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Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01222988
First received: October 12, 2010
Last updated: January 15, 2013
Last verified: January 2013

October 12, 2010
January 15, 2013
October 2010
October 2012   (final data collection date for primary outcome measure)
Treatment Feasibility [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Treatment will be considered feasible if greater than 50 % of participants attend a minimum of 17 of 20 sessions. The treatment will be considered acceptable for further study if greater than 50% of participants rate the maintenance program with a mean score of 6 or higher.
Same as current
Complete list of historical versions of study NCT01222988 on ClinicalTrials.gov Archive Site
Weight Gain Analysis [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Weight regain from week 1 to 52 will be analyzed. Patients who discontinue the study or are lost to follow-up will be assumed to have gained more than 10 kg at 12 months.
Same as current
Not Provided
Not Provided
 
Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention
Not Provided

Obtain a preliminary assessment of the feasibility and acceptability of delivering the sustained lost weight (SLW) intervention in a real-world clinical setting for patients who have completed a 21-week very low calorie diet (VLCD).

Hypothesis: Intervention will be feasible to implement as evidenced by the ability to recruit and retain participants and acceptable to participants as evidenced by self-report of satisfaction with the program and adoption of weight maintenance behaviors.

Secondary Aim: Obtain a preliminary assessment of the effectiveness of the sustained lost weight (SLW) intervention for patients who have completed 21 weeks of a very low calorie diet (VLCD).

Hypothesis: Greater than 75% of participants who receive this novel approach, where maintenance behaviors are individualized based on resting metabolic rate and a physical activity factor, will regain greater or equal to 10 kg. at week 52 follow-up.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Obesity
Dietary Supplement: Optifast Products
Optional Optifast products offered once every other week X 6 months; then monthly.
Other Name: Optifast Dietary Supplements
very low calorie diet program
Intervention: Dietary Supplement: Optifast Products
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completed fast and transition period of the OPTIFAST® program
  • Be able to participate fully in all aspects of the study
  • Willing to refrain from participating in additional weight loss interventions for the duration of the study
  • Willing to provide written informed consent.

Exclusion Criteria:

  • Myocardial infarction within 6 months
  • Unstable angina
  • Stroke
  • Chronic steroid use
  • Active peptic ulcer disease
  • Advanced cirrhosis
  • Active hepatitis
  • Advanced renal disease
  • Active thrombophlebitis
  • Recent skeletal fractures
  • Use of lithium
  • Pancreatitis
  • Pregnancy
  • Type 1 diabetes mellitus
  • History of diabetic ketoacidosis
  • Active bulimia nervosa
  • Severe depression
  • Psychosis
  • Substance abuse
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01222988
10-002960
No
Gretchen E. Ames, Ph.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Gretchen Ames, Ph.D. Mayo Clinic
Mayo Clinic
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP