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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00035653 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| Maryland Cigarette Restitution Fund | OTHER_GOV |
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This is a prospective, single-center randomized trial with three arms, and an allocation ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and coach-directed behavioral weight loss versus self-directed weight loss on insulin-like growth factor (IGF)-1 and IGF-1 to THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed Behavioral Weight Loss arm is a web-based remote delivery and communication system that promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of oral metformin. This is a secondary prevention study for men and women who have survived solid malignant tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Directed | Active Comparator | In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management. |
|
| Coach Directed Behavioral Weight Loss | Experimental | The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight |
|
| Metformin | Experimental | This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| IGF-1 Levels | Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| IGF-1 Levels | IGF-1 at 12 months | 12 months |
| IGF-1 to IGFBP3 Level Ratio (Molar Ratio) | IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Measured by Scale(Kg) | Changes in weight among Metformin group, or coach-directed Groups versus the self-directed arm at 6 and 12 months | 6 and 12 months |
| Body Mass Index Measured by Scale and Tap(kg/m2) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Yeh, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins ProHealth | Baltimore | Maryland | 21207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35730613 | Derived | Tilves C, Yeh HC, Maruthur N, Juraschek SP, Miller E, White K, Appel LJ, Mueller NT. Increases in Circulating and Fecal Butyrate are Associated With Reduced Blood Pressure and Hypertension: Results From the SPIRIT Trial. J Am Heart Assoc. 2022 Jul 5;11(13):e024763. doi: 10.1161/JAHA.121.024763. Epub 2022 Jun 22. | |
| 34987204 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-Directed | In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management. Self-control weight loss |
| FG001 | Coach Directed Behavioral Weight Loss |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 21, 2017 |
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|
| Coach Directed Behavioral Weight Loss | Behavioral | Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals |
|
| Self-control weight loss | Behavioral |
|
| 6 months |
Changes in BMI among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.
| 6 and 12 months |
| EuroQol Score Assessed by Questionnaire | Changes in EuroQol score among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | 6 and 12 months |
| Dietary Intake Assessed by Questionnaire | Changes in dietary intake among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | 6 and 12 months |
| Physical Activity Amount Assessed by Questionnaire | Changes in physical activity amount among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | 6 and 12 months |
| Fasting Glucose Levels | Changes in fasting glucose among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | 6 and 12 months |
| Insulin Levels | Changes in insulin among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | 6 and 12 months |
| Hemoglobin A1C Levels | Changes in Hb-A1C among Metformin arm, or Coach-directed behavioral weight loss arm versus the Self-control weight loss arm at 6 and 12 months. | 6 and 12 months |
| Interleukin (IL)-6 Levels | Changes in IL-6 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | 6 and 12 months |
| Interleukin 8 Levels | Changes in IL-8 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | 6 and 12 months |
| C-reactive Protein (CRP) Levels | Changes in CRP among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | 6 and 12 months |
| Side Effects Assessed by Side Effect Questionnaire | assessing side effect among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | 6 and 12 months |
| Tilves C, Yeh HC, Maruthur N, Juraschek SP, Miller ER, Appel LJ, Mueller NT. A behavioral weight-loss intervention, but not metformin, decreases a marker of gut barrier permeability: results from the SPIRIT randomized trial. Int J Obes (Lond). 2022 Mar;46(3):655-660. doi: 10.1038/s41366-021-01039-2. Epub 2022 Jan 6. |
| 34444833 | Derived | Hu JR, Yeh HC, Mueller NT, Appel LJ, Miller ER 3rd, Maruthur NM, Jerome GJ, Chang AR, Gelber AC, Juraschek SP. Effects of a Behavioral Weight Loss Intervention and Metformin Treatment on Serum Urate: Results from a Randomized Clinical Trial. Nutrients. 2021 Jul 31;13(8):2673. doi: 10.3390/nu13082673. |
| 34006565 | Derived | Mueller NT, Differding MK, Zhang M, Maruthur NM, Juraschek SP, Miller ER 3rd, Appel LJ, Yeh HC. Metformin Affects Gut Microbiome Composition and Function and Circulating Short-Chain Fatty Acids: A Randomized Trial. Diabetes Care. 2021 Jul;44(7):1462-1471. doi: 10.2337/dc20-2257. Epub 2021 May 18. |
