Diabetes Mellitus, Type 2, Hypertension, Obesity
Conditions
Brief summary
Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endoscopically placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction. Up to 200 participants at 9 locations in the United States will participate in this study. The ESG procedure has been performed clinically since 2013 in the United States. The investigators are completing this study to compare how effective the ESG is for achieving long-term weight loss when compared to lifestyle modification only, as well as to evaluate the long-term safety and durability of the procedure and its impact on quality of life. Results of this research may help support having this procedure covered by health insurance plans for future patients.
Interventions
DEVICEOverstitch Endoscopic Suture System
Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.
BEHAVIORALLifestyle Intervention
Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Sponsors
University of Texas
Johns Hopkins University
Brigham and Women's Hospital
Endeavor Health
University of Chicago
Orlando Health, Inc.
Cornell University
Avera McKennan Hospital & University Health Center
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 21-65 2. BMI ≥ 30 and ≤40 kg/m² 3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure 4. History of failure with non-surgical weight-loss methods 5. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling 6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits 7. Ability to give informed consent 8. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods 9. \*\*\*There will be a quota for at least a) 50 patients with hypertension on one or more anti-hypertensive medication, b) 50 patients with type II diabetes mellitus on oral agents only with HgA1c ≤ 9, and thus the cohort of 200 patients will be stratified into three groups (Obesity, Obesity HTH, Obesity DM) and block randomized. No more than 50 participants without comorbidities will be enrolled in the trial.
Exclusion criteria
1. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy) 2. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions. 3. Prior open or laparoscopic bariatric surgery. 4. Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery. 5. Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease. 6. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses. 7. A gastric mass or gastric polyps \> 1 cm in size. 8. A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms. 9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope. 10. Achalasia or any other severe esophageal motility disorder 11. Severe coagulopathy. 12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C \>= 9. 13. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy 14. Chronic abdominal pain 15. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation 16. Hepatic insufficiency or cirrhosis 17. Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing. 18. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist 19. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up. 20. Patients receiving daily prescribed treatment with high dose aspirin (\> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants. 21. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication 22. Patients who are pregnant or breast-feeding. 23. Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly-controlled hypertension, required use of NSAIDs 24. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications 25. Subjects who are taking corticosteroids, immunosuppressants, and narcotics 26. Subjects who are taking diet pills 27. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease. 28. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer. 29. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised. 30. Specific diagnosed genetic disorder such as Prader Willi syndrome. 31. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating 32. Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Excess Weight Loss (EWL) | 12 months | Percentage of excess weight loss in participants at 12 months from randomization. Calculated as (weight loss/baseline excess weight) x 100, where weight loss is defined as follow-up weight minus the initial weight, and baseline excess weight is defined as index weight minus ideal weight X (X=25 kg/m²) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Total Body Weight Loss (TBWL) | 12 months | Percentage of total body weight loss in participants |
| Number of Participants With ≥25% EWL | 12 months | Total number of participants with ≥25% excess weight loss at 12 months from randomization |
| Number of Participants Off Or With Reduction in Antihypertensive Medications | 12 months | Total number participants off or with reduction in antihypertensive medications |
| Change in Blood Pressure | Baseline, 12 months | Change in blood pressure measured in units of millimeters of mercury (mmHg) |
| Change in Blood Pressure for ESG Intervention From Baseline to 24 Months | Baseline, 24 months | Change in blood pressure for participants that received ESG intervention measured in units of millimeters of mercury (mmHg) |
| Number of Participants Off or With Reduction in Diabetes Medications | 12 months | Total number of participants off or with reduction in diabetes medications |
| Change in HgbA1c | Baseline, 12 months | Change in HgbA1c levels |
| Change in HgbA1c for ESG Intervention From Baseline to 24 Months | Baseline, 24 months | Change in HgbA1c levels for participants that received the ESG intervention |
| Number of Participants to Achieve ≥10% TBWL | 12 months | Total number of participants to achieve ≥10% total body weight loss |
| Esophagitis at Repeat Endoscopy | 12 months | Total number of participants to have esophagitis at repeat endoscopy |
| Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Baseline, 12 months | Changes in impact of weight on quality of life score assessed using self-reported IWQOL-lite questionnaire consisting of five domains: physical function (11 items, score range from 11-55 with higher scores indicating more negative outcome), self-esteem (7 items, score range from 7-35 with higher scores indicating more negative outcome), sexual life (4 items, score range from 4-20 with higher scores indicating more negative outcome), public distress (5 items, score range from 5-25 with higher scores indicating more negative outcome), and work (4 items, score range from 4-20 with higher scores indicating more negative outcome). |
| Changes in Health Status Survey Scores | Baseline, 12 months | Changes in subject's view of health assessed using self-reported SF-36 Health Status Survey consisting of 8 scaled scores: physical function (10-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to physical health (4-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to emotional problems (3-item, score range from 0-100 with higher scores indicating more positive outcome), energy/fatigue (4-items, score range from 0-100 with higher scores indicating more positive outcome), emotional well-being (5-items, score range from 0-100 with higher scores indicating more positive outcome), social functioning (2-items, score range from 0-100 with higher scores indicating more positive outcome), pain (2-items, score range from 0-100 with higher scores indicating more positive outcome), general health (5-items, score range from 0-100 with higher scores indicating more positive outcome) |
| Number of Participants With Major Depression or Severe Major Depression at Baseline | Baseline | Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score \< 10; major depression, 10 ≤ score \< 20; severe major depression, x ≥ 20 |
| Number of Participants With Major Depression or Severe Major Depression at 12 Months | 12 months | Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score \< 10; major depression, 10 ≤ score \< 20; severe major depression, x ≥ 20 |
| Change in Eating Behaviors | Baseline, 12 months | Change in eating behaviors evaluated using the self-reported Three Factor Eating Questionnaire (TFEQ) consisting of 3 domains: cognitive restraint (6-items, score range from 0-100 with higher score indicating more restraint), uncontrolled eating (9-items, score range from 0-100 with lower score indicating more control), and emotional eating (3-items, score range 0-100 with higher score indicating eating with negative emotions) |
| Number of Participants to Achieve ≥5% TBWL | 12 months | Total number of participants to achieve ≥5% total body weight loss |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group: Lifestyle Modification Participants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation.
Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. | 123 |
| Treatment Group: Overstitch ESG Procedure Participants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet. ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year
Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.
Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. | 85 |
| Crossover Group: Lifestyle Intervention to ESG Procedure Control group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months.
Overstitch Endoscopic Suture System: Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.
Lifestyle Intervention: Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. | 73 |
| Total | 281 |
Baseline characteristics
| Characteristic | Treatment Group: Overstitch ESG Procedure | Control Group: Lifestyle Modification | Total | Crossover Group: Lifestyle Intervention to ESG Procedure |
|---|---|---|---|---|
| Age, Continuous Level 1: Lifestyle Modification vs ESG | 49.0 years | 46.0 years | 46.5 years | — |
| Age, Continuous Level 2: Crossover Lifestyle to ESG | — | — | 46 years | 46 years |
| Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG African American | 12 Participants | 19 Participants | 31 Participants | — |
| Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG Asian | 0 Participants | 3 Participants | 3 Participants | — |
| Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG Deferred | 1 Participants | 5 Participants | 6 Participants | — |
| Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG Hispanic/Latino | 13 Participants | 19 Participants | 32 Participants | — |
| Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG Other | 1 Participants | 10 Participants | 11 Participants | — |
| Race/Ethnicity, Customized Level 1: Lifestyle Modification vs ESG White | 58 Participants | 67 Participants | 125 Participants | — |
| Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG African American | — | — | 11 Participants | 11 Participants |
| Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG Asian | — | — | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG Deferred | — | — | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG Hispanic/Latino | — | — | 10 Participants | 10 Participants |
| Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG Other | — | — | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized Level 2: Crossover Lifestyle to ESG White | — | — | 40 Participants | 40 Participants |
| Region of Enrollment United States | 85 participants | 123 participants | 208 participants | 73 participants |
| Sex: Female, Male Level 1: Lifestyle Modification vs ESG Female | 74 Participants | 104 Participants | 178 Participants | — |
| Sex: Female, Male Level 1: Lifestyle Modification vs ESG Male | 11 Participants | 19 Participants | 30 Participants | — |
| Sex: Female, Male Level 2: Crossover Lifestyle to ESG Female | — | — | 66 Participants | 66 Participants |
| Sex: Female, Male Level 2: Crossover Lifestyle to ESG Male | — | — | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 77 | 0 / 73 |
