Trial Outcomes & Findings for A Toolbox Approach to Obesity Treatment in Primary Care (NCT NCT01922934)

NCT ID: NCT01922934

Last Updated: 2017-08-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

4730 participants

Primary outcome timeframe

1 year

Results posted on

2017-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Eligible Patients STARTED	428	4302
Eligible Patients COMPLETED	375	4214
Eligible Patients NOT COMPLETED	53	88
Visit 0 - Patient Contacted & Consented STARTED	375	4214
Visit 0 - Patient Contacted & Consented COMPLETED	140	4214
Visit 0 - Patient Contacted & Consented NOT COMPLETED	235	0
Visit 1- Weight Measured STARTED	140	4214
Visit 1- Weight Measured COMPLETED	119	2930
Visit 1- Weight Measured NOT COMPLETED	21	1284
Visit 12 / Final Visits STARTED	119	2930
Visit 12 / Final Visits COMPLETED	113	2640
Visit 12 / Final Visits NOT COMPLETED	6	290

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Eligible Patients Death	0	7
Eligible Patients Physician Decision	17	0
Eligible Patients Did not meet inclusion criteria	36	81
Visit 0 - Patient Contacted & Consented Patient declined to participate	169	0
Visit 0 - Patient Contacted & Consented No response or could not reach	66	0
Visit 1- Weight Measured Did not have weight recorded (visit 1)	21	1284

Baseline Characteristics

A Toolbox Approach to Obesity Treatment in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=119 Participants 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 n=2930 Participants 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 n=3049 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	103 Participants n=5 Participants	2475 Participants n=7 Participants	2578 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	455 Participants n=7 Participants	471 Participants n=5 Participants
Age, Continuous	52 years n=5 Participants	52 years n=7 Participants	52 years n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants	2064 Participants n=7 Participants	2147 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	866 Participants n=7 Participants	902 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	65 Participants n=5 Participants	1859 Participants n=7 Participants	1924 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	1071 Participants n=7 Participants	1125 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	545 Participants n=7 Participants	565 Participants n=5 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	2335 Participants n=7 Participants	2433 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	42 Participants n=7 Participants	42 Participants n=5 Participants
Baseline BMI 30-34.9	62 Participants n=5 Participants	1612 Participants n=7 Participants	1674 Participants n=5 Participants
Baseline BMI 35-39.9	32 Participants n=5 Participants	901 Participants n=7 Participants	933 Participants n=5 Participants
Baseline BMI 40-44.9	25 Participants n=5 Participants	417 Participants n=7 Participants	442 Participants n=5 Participants
Baseline BMI (continuous)	34.6 kg/m^2 n=5 Participants	34.3 kg/m^2 n=7 Participants	34.4 kg/m^2 n=5 Participants
Primary Language English	84 Participants n=5 Participants	2033 Participants n=7 Participants	2117 Participants n=5 Participants
Primary Language Spanish	35 Participants n=5 Participants	897 Participants n=7 Participants	932 Participants n=5 Participants
Diabetes, hypertension, or hyperlipidemia Had at least one	99 Participants n=5 Participants	2376 Participants n=7 Participants	2475 Participants n=5 Participants
Diabetes, hypertension, or hyperlipidemia Have none	20 Participants n=5 Participants	554 Participants n=7 Participants	574 Participants n=5 Participants
Diabetes Yes	58 Participants n=5 Participants	1350 Participants n=7 Participants	1408 Participants n=5 Participants
Diabetes No	61 Participants n=5 Participants	1580 Participants n=7 Participants	1641 Participants n=5 Participants
Hypertension Yes	78 Participants n=5 Participants	2063 Participants n=7 Participants	2141 Participants n=5 Participants
Hypertension No	41 Participants n=5 Participants	867 Participants n=7 Participants	908 Participants n=5 Participants
Hyperlipidemia Yes	63 Participants n=5 Participants	1596 Participants n=7 Participants	1659 Participants n=5 Participants
Hyperlipidemia No	56 Participants n=5 Participants	1334 Participants n=7 Participants	1390 Participants n=5 Participants
Coronary artery disease Yes	21 Participants n=5 Participants	383 Participants n=7 Participants	404 Participants n=5 Participants
Coronary artery disease No	98 Participants n=5 Participants	2547 Participants n=7 Participants	2645 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=113 Participants 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.	Registry-Based Control Group n=2640 Participants 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.
Percentage of Participants Who Achieved >5% Weight Loss at 12 Months	34.5 percentage of participants	15.7 percentage of participants

PRIMARY outcome

Timeframe: 1 year study period

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.

Outcome measures

Outcome measures
Measure	Intervention Group n=119 Participants 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.	Registry-Based Control Group n=2930 Participants 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.
Health Care Utilization - Non-study Clinic Visits	4.44 Number of visits Interval 3.89 to 5.06	4.32 Number of visits Interval 4.2 to 4.43

PRIMARY outcome

Timeframe: 1 year study period

Outcome measures

Outcome measures
Measure	Intervention Group n=119 Participants 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.	Registry-Based Control Group n=2930 Participants 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.
Health Care Utilization - Laboratory Measurements A1C measurements	1.19 Number of measurements Interval 1.01 to 1.41	1.19 Number of measurements Interval 1.15 to 1.23
Health Care Utilization - Laboratory Measurements Creatinine measurements	2.17 Number of measurements Interval 1.71 to 2.74	2.20 Number of measurements Interval 2.1 to 2.31
Health Care Utilization - Laboratory Measurements Lipid measurements	0.45 Number of measurements Interval 0.34 to 0.58	0.41 Number of measurements Interval 0.39 to 0.43

SECONDARY outcome

Timeframe: 1 year study period

Population: Random sample of 120 patient medical records from the DHHA registry Control Group with recorded BMI \> or = to 30 plus one comorbidity

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

Outcome measures

Outcome measures
Measure	Intervention Group n=120 Participants 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.	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. Included in analysis if they had both baseline and 12 month weights available.
Documentation of Obesity ICD-Code for Obesity in Chart · Present	52 Participants	—
Documentation of Obesity ICD-Code for Obesity in Chart · Absent	68 Participants	—
Documentation of Obesity Specific Intervention provided · Present	14 Participants	—
Documentation of Obesity Specific Intervention provided · Absent	106 Participants	—

Adverse Events

Intervention

Serious events: 1 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=140 participants at risk 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.
General disorders Death occurring after being lost to follow up for a year on meal replacement tool	0.71% 1/140 • Number of events 1 • 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. 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.

Other adverse events

Other adverse events
Measure	Intervention n=140 participants at risk 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.
General disorders Fainting on Qsymia	0.71% 1/140 • Number of events 1 • 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. 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.
Psychiatric disorders Depression on Qsymia	0.71% 1/140 • Number of events 1 • 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. 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.
Psychiatric disorders Anxiety/Chest Pain on Qsymia	0.71% 1/140 • Number of events 1 • 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. 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.
Gastrointestinal disorders GERD causing chest pain on Qsymia	0.71% 1/140 • Number of events 1 • 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. 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.
General disorders Unknown chest pain on Qsymia	0.71% 1/140 • Number of events 1 • 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. 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.
Eye disorders Eye pain on Qsymia	0.71% 1/140 • Number of events 1 • 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. 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.
Vascular disorders CVA (stroke) on Weight Watchers	0.71% 1/140 • Number of events 1 • 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. 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.
General disorders Alcohol withdrawal symptoms	1.4% 2/140 • Number of events 2 • 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. 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.

Additional Information

Dr. Daniel H. Bessesen

Denver Health

Phone: 303-602-5021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60