Healthy Pregnancies Project: Cluster Randomized Controlled Trial of a Community Intervention to Reduce Tobacco Use among Alaska Native Women
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Setting
2.2. Study Design
2.3. Participants
2.4. Treatments
2.4.1. Usual Care Components Common to All Study Villages
2.4.2. Control Villages
2.4.3. Intervention Villages
2.5. Measures
2.6. Statistical Methods
3. Results
3.1. Participants
3.2. Intervention Implementation
3.3. Tobacco Use
3.4. Participant Feedback
4. Discussion
4.1. Strengths
4.2. Limitations
4.3. Future Directions
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Time Point | |||
---|---|---|---|
Campaign Component | Delivery (n = 156) % | 2 Months Postpartum (n = 139) % | 6 Months Postpartum (n = 156) % |
1. How much of the brochure did you read? | |||
None of it | 20.5 | 23.7 | 13.5 |
Some | 21.8 | 19.4 | 22.6 |
Most | 14.7 | 12.2 | 12.3 |
All | 34.0 | 41.7 | 43.2 |
Did not receive it | 9.0 | 2.9 | 8.4 |
2. How much of the digital stories DVD did you watch? | |||
None of it | 51.3 | 43.2 | 39.1 |
Some | 9.6 | 7.9 | 9.0 |
Most | 4.5 | 6.5 | 5.8 |
All | 25.6 | 36.0 | 37.2 |
Did not receive it | 9.0 | 6.5 | 9.0 |
3. Did you share the digital stories DVD, brochure, or promotional items (baby bibs) with family members or anyone else in your community? | |||
Yes | 35.3 | 52.5 | 49.7 |
No | 64.7 | 47.5 | 50.3 |
4. Did you talk about what you have learned in this study with anyone else? | |||
Yes | 39.1 | 56.1 | 58.7 |
No | 60.9 | 43.9 | 41.3 |
5. Have you seen a poster in your community about the Native Sisters program? | |||
Yes | 62.2 | 73.4 | 79.5 |
No | 37.8 | 26.6 | 20.5 |
6. Have others in your village talked about the posters, promotional items (hoodies, baby bibs), or Native Sisters program? | |||
Yes | 23.7 | 38.8 | 33.8 |
No | 76.3 | 61.2 | 67.2 |
Total Score (mean ± SD, range) 2 | 3.5 ± 2.1 0–8 | 4.4 ± 2.3 0–8 | 4.5 ± 2.3 0–8 |
Time Point 2 | Intervention n = 188 %, (n) | Usual Care Control n = 164 % (n) | p-Value 1,2 |
---|---|---|---|
Baseline | 63.8 (120/188) | 69.5 (114/164) | 0.37 |
Delivery | |||
Per protocol | 59.3 (96/162) | 64.9 (98/151) | 0.11 |
Intent-to-treat | 64.9 (122/188) | 67.7 (111/164) | 0.45 |
2 months postpartum | |||
Per protocol | 60.3 (85/141) | 65.2 (86/132) | 0.45 |
Intent-to-treat | 70.2 (132/188) | 72.0 (118/164) | 0.73 |
6 months postpartum | |||
Self-report | |||
Per protocol | 66.9 (105/157) | 65.2 (101/155) | 0.74 |
Intent-to-treat | 72.3 (136/188) | 67.1 (110/164) | 0.30 |
Biochemically confirmed | |||
Per protocol | 82.8 (130/157) | 81.3 (126/155) | 0.73 |
Intent-to-treat | 85.6 (161/188) | 82.3 (135/164) | 0.38 |
Baseline Tobacco Users | Baseline Non-Tobacco Users | |||||
---|---|---|---|---|---|---|
Time Point | Intervention Group n = 120 %, (n) | Usual Care Control Group n = 114 % (n) | p-Value 1 | Intervention Group n = 68 %, (n) | Usual Care Control Group n = 50 % (n) | p-Value 1,2 |
Delivery | ||||||
Per protocol | 78.9 (82/104) | 84.9 (90/106) | 0.15 | 24.1 (14/58) | 17.8 (8/45) | 0.51 (0.40) |
Intent-to-treat | 81.7 (98/120) | 86.0 (98/114) | 0.30 | 35.3 (24/68) | 26.0 (13/50) | 0.36 (0.56) |
2 months postpartum | ||||||
Per protocol | 81.4 (70/86) | 88.0 (81/92) | 0.24 | 27.3 (15/55) | 12.5 (5/40) | 0.075 (0.05) |
Intent-to-treat | 86.7 (104/120) | 90.4 (103/114) | 0.38 | 41.2 (28/68) | 30.0 (15/50) | 0.20 (0.45) |
6 months postpartum | ||||||
Self-report | ||||||
Per protocol | 83.7 (82/98) | 84.7 (94/111) | 0.88 | 39.0 (23/59) | 15.9 (7/44) | 0.015 (0.04) |
Intent-to-treat | 86.7 (104/120) | 85.1 (97/114) | 0.74 | 47.1 (32/68) | 26.0 (13/50) | 0.040 (0.09) |
Biochemically confirmed | ||||||
Per protocol | 94.9 (93/98) | 97.3 (108/111) | 0.35 | 62.7 (37/59) | 40.9 (18/44) | 0.014 (0.18) |
Intent-to-treat | 95.8 (115/120) | 97.4 (111/114) | 0.51 | 67.7 (46/68) | 48.0 (24/50) | 0.043 (0.19) |
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Patten, C.A.; Lando, H.A.; Desnoyers, C.A.; Bock, M.J.; Alexie, L.; Decker, P.A.; Hughes, C.A.; Resnicow, K.; Burhansstipanov, L.; Boyer, R.; et al. Healthy Pregnancies Project: Cluster Randomized Controlled Trial of a Community Intervention to Reduce Tobacco Use among Alaska Native Women. Int. J. Environ. Res. Public Health 2020, 17, 9302. https://doi.org/10.3390/ijerph17249302
Patten CA, Lando HA, Desnoyers CA, Bock MJ, Alexie L, Decker PA, Hughes CA, Resnicow K, Burhansstipanov L, Boyer R, et al. Healthy Pregnancies Project: Cluster Randomized Controlled Trial of a Community Intervention to Reduce Tobacco Use among Alaska Native Women. International Journal of Environmental Research and Public Health. 2020; 17(24):9302. https://doi.org/10.3390/ijerph17249302
Chicago/Turabian StylePatten, Christi A., Harry A. Lando, Chris A. Desnoyers, Martha J. Bock, Lucinda Alexie, Paul A. Decker, Christine A. Hughes, Kenneth Resnicow, Linda Burhansstipanov, Rahnia Boyer, and et al. 2020. "Healthy Pregnancies Project: Cluster Randomized Controlled Trial of a Community Intervention to Reduce Tobacco Use among Alaska Native Women" International Journal of Environmental Research and Public Health 17, no. 24: 9302. https://doi.org/10.3390/ijerph17249302