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

NCT ID: NCT01222988

Last Updated: 2013-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

very low calorie diet program

Group Type OTHER

Optifast Products

Intervention Type DIETARY_SUPPLEMENT

Optional Optifast products offered once every other week X 6 months; then monthly.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Optifast Products

Optional Optifast products offered once every other week X 6 months; then monthly.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Optifast Dietary Supplements

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mayo Clinic

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gretchen Ames, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10-002960

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Medifast 5 & 1 Plan
NCT01211301 COMPLETED NA
Low Oxygen Exposure and Weight Status
NCT05289310 RECRUITING NA