ObesityHOMBRENCT03092960
The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
A study testing Minimal intensity intervention and HOMBRE in people with Obesity and Metabolic Syndrome, run by Palo Alto Medical Foundation at 1 site in United States.
Trial summary
The purpose of this study is to test a flexible lifestyle program designed to help Latino men make healthy lifestyle changes to lower their risk of developing diabetes and heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Obesity, Metabolic Syndrome, Lifestyle Intervention
- What is being tested?
- Minimal intensity intervention and HOMBRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to 31 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Latino of any race
- BMI >27 kg/m2
- One or more metabolic syndrome component (high triglycerides, blood pressure, fasting glucose, central obesity, or low HDL cholesterol)
- Primary Care Physician approval of patient study contact
- Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of tow study arms, participate in follow-up for 18 months, and authorize the extraction of relevant information form the Electronic Health Record.
Who cannot join
- Medical exclusions:
- Previous diagnosis of diabetes or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
- Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years;
- Inability to walk without the assistance of another person;
- Severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
- Diagnosis of a terminal illness and/or in hospice care;
Show all 14Show fewer
- Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication
- Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.)
- Have had or plan to undergo bariatric surgery during the study period
- Other exclusions:
- Having no reliable telephone service
- Plan to move out of the area during the study period
- Family/household member of another study participant or of a study staff member
- Investigator discretion for clinical safety or protocol adherence reasons
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Medical Foundation
Palo Alto, California, 94301
About this study
The purpose of this study is to test a flexible lifestyle program designed to help Latino men make healthy lifestyle changes to lower their risk of developing diabetes and heart disease. The program is called HOMBRE (Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas; English translation: Men with choices to improve well being and decrease chronic disease risk).
Read the detailed description
This study is a comparative effectiveness trial where obese Latino men will receive, by random assignment, the HOMBRE intervention or a minimal intensity intervention.
The study is designed to test whether a flexible lifestyle program with choices for program engagement will lead to better health outcomes, compared to a minimal intensity self-directed lifestyle program. If proven successful, this study has the potential to significantly impact health outcomes that matter to Latino men through the innovative design of lifestyle interventions to prevent chronic disease.
- Conditions
- Obesity, Metabolic Syndrome, Lifestyle Intervention, Pre Diabetes
- Being tested
- Minimal intensity intervention, HOMBRE
- Keywords
- Latino, Male
- Medical subject headings
- Obesity, Metabolic Syndrome, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal intensity interventionBehavioural
The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
HOMBREBehavioural
HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
| Study group | Role | What they receive |
|---|---|---|
| Minimal intensity intervention | Active comparator | Patients assigned to this group will received the Minimal intensity intervention. Receives: Behavioral: Minimal intensity intervention |
| HOMBRE | Experimental | Patients assigned to this group will receive the HOMBRE intervention Receives: Behavioral: HOMBRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Men Achieving 5% Weight Loss or More
Number and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight
Measured: Baseline, 18 months
Secondary outcomes (24)
Trajectory of Weight Change From Baseline Through 18 Months
Slope of changes in weights abstracted from EHR from baseline through 18 months
Measured: 18 months
Changes in Weight From Baseline
Weight measurements were abstracted from EHR.
Measured: 6 months
Changes in Weight From Baseline
Weight measurements were abstracted from EHR.
Measured: 12 months
Changes in Weight From Baseline
Weight measurements were abstracted from EHR.
Measured: 18 months
Change in Waist Circumference From Baseline
Waist circumference at 18 months - waist circumference at baseline
Measured: Baseline, 18 months
Change in Systolic Blood Pressure From Baseline
Systolic blood pressure at 18 months - systolic blood pressure at baseline
Measured: Baseline, 18 months
Change in Diastolic Blood Pressure From Baseline
Diastolic blood pressure at 18 months - diastolic blood pressure at baseline
Measured: Baseline, 18 months
Change in Health Behavior: Leisure Time Physical Activity
Physical activity measured at 18 months minus physical activity measured at baseline using Stanford 7-day physical activity recall
Measured: Baseline, 18 months
Change in Health Behavior: Energy Expenditure
The Stanford 7-day Physical Activity Recall data also provided estimates of total daily energy expenditures. Total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs. Total daily energy expenditure at 18 months - Total daily energy expenditure at baseline.
Measured: Baseline, 18 months
Change in Health Behavior: Sedentary Behavior
Weekly hours of sedentary behavior measured at 18 months minus weekly hours of sedentary behavior at baseline using the Sedentary behavior Questionnaire
Measured: Baseline, 18 months
Change in Health Behavior: Diet Quality
Dietary intake was measured using the gold-standard approach of multiple pass 24-hour recalls in Spanish or English using Nutrition Data System for Research (NDSR). Diet quality was assessed by the Dietary Approaches to Stop Hypertension (DASH) score. DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). A higher score reflects higher diet quality. The minimum score is 8 and the maximum is 40. DASH score at 18 months - DASH score at baseline.
