Obesity Group Visits. A Novel Way to Approach the Obesity Epidemic in an Inner-City Setting

NCT04725058 | Active Not Recruiting DMC

• 1 other identifier: 1443169
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (6)

• Change in Weight

  Weight will be measured at baseline and at 3,6, and 12 months.

  Baseline, months 3, 6 and 12.

• Change in HbA1c

  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

  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

  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

  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.

  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 Outcomes (1)

• Change in Coronary Artery Calcification (CAC) score

  Baseline and 12 months.

Study Arms (2)

Medical Group Visit

EXPERIMENTAL

Participants receive obesity management in a group setting let by endocrinologist and nutritionist.

Other: Medical Group Visit

Dietitian-Led Visit

EXPERIMENTAL

Participant receives obesity management in an individual setting lead by registered dietitian.

Other: Dietitian Individual Visit

Interventions

Medical Group Visit OTHER

A group of 20 or more participants will receive obesity management through endocrinologist and registered dietitian in a group seetting.

Also known as: Medical Group

Medical Group Visit

Dietitian Individual Visit OTHER

Participant receives obesity management individually from a registered dietitian.

Dietitian-Led Visit

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

Study Sites (1)

Charles R. Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

Related Publications (5)

• 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.

  PMID: 24570244 BACKGROUND

• 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.

  PMID: 11832527 BACKGROUND

• 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.

  PMID: 23625271 BACKGROUND

• 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.

  PMID: 23323827 BACKGROUND

• 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.

  PMID: 20633095 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Theodore Friedman, MD. PhD

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 26, 2021
• Study Start: February 3, 2020
• Primary Completion: December 28, 2025
• Study Completion: December 28, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, ANALYTIC CODE
• Time Frame: starting 6 months after publication.
• Access Criteria: Contact Petra Duran and PI directly.

Locations

US (1)