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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Optifast Products

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: very low calorie diet program	Dietary supplement: Optifast Products; Optional Optifast products offered once every other week X 6 months; then monthly.; Other Names: Optifast Dietary Supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Feasibility	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.	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Gain Analysis	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.	52 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Gretchen Ames, Ph.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 15, 2010
• First Posted (ESTIMATE): October 18, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 17, 2013
• Last Update Submitted That Met QC Criteria: January 15, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 10-002960