Background:
Few studies have compared diets to determine whether a program focused on 1 dietary change results in collateral effects on other untargeted healthy diet components.
Objective:
To evaluate a diet focused on increased fiber consumption versus the multicomponent American Heart Association (AHA) dietary guidelines.
Design:
Randomized, controlled trial from June 2009 to January 2014. (ClinicalTrials.gov: NCT00911885)
Setting:
Worcester, Massachusetts.
Participants:
240 adults with the metabolic syndrome.
Intervention:
Participants engaged in individual and group sessions.
Measurements:
Primary outcome was weight change at 12 months.
Results:
At 12 months, mean change in weight was −2.1 kg (95% CI, −2.9 to −1.3 kg) in the high-fiber diet group versus −2.7 kg (CI, −3.5 to −2.0 kg) in the AHA diet group. The mean between-group difference was 0.6 kg (CI, −0.5 to 1.7 kg). During the trial, 12 (9.9%) and 15 (12.6%) participants dropped out of the high-fiber and AHA diet groups, respectively ( P = 0.55). Eight participants developed diabetes (hemoglobin A1c level ≥6.5%) during the trial: 7 in the high-fiber diet group and 1 in the AHA diet group (P = 0.066).
Limitations:
Generalizability is unknown. Maintenance of weight loss after cessation of group sessions at 12 months was not assessed. Definitive conclusions cannot be made about dietary equivalence because the study was powered for superiority.
Conclusion:
The more complex AHA diet may result in up to 1.7 kg more weight loss; however, a simplified approach to weight reduction emphasizing only increased fiber intake may be a reasonable alternative for persons with difficulty adhering to more complicated diet regimens.
Primary Funding Source:
National Heart, Lung, and Blood Institute.
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Author, Article, and Disclosure Information
From University of Massachusetts Medical School, Worcester, Massachusetts; Medical School of Yangzhou University, Yangzhou, Jiangsu, China; Rosalind Franklin University of Medicine and Science, North Chicago, Illinois; and University of Massachusetts Lowell, Lowell, Massachusetts.
Disclaimer: The contents of this study are solely the responsibility of the authors and do not necessarily represent the official views of the National Heart, Lung, and Blood Institute.
Acknowledgment: The authors thank the participants for their contributions to the study; Penny Rosenzweig, MS, RD, and Judith C. Palken, MNS, RD, LDN, for delivering the nutritional interventions; Vijayalakshmi Patil, MS, for coordinating nutritional classes; Nancy Mecone, BSN, and Annabella Aguirre, MT, ACSP, MBA, for clinical measurements, blood draws, and catalog samples; Don Northway and Kristie Capurso for participant recruitment; and the data safety and monitoring board members—Cara B. Ebbeling, PhD, RD, Edward Stanek III, PhD, and James Chesebro, MD—for their unyielding support during the trial.
Grant Support: By the National Heart, Lung, and Blood Institute (grant 1R01HL094575; Dr. Ma).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-0611.
Reproducible Research Statement:Study protocol and statistical code: Available from Dr. Ma (e-mail, yunsheng.
Corresponding Author: Yunsheng Ma, MD, PhD, Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655; e-mail, Yunsheng.
Current Author Addresses: Drs. Ma, Li, Wedick, Carmody, Zhang, and Pagoto; Ms. B. Olendzki; Ms. Persuitte; Mr. Merriam; Ms. Culver; and Ms. G. Olendzki: Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655.
Dr. Wang: Department of Preventive Medicine, Medical College of Yangzhou University, 11 Huaihai Road, Yangzhou, Jiangsu, China 225001.
Dr. Fang: Division of Biostatistics and Health Services Research, Department of Quantitative Health Science, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01655.
Dr. Ockene: Division of Cardiovascular Medicine, Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, S3-856, Worcester, MA 01655.
Dr. Schneider: Rosalind Franklin University of Medicine and Science, Department of Psychology, 3333 Green Bay Road, North Chicago, IL 60064.
Dr. Ge: Department of Computer Science, Olsen Hall, University of Massachusetts Lowell, One University Avenue, Lowell, MA 01854.
Author Contributions: Conception and design: Y. Ma, B.C. Olendzki, G.M. Persuitte, W. Li, P.A. Merriam, S.L. Pagoto.
Analysis and interpretation of the data: Y. Ma, B.C. Olendzki, J. Wang, G.M. Persuitte, W. Li, H. Fang, P.A. Merriam, N.M. Wedick, K.L. Schneider, G.F. Olendzki, T. Ge, Z. Zhang.
Drafting of the article: Y. Ma, B.C. Olendzki, J. Wang, G.M. Persuitte, H. Fang, P.A. Merriam, N.M. Wedick, J. Carmody, Z. Zhang, S.L. Pagoto.
Critical revision of the article for important intellectual content: B.C. Olendzki, J. Wang, G.M. Persuitte, H. Fang, P.A. Merriam, N.M. Wedick, A.L. Culver, K.L. Schneider, J. Carmody, Z. Zhang, S.L. Pagoto.
Final approval of the article: Y. Ma, B.C. Olendzki, G.M. Persuitte, H. Fang, N.M. Wedick, K.L. Schneider, G.F. Olendzki, Z. Zhang, S.L. Pagoto.
Provision of study materials or patients: Y. Ma, B.C. Olendzki, S.L. Pagoto.
Statistical expertise: J. Wang, W. Li, H. Fang, N.M. Wedick.
Obtaining of funding: Y. Ma, B.C. Olendzki, W. Li, S.L. Pagoto.
Administrative, technical, or logistic support: P.A. Merriam.
Collection and assembly of data: B.C. Olendzki, G.M. Persuitte, P.A. Merriam, G.F. Olendzki.
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