Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Toolbox Approach to Obesity Treatment in Primary Care (Toolbox)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01922934
Recruitment Status : Completed
First Posted : August 14, 2013
Results First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel Bessesen, Denver Health and Hospital Authority

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity
Interventions Behavioral: Commercial weight loss program
Behavioral: Colorado Weigh
Dietary Supplement: Meal replacements
Drug: Obesity pharmacotherapy
Behavioral: Recreation center passes
Enrollment 4730
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide 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 [1] 4214 [2]
Not Completed 53 88
Reason Not Completed
Death             0             7
Physician Decision             17             0
Did not meet inclusion criteria             36             81
[1]
375 patients determined eligible after original random selection from DHHA data warehouse.
[2]
81 patients did not meet inclusion criteria as they were 80 years or older. 7 patients had died.
Period Title: Visit 0 - Patient Contacted & Consented
Started 375 4214 [1]
Completed 140 [2] 4214
Not Completed 235 0
Reason Not Completed
Patient declined to participate             169             0
No response or could not reach             66             0
[1]
Control group patients were not contacted or offered intervention
[2]
reflects number of patients that were contacted and agreed to attend Visit 0
Period Title: Visit 1- Weight Measured
Started 140 [1] 4214
Completed 119 [2] 2930 [3]
Not Completed 21 1284
Reason Not Completed
Did not have weight recorded (visit 1)             21             1284
[1]
21 patients did not return for Visit 1 to receive tool or have weight measured.
[2]
Patients first received tool and were weighed at Visit 1
[3]
1284 patients did not have any weights recorded in EMR during study timeframe
Period Title: Visit 12 / Final Visits
Started 119 2930
Completed 113 [1] 2640 [2]
Not Completed 6 290
[1]
6 patients did not return for final visit and weight measure
[2]
290 patients did not have a second weight recorded at one year (+/- 6months) of first weight
Arm/Group Title Intervention Group Registry-Based Control Group Total
Hide 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 Number of Baseline Participants 119 2930 3049
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 participants
<=18 years
0
   0.0%
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, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 119 participants 2930 participants 3049 participants
52
(42 to 60)
52
(42 to 61)
52
(42 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 participants
Female
83
  69.7%
2064
  70.4%
2147
  70.4%
Male
36
  30.3%
866
  29.6%
902
  29.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 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%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 participants
American Indian or Alaska Native
1
   0.8%
0
   0.0%
1
   0.0%
Asian
0
   0.0%
8
   0.3%
8
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
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%
0
   0.0%
Unknown or Not Reported
0
   0.0%
42
   1.4%
42
   1.4%
Baseline BMI  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 participants
30-34.9
62
  52.1%
1612
  55.0%
1674
  54.9%
35-39.9
32
  26.9%
901
  30.8%
933
  30.6%
40-44.9
25
  21.0%
417
  14.2%
442
  14.5%
Baseline BMI (continuous)  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 119 participants 2930 participants 3049 participants
34.6
(32.4 to 39.4)
34.3
(31.9 to 37.7)
34.4
(31.9 to 37.8)
Primary Language  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 participants
Yes
58
  48.7%
1350
  46.1%
1408
  46.2%
No
61
  51.3%
1580
  53.9%
1641
  53.8%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 participants
Yes
78
  65.5%
2063
  70.4%
2141
  70.2%
No
41
  34.5%
867
  29.6%
908
  29.8%
Hyperlipidemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 participants
Yes
63
  52.9%
1596
  54.5%
1659
  54.4%
No
56
  47.1%
1334
  45.5%
1390
  45.6%
Coronary artery disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 2930 participants 3049 participants
Yes
21
  17.6%
383
  13.1%
404
  13.3%
No
98
  82.4%
2547
  86.9%
2645
  86.7%
1.Primary Outcome
Title Percentage of Participants Who Achieved >5% Weight Loss at 12 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Registry-Based Control Group
Hide 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.
Overall Number of Participants Analyzed 113 2640
Measure Type: Number
Unit of Measure: percentage of participants
34.5 15.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Registry-Based Control Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Health Care Utilization - Non-study Clinic Visits
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Registry-Based Control Group
Hide 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.
Overall Number of Participants Analyzed 119 2930
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Number of visits
4.44
(3.89 to 5.06)
4.32
(4.20 to 4.43)
3.Primary Outcome
Title Health Care Utilization - Laboratory Measurements
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Registry-Based Control Group
Hide 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.
Overall Number of Participants Analyzed 119 2930
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Number of measurements
A1C measurements
1.19
(1.01 to 1.41)
1.19
(1.15 to 1.23)
Creatinine measurements
2.17
(1.71 to 2.74)
2.20
(2.10 to 2.31)
Lipid measurements
0.45
(0.34 to 0.58)
0.41
(0.39 to 0.43)
4.Secondary Outcome
Title Documentation of Obesity
Hide Description

