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

Mayo Clinic

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Optifast Products

Study type: Interventional

Funder types: Other

Identifiers

NCT01222988

10-002960

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

very low calorie diet program

Other group

Treatment:

Dietary Supplement: Optifast Products