CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 4,730 enrolled
Drug / intervention
Obesity pharmacotherapy +4 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01922934
NCT01922934Phase 4Completed

A Toolbox Approach to Obesity Treatment in Primary Care

Denver Health and Hospital Authority·interventional·Posted Aug 14, 2013·Updated Aug 18, 2017

In Brief

A Phase 4 clinical trial evaluating Commercial weight loss program, Colorado Weigh, and 3 other interventions for Obesity. Completed, enrolled 4,730 participants across 1 site.

Detailed 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 glucose, blood pressure, and cholesterol, and we will look at how much this intervention costs and whether patients need less medication for their weight-related conditions at the end of the study. Impact: If the study is successful, we plan to take the results to the leaders at Denver Health to see if they will make obesity treatment more broadly available for all patients there.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 14, 2013
Enrollment StartJan 1, 2014
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.9 years ago

Interventions

Commercial weight loss programbehavioral

vouchers for Weight Watchers

Colorado Weighbehavioral

Group behavioral weight loss program

Meal replacementsdietary

Health Management Resources meal replacement products (shakes and entrees)

Obesity pharmacotherapydrug

Phentermine or phentermine-topiramate (Qsymia)

Recreation center passesbehavioral

1 year pass to a Denver recreation center