Dataset Information

Effectiveness of a Postpartum Text Message Program (Essential Coaching for Every Mother) on Maternal Psychosocial Outcomes: Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

Women experience changes both physically and psychologically during their transition to motherhood. The postnatal period is a critical time for women to develop maternal self-efficacy. Mobile health interventions may offer a way to reach women during this critical period to offer support and information. Essential Coaching for Every Mother is a text message program that seeks to educate and support women during the first 6 weeks postpartum.

Objective

The primary effectiveness objective is to compare the effectiveness of the Essential Coaching for Every Mother program on maternal psychosocial outcomes (self-efficacy, social support, postpartum depression, and postpartum anxiety) immediately after the intervention and 6 months postpartum, collectively as well as stratified by parity. The primary implementation objective is to evaluate the implementation extent and quality of the Essential Coaching for Every Mother program.

Methods

This will be a hybrid type 1 effectiveness-implementation randomized controlled trial. A total of 140 mothers-to-be or new mothers from Nova Scotia will be recruited and randomized to the intervention or control arm, stratified by parity. The intervention arm will receive the Essential Coaching for Every Mother program, which consists of 53 messages sent twice a day for the first 2 weeks and daily for weeks 3 through 6. The control group will receive usual care. Messages are personalized based on the infant's age and the woman's self-selected preference for breastfeeding or formula feeding and tailored with the infant's name and gender. Women can enroll in the program if they are ≥37 weeks pregnant or within 10 days postpartum, with the first message designed to be sent on the second evening after birth. The actual number of messages received will vary based on the timing of enrollment and the infant's date of birth. Participants will complete questionnaires assessing self-efficacy, social support, and postpartum depression and anxiety at baseline (enrollment after birth) and 6 weeks (postintervention) and 6 months postpartum. Implementation data will be collected throughout the trial, and evaluation feedback will be collected at 6 weeks from women who received the intervention.

Results

Recruitment for this study started on January 5, 2021, and is currently ongoing, with an anticipated date of recruitment completion of January 2022.

Conclusions

This study will assess the effectiveness of a postpartum text message program to improve maternal self-efficacy and social support while decreasing postpartum depression and anxiety. It will also shed light on the implementation effectiveness of the program.

Trial registration

ClinicalTrials.gov NCT04730570; https://clinicaltrials.gov/ct2/show/NCT04730570.

International registered report identifier (irrid)

DERR1-10.2196/27138.

SUBMITTER: Dol J

PROVIDER: S-EPMC8088838 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background"Essential Coaching for Every Mother" is a Canadian text message-based program that sends daily messages to mothers for 6 weeks after they give birth. There is a need to explore the program's effectiveness in terms of the participants' experience to guide refinement and modification.ObjectiveThis study aimed to describe the process evaluation of the Essential Coaching for Every Mother randomized controlled trial through an evaluation of the research implementation extent and quality.MethodsParticipants were recruited from Nova Scotia, Canada, between January 5 and August 1, 2021. Enrolled participants were randomized into the intervention or control group. Participants randomized to the intervention group received standard care along with the Essential Coaching for Every Mother program's text messages related to newborn and maternal care for the first 6 weeks after giving birth, while the control group received standard care. Usage data were collected from the SMS text message program used, and participants completed web-based questionnaires at 6 weeks after birth. Quantitative data and qualitative responses to open-ended questions were used to triangulate findings. Quantitative data were summarized using means, SDs, and percentages, as appropriate, while qualitative data were analyzed using thematic analysis.ResultsOf the 295 unique initial contacts, 150 mothers were eligible and completed the baseline survey to be enrolled in the study (intervention, n=78; control, n=72). Of those randomized into the intervention group, 75 (96%) completed the 6-week follow-up survey to provide feedback on the program. In total, 48 (62%) intervention participants received all messages as designed in the Essential Coaching for Every Mother program, with participants who enrolled late missing on average 4.7 (range 1-12) messages. Intervention participants reported an 89% satisfaction rate with the program, and 100% of participants would recommend the program to other new mothers. Participants liked how the program made them feel, the format, appropriate timing of messages, and content while disliking the frequency of messages and gaps in content. Participants also provided suggestions for future improvement.ConclusionsOur process evaluation has provided a comprehensive understanding of interest in the program as well as identified preference for program components. The findings of this study will be used to update future iterations of the Essential Coaching for Every Mother program.Trial registrationClincalTrials.gov NCT04730570; https://clinicaltrials.gov/ct2/show/NCT04730570.

