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NCT01922934 · ClinicalTrials.gov registry record · Phase 4
A Toolbox Approach to Obesity Treatment in Primary Care
A Phase 4 study, sponsored by Denver Health and Hospital Authority.
- Completed
- Registry status
- Phase 4
- Development phase
- 4,730
- Enrollment target
NCT01922934 is a Phase 4 study that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 4,730 participants.
The verdict
NCT01922934, a Phase 4 study, has completed, sponsored by Denver Health and Hospital Authority.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4,730 participants
- Enrollment target
Study Summary
Obesity is common, causing many medical problems in adults (e.g., diabetes, hypertension, high cholesterol, sleep apnea, heart attack, strokes). A range of treatments have shown to be effective for treating obesity. Treatments include lifestyle modification, meal replacements, and weight loss medication. Most primary care settings do not provide much obesity treatment, though, as primary care providers (PCPs) are not well trained and because reimbursement for treatments is not consistent. Hypothesis: If PCPs have training in weight management and if most costs of treatment are reimbursed, we surmise that a "toolbox" of treatments can produce a clinically important weight loss amount in a large group of patients. Design: We propose to establish a registry of obese patients with at least one common medical condition related to their weight. From the registry, we will randomly select 350 people to be offered treatments to assist with weight loss. The remainder of the registry's patients can still receive obesity treatment but will not be reimbursed. We will conduct the study at Denver Health, a large public health care system that treats a low income, ethnically diverse population. All 350 patients will be offered some self-monitoring tools for weight management and the chance to do a computer assessment to select the right treatment for weight loss. Patients who complete this and record their food intake and physical activity for 1 week will be offered a "Level 2" treatment for weight loss. Level 2 treatments include: a voucher for a commercial weight loss program; intensive group weight loss counseling; meal replacements; gym membership; or weight loss medication. Patients will choose which treatment they want, with the approval of their PCP. Researchers at Denver Health will help with the computer assessment and dispensing the treatments. We are interested in what percentage of patients lose at least 5% of their starting weight. We will also explore changes in glu
Interventions
- BEHAVIORAL Commercial weight loss program
- BEHAVIORAL Colorado Weigh
- DIETARY_SUPPLEMENT Meal replacements
- DRUG Obesity pharmacotherapy
- BEHAVIORAL Recreation center passes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,730 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01922934
The ClinicalTrials.gov registry entry for NCT01922934 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 4,730 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denver Health and Hospital Authority, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Commercial weight loss program is the first listed.
NCT01922934 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01922934 about?
NCT01922934 is a clinical study titled "A Toolbox Approach to Obesity Treatment in Primary Care". Obesity is common, causing many medical problems in adults (e.g., diabetes, hypertension, high cholesterol, sleep apnea, heart attack, strokes). A range of treatments have shown to be effective for treating obesity. Treatments include lifestyle modification, meal replacements, and weight loss medica...
What is the current status of trial NCT01922934?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4,730 participants. The study started on 2014-01. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01922934?
The interventions under investigation include: Commercial weight loss program (BEHAVIORAL), Colorado Weigh (BEHAVIORAL), Meal replacements (DIETARY_SUPPLEMENT), Obesity pharmacotherapy (DRUG), Recreation center passes (BEHAVIORAL).
Who is sponsoring clinical trial NCT01922934?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
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