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
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TERMINATED
332 participants
OBSERVATIONAL
2008-03-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Other Dieters (OD)
Those participating in weight loss programs other than Medifast Direct or Take Shape For Life.
No interventions assigned to this group
Take Shape For Life (TSFL)
Those using Medifast meal replacement products for weight loss while working closely with a Take Shape For Life certified Health Coach.
No interventions assigned to this group
Medifast Direct (MD)
Those using Medifast meal replacement products specifically for weight loss that were purchased directly from the company and individually monitored by the customer.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* BMI ( \> 25.0 kg/m2)
* Beginning a weight loss diet plan (MD, TSFL, or one of a number of commercially available plans)NOTE: subjects must have already committed to a weight-loss plan in order to be eligible for this study. The recruitment process is specifically designed so as NOT to appear to encourage subjects to begin a weight-loss plan. Rather, the purpose of this research is to track information about persons who have already committed to a weight-loss program.
* Willing and able to give informed consent
* Willing and able to comply with study protocol
Exclusion Criteria
* Previous hospitalization for psychiatric disorder or eating disorder
* Current, uncontrolled medical conditions
* Taking unstable doses of weight-loss or appetite-affecting medications (e.g., SSRIs, steroids, Ritalin)
* Taking prescription weight-loss drugs (Phentermine, Sibutramine, Orlistat, etc…)
* Have undergone, or plan to undergo, weight loss surgery (e.g. gastric bypass, lap band, duodenal switch) in the next 6 1/3 years
* Plan to undergo weight-altering cosmetic surgery procedures (e.g. breast reduction/augmentation, tummy tuck, liposuction, or other skin removal procedures) in the next 6 1/3 years
18 Years
69 Years
ALL
No
Sponsors
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Medifast, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa M Davis, PhD
Role: PRINCIPAL_INVESTIGATOR
Medifast, Inc.
Christopher D Coleman, MS
Role: STUDY_DIRECTOR
Medifast, Inc.
Locations
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Medifast Inc.
Owings Mills, Maryland, United States
Countries
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References
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Thearle M, Aronne LJ. Obesity and pharmacologic therapy. Endocrinol Metab Clin North Am. 2003 Dec;32(4):1005-24. doi: 10.1016/s0889-8529(03)00066-5.
Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
Gale SM, Castracane VD, Mantzoros CS. Energy homeostasis, obesity and eating disorders: recent advances in endocrinology. J Nutr. 2004 Feb;134(2):295-8. doi: 10.1093/jn/134.2.295.
Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.
Ditschuneit HH, Flechtner-Mors M, Johnson TD, Adler G. Metabolic and weight-loss effects of a long-term dietary intervention in obese patients. Am J Clin Nutr. 1999 Feb;69(2):198-204. doi: 10.1093/ajcn/69.2.198.
Ditschuneit HH, Flechtner-Mors M. Value of structured meals for weight management: risk factors and long-term weight maintenance. Obes Res. 2001 Nov;9 Suppl 4:284S-289S. doi: 10.1038/oby.2001.132.
Quinn Rothacker D. Five-year self-management of weight using meal replacements: comparison with matched controls in rural Wisconsin. Nutrition. 2000 May;16(5):344-8. doi: 10.1016/s0899-9007(99)00280-4.
Glenny AM, O'Meara S, Melville A, Sheldon TA, Wilson C. The treatment and prevention of obesity: a systematic review of the literature. Int J Obes Relat Metab Disord. 1997 Sep;21(9):715-37. doi: 10.1038/sj.ijo.0800495.
Golan M, Weizman A, Apter A, Fainaru M. Parents as the exclusive agents of change in the treatment of childhood obesity. Am J Clin Nutr. 1998 Jun;67(6):1130-5. doi: 10.1093/ajcn/67.6.1130.
Stata Statistical Software: release 7.0 College Station TX. Stata Corporation: College Station, TX 1994-2001.
Other Identifiers
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20071961
Identifier Type: OTHER
Identifier Source: secondary_id
MED013
Identifier Type: -
Identifier Source: org_study_id
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