AzTrials
AzTrials

ObesityNCT01021917

SUCCESS Tracking Study

An observational study of Obesity, run by Medifast, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Obesity
How many people
332 participants
Where
1 siteUnited States
Study dates
Mar 2008to Jul 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Community-dwelling

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medifast Inc.

    Owings Mills, Maryland, 21117

Other trials in United States

About this study

Official title: Weight Loss & Maintenance of Weight Loss Tracking Study (SUCCESS Tracking Study)

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.

Read the detailed 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.

Conditions
Obesity
Keywords
Obesity, Weight Loss, Meal Replacements
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01021917
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare change in body weight among subjects in Medifast Direct, Take Shape For Life, and Other Dieters.

    Measured: 4 months, 16 months, and at 5y follow-up

Secondary outcomes (4)

  1. To investigate attrition rates among subjects enrolled in Medifast Direct, Take Shape For Life, and Other Dieters.

    Measured: 4 months, 16 months, and at 5 yr follow-up

  2. To evaluate potential predictors of successful weight loss & maintenance of weight loss.

    Measured: 4 months, 16 months, and at 5 yr follow-up

  3. To examine the effects of Medifast Direct and Take Shape For Life programs on intake, health & quality of life outcomes, and eating behaviors.

    Measured: 4 months, 16 months, and at 5y follow-up

  4. To explore potential differences between subgroups in change in body weight and attrition.

    Measured: 4 months, 16 months, and at 5y follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2009 (estimated)
  2. Study startMar 2008
  3. Primary completionJul 2014
  4. Study completionJul 2014

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
332 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01021917
Sponsor's protocol ID
MED013
Other IDs
20071961
Status last verified
Aug 2017
First submitted
25 Nov 2009
Last updated
29 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 14711072

  • 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.

    PubMed 15199035

  • 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.

    PubMed 14747663

  • 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.

    PubMed 12704397

  • 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.

    PubMed 9989680

  • 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.

    PubMed 11707555

  • 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.

    PubMed 10793302

  • 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.

    PubMed 9376884

  • 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.

    PubMed 9625084

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

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Medifast, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare change in body weight among subjects in Medifast Direct, Take Shape For Life, and Other Dieters. (time frame: 4 months, 16 months, and at 5y follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01021917, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in