Comparison of Methods for Delivering a Lifestyle Modification Program for Obese Patients
A Randomized Trial
- Andres G. Digenio, MD, PhD;
- James P. Mancuso, PhD;
- Robert A. Gerber, PharmD, MA, MBA; and
- Roman V. Dvorak, MD, PhD
- From Pfizer, South Lyme, Connecticut, and Pfizer Global Research and Development, Cardiovascular and Metabolic, New London, Connecticut.
Abstract
Background: Physicians frequently prescribe medications for weight loss but offer minimal lifestyle counseling despite the additional benefits of combining both interventions.
Objective: To compare 5 methods of delivering a lifestyle modification program to obese patients receiving sibutramine.
Design: Randomized, 6-month, open-label study. Participants were assigned to intervention groups by using a computer-generated schedule of randomly permuted blocks. Block length was 5.
Setting: 12 independent research clinics with experience running obesity trials.
Patients: 376 patients with obesity (body mass index ≥30 and <40 kg/m2).
Intervention: High-frequency face-to-face lifestyle modification counseling (HF-F2F) (n = 74), low-frequency face-to-face counseling (LF-F2F) (n = 76), high-frequency telephone counseling (HF-TEL) (n = 76), high-frequency e-mail counseling (HF-EMAIL) (n = 74), or no dietitian contact (self-help [SELF]) (n = 76). All participants received sibutramine, 10 mg/d; a lifestyle manual; and access to a weight-loss Web site.
Measurements: Percentage change in body weight at 6 months was the primary outcome. Secondary end points included changes in waist circumference; lipid, glucose, and insulin levels; blood pressure; weight-related symptoms; and quality of life at 6 months.
Results: At 6 months, the mean weight loss, relative to baseline, in the HF-F2F and HF-TEL groups was similar (8.9% [95% CI, 8.0% to 9.8%] and 7.7% [CI, 6.8% to 8.7%]) and significantly greater than that in the other groups (LF-F2F, 6.4% [CI, 5.4% to 7.3%]; HF-EMAIL, 5.9% [CI, 5.0% to 6.8%]; and SELF, 5.2% [CI, 4.3% to 6.1%]). All groups showed significant improvements in waist circumference, high-density lipoprotein cholesterol and triglyceride levels, and measures of quality of life and weight-related symptoms. There were no serious adverse events and no differences in minor events among groups.
Limitation: Most participants were women, and the attrition rate was 30%.
Conclusion: High-frequency telephone contact with a dietitian was similar to HF-F2F contact for supporting lifestyle modification in obese patients trying to lose weight. The findings might be used by providers and health systems to promote healthy lifestyle changes for their patients.
Funding: Pfizer Global Research and Development.
Article and Author Information
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Acknowledgment: The authors thank Thomas A. Wadden, PhD, for his editorial comments; Cathy Dimitratos for assistance with study management; and Bill Moritz, Vamsi Bollu, and Joseph Cappelleri for assistance with the selection and analysis of patient-reported questionnaires.
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Grant Support: By Pfizer Global Research and Development.
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Potential Financial Conflicts of Interest: Employment: A.G. Digenio (Pfizer), J.P. Mancuso (Pfizer), R.A. Gerber (Pfizer), R.V. Dvorak (Pfizer). Stock ownership or options (other than mutual funds): A.G. Digenio (Pfizer), J.P. Mancuso (Pfizer), R.A. Gerber (Pfizer), R.V. Dvorak (Pfizer).
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Reproducible Research Statement: Study protocol and data set: Not available. Statistical code: Available from Dr. Mancuso (e-mail, james.mancuso{at}pfizer.com).
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Requests for Single Reprints: Andres G. Digenio, MD, PhD, PO Box 428, South Lyme, CT 06376; e-mail, agdvdb{at}aol.com.
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Current Author Addresses: Dr. Digenio: PO Box 428, South Lyme, CT 06376.
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Drs. Mancuso and Gerber: Pfizer, Inc., 50 Pequot Avenue, New London, CT 06320.
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Dr. Dvorak: Tericica, Inc., 2000 Sierra Parkway, Brisbane, CA 94005.
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Author Contributions: Conception and design: A.G. Digenio, J.P. Mancuso, R.V. Dvorak.
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Analysis and interpretation of the data: A.G. Digenio, J.P. Mancuso, R.A. Gerber, R.V. Dvorak.
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Drafting of the article: A.G. Digenio, R.V. Dvorak.
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Critical revision of the article for important intellectual content: A.G. Digenio, R.A. Gerber, R.V. Dvorak.
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Final approval of the article: A.G. Digenio, J.P. Mancuso, R.A. Gerber, R.V. Dvorak.
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Statistical expertise: J.P. Mancuso.
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Obtaining of funding: R.V. Dvorak.
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Administrative, technical, or logistic support: J.P. Mancuso, R.A. Gerber.
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Collection and assembly of date: J.P. Mancuso, R.A. Gerber.
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ClinicalTrials.gov registration number: NCT00471172.
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