ObesitySAFETYNCT06183034
Acceptability and Feasibility of a Preoperative Very Low Calorie Diet Intervention on Surgical Weight Loss Outcomes (SAFETY)
A study testing Very Low Calorie Diet in people with Obesity, run by Hartford Hospital at 1 site in United States.
Trial summary
Class 4 obesity is defined as a BMI ≥50Kg/m2, representing approximately ≥150 pounds of excess weight. For patients with Class 4 obesity, metabolic and bariatric surgery (MBS) is the only effective treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Very Low Calorie Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 30 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI greater than or equal to 50 kg/m2
- Eligible and approved for sleeve gastrectomy as primary bariatric treatment (eligibility and approval for sleeve gastrectomy will be determined from a surgical standpoint by the surgeon)
- Able and willing to sign an Informed Consent document
Who cannot join
- Qualified for Roux-en-Y gastric bypass
- On FDA-approved weight loss medications at time of consult
- Are lactose intolerant
- History of Type 1 diabetes
- Have had lap band or other prior bariatric surgery
- Global functioning score (GFR) ≤45 mL/min/1.73 m² (this is assessed as a part of the routine procedure for all patients)
Show all 11Show fewer
- >70 years old (our program does surgery on very few patients over this age)
- Weight is above 300 kgs (~660 lbs.). (The weight limit for SECA scales is 300 kgs maximum).
- Have been diagnosed with end stage renal disease (CKD stage 3-5) and on dialysis
- Severe depression measured by Beck Depression Inventory (BDI) (BDI score greater than or equal to 30)
- History of severe psychiatric disorder (schizophrenia, schizoaffective, or bipolar disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Study of Acceptability and Feasibility of a Preoperative Very Low Calorie Diet Intervention on Surgical Weight Loss Outcomes (SAFETY)
Class 4 obesity is defined as a BMI ≥50Kg/m2, representing approximately ≥150 pounds of excess weight. For patients with Class 4 obesity, metabolic and bariatric surgery (MBS) is the only effective treatment. However, MBS is associated with a higher rate of perioperative morbidity and mortality for patients with Class 4 obesity. Additionally, more patients with Class 4 obesity experience suboptimal weight loss. For patients with Class 4 obesity, preoperative weight loss can reduce the technical difficulty of surgical procedures, rendering MBS safer. Preoperative weight loss may also decrease visceral adipose tissue and liver volume as well as reduce weight-related comorbidities.
A very low-calorie diet (VLCD), which involves restricting caloric intake to approximately 800 kcal/day, is one strategy to help patients achieve weight loss preoperatively. Although studies show that a VLCD prior to MBS yields weight loss, reduces liver volume and rates of perioperative complications, most preoperative VLCDs are short (2-8 weeks) with variable adherence. To date, no study has systematically assessed the feasibility and acceptability of a standard 12-week VLCD among patients with BMI ≥50 pursuing MBS. No study has evaluated postoperative weight loss among patients who have undergone a preoperative VLCD.
This study will be a single arm trial designed to test the feasibility, acceptability, and preliminary efficacy of a 12-week VLCD program prior to sleeve gastrectomy (SG) and associated weight loss up to 1 year following MBS. The investigators will enroll 24 patients aged 18-70, with a BMI≥50Kg/m2, and are approved for SG. Participants will consume up to 5 meal replacement protein shakes and 2 cups of vegetables daily for 12 weeks. Participants will attend weekly in-person office visits with the clinicians at the Hartford Hospital Medical and Surgical Weight Loss Center in Glastonbury, CT to assess weight loss, physical and mental health, feasibility and acceptability of and adherence to the VLCD. The investigators hypothesize that a 12-week VLCD is feasible in this population, defined as ≥70% (18 out of 24 participants) completing the program. The investigators hypothesize that better attendance at the weekly visits and higher adherence to the diet recommendations will provide greater weight loss preoperatively and percent total weight loss at the completion of VLCD, on the day of MBS, and at 3, 6, and 12 months post-surgery. Findings from this study may lead to additional projects that aim to develop and implement an optimal pre-surgery and post-surgery clinical care model for bariatric patients.
- Conditions
- Obesity
- Being tested
- Very Low Calorie Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Calorie DietOther
Participants will receive a very low calorie diet as described in the arm/group
| Study group | Role | What they receive |
|---|---|---|
| Very Low Calorie Diet | Other | Very Low Calorie Diet - caloric intake restricted to approximately 800 kcal/day Receives: Other: Very Low Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who complete the 12-week VLCD program
Completion is defined as attendance at 10 or more weekly visits, including the week 12 visit
Measured: Week 1 through 12 of the 12 week VLCD program
Secondary outcomes (2)
Consumption of 3-5 meal replacement shakes plus 2 cups of vegetables per day for 5 to 7 days
Measured: Measured every day of 12 week VLCD program
VLCD acceptability
Acceptability will be measured using a sum of 8 items on a survey with eight 5-point Likert scale questions (e.g., I find the VLCD meal plan easy to follow) on a scale from 1 [strongly disagree] to 5 [strongly agree]). VLCD acceptability is defined as ≥75% of the participants having a mean survey rating of ≥4.
