Clinical trial NCT04725058: Obesity Group Visits. A Novel Way to Approach the Obesity Epidemic in an Inner-City Setting
Official title: Obesity Group Visits. A Novel Way to Approach the Obesity Epidemic in an Inner-City Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline, months 3, 6 and 12.
measure: Change in HbA1c
timeFrame: Baseline, months 3, 6 and 12.
measure: Change in Healthy Eating Index-2015 Score
timeFrame: Baseline, months 3, 6 and 12.
measure: Change in Physical Activity Measures
timeFrame: Baseline, months 3, 6 and 12.
measure: Change in General Health Questionnaire (GHQ-12) Score
timeFrame: Baseline, months 3, 6 and 12.
measure: Change in Social Determinants of Health Factors (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool.
timeFrame: Baseline and at month-12.
Secondary outcomes:
measure: Change in Coronary Artery Calcification (CAC) score
timeFrame: Baseline and 12 months.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles R. Drew University of Medicine and Science
state: California
Study officials:
affiliation: Charles Drew University of Medicine and Science
name: Theodore Friedman, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.