- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04725058
Obesity Group Visits. A Novel Way to Approach the Obesity Epidemic in an Inner-City Setting
The purpose of this study has two aims: Aim 1: To compare a medical group visit model versus a dietitian-let model (shared composite group visit approach vs individualized dietitian-led approach) to provide obesity care in a real-world diverse inner city population.
Aim 2. To use both perivascular fat attenuation and coronary artery calcium (CAC) scores in those receiving composite group intervention vs. dietitian-led intervention to see if lifestyle intervention can reduce plaque progression and improve perivascular fat attenuation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After being informed about the study and potential risks, all study participants giving written informed consent will be screened to determine eligibility for study entry. At week 0, study participants who meet the eligibility requirements will be randomized in a blind manner (participant only) in a 3:1 block ratio. The study will randomize 750 subjects to the composite group visit and 250 subjects to the dietitian-led group into a 12-months duration study.
For Aim 2: A subset of 200 participants who identify as female and over 50 years old and males over 40 years old randomized to either the composite group arm or the dietitian-led arm will have the option to take part in a sub-study that involves getting a Coronary Artery Calcium (CAC) scan done at the Lundquist Institute. The first 125 subjects in the composite group arm and the first 75 subjects in the dietitian-led arm that express interest and want to undergo CAC scanning and perivascular fat measurements at baseline and at 12-months of intervention will need to sign a separate consent for these procedures. CAC scan readers will be blind to the assigned group. A group of 100 subjects not participating in the aim 1 intervention will be able to join the study under the control group. These participants will not be randomly assigned.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90059
- Charles R. Drew University of Medicine and Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion
- Age ≥ 18
- BMI ≥ 30 kg/m2
- Male, Female, LGBT
- Any ethnicity
- Interested in weight loss and be open to being randomized in either a medical group visit arm or dietitian-led arm (willingly agree to sign consent form)
- Currently within or be eligible to receive care at LAC-DHS and be empaneled to have a primary care provider (PCP) who can adjust their medicines including anti-hypertensive and diabetic medications if needed.
- If had stopped taking weight loss medication (orlistat, lorcaserin, and phentermine/topiramate-ER, phenetermine, diethylpropion, phendimetrazine and benzphetamine) for at least 2 months prior enrollment
- If had stopped taking supplements advertised to increase weight loss at least 3 months prior enrollment
Females >50 years of age and Males >40 years of age meet inclusion criteria to participate in the sub-study that involves getting a Coronary Artery Calcium (CAC) scan done at the Lundquist Institute.
Exclusion Criteria:
- Age <18
- BMI< 30 kg/m2
- Unwilling to sing consent form
- Currently participating in another obesity treatment program
- Currently on a weight loss medication (orlistat, lorcaserin, and phentermine/topiramate-ER, phenetermine, diethylpropion, phendimetrazine and benzphetamine)
- Currently on metformin or topiramate primarily prescribed for weight loss
- Currently pregnant
- Ineligible to receive care at LAC-DHS
- Those with mental illness, substance abuse issues as well as other illnesses who are unable to follow directions related to the study or becomes disruptive to the overall group
- Patients who have had bariatric surgery less than a year from time of enrollment
Females <50 years of age and Males <40 years of age are not eligible to participate in the sub-study that involves getting a Coronary Artery Calcium (CAC) scan done at the Lundquist Institute.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Medical Group Visit
Participants receive obesity management in a group setting let by endocrinologist and nutritionist.
|
A group of 20 or more participants will receive obesity management through endocrinologist and registered dietitian in a group seetting.
Other Names:
|
Experimental: Dietitian-Led Visit
Participant receives obesity management in an individual setting lead by registered dietitian.
|
Participant receives obesity management individually from a registered dietitian.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Weight
Time Frame: Baseline, months 3, 6 and 12.
|
Weight will be measured at baseline and at 3,6, and 12 months.
|
Baseline, months 3, 6 and 12.
|
Change in HbA1c
Time Frame: Baseline, months 3, 6 and 12.
|
Hemoglobin A1c will be measured at baseline, and at moths 0, 3, 6 and 12 to determine the effect of the intervention arm.
|
Baseline, months 3, 6 and 12.
|
Change in Healthy Eating Index-2015 Score
Time Frame: Baseline, months 3, 6 and 12.
|
Diet quality will be assessed by the healthy eating Index-2015 score calculated from the food frequency questionnaire using the diet history questionnaire tool (DHQ) version III software.
