scholarly journals Development of “Advancing People of Color in Clinical Trials Now!”: Web-Based Randomized Controlled Trial Protocol (Preprint)

2019 ◽  
Author(s):  
Alicia Chung ◽  
Azizi Seixas ◽  
Natasha Williams ◽  
Yalini Senathirajah ◽  
Rebecca Robbins ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Intervention Group ◽  
People Of Color ◽  
Control Group ◽  
Research Approach ◽  
Web Based ◽  
Culturally Tailored ◽  
Clinical Trial Enrollment

BACKGROUND Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of “Advancing People of Color in Clinical Trials Now!” (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. OBJECTIVE This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. METHODS ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed <i>t</i> test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. RESULTS We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. CONCLUSIONS ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. CLINICALTRIAL ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17589

scholarly journals Development of “Advancing People of Color in Clinical Trials Now!”: Web-Based Randomized Controlled Trial Protocol

10.2196/17589 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e17589
Author(s):  
Alicia Chung ◽  
Azizi Seixas ◽  
Natasha Williams ◽  
Yalini Senathirajah ◽  
Rebecca Robbins ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Intervention Group ◽  
People Of Color ◽  
Control Group ◽  
Research Approach ◽  
Web Based ◽  
Culturally Tailored ◽  
Clinical Trial Enrollment

Background Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of “Advancing People of Color in Clinical Trials Now!” (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. Objective This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. Methods ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. Results We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. Conclusions ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. Trial Registration ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401 International Registered Report Identifier (IRRID) DERR1-10.2196/17589

scholarly journals Effectiveness of a Peer-Led Web-Based Intervention to Improve General Self-Efficacy in Using Dating Apps Among Young Adults: Randomized Clustered Trial (Preprint)

2019 ◽  
Author(s):  
William CW Wong ◽  
Wai Han Sun ◽  
Shu Ming Cheryl Chia ◽  
Joseph D Tucker ◽  
William PH Mak ◽  
...  
Keyword(s):  
Young Adults ◽  
Hong Kong ◽  
Self Efficacy ◽  
Online Dating ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Dating Apps ◽  
Hong Kong Students ◽  
General Self Efficacy

BACKGROUND Online dating apps are popular platforms for seeking romance and sexual relationships among young adults. As mobile apps can easily gain access to a pool of strangers (“new friends”) at any time and place, it leads to heightened sexual health risks and privacy concerns. OBJECTIVE This study aimed to evaluate the effectiveness of a peer-led web-based intervention for online dating apps to prepare Chinese college students so that they have better self-efficacy when using dating apps. METHODS An open clustered randomized controlled trial was conducted among students from three colleges (The University of Hong Kong, Hang Seng University of Hong Kong, and Yijin Programme of Vocational Training College) in Hong Kong. Students aged 17 to 27 years who attended common core curriculum or general education were randomized into intervention and control groups. The intervention material, developed with high peer engagement, included four short videos, an interactive scenario game, and a risk assessment tool. An existing website promoting physical activities and healthy living was used as a control. Using the information, motivation, and behavioral skills (IMB) approach to design the evaluation, questionnaires covering participants’ sociodemographics and dating app characteristics, as well as the general self-efficacy scale (GSE) as the primary outcome and the risk propensity scale (RPS) as the secondary outcome were administered before, immediately after, and at 1 month after the intervention. Intention-to-treat analysis was adopted, and between-group differences were assessed using the Mann-Whitney <i>U</i> test. A post-hoc multiple linear regression model was used to examine the correlates of the GSE and RPS. RESULTS A total of 578 eligible participants (290 in the intervention group and 288 in the control group) participated in the study with 36 lost to follow-up. There were more female participants (318/542, 58.7%) than male participants in the sample, reflecting the distribution of college students. Over half of the participants (286/542, 52.8%) reported the following reasons for using dating apps: being curious (170/498, 34.1%), trying to make new friends (158/498, 31.7%), and finding friends with similar interests (121/498, 24.3%). Overall, the participants in the intervention group reported favorable experiences when compared with the finding in the control group. There was significant improvement in the GSE score and reduction in the RPS score (<i>P</i>&lt;.001) in the intervention group. University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions. CONCLUSIONS The online intervention was effective in improving general self-efficacy and reducing risk tendency among young students. Future work is needed to determine if this approach is cost-effective and such behavioral change is sustainable. CLINICALTRIAL ClinicalTrials.gov NCT03685643; https://clinicaltrials.gov/ct2/show/NCT03685643. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-018-3167-5

scholarly journals Healthy Eating and Active Living for Diabetes-Glycemic Index (HEALD-GI): A Pragmatic Randomized Controlled Trial