| other Total, other adverse events | 46 / 110 | 77 / 77 | 64 / 73 |
| serious Total, serious adverse events | 1 / 110 | 12 / 77 | 4 / 73 |
Outcome results
Primary
Percentage of Excess Weight Loss (EWL)
Percentage of excess weight loss in participants at 12 months from randomization. Calculated as (weight loss/baseline excess weight) x 100, where weight loss is defined as follow-up weight minus the initial weight, and baseline excess weight is defined as index weight minus ideal weight X (X=25 kg/m²)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Lifestyle Modification | Percentage of Excess Weight Loss (EWL) | 3.2 percentage of EWL | Standard Deviation 18.6 |
| Treatment Group: Overstitch ESG Procedure | Percentage of Excess Weight Loss (EWL) | 49.2 percentage of EWL | Standard Deviation 32 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Percentage of Excess Weight Loss (EWL) | 44.1 percentage of EWL | Standard Deviation 35.7 |
Secondary
Change in Blood Pressure
Change in blood pressure measured in units of millimeters of mercury (mmHg)
Time frame: Baseline, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: Lifestyle Modification | Change in Blood Pressure | Diastolic | 0.1 mmHg | Standard Deviation 10.3 |
| Control Group: Lifestyle Modification | Change in Blood Pressure | Systolic | -0.7 mmHg | Standard Deviation 14.5 |
| Treatment Group: Overstitch ESG Procedure | Change in Blood Pressure | Systolic | -5.2 mmHg | Standard Deviation 16.1 |
| Treatment Group: Overstitch ESG Procedure | Change in Blood Pressure | Diastolic | -3.3 mmHg | Standard Deviation 12 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in Blood Pressure | Systolic | -3.5 mmHg | Standard Deviation 18.5 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in Blood Pressure | Diastolic | -3.0 mmHg | Standard Deviation 11.6 |
Secondary
Change in Blood Pressure for ESG Intervention From Baseline to 24 Months
Change in blood pressure for participants that received ESG intervention measured in units of millimeters of mercury (mmHg)
Time frame: Baseline, 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: Lifestyle Modification | Change in Blood Pressure for ESG Intervention From Baseline to 24 Months | Systolic | -4.0 mmHg | Standard Deviation 16 |
| Control Group: Lifestyle Modification | Change in Blood Pressure for ESG Intervention From Baseline to 24 Months | Diastolic | -2.4 mmHg | Standard Deviation 10 |
Secondary
Change in Eating Behaviors
Change in eating behaviors evaluated using the self-reported Three Factor Eating Questionnaire (TFEQ) consisting of 3 domains: cognitive restraint (6-items, score range from 0-100 with higher score indicating more restraint), uncontrolled eating (9-items, score range from 0-100 with lower score indicating more control), and emotional eating (3-items, score range 0-100 with higher score indicating eating with negative emotions)
Time frame: Baseline, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: Lifestyle Modification | Change in Eating Behaviors | Uncontrolled Eating | -8.7 score on a scale | Standard Deviation 18 |
| Control Group: Lifestyle Modification | Change in Eating Behaviors | Cognitive Restraint | 4.6 score on a scale | Standard Deviation 17.6 |
| Control Group: Lifestyle Modification | Change in Eating Behaviors | Emotional Eating | -6.7 score on a scale | Standard Deviation 23.5 |
| Treatment Group: Overstitch ESG Procedure | Change in Eating Behaviors | Uncontrolled Eating | -14.4 score on a scale | Standard Deviation 23.4 |
| Treatment Group: Overstitch ESG Procedure | Change in Eating Behaviors | Cognitive Restraint | 12.6 score on a scale | Standard Deviation 19.5 |
| Treatment Group: Overstitch ESG Procedure | Change in Eating Behaviors | Emotional Eating | -18.3 score on a scale | Standard Deviation 29.8 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in Eating Behaviors | Cognitive Restraint | 6.0 score on a scale | Standard Deviation 18.1 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in Eating Behaviors | Emotional Eating | -7.7 score on a scale | Standard Deviation 24 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in Eating Behaviors | Uncontrolled Eating | -10.4 score on a scale | Standard Deviation 16.1 |
Secondary
Change in HgbA1c
Change in HgbA1c levels
Time frame: Baseline, 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Lifestyle Modification | Change in HgbA1c | 0.13 Percent of Glycosylated Hemoglobin | Standard Deviation 0.46 |
| Treatment Group: Overstitch ESG Procedure | Change in HgbA1c | -0.36 Percent of Glycosylated Hemoglobin | Standard Deviation 0.67 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in HgbA1c | -0.4 Percent of Glycosylated Hemoglobin | Standard Deviation 0.56 |
Secondary
Change in HgbA1c for ESG Intervention From Baseline to 24 Months
Change in HgbA1c levels for participants that received the ESG intervention
Time frame: Baseline, 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Lifestyle Modification | Change in HgbA1c for ESG Intervention From Baseline to 24 Months | -0.1 Percent of Glycosylated Hemoglobin | Standard Deviation 1 |
Secondary
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite)
Changes in impact of weight on quality of life score assessed using self-reported IWQOL-lite questionnaire consisting of five domains: physical function (11 items, score range from 11-55 with higher scores indicating more negative outcome), self-esteem (7 items, score range from 7-35 with higher scores indicating more negative outcome), sexual life (4 items, score range from 4-20 with higher scores indicating more negative outcome), public distress (5 items, score range from 5-25 with higher scores indicating more negative outcome), and work (4 items, score range from 4-20 with higher scores indicating more negative outcome).