The minimum and maximum scores ranges fron 0 to 100.
Higher scores greater than 60 indicate better diet quality.
|
Baseline, months 3, 6 and 12.
|
Change in Physical Activity Measures
Time Frame: Baseline, months 3, 6 and 12.
|
The IPAQ short form is a seven-item instrument evaluation tool of physical activity among the adults that measures a range of physical activity from vigorous to sedentary over the last 7 days.
The specific type of activities assessed are walking, moderate intensity activities and vigorous intensity activities.
All continuous scores are expressed in metabolic equivalent minutes(MET-minutes) per week with walking =3.3 METs, Moderate PA=4.0 METs and Vigorous PA = 8.0 METs.
An overall total physical activity score can be computed as the sum of the total MET-minutes/week scores where more MET-minutes per week indicate more physical activity
|
Baseline, months 3, 6 and 12.
|
Change in General Health Questionnaire (GHQ-12) Score
Time Frame: Baseline, months 3, 6 and 12.
|
The General Health Questionnaire (GHQ-12) consists of 12-item rating scale for assessing psychological distress over the past few weeks.
Scale score ranges from 0-12, with a higher score indicating a higher level of psychological distress.
|
Baseline, months 3, 6 and 12.
|
Change in Social Determinants of Health Factors (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool.
Time Frame: Baseline and at month-12.
|
Change from baseline to 12-month follow-up PRAPARE score.
The PRAPARE assessment tool will be used to calculate a tally risk score indicating the cumulative number of SDOH risks a patient faces (including 15 SDOH domains).
|
Baseline and at month-12.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Coronary Artery Calcification (CAC) score
Time Frame: Baseline and 12 months.
|
Coronary Artery Scanning will be measured at baseline and at month 12 to determine calcium scores.
The minimum and maximum scores ranges from 0 to 400.
Higher scores means worse outcome.
We categorized the total CAC scores into 0-100 no/mild risk; scores 101-400 moderate risk; and > 400 severe risk.
|
Baseline and 12 months.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Theodore Friedman, MD. PhD, Charles Drew University of Medicine and Science
Publications and helpful links
General Publications
- Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Ryan DH, Bray GA. Pharmacologic treatment options for obesity: what is old is new again. Curr Hypertens Rep. 2013 Jun;15(3):182-9. doi: 10.1007/s11906-013-0343-6.
- Carvajal R, Wadden TA, Tsai AG, Peck K, Moran CH. Managing obesity in primary care practice: a narrative review. Ann N Y Acad Sci. 2013 Apr;1281(1):191-206. doi: 10.1111/nyas.12004. Epub 2013 Jan 16.
- Vadheim LM, Brewer KA, Kassner DR, Vanderwood KK, Hall TO, Butcher MK, Helgerson SD, Harwell TS. Effectiveness of a lifestyle intervention program among persons at high risk for cardiovascular disease and diabetes in a rural community. J Rural Health. 2010 Summer;26(3):266-72. doi: 10.1111/j.1748-0361.2010.00288.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1443169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Medical Group Visit
-
Memorial Sloan Kettering Cancer CenterCompletedStem Cell Transplant PatientsUnited States
-
Istanbul Medipol University HospitalCompletedPostoperative Pain | Endodontically Treated Teeth | Vibration; ExposureTurkey
-
Novindiet ClinicTehran University of Medical Sciences; University of NottinghamCompletedObesity | OverweightIran, Islamic Republic of
-
The Scientific and Technological Research Council...RecruitingStroke | Caregiver | Home Visit | VirtualTurkey
-
CHU de ReimsCompleted
-
University of ChicagoNational Institute on Minority Health and Health Disparities (NIMHD); Advocate... and other collaboratorsNot yet recruitingStroke | Hypertension | Obesity | Peripheral Vascular Diseases | Hyperlipidemias | T2DM (Type 2 Diabetes Mellitus) | Heart Disease Chronic
-
University of ChicagoCompleted
-
Boston Medical CenterWithdrawnObesity | Metabolic Syndrome
-
Ajou University School of MedicineCompletedDietary Modification | Alteration of Cognitive Function
-
University of Colorado, DenverNational Institute on Aging (NIA)Enrolling by invitationPrimary Health Care | Advance Care PlanningUnited States