A Toolbox Approach to Obesity Treatment in Primary Care

• Sponsor: Denver Health and Hospital Authority (Other)
• Overall Status: Completed
• CT.gov ID: NCT01922934
• Collaborator: (none)
• Enrollment: 4,730
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 152.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Commercial weight loss program; Behavioral: Colorado Weigh; Dietary Supplement: Meal replacements; Drug: Obesity pharmacotherapy; Behavioral: Recreation center passes	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4730 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Toolbox Approach to Obesity Treatment in Primary Care
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 350 randomly-selected patients at 4 clinics get a "toolbox" of weight loss options, including self-monitoring tools; education materials; recreation center passes; commercial weight loss program (Weight Watchers); intensive group counseling (Colorado Weigh); meal replacements; and obesity pharmacotherapy. The initial assessment, a computer program, takes diet and exercise history and helps patients choose personal treatment goals. Interested patients get a starter kit with self-monitoring tools and meal replacements. Subjects must show self-monitoring of diet and exercise to get more intensive therapies. Patients pay a $5-$10 co-pay for the therapies. They select a primary intensive therapy, but are able to add/change depending on results, adherence and budget availability.	Behavioral: Commercial weight loss program; vouchers for Weight Watchers; Behavioral: Colorado Weigh; Group behavioral weight loss program; Dietary Supplement: Meal replacements; Health Management Resources meal replacement products (shakes and entrees); Drug: Obesity pharmacotherapy; Phentermine or phentermine-topiramate (Qsymia); Other Names: Phentermine or phentermine-topiramate (Qsymia) ; Behavioral: Recreation center passes; 1 year pass to a Denver recreation center
No Intervention: Control Registry patients not selected to be offered the toolbox will receive usual care for weight management. Usual care for obesity at DH includes brief weight loss advice provided by PCPs or prescribing of weight loss medication, for which patients pay out of pocket.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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 Outcome Measures

1. Documentation of Obesity [1 year study period]

   To assess: Presence of ICD-9 code for obesity in the DHHA registry Control Group 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Denver Health and Hospital Authority	Denver	Colorado	United States	80204

Sponsors and Collaborators

• Denver Health and Hospital Authority

Investigators

• Principal Investigator: Daniel H Bessesen, MD, Chief of Endocrinology at Denver Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Bessesen, Principal Investigator, Denver Health and Hospital Authority
• ClinicalTrials.gov Identifier: NCT01922934
• Other Study ID Numbers: GM3469
• First Posted: Aug 14, 2013
• Last Update Posted: Aug 18, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Obesity; Topiramate; Phentermine

Study Results

Participant Flow

Arm/Group Title	Intervention	Control
Arm/Group Description	428 randomly-selected patients from four Denver Health clinics are identified for the intervention arm which offers a "toolbox" of weight loss options. The "toolbox" includes: self-monitoring tools; education materials; recreation center passes; commercial weight loss program vouchers (Weight Watchers); intensive group counseling (Colorado Weigh); meal replacements (shakes & entrees); and obesity pharmacotherapy (Qsymia & phentermine). At the initial assessment (visit 0), a computer program helps patients choose a personal treatment mode and they receive a starter kit with self-monitoring tools and meal replacements. Subjects must show self-monitoring of diet and exercise to receive more intensive therapies at their next visit (visit 1). At subsequent monthly visits, patients select a primary intensive therapy, but are able to add/change tools throughout the one year study period. Patients pay a $5-$10 co-pay for the therapies.	4302 Registry patients not selected to be offered the "toolbox" options will receive usual care for weight management. Usual care for obesity at DH includes brief weight loss advice provided by PCPs or prescribing of weight loss medication, for which patients pay out of pocket.
Period Title: Eligible Patients
STARTED	428	4302
COMPLETED	375	4214
NOT COMPLETED	53	88
Period Title: Eligible Patients
STARTED	375	4214
COMPLETED	140	4214
NOT COMPLETED	235	0
Period Title: Eligible Patients
STARTED	140	4214
COMPLETED	119	2930
NOT COMPLETED	21	1284
Period Title: Eligible Patients
STARTED	119	2930
COMPLETED	113	2640
NOT COMPLETED	6	290

