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

Sponsor
Charles Drew University of Medicine and Science (Other)
Overall Status
Recruiting
CT.gov ID
NCT04725058
Collaborator
(none)
1,000
Enrollment
1
Location
2
Arms
48.8
Anticipated Duration (Months)
20.5
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Medical Group Visit
  • Other: Dietitian Individual Visit
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Obesity Group Visits. A Novel Way to Approach the Obesity Epidemic in an Inner-City Setting
Actual Study Start Date :
Feb 3, 2020
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Medical Group Visit

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

Other: Medical Group Visit
A group of 20 or more participants will receive obesity management through endocrinologist and registered dietitian in a group seetting.
Other Names:
  • Medical Group
  • Experimental: Dietitian-Led Visit

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

    Other: Dietitian Individual Visit
    Participant receives obesity management individually from a registered dietitian.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Weight [Baseline, months 3, 6 and 12.]

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

    2. Change in HbA1c [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.

    3. Change in Healthy Eating Index-2015 Score [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.

    4. Change in Physical Activity Measures [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

    5. Change in General Health Questionnaire (GHQ-12) Score [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.

    6. Change in Social Determinants of Health Factors (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool. [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).

    Secondary Outcome Measures

    1. Change in Coronary Artery Calcification (CAC) score [Baseline and 12 months.]

      Coronary Artery Scanning will be measured at baseline and at month 12 to determine calcium scores.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Charles R. Drew University of Medicine and ScienceLos AngelesCaliforniaUnited States90059

    Sponsors and Collaborators

    • Charles Drew University of Medicine and Science

    Investigators

    • Principal Investigator: Theodore Friedman, MD. PhD, Charles Drew University of Medicine and Science

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Theodore Friedman, Professor of Medicine, Charles Drew University of Medicine and Science
    ClinicalTrials.gov Identifier:
    NCT04725058
    Other Study ID Numbers:
    • 1443169
    First Posted:
    Jan 26, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2021