NCT01021917

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

6.3 years

First QC Date

November 25, 2009

Last Update Submit

August 28, 2017

Conditions

Obesity

Keywords

ObesityWeight LossMeal Replacements

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • 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

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community-dwelling

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medifast Inc.

Owings Mills, Maryland, 21117, United States

Location

Related Publications (10)

  • 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.

    PMID: 14711072BACKGROUND

  • 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.

    PMID: 15199035BACKGROUND

  • 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.

    PMID: 14747663BACKGROUND

  • 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.

    PMID: 12704397BACKGROUND

  • 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.

    PMID: 9989680BACKGROUND

  • 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.

    PMID: 11707555BACKGROUND

  • 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.

    PMID: 10793302BACKGROUND

  • 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.

    PMID: 9376884BACKGROUND

  • 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.

    PMID: 9625084BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Lisa M Davis, PhD

    Medifast, Inc.

    PRINCIPAL INVESTIGATOR

  • Christopher D Coleman, MS

    Medifast, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2009

First Posted

November 30, 2009

Study Start

March 1, 2008

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

US(1)