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=5 Participants
|
49.9 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Education
Did not complete high school
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education
High school graduate or GED
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Education
Some college
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Education
College degree
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
More than a college degree
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
Prefer not to answer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Annual household income
Less than $10,000
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Annual household income
$10,000 - $19,999
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Annual household income
$20,000 - $39,999
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Annual household income
$40,000 - $59,999
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Annual household income
$60,000 - $79,999
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Annual household income
$80,000 or higher
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Annual household income
Prefer not to answer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital status
Single, never married
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Marital status
Married or partnered
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Marital status
Divorced or separated
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Marital status
Widowed
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Marital status
Prefer not to answer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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