Trial Outcomes & Findings for An Intervention to Promote Smoking Cessation Among Adults With Food Insecurity (NCT NCT05259852)
NCT ID: NCT05259852
Last Updated: 2024-07-05
Results Overview
In the past 3 months, how many times did you stop using tobacco for 24 hours or more because you were trying to quit smoking?
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
3 months
Results posted on
2024-07-05
Participant Flow
Participant milestones
| Measure |
Food Assistance and Cessation Resources Navigation Plus Economic Assistance
Food Assistance and Cessation Resources Navigation Plus Economic Assistance: The intervention arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period. In addition, the intervention arm involves providing participants with economic assistance for food in the form of a reloadable debit card ($83 every 4 weeks for 12 weeks, for a maximum amount of $250).
|
Food Assistance and Cessation Resources Navigation
Food Assistance and Cessation Resources Navigation: The comparison arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
25
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Intervention to Promote Smoking Cessation Among Adults With Food Insecurity
Baseline characteristics by cohort
| Measure |
Food Assistance and Cessation Resources Navigation Plus Economic Assistance
n=28 Participants
Food Assistance and Cessation Resources Navigation Plus Economic Assistance: The intervention arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period. In addition, the intervention arm involves providing participants with economic assistance for food in the form of a reloadable debit card ($83 every 4 weeks for 12 weeks, for a maximum amount of $250).
|
Food Assistance and Cessation Resources Navigation
n=27 Participants
Food Assistance and Cessation Resources Navigation: The comparison arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 15.3 • n=99 Participants
|
49.9 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
50.4 years
STANDARD_DEVIATION 13.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 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
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 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
|
28 participants
n=99 Participants
|
27 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
Education
Did not complete high school
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Education
High school graduate or GED
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Education
Some college
|
15 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Education
College degree
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Education
More than a college degree
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Education
Prefer not to answer
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Annual household income
Less than $10,000
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Annual household income
$10,000 - $19,999
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Annual household income
$20,000 - $39,999
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Annual household income
$40,000 - $59,999
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Annual household income
$60,000 - $79,999
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Annual household income
$80,000 or higher
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Annual household income
Prefer not to answer
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Marital status
Single, never married
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Marital status
Married or partnered
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Marital status
Divorced or separated
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Marital status
Widowed
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Marital status
Prefer not to answer
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Complete case analysis
In the past 3 months, how many times did you stop using tobacco for 24 hours or more because you were trying to quit smoking?
Outcome measures
| Measure |
Food Assistance and Cessation Resources Navigation Plus Economic Assistance
n=25 Participants
Food Assistance and Cessation Resources Navigation Plus Economic Assistance: The intervention arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period. In addition, the intervention arm involves providing participants with economic assistance for food in the form of a reloadable debit card ($83 every 4 weeks for 12 weeks, for a maximum amount of $250).
|
Food Assistance and Cessation Resources Navigation
n=19 Participants
Food Assistance and Cessation Resources Navigation: The comparison arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period.
|
|---|---|---|
|
Number of 24-hour Quit Attempts
|
2.6 number of 24-hour quit attempts
Standard Deviation 1.8
|
1.8 number of 24-hour quit attempts
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: complete case analysis
In the past 3 months, what was the longest time (in days) you went without using tobacco?
Outcome measures
| Measure |
Food Assistance and Cessation Resources Navigation Plus Economic Assistance
n=25 Participants
Food Assistance and Cessation Resources Navigation Plus Economic Assistance: The intervention arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period. In addition, the intervention arm involves providing participants with economic assistance for food in the form of a reloadable debit card ($83 every 4 weeks for 12 weeks, for a maximum amount of $250).
|
Food Assistance and Cessation Resources Navigation
n=19 Participants
Food Assistance and Cessation Resources Navigation: The comparison arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period.
|
|---|---|---|
|
Longest Length of Abstinence in Days
|
18.7 days
Standard Deviation 21.0
|
9.3 days
Standard Deviation 15.5
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: complete case analysis
6-item Adult/Household Food Security Survey by the US Dept of Agriculture
Outcome measures
| Measure |
Food Assistance and Cessation Resources Navigation Plus Economic Assistance
n=25 Participants
Food Assistance and Cessation Resources Navigation Plus Economic Assistance: The intervention arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period. In addition, the intervention arm involves providing participants with economic assistance for food in the form of a reloadable debit card ($83 every 4 weeks for 12 weeks, for a maximum amount of $250).
|
Food Assistance and Cessation Resources Navigation
n=19 Participants
Food Assistance and Cessation Resources Navigation: The comparison arm involves an initial telephone call with a community health worker (CHW). The content of the call focuses on providing participants with referrals for available food assistance resources in the community and referrals for tobacco cessation services. There are two additional follow-up calls approximately 4 weeks apart, for a total of 3 CHW navigator calls over the 12-week study period.
|
|---|---|---|
|
Level of Food Security
High/marginal food security
|
4 Participants
|
4 Participants
|
|
Level of Food Security
Low food security
|
12 Participants
|
7 Participants
|
|
Level of Food Security
Very low food security
|
9 Participants
|
8 Participants
|
Adverse Events
Food Assistance and Cessation Resources Navigation Plus Economic Assistance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Food Assistance and Cessation Resources Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place