Trial Outcomes & Findings for Community Intervention to Reduce Tobacco Use in Pregnant Women (NCT NCT02083081)

NCT ID: NCT02083081

Last Updated: 2022-06-28

Results Overview

Total number of participants to have biochemically confirmed tobacco abstinence at 6-months post-partum

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 352 participants
• Primary outcome timeframe: 6 months postpartum
• Results posted on: 2022-06-28

Participant Flow

Participant milestones

Measure	Community Intervention Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women Community level intervention: Community intervention plus individual counseling	Usual Care Usual care provided by health aides to pregnant women
Overall Study STARTED	188	164
Overall Study COMPLETED	157	155
Overall Study NOT COMPLETED	31	9

Reasons for withdrawal

Measure	Community Intervention Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women Community level intervention: Community intervention plus individual counseling	Usual Care Usual care provided by health aides to pregnant women
Overall Study Lost to Follow-up	31	9

Baseline Characteristics

Community Intervention to Reduce Tobacco Use in Pregnant Women

Baseline characteristics by cohort

Measure	Community Intervention n=188 Participants Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women Community level intervention: Community intervention plus individual counseling	Usual Care n=164 Participants Usual care provided by health aides to pregnant women	Total n=352 Participants Total of all reporting groups
Age, Continuous	25.9 years STANDARD_DEVIATION 5.0 • n=5 Participants	25.8 years STANDARD_DEVIATION 5.0 • n=7 Participants	25.8 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	188 Participants n=5 Participants	164 Participants n=7 Participants	352 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	188 Participants n=5 Participants	164 Participants n=7 Participants	352 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=7 Participants	0 Participants n=5 Participants
gestational age, weeks	27.3 weeks STANDARD_DEVIATION 9.5 • n=5 Participants	26.2 weeks STANDARD_DEVIATION 10.1 • n=7 Participants	26.8 weeks STANDARD_DEVIATION 9.8 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months postpartum

Total number of participants to have biochemically confirmed tobacco abstinence at 6-months post-partum

Outcome measures

Measure	Community Intervention n=188 Participants Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women Community level intervention: Community intervention plus individual counseling	Usual Care n=164 Participants Usual care provided by health aides to pregnant women
Number of Participants With Tobacco Abstinence at 6-months Post-partum	161 Participants	135 Participants

PRIMARY outcome

Timeframe: Approximately 9 months

Total number of participants to have biochemically confirmed tobacco abstinence at end of pregnancy (delivery).

Outcome measures

Measure	Community Intervention n=188 Participants Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women Community level intervention: Community intervention plus individual counseling	Usual Care n=164 Participants Usual care provided by health aides to pregnant women
Number of Participants With Tobacco Abstinence at End of Pregnancy	122 Participants	111 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months postpartum

Change from baseline in self-efficacy for non-tobacco use scores measured by the self-reported Smoking Confidence Questionnaire. Total scores range from 0-30, higher scores indicate better outcome.

Outcome measures

Measure	Community Intervention n=156 Participants Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women Community level intervention: Community intervention plus individual counseling	Usual Care n=153 Participants Usual care provided by health aides to pregnant women
Change in Self-efficacy for Non-tobacco Use Scores	7.2 score on a scale Standard Deviation 2.7	7.5 score on a scale Standard Deviation 2.6

Adverse Events

Community Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

Christi Patten PhD

Mayo Clinic

Phone: 507-538-7370

Email: patten.christi@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place