Measured: Baseline, 18 months
Change in Health Behavior: Fruit and Vegetable Intake
Fruit and vegetable intake measured at 18 months minus fruit and vegetable intake measured at baseline using 24-hour multiple pass recalls. Fruit and vegetable intake is measured in servings per day.
Measured: Baseline, 18 months
Change in Health Behavior: Total Calorie Intake
Total calorie intake per day measured at 18 months minus total calorie intake per day measured at baseline using 24-hour multiple pass dietary recalls.
Measured: Baseline, 18 months
Change in Health Behavior: Total Fat
Total fat consumption per day measured at 18 months minus total fat consumption per day measured at baseline using 24-hour multiple pass dietary recalls.
Measured: Baseline, 18 months
Change in Psychosocial Well-being: Obesity-specific Quality of Life
Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. Obesity-related quality of life measured at 18 months - obesity-related quality of life measured at baseline.
Measured: Baseline, 18 months
Change in Psychosocial Well-being: Depressive Symptoms
The Patient Health Questionnaire PHQ-9 is a self-report questionnaire with 9 items. Respondents answered questions regarding how often a symptom has bothered them over the last two weeks. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). PHQ-9 total score is the sum of the nine items, ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score at 18 months - PHQ-9 score at baseline.
Measured: Baseline, 18 months
Change in Perceived Stress
Perceived stress scale with a range of 0 to 40 with higher scores indicating higher stress. Perceived stress at 18 months - Perceived stress at baseline.
Measured: Baseline, 18 months
Change in Psychosocial Well-being: Sleep Disturbance T-score
Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. Sleep disturbance score at 18 months - sleep disturbance score at baseline.
Measured: Baseline, 18 months
Change in Psychosocial Well-being: Sleep Impairment T-score
Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. Sleep impairment score at 18 months - sleep impairment at baseline.
Measured: Baseline, 18 months
Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Mobility Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Utility-based quality of life was measured by EuroQol EQ-5D. Number and percentage of participants who had no problems with mobility.
Measured: 18 months
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Self Care Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Number and percentage of participants who had no problems with self care was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.
Measured: 18 months
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Usual Activities Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Number and percentage of participants who had no problems with usual activities (e.g. work, study, housework, family or leisure activities).
Measured: 18 months
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Pain/Discomfort Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Number and percentage of participants who had no problems with pain was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.
Measured: 18 months
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Anxiety and Depression Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Number and percentage of participants who had no problems with anxiety and depression was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start3 Apr 2017
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Illinois Chicago, RTI International, University of Pittsburgh, Arizona State University, Stanford University
- Responsible party
- Sponsor
- Investigators
- Lisa Goldman Rosas, PhD, MPH, Principal investigator, Stanford UniversityKristen M Azar, RN, MSN, MPH, Principal investigator, Sutter Health Research Development & Dissemination
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092960
- Sponsor's protocol ID
- 981746
- Acronym
- HOMBRE
- Status last verified
- Oct 2021
- First submitted
- 15 Mar 2017
- Last updated
- 17 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rosas LG, Lv N, Xiao L, Venditti EM, Lewis MA, Azar KMJ, Hooker SP, Zavella P, Ma J. HOMBRE: A Trial Comparing 2 Weight Loss Approaches for Latino Men. Am J Prev Med. 2022 Sep;63(3):341-353. doi: 10.1016/j.amepre.2022.03.032. Epub 2022 May 30.
PubMed 35654660Rosas LG, Lv N, Xiao L, Azar KM, Hooker SP, Venditti EM, Lewis MA, Zavella P, Ma J. Preferences for Technology-Mediated Behavioral Lifestyle Interventions With Different Levels of Coach and Peer Support Among Latino Men: Comparative Study Within One Arm of a Randomized Controlled Trial. JMIR Form Res. 2022 Feb 4;6(2):e29537. doi: 10.2196/29537.
PubMed 35119377
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
- ClinicalTrials.gov ID
- NCT03092960
- Acronym / sponsor ID
- HOMBRE / 981746
- Conditions
- Obesity, Metabolic Syndrome, Lifestyle Intervention, Pre Diabetes
- Keywords
- Latino, Male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Illinois Chicago, RTI International, University of Pittsburgh, Arizona State University, Stanford University
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Posted 17 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a flexible lifestyle program designed to help Latino men make healthy lifestyle changes to lower their risk of developing diabetes and heart disease. The program is called HOMBRE (Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas; English translation: Men with choices to improve well being and decrease chronic disease risk).