| 29361843 | Derived | Juraschek SP, Plante TB, Charleston J, Miller ER, Yeh HC, Appel LJ, Jerome GJ, Gayles D, Durkin N, White K, Dalcin A, Hermosilla M. Use of online recruitment strategies in a randomized trial of cancer survivors. Clin Trials. 2018 Apr;15(2):130-138. doi: 10.1177/1740774517745829. Epub 2018 Jan 24. |
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
| FG002 | Metformin | This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-Directed | In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management. Self-control weight loss |
| BG001 | Coach Directed Behavioral Weight Loss | The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals |
| BG002 | Metformin | This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | IGF-1 Levels | Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months. | Posted | Mean | Standard Deviation | ng/ml | 6 months |
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| ||||||||||||||||||||||||||||||||
| Secondary | IGF-1 Levels | IGF-1 at 12 months | Data was obtained for 39 participants in the self-directed arm, 37 in the coach directed arm and 37 in the metformin arm for this outcome measure. | Posted | Mean | Standard Deviation | ng/ml | 12 months |
| |||||||||||||||||||||||||||||||||
| Secondary | IGF-1 to IGFBP3 Level Ratio (Molar Ratio) | IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months. | Data was obtained for 39 participants in the self-directed arm, 37 in the coach directed arm and 36 in the metformin arm for this outcome measure. | Posted | Mean | Standard Deviation | ratio | 6 months |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Weight Measured by Scale(Kg) | Changes in weight among Metformin group, or coach-directed Groups versus the self-directed arm at 6 and 12 months | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Body Mass Index Measured by Scale and Tap(kg/m2) | Changes in BMI among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | EuroQol Score Assessed by Questionnaire | Changes in EuroQol score among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Dietary Intake Assessed by Questionnaire | Changes in dietary intake among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Physical Activity Amount Assessed by Questionnaire | Changes in physical activity amount among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Fasting Glucose Levels | Changes in fasting glucose among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Insulin Levels | Changes in insulin among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Hemoglobin A1C Levels | Changes in Hb-A1C among Metformin arm, or Coach-directed behavioral weight loss arm versus the Self-control weight loss arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interleukin (IL)-6 Levels | Changes in IL-6 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Interleukin 8 Levels | Changes in IL-8 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | C-reactive Protein (CRP) Levels | Changes in CRP among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Side Effects Assessed by Side Effect Questionnaire | assessing side effect among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months. | Not Posted | 6 and 12 months | Participants |
12 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-Directed | In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management. Self-control weight loss | 0 | 40 | 5 | 40 | 10 | 40 |
| EG001 | Coach Directed Behavioral Weight Loss | The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight Coach Directed Behavioral Weight Loss: Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals | 0 | 39 | 5 | 39 | 3 | 39 |
| EG002 | Metformin | This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals Metformin: Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months. | 0 | 42 | 12 | 42 | 6 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| CVD | Cardiac disorders | Systematic Assessment |
| ||
| Other | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Heart Disease | Cardiac disorders | Systematic Assessment |
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| Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Gallstone | Gastrointestinal disorders | Systematic Assessment |
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| Gallstone removal | Surgical and medical procedures | Systematic Assessment |
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| bariatric surgery | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Yeh | Johns Hopkins University | 410-614-4316 | hyeh1@jhmi.edu |
| Aug 26, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D008175 | Lung Neoplasms |
| D003110 | Colonic Neoplasms |
| D008545 | Melanoma |
| D016889 | Endometrial Neoplasms |
| D008113 | Liver Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D012004 | Rectal Neoplasms |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Male |
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| Other non-black races |
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