A Toolbox Approach to Obesity Treatment in Primary Care
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | December 2016 |
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.
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.
Background: Obesity is prevalent and is a root cause of many common medical conditions
affecting U.S. adults. A range of treatment options have demonstrated efficacy in producing
weight loss and reducing health risks in randomized controlled trials. However, very little
obesity treatment is currently delivered in most primary care settings. Inadequate
reimbursement for treatment modalities and a lack of systematic training of primary care
providers (PCPs) are two of the major barriers to more widespread treatment.
Hypothesis: If PCPs are given training and support for weight management, and if treatment
options with proven efficacy are offered to obese adults with weight related co-morbidities
with the majority of the treatment cost reimbursed, then clinically meaningful weight loss
will be produced in a significant number of these individuals at a reasonable cost.
Design: This application proposes a 12 month intervention trial among obese adults cared for
at 4 primary care clinics affiliated with Denver Health (DH), an integrated health care
system serving an ethnically diverse medically underserved population. From among a large
population of patients (~8,000) with obesity and at least one co-morbid condition, 350
individuals will be randomly selected to be offered a "toolbox" of treatment options. The
remainder will be assigned to a control condition. The "toolbox" will include: 1) meal
replacements; 2) group weight loss counseling; 3) membership at recreation centers; 4)
pharmacotherapy with phentermine; and 5) other options. Patients in the intervention arm
will undergo an initial evaluation using an "expert systems" computer program. They will
then be required to self-monitor diet and physical activity before gaining access to the
higher cost weight management services in the toolbox. Primary care providers will help
patients choose treatment approaches, encourage adherence, and monitor success. Patient
Navigators will assist patients in accessing prescribed treatments. The primary outcome will
be the fraction of patients in each group who achieve a 5% weight loss after 12 months of
intervention. Secondary outcomes will include uptake and utilization of treatment options,
changes in cardiovascular disease risk factors, and other health care utilization, in
particular outpatient medications for diabetes, hypertension, and lipids. While the
treatment modalities to be used in this trial are not new, an intervention delivering a
toolbox of weight management services in a safety net clinical setting and examining the
effect on health care utilization is innovative. The submitted letters of support attest to
the need for more data so that health care providers and payers can make evidence-based
decisions regarding the provision of obesity treatment to large patient populations.
Impact: A positive result would encourage the broader adoption of a toolbox approach to
weight management in primary care settings. A negative result would strongly suggest that
even with a "best case scenario" of training and support for obesity treatment, the primary
care clinic is not an effective route of delivery for weight management. Either result would
be important in shaping future policy decisions about obesity treatment.
affecting U.S. adults. A range of treatment options have demonstrated efficacy in producing
weight loss and reducing health risks in randomized controlled trials. However, very little
obesity treatment is currently delivered in most primary care settings. Inadequate
reimbursement for treatment modalities and a lack of systematic training of primary care
providers (PCPs) are two of the major barriers to more widespread treatment.
Hypothesis: If PCPs are given training and support for weight management, and if treatment
options with proven efficacy are offered to obese adults with weight related co-morbidities
with the majority of the treatment cost reimbursed, then clinically meaningful weight loss
will be produced in a significant number of these individuals at a reasonable cost.
Design: This application proposes a 12 month intervention trial among obese adults cared for
at 4 primary care clinics affiliated with Denver Health (DH), an integrated health care
system serving an ethnically diverse medically underserved population. From among a large
population of patients (~8,000) with obesity and at least one co-morbid condition, 350
individuals will be randomly selected to be offered a "toolbox" of treatment options. The
remainder will be assigned to a control condition. The "toolbox" will include: 1) meal
replacements; 2) group weight loss counseling; 3) membership at recreation centers; 4)
pharmacotherapy with phentermine; and 5) other options. Patients in the intervention arm
will undergo an initial evaluation using an "expert systems" computer program. They will
then be required to self-monitor diet and physical activity before gaining access to the
higher cost weight management services in the toolbox. Primary care providers will help
patients choose treatment approaches, encourage adherence, and monitor success. Patient
Navigators will assist patients in accessing prescribed treatments. The primary outcome will
be the fraction of patients in each group who achieve a 5% weight loss after 12 months of
intervention. Secondary outcomes will include uptake and utilization of treatment options,
changes in cardiovascular disease risk factors, and other health care utilization, in
particular outpatient medications for diabetes, hypertension, and lipids. While the
treatment modalities to be used in this trial are not new, an intervention delivering a
toolbox of weight management services in a safety net clinical setting and examining the
effect on health care utilization is innovative. The submitted letters of support attest to
the need for more data so that health care providers and payers can make evidence-based
decisions regarding the provision of obesity treatment to large patient populations.
Impact: A positive result would encourage the broader adoption of a toolbox approach to
weight management in primary care settings. A negative result would strongly suggest that
even with a "best case scenario" of training and support for obesity treatment, the primary
care clinic is not an effective route of delivery for weight management. Either result would
be important in shaping future policy decisions about obesity treatment.
Inclusion Criteria:
1. BMI > 30 kg/m2 and < 45 kg/m2
2. Any one of the following (weight-related) diagnoses: type 2 diabetes or pre-diabetes,
including those treated with glucose lowering medications; hypertension, including
patients treated with anti-hypertensive medications; hyperlipidemia, including those
treated with lipid lowering agents; atherosclerotic cardiovascular disease, including
coronary heart disease, cerebrovascular disease, or peripheral vascular disease;
obstructive sleep apnea
3. Visited their primary care provider (PCP) at least twice during the past 12 months,
including once in the last 6 months
Exclusion Criteria:
Heart attack or stroke within the past 6 months; cancer treated within the past 5 years,
except for non-melanoma skin cancer or localized prostate cancer; other medical
contraindications to weight loss (e.g., end-stage renal disease, cirrhosis); active
substance abuse; current treatment for bipolar disorder or schizophrenia; discretion of
PCP (see below)
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