Measured: data collected at week 1, week 6, and week 12 of VLCD program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start5 Mar 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183034
- Sponsor's protocol ID
- R-HHC-2023-0179
- Acronym
- SAFETY
- Status last verified
- Nov 2023
- First submitted
- 13 Dec 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Acceptability and Feasibility of a Preoperative Very Low Calorie Diet Intervention on Surgical Weight Loss Outcomes (SAFETY)
- ClinicalTrials.gov ID
- NCT06183034
- Acronym / sponsor ID
- SAFETY / R-HHC-2023-0179
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- 5 Mar 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Dec 2023 (actual)
- 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.
Class 4 obesity is defined as a BMI ≥50Kg/m2, representing approximately ≥150 pounds of excess weight. For patients with Class 4 obesity, metabolic and bariatric surgery (MBS) is the only effective treatment. However, MBS is associated with a higher rate of perioperative morbidity and mortality for patients with Class 4 obesity. Additionally, more patients with Class 4 obesity experience suboptimal weight loss. For patients with Class 4 obesity, preoperative weight loss can reduce the technical difficulty of surgical procedures, rendering MBS safer. Preoperative weight loss may also decrease visceral adipose tissue and liver volume as well as reduce weight-related comorbidities.
A very low-calorie diet (VLCD), which involves restricting caloric intake to approximately 800 kcal/day, is one strategy to help patients achieve weight loss preoperatively. Although studies show that a VLCD prior to MBS yields weight loss, reduces liver volume and rates of perioperative complications, most preoperative VLCDs are short (2-8 weeks) with variable adherence. To date, no study has systematically assessed the feasibility and acceptability of a standard 12-week VLCD among patients with BMI ≥50 pursuing MBS. No study has evaluated postoperative weight loss among patients who have undergone a preoperative VLCD.
This study will be a single arm trial designed to test the feasibility, acceptability, and preliminary efficacy of a 12-week VLCD program prior to sleeve gastrectomy (SG) and associated weight loss up to 1 year following MBS. The investigators will enroll 24 patients aged 18-70, with a BMI≥50Kg/m2, and are approved for SG. Participants will consume up to 5 meal replacement protein shakes and 2 cups of vegetables daily for 12 weeks. Participants will attend weekly in-person office visits with the clinicians at the Hartford Hospital Medical and Surgical Weight Loss Center in Glastonbury, CT to assess weight loss, physical and mental health, feasibility and acceptability of and adherence to the VLCD. The investigators hypothesize that a 12-week VLCD is feasible in this population, defined as ≥70% (18 out of 24 participants) completing the program. The investigators hypothesize that better attendance at the weekly visits and higher adherence to the diet recommendations will provide greater weight loss preoperatively and percent total weight loss at the completion of VLCD, on the day of MBS, and at 3, 6, and 12 months post-surgery. Findings from this study may lead to additional projects that aim to develop and implement an optimal pre-surgery and post-surgery clinical care model for bariatric patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very Low Calorie Diet | Other | Other: Very Low Calorie DietVery Low Calorie Diet - caloric intake restricted to approximately 800 kcal/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI greater than or equal to 50 kg/m2
- Eligible and approved for sleeve gastrectomy as primary bariatric treatment (eligibility and approval for sleeve gastrectomy will be determined from a surgical standpoint by the surgeon)
- Able and willing to sign an Informed Consent document
Key exclusion criteria (11 listed)
- Qualified for Roux-en-Y gastric bypass
- On FDA-approved weight loss medications at time of consult
- Are lactose intolerant
- History of Type 1 diabetes
- Have had lap band or other prior bariatric surgery
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 |
|---|---|---|
| Very Low Calorie DietParticipants will receive a very low calorie diet as described in the arm/group | Other | Very Low Calorie Diet |
Primary outcome
Percentage of participants who complete the 12-week VLCD program
Time frame: Week 1 through 12 of the 12 week VLCD program
Completion is defined as attendance at 10 or more weekly visits, including the week 12 visit
2 secondary outcomes
Consumption of 3-5 meal replacement shakes plus 2 cups of vegetables per day for 5 to 7 days
Time frame: Measured every day of 12 week VLCD program
VLCD acceptability
Time frame: data collected at week 1, week 6, and week 12 of VLCD program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very Low Calorie Diet in people with Obesity, run by Hartford Hospital 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Devika Umashanker, MD (860-224-5161, devika.umashanker@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who complete the 12-week VLCD program (time frame: Week 1 through 12 of the 12 week VLCD program). 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 28 Feb 2024.