Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04725058

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 90 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry 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.

Treatments and study arms

Medical Group Visit

Other

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

Dietitian Individual Visit

Other

Participant receives obesity management individually from a registered dietitian.

Primary outcomes

Change in WeightBaseline, months 3, 6 and 12.

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

Change in HbA1cBaseline, 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.

Change in Healthy Eating Index-2015 ScoreBaseline, 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.

Change in Physical Activity MeasuresBaseline, 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

Change in General Health Questionnaire (GHQ-12) ScoreBaseline, 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.

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).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Charles R. Drew University of Medicine and Science🇺🇸 Los Angeles, California, United States

Open map