Time frame: Baseline, 12 months
Population: Not all participants provided answers to all the domains of the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: Lifestyle Modification | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Public Distress (5 items) | -0.9 score on a scale | Standard Deviation 3.2 |
| Control Group: Lifestyle Modification | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Work Results (4 items) | -0.3 score on a scale | Standard Deviation 2.7 |
| Control Group: Lifestyle Modification | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Self-Esteem (7 items) | -1.6 score on a scale | Standard Deviation 5.2 |
| Control Group: Lifestyle Modification | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Sexual Life (4 items) | -1.4 score on a scale | Standard Deviation 3.9 |
| Control Group: Lifestyle Modification | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Physical Function (11 items) | -2.5 score on a scale | Standard Deviation 6.6 |
| Treatment Group: Overstitch ESG Procedure | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Self-Esteem (7 items) | -9.2 score on a scale | Standard Deviation 7.1 |
| Treatment Group: Overstitch ESG Procedure | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Public Distress (5 items) | -2.5 score on a scale | Standard Deviation 2.9 |
| Treatment Group: Overstitch ESG Procedure | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Physical Function (11 items) | -12.0 score on a scale | Standard Deviation 7.4 |
| Treatment Group: Overstitch ESG Procedure | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Work Results (4 items) | -2.2 score on a scale | Standard Deviation 2.7 |
| Treatment Group: Overstitch ESG Procedure | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Sexual Life (4 items) | -4.2 score on a scale | Standard Deviation 4.1 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Work Results (4 items) | -1.9 score on a scale | Standard Deviation 2.8 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Physical Function (11 items) | -8.6 score on a scale | Standard Deviation 6.9 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Self-Esteem (7 items) | -7.8 score on a scale | Standard Deviation 6.7 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Sexual Life (4 items) | -2.6 score on a scale | Standard Deviation 3.5 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) | Public Distress (5 items) | -1.8 score on a scale | Standard Deviation 3.1 |
Secondary
Changes in Health Status Survey Scores
Changes in subject's view of health assessed using self-reported SF-36 Health Status Survey consisting of 8 scaled scores: physical function (10-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to physical health (4-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to emotional problems (3-item, score range from 0-100 with higher scores indicating more positive outcome), energy/fatigue (4-items, score range from 0-100 with higher scores indicating more positive outcome), emotional well-being (5-items, score range from 0-100 with higher scores indicating more positive outcome), social functioning (2-items, score range from 0-100 with higher scores indicating more positive outcome), pain (2-items, score range from 0-100 with higher scores indicating more positive outcome), general health (5-items, score range from 0-100 with higher scores indicating more positive outcome)
Time frame: Baseline, 12 months
Population: Not all participants provided answers to all the domains of the SF-36 Health Status Survey questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group: Lifestyle Modification | Changes in Health Status Survey Scores | Physical Functioning | 2.1 score on a scale | Standard Deviation 25.5 |
| Control Group: Lifestyle Modification | Changes in Health Status Survey Scores | Physical Health | 4.9 score on a scale | Standard Deviation 37.7 |
| Control Group: Lifestyle Modification | Changes in Health Status Survey Scores | Emotional Problems | -0.8 score on a scale | Standard Deviation 30.7 |
| Control Group: Lifestyle Modification | Changes in Health Status Survey Scores | Energy/Fatigue | 9.0 score on a scale | Standard Deviation 18.5 |
| Control Group: Lifestyle Modification | Changes in Health Status Survey Scores | Emotional Well-Being | 2.1 score on a scale | Standard Deviation 13.2 |
| Control Group: Lifestyle Modification | Changes in Health Status Survey Scores | Social Functioning | 3.2 score on a scale | Standard Deviation 18.3 |
| Control Group: Lifestyle Modification | Changes in Health Status Survey Scores | Pain | 4.4 score on a scale | Standard Deviation 21.5 |
