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A Toolbox Approach to Obesity Treatment in Primary Care

A Toolbox Approach to Obesity Treatment in Primary Care

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01922934
Acronym
Toolbox
Enrollment
4730
Registered
2013-08-14
Start date
2014-01-31
Completion date
2016-08-31
Last updated
2017-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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

BEHAVIORALColorado Weigh

Group behavioral weight loss program

DIETARY_SUPPLEMENTMeal replacements

Health Management Resources meal replacement products (shakes and entrees)

Phentermine or phentermine-topiramate (Qsymia)

BEHAVIORALRecreation center passes

1 year pass to a Denver recreation center

Sponsors

Denver Health and Hospital Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Percentage of Participants Who Achieved >5% Weight Loss at 12 Months1 yearParticipants 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 Visits1 year study periodEvaluation 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 Measurements1 year study periodEvaluation 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

MeasureTime frameDescription
Documentation of Obesity1 year study periodTo 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

ArmCount
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
Total3,049

Withdrawals & dropouts

PeriodReasonFG000FG001
Eligible PatientsDeath07
Eligible PatientsDid not meet inclusion criteria3681
Eligible PatientsPhysician Decision170
Visit 0 - Patient Contacted & ConsentedNo response or could not reach660
Visit 0 - Patient Contacted & ConsentedPatient declined to participate1690
Visit 1- Weight MeasuredDid not have weight recorded (visit 1)211,284

Baseline characteristics

CharacteristicIntervention GroupTotalRegistry-Based Control Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
16 Participants471 Participants455 Participants
Age, Categorical
Between 18 and 65 years
103 Participants2578 Participants2475 Participants
Age, Continuous52 years52 years52 years
Baseline BMI
30-34.9
62 Participants1674 Participants1612 Participants
Baseline BMI
35-39.9
32 Participants933 Participants901 Participants
Baseline BMI
40-44.9
25 Participants442 Participants417 Participants
Baseline BMI (continuous)34.6 kg/m^234.4 kg/m^234.3 kg/m^2
Coronary artery disease
No
98 Participants2645 Participants2547 Participants
Coronary artery disease
Yes
21 Participants404 Participants383 Participants
Diabetes
No
61 Participants1641 Participants1580 Participants
Diabetes
Yes
58 Participants1408 Participants1350 Participants
Diabetes, hypertension, or hyperlipidemia
Had at least one
99 Participants2475 Participants2376 Participants
Diabetes, hypertension, or hyperlipidemia
Have none
20 Participants574 Participants554 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
65 Participants1924 Participants1859 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
54 Participants1125 Participants1071 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Hyperlipidemia
No
56 Participants1390 Participants1334 Participants
Hyperlipidemia
Yes
63 Participants1659 Participants1596 Participants
Hypertension
No
41 Participants908 Participants867 Participants
Hypertension
Yes
78 Participants2141 Participants2063 Participants
Primary Language
English
84 Participants2117 Participants2033 Participants
Primary Language
Spanish
35 Participants932 Participants897 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants8 Participants8 Participants
Race (NIH/OMB)
Black or African American
20 Participants565 Participants545 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants42 Participants42 Participants
Race (NIH/OMB)
White
98 Participants2433 Participants2335 Participants
Sex: Female, Male
Female
83 Participants2147 Participants2064 Participants
Sex: Female, Male
Male
36 Participants902 Participants866 Participants

Adverse events

Event typeEG000
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

Primary

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

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Intervention GroupHealth Care Utilization - Laboratory MeasurementsA1C measurements1.19 Number of measurements
Intervention GroupHealth Care Utilization - Laboratory MeasurementsCreatinine measurements2.17 Number of measurements
Intervention GroupHealth Care Utilization - Laboratory MeasurementsLipid measurements0.45 Number of measurements
Registry-Based Control GroupHealth Care Utilization - Laboratory MeasurementsA1C measurements1.19 Number of measurements
Registry-Based Control GroupHealth Care Utilization - Laboratory MeasurementsCreatinine measurements2.20 Number of measurements
Registry-Based Control GroupHealth Care Utilization - Laboratory MeasurementsLipid measurements0.41 Number of measurements
Primary

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

ArmMeasureValue (LEAST_SQUARES_MEAN)
Intervention GroupHealth Care Utilization - Non-study Clinic Visits4.44 Number of visits
Registry-Based Control GroupHealth Care Utilization - Non-study Clinic Visits4.32 Number of visits
Primary

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

ArmMeasureValue (NUMBER)
Intervention GroupPercentage of Participants Who Achieved >5% Weight Loss at 12 Months34.5 percentage of participants
Registry-Based Control GroupPercentage of Participants Who Achieved >5% Weight Loss at 12 Months15.7 percentage of participants
p-value: <0.001Chi-squared
Secondary

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

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Intervention GroupDocumentation of ObesityICD-Code for Obesity in ChartPresent52 Participants
Intervention GroupDocumentation of ObesityICD-Code for Obesity in ChartAbsent68 Participants
Intervention GroupDocumentation of ObesitySpecific Intervention providedPresent14 Participants
Intervention GroupDocumentation of ObesitySpecific Intervention providedAbsent106 Participants

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026