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| ID | Type | Description | Link |
|---|---|---|---|
| 20071961 | Other Identifier | Western Institutional Review Board |
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Given the length of time data was collected (i.e. 5 1/3 years), we do not anticipate a change any potential conclusions by completing the final survey.
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The overall purpose of this research is to evaluate the long-term outcomes associated with participation in Medifast Direct and Take Shape For Life weight-loss programs in comparison with non-Medifast weight-loss programs. Another important goal of this research is to determine whether the differences between Medifast Direct and Take Shape For Life programs affect weight-loss and maintenance of weight-loss in customers.
Researchers desire to capture the behaviors and outcomes of those individuals who would enroll in these programs without the additional encouragement to be a participant in a research study. The study will employ an observational prospective design intended to introduce as little interference as possible with subjects' behaviors. This is in order to capture the pure effects of the weight-loss programs themselves, and to reduce the potentially confounding effects of merely participating in a research study. Subjects who have already committed to a weight-loss program (Medifast Direct, Take Shape For Life , or other) will be recruited to join this study, and will be asked to complete several questionnaires over a period of up to 6 â…“ years after enrollment. Questionnaires will measure information regarding anthropometrics, sociodemographics, and health & quality of life outcomes. The overall goal of this research is to be able to describe and compare the long-term dieting behaviors and outcomes among participants in Medifast Direct and Take Shape For Life programs in comparison with other dieters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Other Dieters (OD) | Those participating in weight loss programs other than Medifast Direct or Take Shape For Life. | ||
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| To compare change in body weight among subjects in Medifast Direct, Take Shape For Life, and Other Dieters. | 4 months, 16 months, and at 5y follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate attrition rates among subjects enrolled in Medifast Direct, Take Shape For Life, and Other Dieters. | 4 months, 16 months, and at 5 yr follow-up | |
| To evaluate potential predictors of successful weight loss & maintenance of weight loss. | 4 months, 16 months, and at 5 yr follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Community-dwelling
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Davis, PhD | Medifast, Inc. | Principal Investigator |
| Christopher D Coleman, MS | Medifast, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medifast Inc. | Owings Mills | Maryland | 21117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14711072 | Background | 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. | |
| 15199035 | Background | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| To examine the effects of Medifast Direct and Take Shape For Life programs on intake, health & quality of life outcomes, and eating behaviors. | 4 months, 16 months, and at 5y follow-up |
| To explore potential differences between subgroups in change in body weight and attrition. | 4 months, 16 months, and at 5y follow-up |
| 14747663 | Background | 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. |
| 12704397 | Background | 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. |
| 9989680 | Background | 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. |
| 11707555 | Background | 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. |
| 10793302 | Background | 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. |
| 9376884 | Background | 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. |
| 9625084 | Background | 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. |
| Background | Stata Statistical Software: release 7.0 College Station TX. Stata Corporation: College Station, TX 1994-2001. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |