An interventional study of Medical Group Visit and Dietitian Individual Visit in Obesity, sponsored by Charles Drew University of Medicine and Science. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Charles Drew University of Medicine and Science · Not applicable, Interventional, and Treatment
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Charles Drew University of Medicine and Science is the lead sponsor of 43 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥ 18
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:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive obesity management in a group setting let by endocrinologist and nutritionist.
Other: Medical Group Visit
Participant receives obesity management in an individual setting lead by registered dietitian.
Other: Dietitian Individual Visit
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
Participant receives obesity management individually from a registered dietitian.
Change in Weight
Weight will be measured at baseline and at 3,6, and 12 months.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: Baseline and at month-12.
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.
Time frame: Baseline and 12 months.
Plan to share: Yes — All IPD that underlie results in a publication.
Supporting information: Statistical analysis plan, Informed consent form, Analytic code
Time frame: starting 6 months after publication.
Access criteria: Contact Petra Duran and PI directly.
Started Feb 2020 (actual). Primary completion is estimated for Dec 2025, 70 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 70 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Charles Drew University of Medicine and Science