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

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Group Visit
Dietitian Individual Visit
Sponsored by
Charles Drew University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

  • 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.

Sites / Locations

  • Charles R. Drew University of Medicine and ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Medical Group Visit

Dietitian-Led Visit

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Coronary Artery Calcification (CAC) score
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.

Full Information

First Posted
January 11, 2021
Last Updated
August 29, 2023
Sponsor
Charles Drew University of Medicine and Science
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1. Study Identification

Unique Protocol Identification Number
NCT04725058
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles Drew University of Medicine and Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medical Group Visit
Arm Type
Experimental
Arm Description
Participants receive obesity management in a group setting let by endocrinologist and nutritionist.
Arm Title
Dietitian-Led Visit
Arm Type
Experimental
Arm Description
Participant receives obesity management in an individual setting lead by registered dietitian.
Intervention Type
Other
Intervention Name(s)
Medical Group Visit
Other Intervention Name(s)
Medical Group
Intervention Description
A group of 20 or more participants will receive obesity management through endocrinologist and registered dietitian in a group seetting.
Intervention Type
Other
Intervention Name(s)
Dietitian Individual Visit
Intervention Description
Participant receives obesity management individually from a registered dietitian.
Primary Outcome Measure Information:
Title
Change in Weight
Description
Weight will be measured at baseline and at 3,6, and 12 months.
Time Frame
Baseline, months 3, 6 and 12.
Title
Change in HbA1c
Description
Hemoglobin A1c will be measured at baseline, and at moths 0, 3, 6 and 12 to determine the effect of the intervention arm.
Time Frame
Baseline, months 3, 6 and 12.
Title
Change in Healthy Eating Index-2015 Score
Description
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.
Time Frame
Baseline, months 3, 6 and 12.
Title
Change in Physical Activity Measures
Description
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
Time Frame
Baseline, months 3, 6 and 12.
Title
Change in General Health Questionnaire (GHQ-12) Score
Description
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.
Time Frame
Baseline, months 3, 6 and 12.
Title
Change in Social Determinants of Health Factors (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool.
Description
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).
Time Frame
Baseline and at month-12.
Secondary Outcome Measure Information:
Title
Change in Coronary Artery Calcification (CAC) score
Description
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.
Time Frame
Baseline and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petra Duran, BS
Phone
3233573428
Email
petraduran@cdrewu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Friedman, MD. PhD
Organizational Affiliation
Charles Drew University of Medicine and Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles R. Drew University of Medicine and Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Duran
Phone
323-357-3428

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication.
IPD Sharing Time Frame
starting 6 months after publication.
IPD Sharing Access Criteria
Contact Petra Duran and PI directly.
Citations:
PubMed Identifier
24570244
Citation
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.
Results Reference
result
PubMed Identifier
11832527
Citation
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.
Results Reference
result
PubMed Identifier
23625271
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.
Results Reference
result
PubMed Identifier
23323827
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.
Results Reference
result
PubMed Identifier
20633095
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.
Results Reference
result

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

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