ObesityNCT01222988
Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention
A study testing Optifast Products in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity
- What is being tested?
- Optifast Products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Myocardial infarction within 6 months
- Unstable angina
- Stroke
- Chronic steroid use
- Active peptic ulcer disease
- Advanced cirrhosis
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Obesity
- Being tested
- Optifast Products
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optifast ProductsDietary supplement
Also called Optifast Dietary Supplements
Optional Optifast products offered once every other week X 6 months; then monthly.
| Study group | Role | What they receive |
|---|---|---|
| very low calorie diet program | Other | Not described Receives: Dietary Supplement: Optifast Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Secondary outcomes (1)
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Gretchen Ames, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222988
- Sponsor's protocol ID
- 10-002960
- Status last verified
- Jan 2013
- First submitted
- 12 Oct 2010
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Maintenance Following Very Low Calorie Diet: The Sustain Lost Weight (SLW) Intervention
- ClinicalTrials.gov ID
- NCT01222988
- Acronym / sponsor ID
- 10-002960
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| very low calorie diet program | Other | Dietary Supplement: Optifast Products |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- Myocardial infarction within 6 months
- Unstable angina
- Stroke
- Chronic steroid use
- Active peptic ulcer disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optifast ProductsAlso: Optifast Dietary SupplementsOptional Optifast products offered once every other week X 6 months; then monthly. | Dietary supplement | very low calorie diet program |
Primary outcome
Treatment Feasibility
Time frame: 52 weeks
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.
1 secondary outcome
Weight Gain Analysis
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen Ames, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optifast Products in people with Obesity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Feasibility (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.