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| ID | Type | Description | Link |
|---|---|---|---|
| P50MD017344 | U.S. NIH Grant/Contract | View source |
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The study was discontinued prematurely for administrative reasons
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The purpose of this study is to conduct a three-arm 52-week, randomized controlled trial with double blind treatment to evaluate the effects of a drug called tirzepatide in combination with an innovative, culturally-appropriate, intensive lifestyle intervention (ILI) delivered by community health workers (CHWs) in Latino adults with obesity. Participants will be randomized to 1) standard care (SC, n=25); 2) culturally-tailored dietary and behavioral intensive lifestyle intervention (ILI, n=25) provided by CHWs plus placebo; or 3) ILI plus tirzepatide (ILI-TRZ) for 52 weeks to evaluate the intervention's effect on: i) weight loss; ii) clinical efficacy (change in body fat mass, liver fat, intra-abdominal fat mass and intrahepatic triglyceride content, oral glucose tolerance, glycemic control, insulin sensitivity and b-cell function, plasma lipids, blood pressure, sleep duration, quality and behaviors, physical performance scores); iii) adherence and fidelity to the intervention (adherence to the intervention and barriers to long term adherence, quality-of-life, fidelity of the implementation by CHWs, CHW's and study participants' acceptability and satisfaction with the intervention and eating behaviors. Placebo or tirzepatide will be injected subcutaneously in the abdomen or thigh once a week for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Active Comparator | In this arm, participants will receive the standard care intervention from community health workers. |
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| Intensive lifestyle intervention plus placebo | Experimental | In this arm, participants will receive a culturally-tailored dietary and behavioral intensive lifestyle intervention from community health workers, and will receive placebo subcutaneous injections weekly during the 52-week intervention. |
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| Intensive lifestyle intervention plus tirzepatide | Experimental | In this arm, participants will receive the behavioral plant-based intervention from community health workers, and will receive subcutaneous injections of tirzepatide weekly during the 52-week intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Behavioral | Participants will meet with community health workers to receive general health information through individual check-ins. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Percent change in body weight | After 24 weeks of intervention |
| Change in body weight | Percent change in body weight | After 52 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants losing at least 5% in body weight | Proportion of participants in each group that lose at least 5% in body weight | After 24 weeks of intervention |
| Proportion of participants losing at least 5% in body weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Jacome Sosa | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States |
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| Culturally-tailored dietary and behavioral intensive lifestyle intervention | Behavioral | Participants will meet with community health workers to receive information focused on healthy eating while still adhering to a culturally-tailored plant-forward diet. |
|
| Placebo | Drug | Participants will receive placebo subcutaneous injections. |
|
| Tirzepatide | Drug | Participants will receive subcutaneous injections of tirzepatide that gradually increase up to 15 mg per week. |
|
Proportion of participants in each group that lose at least 5% in body weight
| After 52 weeks of intervention |
| Proportion of participants losing at least 10% in body weight | Proportion of participants in each group that lose at least 10% in body weight | After 24 weeks of intervention |
| Proportion of participants losing at least 10% in body weight | Proportion of participants in each group that lose at least 10% in body weight | After 52 weeks of intervention |
| Proportion of participants losing at least 15% in body weight | Proportion of participants in each group that lose at least 15% in body weight | After 24 weeks of intervention |
| Proportion of participants losing at least 15% in body weight | Proportion of participants in each group that lose at least 15% in body weight | After 52 weeks of intervention |
| Fat mass and fat free mass | Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA) | Before and after 24 weeks of intervention |
| Fat mass and fat free mass | Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA) | Before and after 52 weeks of intervention |
| β-cell function | β-cell function will be assessed from a modified 3-hour oral glucose tolerance test | Before and after 24 weeks of intervention |
| β-cell function | β-cell function will be assessed from a modified 3-hour oral glucose tolerance test | Before and after 52 weeks of intervention |
| Insulin clearance | Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test | Before and after 24 weeks of intervention |
| Insulin clearance | Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test | Before and after 52 weeks of intervention |
| Plasma lipids | Fasting plasma lipid profile will be assessed by routine blood tests | Before and after 24 weeks of intervention |
| Plasma lipids | Fasting plasma lipid profile will be assessed by routine blood tests | Before and after 52 weeks of intervention |
| Blood pressure | Systolic and diastolic blood pressure will be measured | Before and after 24 weeks of intervention |
| Blood pressure | Systolic and diastolic blood pressure will be measured | Before and after 52 weeks of intervention |
| Sleep quality | Sleep quality will be assessed by polysomnography. | Before and after 24 weeks of intervention |
| Sleep quality | Sleep quality will be assessed by polysomnography. | Before and after 52 weeks of intervention |
| Sleep quantity | Sleep quantity will be assessed by polysomnography. | Before and after 24 weeks of intervention |
| Sleep quantity | Sleep quantity will be assessed by polysomnography. | Before and after 52 weeks of intervention |
| Liver fat | Liver fat will be assessed by using ultrasound | Before and after 24 weeks of intervention |
| Liver fat | Liver fat will be assessed by using ultrasound | Before and after 52 weeks of intervention |
| Intra-abdominal fat mass and intrahepatic triglyceride content | Intra-abdominal fat mass and intrahepatic triglyceride content will be assessed via magnetic resonance imaging (MRI) | Before and after 52 weeks of intervention |
| Physical performance | Physical performance will be measured as the time in seconds that takes to walk 50 ft and to stand up 5 times from a chair. | Before and after 24 weeks of intervention |
| Physical performance | Physical performance will be measured as the time in seconds that takes to walk 50 ft and to stand up 5 times from a chair. | Before and after 52 weeks of intervention |
| Grip strength | Grip strength will be measured using a hand dynamometer. | Before and after 24 weeks of intervention |
| Grip strength | Grip strength will be measured using a hand dynamometer. | Before and after 52 weeks of intervention |
| Lifestyle program adherence | Number of sessions attended | After 24 weeks of intervention |
| Lifestyle program adherence | Number of sessions attended | After 52 weeks of intervention |
| Drug/placebo adherence | Number of injections received | After 24 weeks of intervention |
| Drug/placebo adherence | Number of injections received | After 52 weeks of intervention |
| Program acceptability from community health workers and study participants | Community health workers' and study participants' perceptions of program acceptability via questionnaire | After 24 weeks of intervention |
| Program acceptability from community health workers and study participants | Community health workers' and study participants' perceptions of program acceptability via questionnaire | After 52 weeks of intervention |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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