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1289-1289
Author(s):  
Hayford Avedzi ◽  
Allison Soprovich ◽  
Stephanie Ramage ◽  
Abdulrhman Alghamdi ◽  
Kate Storey ◽  
...  
Keyword(s):  
Nutrition Education ◽  
Glycemic Index ◽  
Self Efficacy ◽  
Text Messaging ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Dietary Intakes ◽  
Web Based ◽  
Phone Calls

Abstract Objectives Rigorous evidence is needed to support uptake of recommendations to include low glycemic index (GI) foods in daily meal planning as an effective dietary self-care strategy for people with type 2 diabetes (T2D). We evaluated the effectiveness of a 12-week web-based GI-targeted nutrition education intervention on dietary intakes and GI-related knowledge among adults with T2D. Methods Participants were randomized to a control group (n = 34) that received standard printed copies of Canada's Food Guide and Diabetes Canada's GI resources or an intervention group (n = 33) that received those same materials, plus an online platform with six self-directed learning modules and supplementary print material. Each module consisted of a customized video, links to reliable websites, chat rooms, and quizzes. Evidence-based GI concept information included GI values of foods and advice for low-GI shopping, recipes, and cooking tips by a Registered Dietitian. Preferred supports through email, text messaging, phone calls, or postal mail to reinforce participants’ learning were also provided. The primary outcome, average daily dietary GI intake, was assessed using 3-day food records. Additional measures including GI knowledge and self-efficacy, glycated hemoglobin A1c, lipids, systolic blood pressure, body mass index, waist circumference, and computer proficiency, were assessed at baseline and at three months post-intervention. Results Participants (N = 67) were 64% men; mean (standard deviation [SD]) age 69.5 (9.3) years, with mean diabetes duration of 19.0 (13.7) years, BMI 30.1 (5.7) kg/m2 and A1c 7.1 (1.2)% at baseline. Mean daily GI intake decreased in the intervention group by 2.79 (7.77) compared to a 0.76 (6.48) increase in the control group (adjusted mean difference [95% CI]; −3.77 [−6.95, −0.58]). Mean GI knowledge 2.14 [0.59, 3.69], understanding of GI concept 1.65 [0.85, 2.44] and self-efficacy for consuming low-GI foods 1.29 [0.51, 2.07] increased among the intervention group (P &lt; 0.01) compared with the control group. Conclusions Web-based GI-targeted education program improved the quality of carbohydrate consumption among adults with T2D and may have been mediated through increases in knowledge and self-efficacy. Web-based nutrition education may be an effective alternative in this population. Funding Sources Canadian Foundation for Dietetic Research.

scholarly journals Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

2019 ◽  
Vol 53 ◽  
Author(s):  
Luciana Regina Ferreira da Mata ◽  
Cissa Azevedo ◽  
Mariana Ferreira Vaz Gontijo Bernardes ◽  
Tânia Couto Machado Chianca ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Home Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Teaching Program ◽  
Significant Difference ◽  
The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

scholarly journals The impact of social network-based nursing care training on oncology nurses’ occupational stress and self-efficacy: Non-randomized clinical trial

2020 ◽  
Author(s):  
Mehri Bozorgnejad ◽  
Tahereh Najafi Ghezeljeh ◽  
Hamid Haghani ◽  
Amin Iri
Keyword(s):  
Clinical Trial ◽  
Social Network ◽  
Randomized Clinical Trial ◽  
Occupational Stress ◽  
Nursing Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Oncology Nurses ◽  
Control Group ◽  
Care Training