Baseline Characteristics

Arm/Group Title	Intervention Group	Registry-Based Control Group	Total
Arm/Group Description	Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.	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.	Total of all reporting groups
Overall Participants	119	2930	3049
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	103 86.6%	2475 84.5%	2578 84.6%
>=65 years	16 13.4%	455 15.5%	471 15.4%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	52	52	52
Sex: Female, Male (Count of Participants)
Female	83 69.7%	2064 70.4%	2147 70.4%
Male	36 30.3%	866 29.6%	902 29.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	65 54.6%	1859 63.4%	1924 63.1%
Not Hispanic or Latino	54 45.4%	1071 36.6%	1125 36.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.8%	0 0%	1 0%
Asian	0 0%	8 0.3%	8 0.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	20 16.8%	545 18.6%	565 18.5%
White	98 82.4%	2335 79.7%	2433 79.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	42 1.4%	42 1.4%
Baseline BMI (Count of Participants)
30-34.9	62 52.1%	1612 55%	1674 54.9%
35-39.9	32 26.9%	901 30.8%	933 30.6%
40-44.9	25 21%	417 14.2%	442 14.5%
Baseline BMI (continuous) (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	34.6	34.3	34.4
Primary Language (Count of Participants)
English	84 70.6%	2033 69.4%	2117 69.4%
Spanish	35 29.4%	897 30.6%	932 30.6%
Diabetes, hypertension, or hyperlipidemia (Count of Participants)
Had at least one	99 83.2%	2376 81.1%	2475 81.2%
Have none	20 16.8%	554 18.9%	574 18.8%
Diabetes (Count of Participants)
Yes	58 48.7%	1350 46.1%	1408 46.2%
No	61 51.3%	1580 53.9%	1641 53.8%
Hypertension (Count of Participants)
Yes	78 65.5%	2063 70.4%	2141 70.2%
No	41 34.5%	867 29.6%	908 29.8%
Hyperlipidemia (Count of Participants)
Yes	63 52.9%	1596 54.5%	1659 54.4%
No	56 47.1%	1334 45.5%	1390 45.6%
Coronary artery disease (Count of Participants)
Yes	21 17.6%	383 13.1%	404 13.3%
No	98 82.4%	2547 86.9%	2645 86.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved >5% Weight Loss at 12 Months
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Registry-Based Control Group
Arm/Group Description	Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool. Included in analysis if they had both baseline and 12 month weights available.	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. Included in analysis if they had both baseline and 12 month weights available.
Measure Participants	113	2640
Number [percentage of participants]	34.5 29%	15.7 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group, Registry-Based Control Group
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

2. Primary Outcome

Title	Health Care Utilization - Non-study Clinic Visits
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Registry-Based Control Group
Arm/Group Description	Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.	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.
Measure Participants	119	2930
Least Squares Mean (95% Confidence Interval) [Number of visits]	4.44	4.32

3. Secondary Outcome

Title	Documentation of Obesity
Description	To assess: Presence of ICD-9 code for obesity in the DHHA registry Control Group 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

Outcome Measure Data

Analysis Population Description

Random sample of 120 patient medical records from the DHHA registry Control Group with recorded BMI > or = to 30 plus one comorbidity

Arm/Group Title	Random Sample of DHHA Registry Control Group
Arm/Group Description	We selected a random sample of 120 patients from the DHHA registry Control Group for a chart review. The dates used matched the study intervention period. Six reviewers, 3 MDs and 3 study personnel, reviewed medical records for the following: Presence of ICD-9 code for obesity Evidence that the the PCP discussed weight loss with the patient Evidence of a specific intervention for weight management. Each record was evaluated by two reviewers, 1 MD and 1 study personnel .
Measure Participants	120
Present	52 43.7%
Absent	68 57.1%
Present	14 11.8%
Absent	106 89.1%

4. Primary Outcome

Title	Health Care Utilization - Laboratory Measurements
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Registry-Based Control Group
Arm/Group Description	Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.	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.
Measure Participants	119	2930
A1C measurements	1.19	1.19
Creatinine measurements	2.17	2.20
Lipid measurements	0.45	0.41

Adverse Events

Time Frame	Adverse events were collected from the time the first patient in the intervention arm received a tool at their study visit #1 (1/14/2015) through when the final study patient was seen for receiving a tool at their study visit #12 (8/12/2016). Thus, adverse events were collected over a period of 19 months. Adverse events were not collected on those in the control arm; those subjects participated passively by a waiver of consent and never had any interaction with the study team.
Adverse Event Reporting Description	The definitions used by clinicaltrials.gov for adverse event and serious adverse event apply. Adverse events were only collected and reported on the intervention arm only and not on the control arm, as those in the control participated passively by a waiver of consent and never had any interaction with the study team or knowledge of the study's existence. This waiver was approved by the IRB.
Arm/Group Title	Intervention
Arm/Group Description	428 randomly-selected patients from four Denver Health clinics were selected to be offered a "toolbox" of weight loss options, including: self-monitoring tools; education materials; recreation center passes; commercial weight loss program vouchers (Weight Watchers); intensive group counseling (Colorado Weigh); meal replacements (shakes & entrees); and obesity pharmacotherapy (Qsymia & phentermine) for a $5-$10 co-pay for the therapies. Of these 428 patients, 140 came in and consented at the computer program visit at which these options were offered. 119 of these patients came in for a visit one where they received their tool for the first time. Adverse events from the group of 140 patients who consented to receive the intervention are reported.
All Cause Mortality
	Intervention
	Affected / at Risk (%)	# Events
Total	1/140 (0.7%)
Serious Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	1/140 (0.7%)
General disorders
Death occurring after being lost to follow up for a year on meal replacement tool	1/140 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	9/140 (6.4%)
Eye disorders
Eye pain on Qsymia	1/140 (0.7%)	1
Gastrointestinal disorders
GERD causing chest pain on Qsymia	1/140 (0.7%)	1
General disorders
Fainting on Qsymia	1/140 (0.7%)	1
Unknown chest pain on Qsymia	1/140 (0.7%)	1
Alcohol withdrawal symptoms	2/140 (1.4%)	2
Psychiatric disorders
Depression on Qsymia	1/140 (0.7%)	1
Anxiety/Chest Pain on Qsymia	1/140 (0.7%)	1
Vascular disorders
CVA (stroke) on Weight Watchers	1/140 (0.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.