Trial Outcomes & Findings for Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH (NCT NCT02424188)

NCT ID: NCT02424188

Last Updated: 2025-06-25

Results Overview

7-day point prevalence, biochemically validated

Recruitment status

COMPLETED

Study phase

Target enrollment

192 participants

Primary outcome timeframe

measured at 18 months

Results posted on

2025-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	TRIUMPH Intervention Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual referral to quit line
Overall Study STARTED	97	95
Overall Study COMPLETED	93	90
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	TRIUMPH Intervention Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual referral to quit line
Overall Study Death	2	2
Overall Study Lost to Follow-up	1	3
Overall Study Incarceration	1	0

Baseline Characteristics

Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TRIUMPH Intervention n=97 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=95 Participants referral to quit line	Total n=192 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=99 Participants	86 Participants n=107 Participants	175 Participants n=206 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants	9 Participants n=107 Participants	17 Participants n=206 Participants
Age, Continuous	48 years STANDARD_DEVIATION 12.1 • n=99 Participants	51.3 years STANDARD_DEVIATION 11 • n=107 Participants	49.6 years STANDARD_DEVIATION 11.7 • n=206 Participants
Sex: Female, Male Female	45 Participants n=99 Participants	52 Participants n=107 Participants	97 Participants n=206 Participants
Sex: Female, Male Male	52 Participants n=99 Participants	43 Participants n=107 Participants	95 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=99 Participants	92 Participants n=107 Participants	185 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	47 Participants n=99 Participants	46 Participants n=107 Participants	93 Participants n=206 Participants
Race (NIH/OMB) White	45 Participants n=99 Participants	45 Participants n=107 Participants	90 Participants n=206 Participants
Race (NIH/OMB) More than one race	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment United States	97 Participants n=99 Participants	95 Participants n=107 Participants	192 Participants n=206 Participants
Primary Psychiatric Diagnosis Schizophrenia	12 Participants n=99 Participants	15 Participants n=107 Participants	27 Participants n=206 Participants
Primary Psychiatric Diagnosis Schizoaffective disorder	30 Participants n=99 Participants	25 Participants n=107 Participants	55 Participants n=206 Participants
Primary Psychiatric Diagnosis Bipolar disorder	29 Participants n=99 Participants	33 Participants n=107 Participants	62 Participants n=206 Participants
Primary Psychiatric Diagnosis Major depressive disorder	26 Participants n=99 Participants	22 Participants n=107 Participants	48 Participants n=206 Participants
Smoking, Willingness to quit Quit in 2 months	61 Participants n=99 Participants	58 Participants n=107 Participants	119 Participants n=206 Participants
Smoking, Willingness to quit Quit in 6 months	36 Participants n=99 Participants	37 Participants n=107 Participants	73 Participants n=206 Participants
Fagerstrom Test for Nicotine Dependence	4.5 scores on a scale STANDARD_DEVIATION 2 • n=99 Participants	4.6 scores on a scale STANDARD_DEVIATION 2 • n=107 Participants	4.5 scores on a scale STANDARD_DEVIATION 2 • n=206 Participants

PRIMARY outcome

Timeframe: measured at 18 months

7-day point prevalence, biochemically validated

Outcome measures

Outcome measures
Measure	TRIUMPH Intervention n=97 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=95 Participants referral to quit line
Number of Participants With Smoking Abstinence	27 Participants	6 Participants

SECONDARY outcome

Timeframe: from 15 to 18 months

Participants with 3 month smoking abstinence

Outcome measures

Outcome measures
Measure	TRIUMPH Intervention n=97 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=95 Participants referral to quit line
Smoking Abstinence - 3 Months	14 Participants	4 Participants

SECONDARY outcome

Timeframe: measured at 6 and 12 months

7-day point prevalence, biochemically validated

Outcome measures

Outcome measures
Measure	TRIUMPH Intervention n=97 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=95 Participants referral to quit line
Smoking Abstinence 6 month · abstinent	13 Participants	3 Participants
Smoking Abstinence 6 month · not abstinent	84 Participants	92 Participants
Smoking Abstinence 12 month · abstinent	18 Participants	2 Participants
Smoking Abstinence 12 month · not abstinent	79 Participants	93 Participants

SECONDARY outcome

Timeframe: measured from 6 months to 18 months

participants who reported smoking abstinence continuously from 6 months 18 months

Outcome measures

Outcome measures
Measure	TRIUMPH Intervention n=97 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=95 Participants referral to quit line
12 Months Continuous Smoking Abstinence Abstinent	6 Participants	0 Participants
12 Months Continuous Smoking Abstinence Not abstinent	91 Participants	95 Participants

