Acceptability and Feasibility of a Preoperative Very Low Calorie Diet Intervention on Surgical Weight Loss Outcomes (SAFETY)

NCT06183034 | Unknown

• 1 other identifier: R-HHC-2023-0179
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  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 every day of 12 week VLCD program

• VLCD acceptability

  data collected at week 1, week 6, and week 12 of VLCD program

Other Outcomes (1)

• Weight in pounds

  Measured on the day of bariatric surgery and at 3, 6, and 12 month post-surgery follow up visit

Study Arms (1)

Very Low Calorie Diet

OTHER

Very Low Calorie Diet - caloric intake restricted to approximately 800 kcal/day

Other: Very Low Calorie Diet

Interventions

Very Low Calorie Diet OTHER

Participants will receive a very low calorie diet as described in the arm/group

Very Low Calorie Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• \>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)

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Devika Umashanker, MD

CONTACT

860-224-5161; devika.umashanker@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: March 5, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 30, 2025
• Last Updated: February 28, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)