Trial record 9 of 37 for:    Open Studies | "Weight Reduction Programs"

A Toolbox Approach to Obesity Treatment in Primary Care

This study is not yet open for participant recruitment.
Verified August 2013 by Denver Health and Hospital Authority
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 13, 2013
Last verified: August 2013
  Purpose

Background: Obesity is common and it causes many medical problems in adults such as diabetes, high blood pressure, high cholesterol, sleep apnea, heart attack, and stroke. A range of treatments have been shown to be effective to treat obesity. These treatments include intensive lifestyle modification, meal replacements, and weight loss medication. However, most primary care settings do not provide very much obesity treatment. This is because primary care providers (PCPs) are not well trained and because reimbursement for the treatments is not consistent.

Hypothesis: If PCPs have training in weight management and if most of the cost of treatment is reimbursed, we believe that a "toolbox" of treatments can produce a clinically important amount of weight loss in a large group of patients.

Design: We are proposing to establish a registry of patients who have obesity and at least one common medical condition related to their weight. From the registry, we will randomly select 350 people who will be offered treatments to assist with weight loss. The remainder of the patients in the registry can still receive treatment for obesity but will not have reimbursement for the treatments. We will conduct the study at Denver Health, which is 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 take a computer assessment to select the right treatment for weight loss. Patients who complete this and who record their food intake and physical activity for 1 week will be offered a "Level 2" treatment to help with weight loss. The Level 2 treatments will include: a voucher for a commercial weight loss program; an intensive group behavioral weight loss program; meal replacements; fitness center membership; or weight loss medication. Patients will be able to choose which treatment they want, with the approval of their PCP. A Patient Navigator at Denver Health will help with the computer assessment and with accessing the treatments. Each patient who completes the self-monitoring will be offered the Level 2 treatment for one year. We are interested to see what percentage of patients lose at least 5% of their starting weight. We will also look at changes in blood sugar, blood pressure, and cholesterol, and we will look at how much it costs to do this intervention 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 With Co-morbid Conditions
Behavioral: Commercial weight loss program
Behavioral: Colorado Weigh
Dietary Supplement: Meal replacements
Drug: Pharmacotherapy for obesity
Behavioral: Recrecation 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 a 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: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
350 patients at one of 4 intervention clinics will be randomly selected to be offered a "toolbox" of weight management interventions. The toolbox will include: self-monitoring tools; educational materials; physical activity resources; a commercial weight loss program; an intensive group behavior modification program; a meal replacement approach; and weight loss medication. The initial assessment will use a computer program to take a diet and physical activity history and help patients choose personal treatment goals. Interested patients will be given a "starter kit" including self-monitoring tools and samples of meal replacement products. Subjects will be required to demonstrate self-monitoring of diet and physical activity to be eligible for the more intensive therapies. Patients will pay a 25% "co-pay" for the higher cost therapies. Patients will select a primary intensive therapy, but will be able to add or 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
Slim-Fast
Drug: Pharmacotherapy for obesity
Phentermine or phentermine-topiramate (Qsymia)
Behavioral: Recrecation 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01922934

Locations
United States, Colorado
Denver Health and Hospital Authority Not yet recruiting
Denver, Colorado, United States, 80204
Principal Investigator: Daniel H Bessesen, MD         
Sub-Investigator: Adam G Tsai, MD, MSCE         
Sponsors and Collaborators
Denver Health and Hospital Authority
  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 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014