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
Hide Outcome Measure Data
Hide 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
Hide 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:

  1. Presence of ICD-9 code for obesity
  2. Evidence that the the PCP discussed weight loss with the patient
  3. Evidence of a specific intervention for weight management. Each record was evaluated by two reviewers, 1 MD and 1 study personnel .
Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
ICD-Code for Obesity in Chart Present
52
  43.3%
Absent
68
  56.7%
Specific Intervention provided Present
14
  11.7%
Absent
106
  88.3%
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
Hide 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 (%)
Total   1/140 (0.71%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intervention
Affected / at Risk (%) # Events
Total   1/140 (0.71%)    
General disorders   
Death occurring after being lost to follow up for a year on meal replacement tool * [1]  1/140 (0.71%)  1
*
Indicates events were collected by non-systematic assessment
[1]
After being lost-to-follow-up for 1 year after 1 visit where meal replacements were dispensed, study staff learned tyring to follow up for final feedback visit that patient had passed away. The PI, IRB, and Sponsor determined his death was unrelated
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention
Affected / at Risk (%) # Events
Total   9/140 (6.43%)    
Eye disorders   
Eye pain on Qsymia * [1]  1/140 (0.71%)  1
Gastrointestinal disorders   
GERD causing chest pain on Qsymia * [2]  1/140 (0.71%)  1
General disorders   
Fainting on Qsymia * [3]  1/140 (0.71%)  1
Unknown chest pain on Qsymia * [4]  1/140 (0.71%)  1
Alcohol withdrawal symptoms * [5]  2/140 (1.43%)  2
Psychiatric disorders   
Depression on Qsymia * [6]  1/140 (0.71%)  1
Anxiety/Chest Pain on Qsymia * [7]  1/140 (0.71%)  1
Vascular disorders   
CVA (stroke) on Weight Watchers * [8]  1/140 (0.71%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Eye pain on Qsymia; (medication tool used in routine clinical care); classified as other adverse event, not SAE
[2]
GERD causing chest pain on Qsymia;( medication tool used in routine clinical care); classified as other adverse event, not SAE
[3]
Fainting on Qsymia (study medication tool used in routine clinical care); classified as other adverse event, not SAE
[4]
Unknown chest pain on Qsymia; (medication tool used in routine clinical care); classified as other adverse event, not SAE
[5]
Alcohol withdrawal symptoms; unrelated to study tool or procedures; classified as other adverse event, not SAE
[6]
Depression on Qsymia (medication tool in the study used in routine clinical care); classified as other adverse event, not SAE
[7]
Anxiety/Chest Pain on Qsymia; (medication tool used in routine clinical care); classified as other adverse event, not SAE
[8]
CVA (stroke) on Weight Watchers; one of the study tools available that would be determined as unrelated to stroke; classified as other adverse event, not SAE
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel H. Bessesen
Organization: Denver Health
Phone: 303-602-5021
EMail: daniel.bessesen@ucdenver.edu
Layout table for additonal information
Responsible Party: Daniel Bessesen, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01922934     History of Changes
Other Study ID Numbers: GM3469
First Submitted: August 12, 2013
First Posted: August 14, 2013
Results First Submitted: February 1, 2017
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017