SUCCESS Tracking Study

Obesity Clinical Trial

Official title:

Weight Loss & Maintenance of Weight Loss Tracking Study (SUCCESS Tracking Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01021917
• Other study ID #: MED013
• Secondary ID: 20071961
• Status: Terminated
• Phase: N/A
• First received: November 25, 2009
• Last updated: August 28, 2017
• Start date: March 2008
• Est. completion date: July 2014

Study information

• Verified date: August 2017
• Source: Medifast, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 ⅓ 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 332
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Adult males and females between the ages of 18 - 69 years

• 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:

• Unable to give informed consent

• 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

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Medifast Inc.	Owings Mills	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Medifast, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

Gale SM, Castracane VD, Mantzoros CS. Energy homeostasis, obesity and eating disorders: recent advances in endocrinology. J Nutr. 2004 Feb;134(2):295-8. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Stata Statistical Software: release 7.0 College Station TX. Stata Corporation: College Station, TX 1994-2001.

Thearle M, Aronne LJ. Obesity and pharmacologic therapy. Endocrinol Metab Clin North Am. 2003 Dec;32(4):1005-24. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	To evaluate potential predictors of successful weight loss & maintenance of weight loss.		4 months, 16 months, and at 5 yr follow-up
Secondary	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
Secondary	To explore potential differences between subgroups in change in body weight and attrition.		4 months, 16 months, and at 5y follow-up