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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01922934
First Posted: August 14, 2013
Last Update Posted: August 18, 2017
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.
Information provided by (Responsible Party):
Daniel Bessesen, Denver Health and Hospital Authority
Results First Submitted: February 1, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intervention 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.
Control 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.

Participant Flow for 4 periods

Period 1:   Eligible Patients
    Intervention   Control
STARTED   428   4302 
COMPLETED   375 [1]   4214 [2] 
NOT COMPLETED   53   88 
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 2:   Visit 0 - Patient Contacted & Consented
    Intervention   Control
STARTED   375   4214 [1] 
COMPLETED   140 [2]   4214 
NOT COMPLETED   235   0 
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 3:   Visit 1- Weight Measured
    Intervention   Control
STARTED   140 [1]   4214 
COMPLETED   119 [2]   2930 [3] 
NOT COMPLETED   21   1284 
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 4:   Visit 12 / Final Visits
    Intervention   Control
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Group Subjects who were offered the toolbox of weight loss interventions and paid at least one co-pay to start using a tool.
Registry-Based Control Group 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 Total of all reporting groups

Baseline Measures
   Intervention Group   Registry-Based Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 119   2930   3049 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Median (Inter-Quartile Range)
 52 
 (42 to 60) 
 52 
 (42 to 61) 
 52 
 (42 to 61) 
Sex: Female, Male 
[Units: Participants]
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) 
[Units: Participants]
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%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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) 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
 34.6 
 (32.4 to 39.4) 
 34.3 
 (31.9 to 37.7) 
 34.4 
 (31.9 to 37.8) 
Primary Language 
[Units: Participants]
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 
[Units: Participants]
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 
[Units: Participants]
Count of Participants
     
Yes      58  48.7%      1350  46.1%      1408  46.2% 
No      61  51.3%      1580  53.9%      1641  53.8% 
Hypertension 
[Units: Participants]
Count of Participants
     
Yes      78  65.5%      2063  70.4%      2141  70.2% 
No      41  34.5%      867  29.6%      908  29.8% 
Hyperlipidemia 
[Units: Participants]
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 
[Units: Participants]
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
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Achieved >5% Weight Loss at 12 Months   [ Time Frame: 1 year ]

2.  Primary:   Health Care Utilization - Non-study Clinic Visits   [ Time Frame: 1 year study period ]

3.  Primary:   Health Care Utilization - Laboratory Measurements   [ Time Frame: 1 year study period ]

4.  Secondary:   Documentation of Obesity   [ Time Frame: 1 year study period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Daniel H. Bessesen
Organization: Denver Health
phone: 303-602-5021
e-mail: daniel.bessesen@ucdenver.edu



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