Background & Aim: Inadequate clinical knowledge is one of the leading causes of stress and low occupational self-efficacy among nurses. Nursing training can enhance self-efficacy and reduce stress. Therefore, this study aimed to determine the effect of social network-based nursing care training, using mobile phones, occupational stress, and self-efficacy among oncology nurses. Methods & Materials: This non-randomized clinical trial study was conducted on 78 nurses working in oncology wards of two selected educational hospitals in Tehran in 2018. The nurses entered the study through available sampling. They were randomly assigned to two groups of control and intervention. Nursing care training in chemotherapy was provided to the nurses in the intervention group through a mobile phone social network for four weeks. On the other hand, the nurses in the control group were provided with the routine training pamphlets and brochures in the oncology ward. The nurses’ stress level was examined using an expanded nursing stress scale and their occupational stress was measured using a job self-efficacy questionnaire once before the intervention and then one month after the intervention. The data analysis was then performed according to independent t-test, paired t-test, and chi-square using SPSS software version 16. Results: The two groups were homogeneous in terms of age, gender, work experience, and education. There was no significant difference in terms of occupational stress and self-efficacy between the two groups before the intervention (P<0.05). The changes in the occupational stress score were statistically significant (P<0.05) among the nurses in the intervention group. Moreover, the changes in the occupational self-efficacy score were statistically significant among nurses in the intervention group compared to the control group (P<0.05). Conclusion: Educational intervention through social networking can lead to a reduction of occupational stress and an increase in self-efficacy among oncology nurses. Reducing stress and increasing nurses’ occupational self-efficacy will improve their performance at the bedside. This is an easy, inexpensive, and effective training method that can be used by health managers and educators to enhance employee’s performance.

scholarly journals The Effect of Oketani Breast Massage on Successful Breastfeeding, Mothers’ Breastfeeding Support Need, and Breastfeeding Self-Efficacy: A Clinical Trial Study

2020 ◽  
Author(s):  
Maryam Mahdizadeh Shahri ◽  
Manijeh Nourian ◽  
Maryam Varzeshnejad ◽  
Maliheh Nasiri
Keyword(s):  
Clinical Trial ◽  
Success Rate ◽  
Self Efficacy ◽  
Assessment Tool ◽  
Intervention Group ◽  
Onset Time ◽  
Control Group ◽  
Time Interval ◽  
Cesarean Sections ◽  
Need For Support

Abstract Background: The most important factor in the survival and health of infants is breastfeeding. One of the complications of cesarean sections is their negative effect on the quality of breastfeeding. This study aimed to determine the effect of Oketani breast massage on the maternal need for support during breastfeeding, breastfeeding success, and breastfeeding selfefficacy. Methods: The research sample in this clinical trial study included pregnant women who referred to Mahdiyeh, Taleghani, and Imam Hossein hospitals as candidates for a cesarean section. The mothers were selected using convenience sampling and randomly assigned to the intervention group (n = 55) and the control group (n = 58). The data were collected using, the Infant Breastfeeding Assessment Tool (IBFAT), the Breastfeeding Charting System (LATCH), and the Breastfeeding Self-Efficacy Scale (BSES). To assess the breastfeeding success rate, the number of breastfeeding times, and the onset time of the first breastfeeding were recorded. The collected data were analyzed using SPSS software (version 20) via the independent samples t-test, the Mann–Whitney U test, and chi-square test. Results: The results of the study suggested that the breastfeeding success rate in both the first two breastfeeding stages and the last pre-discharge breastfeeding was significantly higher for the participants in the intervention group than the members of the control group (p <0.001). Besides, the mother's need for support in the first two breastfeeding stages (p = 0.044) and the last pre-discharge breastfeeding (p <0.001) in the intervention group was less than that of the mothers in the control group. The number of breastfeeding in the intervention group was higher than the control group (p = 0.002). Furthermore, the mothers in the intervention group breastfed their infants in a significantly less time interval (p = 0.002). The breastfeeding self-efficacy was significantly higher in the intervention group than in the control group (p <0.001). Conclusion: Oketani massage can be used as a care intervention by nurses to improve breastfeeding in mothers who undergo cesarean sections and have more breastfeeding problems. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20190129042542N1.

