Obesity
Conditions
Brief 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.
Detailed description
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.
Interventions
vouchers for Weight Watchers
Group behavioral weight loss program
Health Management Resources meal replacement products (shakes and entrees)
Phentermine or phentermine-topiramate (Qsymia)
1 year pass to a Denver recreation center
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved >5% Weight Loss at 12 Months | 1 year | Participants who had both a baseline and 12 month weight measurement were included. Weight change at 12 months was measured as a percent difference from their starting weight. |
| Health Care Utilization - Non-study Clinic Visits | 1 year study period | Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of non-study clinic visits. |
| Health Care Utilization - Laboratory Measurements | 1 year study period | Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of number of lab measurements taken during the period (including A1C, creatinine, and lipids). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Documentation of Obesity | 1 year study period | To assess: 1. Presence of ICD-9 code for obesity in the DHHA registry Control Group 2. Evidence of a specific intervention for weight management resembling what was offered in the toolbox intervention: weight loss medication prescribed, gym membership, weight loss program or referral to wt loss specialist, and meal replacements |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool. | 119 |
| Registry-Based Control Group Eligible subjects from an obesity registry (i.e. BMI \>/= 30 and at least one weight-related comorbidity) who had at least one measured weight during usual care during the 12-month study period. | 2,930 |
| Total | 3,049 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Eligible Patients | Death | 0 | 7 |
| Eligible Patients | Did not meet inclusion criteria | 36 | 81 |
| Eligible Patients | Physician Decision | 17 | 0 |
| Visit 0 - Patient Contacted & Consented | No response or could not reach | 66 | 0 |
| Visit 0 - Patient Contacted & Consented | Patient declined to participate | 169 | 0 |
| Visit 1- Weight Measured | Did not have weight recorded (visit 1) | 21 | 1,284 |
Baseline characteristics
| Characteristic | Intervention Group | Total | Registry-Based Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 471 Participants | 455 Participants |
| Age, Categorical Between 18 and 65 years | 103 Participants | 2578 Participants | 2475 Participants |
| Age, Continuous | 52 years | 52 years | 52 years |
| Baseline BMI 30-34.9 | 62 Participants | 1674 Participants | 1612 Participants |
| Baseline BMI 35-39.9 | 32 Participants | 933 Participants | 901 Participants |
| Baseline BMI 40-44.9 | 25 Participants | 442 Participants | 417 Participants |
| Baseline BMI (continuous) | 34.6 kg/m^2 | 34.4 kg/m^2 | 34.3 kg/m^2 |
| Coronary artery disease No | 98 Participants | 2645 Participants | 2547 Participants |
| Coronary artery disease Yes | 21 Participants | 404 Participants | 383 Participants |
| Diabetes No | 61 Participants | 1641 Participants | 1580 Participants |
| Diabetes Yes | 58 Participants | 1408 Participants | 1350 Participants |
| Diabetes, hypertension, or hyperlipidemia Had at least one | 99 Participants | 2475 Participants | 2376 Participants |
| Diabetes, hypertension, or hyperlipidemia Have none | 20 Participants | 574 Participants | 554 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 65 Participants | 1924 Participants | 1859 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 1125 Participants | 1071 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hyperlipidemia No | 56 Participants | 1390 Participants | 1334 Participants |
| Hyperlipidemia Yes | 63 Participants | 1659 Participants | 1596 Participants |
| Hypertension No | 41 Participants | 908 Participants | 867 Participants |
| Hypertension Yes | 78 Participants | 2141 Participants | 2063 Participants |
| Primary Language English | 84 Participants | 2117 Participants | 2033 Participants |
| Primary Language Spanish | 35 Participants | 932 Participants | 897 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 565 Participants | 545 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 42 Participants | 42 Participants |
| Race (NIH/OMB) White | 98 Participants | 2433 Participants | 2335 Participants |
| Sex: Female, Male Female | 83 Participants | 2147 Participants | 2064 Participants |
| Sex: Female, Male Male | 36 Participants | 902 Participants | 866 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 140 |
| other Total, other adverse events | 9 / 140 |
| serious Total, serious adverse events | 1 / 140 |
Outcome results
Health Care Utilization - Laboratory Measurements
Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of number of lab measurements taken during the period (including A1C, creatinine, and lipids).
Time frame: 1 year study period
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Intervention Group | Health Care Utilization - Laboratory Measurements | A1C measurements | 1.19 Number of measurements |
| Intervention Group | Health Care Utilization - Laboratory Measurements | Creatinine measurements | 2.17 Number of measurements |
| Intervention Group | Health Care Utilization - Laboratory Measurements | Lipid measurements | 0.45 Number of measurements |
| Registry-Based Control Group | Health Care Utilization - Laboratory Measurements | A1C measurements | 1.19 Number of measurements |
| Registry-Based Control Group | Health Care Utilization - Laboratory Measurements | Creatinine measurements | 2.20 Number of measurements |
| Registry-Based Control Group | Health Care Utilization - Laboratory Measurements | Lipid measurements | 0.41 Number of measurements |
Health Care Utilization - Non-study Clinic Visits
Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of non-study clinic visits.
Time frame: 1 year study period
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Intervention Group | Health Care Utilization - Non-study Clinic Visits | 4.44 Number of visits |
| Registry-Based Control Group | Health Care Utilization - Non-study Clinic Visits | 4.32 Number of visits |
Percentage of Participants Who Achieved >5% Weight Loss at 12 Months
Participants who had both a baseline and 12 month weight measurement were included. Weight change at 12 months was measured as a percent difference from their starting weight.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Percentage of Participants Who Achieved >5% Weight Loss at 12 Months | 34.5 percentage of participants |
| Registry-Based Control Group | Percentage of Participants Who Achieved >5% Weight Loss at 12 Months | 15.7 percentage of participants |
Documentation of Obesity
To assess: 1. Presence of ICD-9 code for obesity in the DHHA registry Control Group 2. Evidence of a specific intervention for weight management resembling what was offered in the toolbox intervention: weight loss medication prescribed, gym membership, weight loss program or referral to wt loss specialist, and meal replacements
Time frame: 1 year study period
Population: Random sample of 120 patient medical records from the DHHA registry Control Group with recorded BMI \> or = to 30 plus one comorbidity
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Intervention Group | Documentation of Obesity | ICD-Code for Obesity in Chart | Present | 52 Participants |
| Intervention Group | Documentation of Obesity | ICD-Code for Obesity in Chart | Absent | 68 Participants |
| Intervention Group | Documentation of Obesity | Specific Intervention provided | Present | 14 Participants |
| Intervention Group | Documentation of Obesity | Specific Intervention provided | Absent | 106 Participants |