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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
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Dietary Supplement: Optifast Products

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.
Enrollment: 30
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
very low calorie diet program Dietary Supplement: Optifast Products
Optional Optifast products offered once every other week X 6 months; then monthly.
Other Name: Optifast Dietary Supplements

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222988

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Gretchen Ames, Ph.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Gretchen E. Ames, Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01222988     History of Changes
Other Study ID Numbers: 10-002960
Study First Received: October 12, 2010
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 27, 2015