scholarly journals Telephone intervention to promote maternal breastfeeding self-efficacy: randomized clinical trial

2021 ◽  
Vol 55 ◽  
Author(s):  
Hilana Dayana Dodou ◽  
Raylla Araújo Bezerra ◽  
Anne Fayma Lopes Chaves ◽  
Camila Teixeira Moreira Vasconcelos ◽  
Lorena Pinheiro Barbosa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Educational Intervention ◽  
Self Efficacy ◽  
Short Form ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Telephone Intervention ◽  
Clinical Trial Registry

ABSTRACT Objective: To analyze the effects of an educational intervention via telephone on maternal breastfeeding self-efficacy. Method: Randomized controlled clinical trial including 240 puerperae from a secondary care hospital randomized into two groups: control and intervention. The educational intervention took place at seven, 30, 90, and 150 days postpartum and centered on self-efficacy and motivational interviewing principles. Self-efficacy was measured by the Breastfeeding Self-Efficacy Scale – Short Form. The data followed the abnormal distribution, so non-parametric tests were used. Results: The intervention group obtained higher median breastfeeding self-efficacy scores across the three outcome measures when compared to the control group (p < 0,001). Furthermore, the intervention group showed increased self-efficacy scores at all monitoring moments, which shows that the educational intervention was able to raise and maintain women’s confidence in breastfeeding their child over time. Conclusion: The use of a telephone-based intervention focused on self-efficacy principles and delivered by trained nurses effectively promoted maternal confidence in breastfeeding. Brazilian Clinical Trial Registry: RBR-7m7vc8.

scholarly journals Effectiveness of a Peer-Led Web-Based Intervention to Improve General Self-Efficacy in Using Dating Apps Among Young Adults: Randomized Clustered Trial

10.2196/16378 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e16378
Author(s):  
William CW Wong ◽  
Wai Han Sun ◽  
Shu Ming Cheryl Chia ◽  
Joseph D Tucker ◽  
William PH Mak ◽  
...  
Keyword(s):  
Young Adults ◽  
Hong Kong ◽  
Self Efficacy ◽  
Online Dating ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Dating Apps ◽  
Hong Kong Students ◽  
General Self Efficacy

Background Online dating apps are popular platforms for seeking romance and sexual relationships among young adults. As mobile apps can easily gain access to a pool of strangers (“new friends”) at any time and place, it leads to heightened sexual health risks and privacy concerns. Objective This study aimed to evaluate the effectiveness of a peer-led web-based intervention for online dating apps to prepare Chinese college students so that they have better self-efficacy when using dating apps. Methods An open clustered randomized controlled trial was conducted among students from three colleges (The University of Hong Kong, Hang Seng University of Hong Kong, and Yijin Programme of Vocational Training College) in Hong Kong. Students aged 17 to 27 years who attended common core curriculum or general education were randomized into intervention and control groups. The intervention material, developed with high peer engagement, included four short videos, an interactive scenario game, and a risk assessment tool. An existing website promoting physical activities and healthy living was used as a control. Using the information, motivation, and behavioral skills (IMB) approach to design the evaluation, questionnaires covering participants’ sociodemographics and dating app characteristics, as well as the general self-efficacy scale (GSE) as the primary outcome and the risk propensity scale (RPS) as the secondary outcome were administered before, immediately after, and at 1 month after the intervention. Intention-to-treat analysis was adopted, and between-group differences were assessed using the Mann-Whitney U test. A post-hoc multiple linear regression model was used to examine the correlates of the GSE and RPS. Results A total of 578 eligible participants (290 in the intervention group and 288 in the control group) participated in the study with 36 lost to follow-up. There were more female participants (318/542, 58.7%) than male participants in the sample, reflecting the distribution of college students. Over half of the participants (286/542, 52.8%) reported the following reasons for using dating apps: being curious (170/498, 34.1%), trying to make new friends (158/498, 31.7%), and finding friends with similar interests (121/498, 24.3%). Overall, the participants in the intervention group reported favorable experiences when compared with the finding in the control group. There was significant improvement in the GSE score and reduction in the RPS score (P<.001) in the intervention group. University of Hong Kong students were more susceptible to risk reduction after the intervention when compared with students from the other two institutions. Conclusions The online intervention was effective in improving general self-efficacy and reducing risk tendency among young students. Future work is needed to determine if this approach is cost-effective and such behavioral change is sustainable. Trial Registration ClinicalTrials.gov NCT03685643; https://clinicaltrials.gov/ct2/show/NCT03685643. International Registered Report Identifier (IRRID) RR2-10.1186/s13063-018-3167-5

