 24 (10): 941-9. 10.1016/j.nut.2008.04.005.CrossRefPubMedPubMedCentral
33.
King DE, Egan BM, Woolson RF, Mainous AG, Al-Solaiman Y, Jesri A: Effect of a high-fiber diet vs a fiber-supplemented diet on C-reactive protein level. Arch Intern Med. 2007, 167: 502-6. 10.1001/archinte.167.5.502.CrossRefPubMed
34.
King DE: Dietary fiber, inflammation, and cardiovascular disease. Mol Nutr Food Res. 2005, 49: 594-600. 10.1002/mnfr.200400112.CrossRefPubMed
35.
Qi L, van Dam RM, Liu S, Franz M, Mantzoros C, Hu FB: Whole-grain, bran, and cereal fiber intakes and markers of systemic inflammation in diabetic women. Diabetes care. 2006, 29: 207-11. 10.2337/diacare.29.02.06.dc05-1903.CrossRefPubMed
36.
Liu S, Manson JE, Buring JE, Stampfer MJ, Willett WC, Ridker PM: Relation between a diet with a high glycemic load and plasma concentrations of high-sensitivity C-reactive protein in middle-aged women. The American journal of clinical nutrition. 2002, 75: 492-8.PubMed
37.
Berg AH, Scherer PE: Adipose tissue, inflammation, and cardiovascular disease. Circ Res. 2005, 96: 939-49. 10.1161/01.RES.0000163635.62927.34.CrossRefPubMed
38.
Vuksan V, Sievenpiper JL, Owen R, Swilley JA, Spadafora P, Jenkins DJ, Vidgen E, Brighenti F, Josse RG, Leiter LA, Xu Z, Novokmet R: Beneficial effects of viscous dietary fiber from Konjac-mannan in subjects with the insulin resistance syndrome: results of a controlled metabolic trial. Diabetes care. 2000, 23: 9-14. 10.2337/diacare.23.1.9.CrossRefPubMed
39.
Olendzki B, Ma Y, Schneider K, Merriam P, Culver A, Ockene IS, Pagoto S: A simple dietary message to improve dietary quality: results from a pilot investigation. Nutrition. 2009, 25 (7-8): 734-44. 10.1016/j.nut.2009.01.009.CrossRef
40.
Lichtenstein AH, Appel LJ, Brands M, Carnethon M, Daniels S, Franch HA, Franklin B, Kris-Etherton P, Harris WS, Howard B, Karanja N, Lefevre M, Rudel L, Sacks F, Van Horn L, Winston M, Wylie-Rosett J: Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee. Circulation. 2006, 114: 82-96. 10.1161/CIRCULATIONAHA.106.176158.CrossRefPubMed
41.
Zivkovic AM, German JB, Sanyal AJ: Comparative review of diets for the metabolic syndrome: implications for nonalcoholic fatty liver disease. The American journal of clinical nutrition. 2007, 86: 285-300.PubMed
42.
Feldeisen SE, Tucker KL: Nutritional strategies in the prevention and treatment of metabolic syndrome. Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme. 2007, 32: 46-60. 10.1139/H06-101.CrossRefPubMed
43.
Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC, Spertus JA, Costa F: Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005, 112: 2735-52. 10.1161/CIRCULATIONAHA.105.169404.CrossRefPubMed
44.
Carmina E: Metabolic syndrome in polycystic ovary syndrome. Minerva Ginecol. 2006, 58: 109-14.PubMed
45.
Atkins RC: Atkins' New Diet Revolution. 1998, New York: Avon Books
46.
Devins G, Orme C: Center for Epidemiologic Studies Depression Scale. Test Critiques. Edited by: Sweetland R. 1985, Kansas City: Test Corp of America, a subsidiary of Westport Publishers, Inc, 144-60.
47.
Radloff L: The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas. 1977, 1: 385-401. 10.1177/014662167700100306.CrossRef
48.
Comstock GW, Helsing KJ: Symptoms of depression in two communities. Psychol Med. 1976, 6: 551-63. 10.1017/S0033291700018171.CrossRefPubMed
49.
Ryan P: sxd1.1: Update to random allocation of treatment to blocks. Stata Technical Bulletin. 1999, 36-7.
50.
Rosal MC, Ebbeling CB, Lofgren I, Ockene JK, Ockene IS, Hebert JR: Facilitating dietary change: the patient-centered counseling model. J Am Diet Assoc. 2001, 101: 332-41. 10.1016/S0002-8223(01)00086-4.CrossRefPubMed
51.
Park Y, Hunter DJ, Spiegelman D, Bergkvist L, Berrino F, Brandt van den PA, Buring JE, Colditz GA, Freudenheim JL, Fuchs CS, Giovannucci E, Goldbohm RA, Graham S, Harnack L, Hartman AM, Jacobs DR, Kato I, Krogh V, Leitzmann MF, McCullough ML, Miller AB, Pietinen P, Rohan TE, Schatzkin A, Willett WC, Wolk A, Zeleniuch-Jacquotte A, Zhang SM, Smith-Warner SA: Dietary fiber intake and risk of colorectal cancer: a pooled analysis of prospective cohort studies. JAMA. 2005, 294: 2849-57. 10.1001/jama.294.22.2849.CrossRefPubMed
52.
53.
Frison L, Pocock SJ: Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design. Stat Med. 1992, 11: 1685-704. 10.1002/sim.4780111304.CrossRefPubMed
54.
Rabe-Hesketh S, Skrondal A, Pickles A: Reliable estimation of generalised linear mixed models using adaptive quadrature. The Stata Journal. 2002, 2: 1-21.
55.
Rabe-Hesketh S, Skrondal A, Pickles A: Maximum likelihood estimation of generalized linear models with covariate measurement error. The Stata Journal. 2003, 4: 386-411.
56.
Kranz S, Mitchell DC, Siega-Riz AM, Smiciklas-Wright H: Dietary fiber intake by American preschoolers is associated with more nutrient-dense diets. J Am Diet Assoc. 2005, 105: 221-5. 10.1016/j.jada.2004.11.005.CrossRefPubMed
57.
Ma Y, Pagoto S, Griffith J, Merriam P, Ockene I, Hafner A, Olendzki B: A Dietary Quality Comparison of Popular Weight Loss Plans. J Am Diet Assoc. 2007, 107: 1786-91. 10.1016/j.jada.2007.07.013.CrossRefPubMedPubMedCentral
58.
Quatromoni PA, Copenhafer DL, D'Agostino RB, Millen BE: Dietary patterns predict the development of overweight in women: The Framingham Nutrition Studies. J Am Diet Assoc. 2002, 102: 1239-46. 10.1016/S0002-8223(02)90275-0.CrossRefPubMed
Metadata
Title
Design and methods for testing a simple dietary message to improve weight loss and dietary quality
Authors
Philip A Merriam
Yunsheng Ma
Barbara C Olendzki
Kristin L Schneider
Wenjun Li
Ira S Ockene
Sherry L Pagoto
Publication date
01-12-2009
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2009
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/1471-2288-9-87

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