A Toolbox Approach to Obesity Treatment in Primary Care

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daniel Bessesen, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01922934
First received: August 12, 2013
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Obesity
Behavioral: Commercial weight loss program
Behavioral: Colorado Weigh
Dietary Supplement: Meal replacements
Drug: Obesity pharmacotherapy
Behavioral: Recreation center passes
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Toolbox Approach to Obesity Treatment in Primary Care

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Weight change [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Weight loss as a percentage of starting weight


Secondary Outcome Measures:
  • Health care utilization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Changes in utilization of utilization of health care resources (prescription drugs, labs, outpatient visits, procedures, urgent care visits, ER visits and hospitalizations)

  • Documentation of obesity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Fraction of patients with an International Classification of Diseases (or ICD-9 code) for obesity; evidence that the PCP discussed weight loss with the patient; evidence of a specific intervention for weight management (e.g., Weight Watchers, medication).


Other Outcome Measures:
  • Cardiovascular risk factors [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Changes in blood pressure, glycemic control, and lipids


Estimated Enrollment: 350
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922934

Locations
United States, Colorado
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
  More Information

No publications provided

Responsible Party: Daniel Bessesen, Principal Investigator, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01922934     History of Changes
Other Study ID Numbers: GM3469
Study First Received: August 12, 2013
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Phentermine
Topiramate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 19, 2014