scholarly journals Clinical Trial of a Home Safety Toolkit for Alzheimer’s Disease

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Kathy J. Horvath ◽  
Scott A. Trudeau ◽  
James L. Rudolph ◽  
Paulette A. Trudeau ◽  
Mary E. Duffy ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Self Efficacy ◽  
Intervention Group ◽  
Risky Behaviors ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Home Safety ◽  
Significant Group ◽  
Related Disorder ◽  
Unpaid Care

This randomized clinical trial tested a new self-directed educational intervention to improve caregiver competence to create a safer home environment for persons with dementia living in the community. The sample included 108 patient/caregiver dyads: the intervention group (n=60) received the Home Safety Toolkit (HST), including a new booklet based on health literacy principles, and sample safety items to enhance self-efficacy to make home safety modifications. The control group (n=48) received customary care. Participants completed measures at baseline and at twelve-week follow-up. Multivariate Analysis of Covariance (MANCOVA) was used to test for significant group differences. All caregiver outcome variables improved in the intervention group more than in the control. Home safety was significant atP≤0.001, caregiver strain atP≤0.001, and caregiver self-efficacy atP=0.002. Similarly, the care receiver outcome of risky behaviors and accidents was lower in the intervention group (P≤0.001). The self-directed use of this Home Safety Toolkit activated the primary family caregiver to make the home safer for the person with dementia of Alzheimer's type (DAT) or related disorder. Improving the competence of informal caregivers is especially important for patients with DAT in light of all stakeholders reliance on their unpaid care.

Randomized Clinical Trial of a Prenatal Breastfeeding and Mental Health Mixed Management Intervention

2021 ◽  
pp. 089033442199105
Author(s):  
Ying Zhao ◽  
Qiping Lin ◽  
Xinli Zhu ◽  
Jing Wang
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Depressive Symptoms ◽  
Self Efficacy ◽  
Intervention Group ◽  
Health Promotion Program ◽  
Control Group ◽  
Feeding Patterns ◽  
Effective Prevention ◽  
Management Intervention

Background The continuity of maternal depressive symptoms throughout the perinatal period and breastfeeding problems have adverse influences on breastfeeding. Research aim To compare the feeding patterns and breastfeeding experiences, maternal health and mental health, and breastfeeding self-efficacy between women with depressive symptoms who participated in a prenatal individualized mixed management intervention and those who received usual care. Methods Chinese primigravida ( N = 182) with an Edinburgh Postnatal Depression Scale score ≥ 9 in late pregnancy (≥ 28 weeks and < 35 weeks) were randomly assigned to the intervention group ( n = 84) or the control group ( n = 84). Intervention group participants received four sessions of individualized mixed management combining psycho-education and breastfeeding education. Breastfeeding self-efficacy, feeding patterns, maternal depression, and health status were evaluated in both groups. Results Significant differences were noted between the groups in breastfeeding self-efficacy at 42 days postpartum ( p < .05) and feeding patterns at 3 months and 6 months postpartum ( p < .05). Repeated measures analysis of variance showed significant differences in the EPDS scores between groups at three postpartum time points ( p < .05). The intervention group had significantly lower postpartum depression as diagnosed by the MINI ( p < .05). Conclusions A prenatal individualized mixed management intervention holds promise as an effective prevention and health promotion program addressing breastfeeding outcomes and maternal mental health. This RCT was registered (ChiCTR-IOR-17013761) with Chinese Clinical Trial Registry, http://www.chictr.org.cn/enIndex.aspx on 12/7/2017.

Sign in / Sign up

Export Citation Format

Share Document