A Toolbox Approach to Obesity Treatment in Primary Care
Toolbox
1 other identifier
interventional
4,730
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 obesity
Started Jan 2014
Typical duration for phase_4 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2013
CompletedFirst Posted
Study publicly available on registry
August 14, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
August 18, 2017
CompletedAugust 18, 2017
February 1, 2017
2.6 years
August 12, 2013
February 1, 2017
July 20, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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.
1 year
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.
1 year study period
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).
1 year study period
Secondary Outcomes (1)
Documentation of Obesity
1 year study period
Study Arms (2)
Intervention
EXPERIMENTAL350 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.
Control
NO INTERVENTIONRegistry 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.
Interventions
Health Management Resources meal replacement products (shakes and entrees)
Phentermine or phentermine-topiramate (Qsymia)
Eligibility Criteria
You may qualify if:
- BMI \> 30 kg/m2 and \< 45 kg/m2
- 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
- Visited their primary care provider (PCP) at least twice during the past 12 months, including once in the last 6 months
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
Related Publications (2)
Saxon DR, Chaussee EL, Juarez-Colunga E, Tsai AG, Iwamoto SJ, Speer RB, Heyn H, Kealey EH, Bessesen DH. A Toolbox Approach to Obesity Treatment in Urban Safety-Net Primary Care Clinics: a Pragmatic Clinical Trial. J Gen Intern Med. 2019 Nov;34(11):2405-2413. doi: 10.1007/s11606-019-05222-0. Epub 2019 Aug 26.
PMID: 31485965DERIVEDIwamoto S, Saxon D, Tsai A, Leister E, Speer R, Heyn H, Kealey E, Juarez-Colunga E, Gudzune K, Bleich S, Clark J, Bessesen D. Effects of Education and Experience on Primary Care Providers' Perspectives of Obesity Treatments during a Pragmatic Trial. Obesity (Silver Spring). 2018 Oct;26(10):1532-1538. doi: 10.1002/oby.22223. Epub 2018 Sep 26.
PMID: 30257072DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Daniel H. Bessesen
- Organization
- Denver Health
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel H Bessesen, MD
Chief of Endocrinology at Denver Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 12, 2013
First Posted
August 14, 2013
Study Start
January 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 18, 2017
Results First Posted
August 18, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share