Detailed description
This study is a comparative effectiveness trial where obese Latino men will receive, by random assignment, the HOMBRE intervention or a minimal intensity intervention.
The study is designed to test whether a flexible lifestyle program with choices for program engagement will lead to better health outcomes, compared to a minimal intensity self-directed lifestyle program. If proven successful, this study has the potential to significantly impact health outcomes that matter to Latino men through the innovative design of lifestyle interventions to prevent chronic disease.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal intensity intervention | Active comparator | Behavioral: Minimal intensity interventionPatients assigned to this group will received the Minimal intensity intervention. |
| HOMBRE | Experimental | Behavioral: HOMBREPatients assigned to this group will receive the HOMBRE intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Latino of any race
- BMI >27 kg/m2
- One or more metabolic syndrome component (high triglycerides, blood pressure, fasting glucose, central obesity, or low HDL cholesterol)
- Primary Care Physician approval of patient study contact
- Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of tow study arms, participate in follow-up for 18 months, and authorize the extraction of relevant information form the Electronic Health Record.
Key exclusion criteria (14 listed)
- Previous diagnosis of diabetes or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
- Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years;
- Inability to walk without the assistance of another person;
- Severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
- Diagnosis of a terminal illness and/or in hospice care;
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 |
|---|---|---|
| Minimal intensity interventionThe minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant. | Behavioural | Minimal intensity intervention |
| HOMBREHOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach. | Behavioural | HOMBRE |
Primary outcome
Number and Percentage of Men Achieving 5% Weight Loss or More
Time frame: Baseline, 18 months
Number and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight
24 secondary outcomes
Trajectory of Weight Change From Baseline Through 18 Months
Time frame: 18 months
Changes in Weight From Baseline
Time frame: 6 months
Changes in Weight From Baseline
Time frame: 12 months
Changes in Weight From Baseline
Time frame: 18 months
Change in Waist Circumference From Baseline
Time frame: Baseline, 18 months
Change in Systolic Blood Pressure From Baseline
Time frame: Baseline, 18 months
Change in Diastolic Blood Pressure From Baseline
Time frame: Baseline, 18 months
Change in Health Behavior: Leisure Time Physical Activity
Time frame: Baseline, 18 months
Change in Health Behavior: Energy Expenditure
Time frame: Baseline, 18 months
Change in Health Behavior: Sedentary Behavior
Time frame: Baseline, 18 months
Change in Health Behavior: Diet Quality
Time frame: Baseline, 18 months
Change in Health Behavior: Fruit and Vegetable Intake
Time frame: Baseline, 18 months
Change in Health Behavior: Total Calorie Intake
Time frame: Baseline, 18 months
Change in Health Behavior: Total Fat
Time frame: Baseline, 18 months
Change in Psychosocial Well-being: Obesity-specific Quality of Life
Time frame: Baseline, 18 months
Change in Psychosocial Well-being: Depressive Symptoms
Time frame: Baseline, 18 months
Change in Perceived Stress
Time frame: Baseline, 18 months
Change in Psychosocial Well-being: Sleep Disturbance T-score
Time frame: Baseline, 18 months
Change in Psychosocial Well-being: Sleep Impairment T-score
Time frame: Baseline, 18 months
Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Mobility Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Time frame: 18 months
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Self Care Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Time frame: 18 months
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Usual Activities Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Time frame: 18 months
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Pain/Discomfort Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Time frame: 18 months
Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Anxiety and Depression Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35654660Rosas LG, Lv N, Xiao L, Venditti EM, Lewis MA, Azar KMJ, Hooker SP, Zavella P, Ma J. HOMBRE: A Trial Comparing 2 Weight Loss Approaches for Latino Men. Am J Prev Med. 2022 Sep;63(3):341-353. doi: 10.1016/j.amepre.2022.03.032. Epub 2022 May 30.
- Derived from this study: PubMed 35119377Rosas LG, Lv N, Xiao L, Azar KM, Hooker SP, Venditti EM, Lewis MA, Zavella P, Ma J. Preferences for Technology-Mediated Behavioral Lifestyle Interventions With Different Levels of Coach and Peer Support Among Latino Men: Comparative Study Within One Arm of a Randomized Controlled Trial. JMIR Form Res. 2022 Feb 4;6(2):e29537. doi: 10.2196/29537.
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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.
Lisa Goldman Rosas, PhD, MPH principal investigator
Stanford University
Kristen M Azar, RN, MSN, MPH principal investigator
Sutter Health Research Development & Dissemination
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal intensity intervention and HOMBRE in people with Obesity and Metabolic Syndrome, run by Palo Alto Medical Foundation 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 17 Nov 2021. 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?
Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Men Achieving 5% Weight Loss or More (time frame: Baseline, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03092960, which also lists 2 linked publications.
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 17 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.