| Control Group: Lifestyle Modification | Changes in Health Status Survey Scores | General Health | 4.0 score on a scale | Standard Deviation 14.7 |
| Treatment Group: Overstitch ESG Procedure | Changes in Health Status Survey Scores | Emotional Problems | 4.7 score on a scale | Standard Deviation 30.8 |
| Treatment Group: Overstitch ESG Procedure | Changes in Health Status Survey Scores | Pain | 10.1 score on a scale | Standard Deviation 17.6 |
| Treatment Group: Overstitch ESG Procedure | Changes in Health Status Survey Scores | Energy/Fatigue | 14.1 score on a scale | Standard Deviation 26.1 |
| Treatment Group: Overstitch ESG Procedure | Changes in Health Status Survey Scores | Emotional Well-Being | 1.5 score on a scale | Standard Deviation 18.5 |
| Treatment Group: Overstitch ESG Procedure | Changes in Health Status Survey Scores | Social Functioning | 9.0 score on a scale | Standard Deviation 29.2 |
| Treatment Group: Overstitch ESG Procedure | Changes in Health Status Survey Scores | Physical Functioning | 18.9 score on a scale | Standard Deviation 26.9 |
| Treatment Group: Overstitch ESG Procedure | Changes in Health Status Survey Scores | Physical Health | 18.4 score on a scale | Standard Deviation 33.7 |
| Treatment Group: Overstitch ESG Procedure | Changes in Health Status Survey Scores | General Health | 20.4 score on a scale | Standard Deviation 19.2 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Changes in Health Status Survey Scores | Emotional Problems | 8.6 score on a scale | Standard Deviation 30.3 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Changes in Health Status Survey Scores | Physical Health | 15.1 score on a scale | Standard Deviation 31 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Changes in Health Status Survey Scores | Physical Functioning | 18.4 score on a scale | Standard Deviation 22.5 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Changes in Health Status Survey Scores | Energy/Fatigue | 13.0 score on a scale | Standard Deviation 20 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Changes in Health Status Survey Scores | Pain | 7.3 score on a scale | Standard Deviation 23 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Changes in Health Status Survey Scores | Social Functioning | 8.8 score on a scale | Standard Deviation 20 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Changes in Health Status Survey Scores | Emotional Well-Being | 4.6 score on a scale | Standard Deviation 14.5 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Changes in Health Status Survey Scores | General Health | 12.6 score on a scale | Standard Deviation 14.5 |
Secondary
Esophagitis at Repeat Endoscopy
Total number of participants to have esophagitis at repeat endoscopy
Time frame: 12 months
Population: Those ESG patients who have achieved \>25% EWL at the end of Level 1 will not undergo a repeat endoscopy and will continue to follow-up with a lifestyle intervention in Level 2. Those ESG patients who have not achieved \>25% EWL at the end of Level 1 will undergo a repeat upper endoscopy at 52
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group: Lifestyle Modification | Esophagitis at Repeat Endoscopy | 0 Participants |
Secondary
Number of Participants Off Or With Reduction in Antihypertensive Medications
Total number participants off or with reduction in antihypertensive medications
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group: Lifestyle Modification | Number of Participants Off Or With Reduction in Antihypertensive Medications | 9 Participants |
| Treatment Group: Overstitch ESG Procedure | Number of Participants Off Or With Reduction in Antihypertensive Medications | 13 Participants |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Number of Participants Off Or With Reduction in Antihypertensive Medications | 14 Participants |
Secondary
Number of Participants Off or With Reduction in Diabetes Medications
Total number of participants off or with reduction in diabetes medications
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group: Lifestyle Modification | Number of Participants Off or With Reduction in Diabetes Medications | 3 Participants |
| Treatment Group: Overstitch ESG Procedure | Number of Participants Off or With Reduction in Diabetes Medications | 11 Participants |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Number of Participants Off or With Reduction in Diabetes Medications | 10 Participants |
Secondary
Number of Participants to Achieve ≥10% TBWL
Total number of participants to achieve ≥10% total body weight loss
