SUCCESS Tracking Study
28 augustus 2017 bijgewerkt door: Medifast, Inc.
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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Verwacht)
332
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Maryland
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Owings Mills, Maryland, Verenigde Staten, 21117
- Medifast Inc.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 69 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Community-dwelling
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-control
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
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Other Dieters (OD)
Those participating in weight loss programs other than Medifast Direct or Take Shape For Life.
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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.
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To compare change in body weight among subjects in Medifast Direct, Take Shape For Life, and Other Dieters.
Tijdsspanne: 4 months, 16 months, and at 5y follow-up
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4 months, 16 months, and at 5y follow-up
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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To investigate attrition rates among subjects enrolled in Medifast Direct, Take Shape For Life, and Other Dieters.
Tijdsspanne: 4 months, 16 months, and at 5 yr follow-up
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4 months, 16 months, and at 5 yr follow-up
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To evaluate potential predictors of successful weight loss & maintenance of weight loss.
Tijdsspanne: 4 months, 16 months, and at 5 yr follow-up
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4 months, 16 months, and at 5 yr follow-up
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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.
Tijdsspanne: 4 months, 16 months, and at 5y follow-up
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4 months, 16 months, and at 5y follow-up
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To explore potential differences between subgroups in change in body weight and attrition.
Tijdsspanne: 4 months, 16 months, and at 5y follow-up
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4 months, 16 months, and at 5y follow-up
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Lisa M Davis, PhD, Medifast, Inc.
- Studie directeur: Christopher D Coleman, MS, Medifast, Inc.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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. 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2008
Primaire voltooiing (Werkelijk)
1 juli 2014
Studie voltooiing (Werkelijk)
1 juli 2014
Studieregistratiedata
Eerst ingediend
25 november 2009
Eerst ingediend dat voldeed aan de QC-criteria
25 november 2009
Eerst geplaatst (Schatting)
30 november 2009
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 augustus 2017
Laatste update ingediend die voldeed aan QC-criteria
28 augustus 2017
Laatst geverifieerd
1 augustus 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MED013
- 20071961 (Andere identificatie: Western Institutional Review Board)
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