SECONDARY outcome

Timeframe: Baseline, 6 and 18 months

weight in kilograms

Outcome measures

Outcome measures
Measure	TRIUMPH Intervention n=97 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=95 Participants referral to quit line
Weight Baseline	92.1 kilograms Interval 87.6 to 96.0	89.8 kilograms Interval 85.3 to 94.3
Weight 6 month	92.2 kilograms Interval 87.6 to 96.0	89.6 kilograms Interval 84.9 to 94.4
Weight 18 month	92.2 kilograms Interval 87.4 to 97.0	88.4 kilograms Interval 83.4 to 93.3

SECONDARY outcome

Timeframe: Baseline, 18 months

Outcome measures

Outcome measures
Measure	TRIUMPH Intervention n=97 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=95 Participants referral to quit line
Body Mass Index Baseline	32.1 kg/m^2 Standard Deviation 8.2	32 kg/m^2 Standard Deviation 7
Body Mass Index 18 months	32.3 kg/m^2 Standard Deviation 8.9	31.3 kg/m^2 Standard Deviation 7.3

SECONDARY outcome

Timeframe: 18 months

Population: A substantial proportion of the follow-up visits were off-site where the standardized six-minute walk course could not be used.

Outcome measures

Outcome measures
Measure	TRIUMPH Intervention n=87 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=82 Participants referral to quit line
Six Minute Walk Baseline	1000.7 feet Standard Deviation 403.1	943.8 feet Standard Deviation 321.5
Six Minute Walk 18 month	953.6 feet Standard Deviation 208.2	942.4 feet Standard Deviation 384.1

SECONDARY outcome

Timeframe: 18 months

The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke

Outcome measures

Outcome measures
Measure	TRIUMPH Intervention n=97 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=95 Participants referral to quit line
Framingham Stroke Risk Profile Score Baseline	9.5 score on a scale Standard Deviation 2.6	11.1 score on a scale Standard Deviation 2.9
Framingham Stroke Risk Profile Score 18 months	9.3 score on a scale Standard Deviation 2.7	11.6 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 6 and 18 months

Population: No modeled

SF-12 Mental Health Index and Physical Composite (scores range from 0-100), the higher the score means a better outcome

Outcome measures

Outcome measures
Measure	TRIUMPH Intervention n=97 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=95 Participants referral to quit line
Health Status as Assessed by the Short Form -12 (SF-12) Index physical score-baseline	45.0 score on a scale Standard Deviation 10.6	43.2 score on a scale Standard Deviation 10.3
Health Status as Assessed by the Short Form -12 (SF-12) Index physical score-6 month	45.5 score on a scale Standard Deviation 8.6	42.5 score on a scale Standard Deviation 10.5
Health Status as Assessed by the Short Form -12 (SF-12) Index physical score-18 month	45.8 score on a scale Standard Deviation 9.2	43.1 score on a scale Standard Deviation 8.2
Health Status as Assessed by the Short Form -12 (SF-12) Index mental score- baseline	46.8 score on a scale Standard Deviation 7.6	45.5 score on a scale Standard Deviation 9.6
Health Status as Assessed by the Short Form -12 (SF-12) Index mental score- 6 month	48.3 score on a scale Standard Deviation 9.2	46.2 score on a scale Standard Deviation 10.3
Health Status as Assessed by the Short Form -12 (SF-12) Index mental score- 18 month	48.3 score on a scale Standard Deviation 7.9	48.0 score on a scale Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline

Population: Data not collected at follow up due to excessive participant burden and insufficient staff needed to maintain adequate inter-rater reliability at follow-up time points.

Brief Psychiatric Rating Scale. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.

Outcome measures

Outcome measures
Measure	TRIUMPH Intervention n=93 Participants Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=90 Participants referral to quit line
Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale	42.0 score on a scale Standard Deviation 12.5	41.0 score on a scale Standard Deviation 10.7

Adverse Events

TRIUMPH Intervention

Serious events: 31 serious events

Other events: 0 other events

Deaths: 2 deaths

Treatment as Usual

Serious events: 23 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	TRIUMPH Intervention n=97 participants at risk Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support TRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support	Treatment as Usual n=95 participants at risk referral to quit line
Psychiatric disorders Psychiatric hospitalization	11.3% 11/97 • Number of events 13 • Up to 18 months	9.5% 9/95 • Number of events 11 • Up to 18 months
General disorders Medical hospitalization	20.6% 20/97 • Number of events 23 • Up to 18 months	16.8% 16/95 • Number of events 19 • Up to 18 months

Other adverse events

Adverse event data not reported

Additional Information

Gail Daumit, MD, MHS

Johns Hopkins University School of Medicine

Phone: 410-614-6460

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place