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group: Lifestyle Modification | Number of Participants to Achieve ≥10% TBWL | 6 Participants |
| Treatment Group: Overstitch ESG Procedure | Number of Participants to Achieve ≥10% TBWL | 48 Participants |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Number of Participants to Achieve ≥10% TBWL | 40 Participants |
Secondary
Number of Participants to Achieve ≥5% TBWL
Total number of participants to achieve ≥5% total body weight loss
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group: Lifestyle Modification | Number of Participants to Achieve ≥5% TBWL | 18 Participants |
| Treatment Group: Overstitch ESG Procedure | Number of Participants to Achieve ≥5% TBWL | 70 Participants |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Number of Participants to Achieve ≥5% TBWL | 61 Participants |
Secondary
Number of Participants With ≥25% EWL
Total number of participants with ≥25% excess weight loss at 12 months from randomization
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group: Lifestyle Modification | Number of Participants With ≥25% EWL | 13 Participants |
| Treatment Group: Overstitch ESG Procedure | Number of Participants With ≥25% EWL | 59 Participants |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Number of Participants With ≥25% EWL | 51 Participants |
Secondary
Number of Participants With Major Depression or Severe Major Depression at 12 Months
Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score \< 10; major depression, 10 ≤ score \< 20; severe major depression, x ≥ 20
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: Lifestyle Modification | Number of Participants With Major Depression or Severe Major Depression at 12 Months | Number with Major Depression | 10 Participants |
| Control Group: Lifestyle Modification | Number of Participants With Major Depression or Severe Major Depression at 12 Months | Number with Severe Major Depression | 2 Participants |
| Treatment Group: Overstitch ESG Procedure | Number of Participants With Major Depression or Severe Major Depression at 12 Months | Number with Major Depression | 2 Participants |
| Treatment Group: Overstitch ESG Procedure | Number of Participants With Major Depression or Severe Major Depression at 12 Months | Number with Severe Major Depression | 0 Participants |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Number of Participants With Major Depression or Severe Major Depression at 12 Months | Number with Major Depression | 1 Participants |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Number of Participants With Major Depression or Severe Major Depression at 12 Months | Number with Severe Major Depression | 0 Participants |
Secondary
Number of Participants With Major Depression or Severe Major Depression at Baseline
Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score \< 10; major depression, 10 ≤ score \< 20; severe major depression, x ≥ 20
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group: Lifestyle Modification | Number of Participants With Major Depression or Severe Major Depression at Baseline | Number with Major Depression | 14 Participants |
| Control Group: Lifestyle Modification | Number of Participants With Major Depression or Severe Major Depression at Baseline | Number with Severe Major Depression | 2 Participants |
| Treatment Group: Overstitch ESG Procedure | Number of Participants With Major Depression or Severe Major Depression at Baseline | Number with Major Depression | 7 Participants |
| Treatment Group: Overstitch ESG Procedure | Number of Participants With Major Depression or Severe Major Depression at Baseline | Number with Severe Major Depression | 1 Participants |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Number of Participants With Major Depression or Severe Major Depression at Baseline | Number with Major Depression | 9 Participants |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Number of Participants With Major Depression or Severe Major Depression at Baseline | Number with Severe Major Depression | 1 Participants |
Secondary
Percentage of Total Body Weight Loss (TBWL)
Percentage of total body weight loss in participants
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group: Lifestyle Modification | Percentage of Total Body Weight Loss (TBWL) | 0.8 percentage of TBWL | Standard Deviation 5 |
| Treatment Group: Overstitch ESG Procedure | Percentage of Total Body Weight Loss (TBWL) | 13.6 percentage of TBWL | Standard Deviation 8 |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Percentage of Total Body Weight Loss (TBWL) | 12.3 percentage of TBWL | Standard Deviation 8.3 |