Project description:Importancee-Cigarettes are the most commonly used tobacco product among young adults (YAs). Despite the harms of nicotine exposure among YAs, there are few, if any, empirically tested vaping cessation interventions available.ObjectiveTo determine the effectiveness of a text message program for vaping cessation among YAs vs assessment-only control.Design, setting, and participantsA parallel, 2-group, double-blind, individually randomized clinical trial was conducted from December 2019 to November 2020 among YA e-cigarette users. Eligible individuals were US residents aged 18 to 24 years who owned a mobile phone with an active text message plan, reported past 30-day e-cigarette use, and were interested in quitting in the next 30 days. Participants were recruited via social media ads, the intervention was delivered via text message, and assessments were completed via website or mobile phone. Follow-up was conducted at 1 and 7 months postrandomization; follow-up data collection began January 2020 and ended in November 2020. The study was prespecified in the trial protocol.InterventionsAll participants received monthly assessments via text message about e-cigarette use. The assessment-only control arm (n = 1284) received no additional intervention. The active intervention arm (n = 1304) also received This is Quitting, a fully automated text message program for vaping cessation that delivers social support and cognitive and behavioral coping skills training.Main outcomes and measuresThe primary outcome was self-reported 30-day point prevalence abstinence (ppa) at 7 months analyzed under intention-to-treat analysis, which counted nonresponders as vaping. Secondary outcomes were 7-day ppa under intention-to-treat analysis and retention weighted complete case analysis of 30-day and 7-day ppa.ResultsOf the 2588 YA e-cigarette users included in the trial, the mean (SD) age was 20.4 (1.7) years, 1253 (48.4%) were male, 2159 (83.4%) were White, 275 (10.6%) were Hispanic, and 493 (19.0%) were a sexual minority. Most participants (n = 2129; 82.3%) vaped within 30 minutes of waking. The 7-month follow-up rate was 76.0% (n = 1967), with no differential attrition. Abstinence rates were 24.1% (95% CI, 21.8%-26.5%) among intervention participants and 18.6% (95% CI, 16.7%-20.8%) among control participants (odds ratio, 1.39; 95% CI, 1.15-1.68; P < .001). No baseline variables moderated the treatment-outcome relationship, including nicotine dependence.Conclusions and relevanceResults of this randomized clinical trial demonstrated that a tailored and interactive text message intervention was effective in promoting vaping cessation among YAs. These results establish a benchmark of intervention effectiveness.Trial registrationClinicalTrials.gov Identifier: NCT04251273.

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Project description:IntroductionMany studies have now demonstrated the efficacy of text messaging in positively changing behaviours. We aimed to identify features and factors that explain the effectiveness of a successful text messaging program in terms of user engagement, perceived usefulness, behavior change and program delivery preferences.MethodsMixed methods qualitative design combining four data sources; (i) analytic data extracted directly from the software system, (ii) participant survey, (iii) focus groups to identify barriers and enablers to implementation and mechanisms of effect and (iv) recruitment screening logs and text message responses to examine engagement. This evaluation was conducted within the TEXT ME trial-a parallel design, single-blind randomized controlled trial (RCT) of 710 patients with coronary heart disease (CHD). Qualitative data were interpreted using inductive thematic analysis.Results307/352 (87% response rate) of recruited patients with CHD completed the program evaluation survey at six months and 25 participated in a focus group. Factors increasing engagement included (i) ability to save and share messages, (ii) having the support of providers and family, (iii) a feeling of support through participation in the program, (iv) the program being initiated close to the time of a cardiovascular event, (v) personalization of the messages, (vi) opportunity for initial face-to-face contact with a provider and (vii) that program and content was perceived to be from a credible source. Clear themes relating to program delivery were that diet and physical activity messages were most valued, four messages per week was ideal and most participants felt program duration should be provided for at least for six months or longer.ConclusionsThis study provides context and insight into the factors influencing consumer engagement with a text message program aimed at improving health-related behavior. The study suggests program components that may enhance potential success but will require integration at the development stage to optimize up-scaling.Trial registrationAustralia and New Zealand Clinical Trials Registry, ACTRN12611000161921.

Project description:BACKGROUND:Little is known about the feasibility and acceptability of tailored text message based weight loss programs for English and Spanish-language speakers. OBJECTIVE:This pilot study evaluated the feasibility, acceptability, and estimated impact of a tailored text message based weight loss program for English and Spanish-language speakers. The purpose of this pilot study was to inform the development of a full-scale randomized trial. METHODS:There were 20 overweight or obese participants (mean age 40.10, SD 8.05; 8/20, 40% male; 9/20, 45% Spanish-speakers) that were recruited in San Diego, California, from March to May 2011 and evaluated in a one-group pre/post clinical trial. For 8 weeks, participants received and responded to 3-5 text messages daily sent from a fully automated text messaging system. They also received printed weight loss materials and brief 10-15 minute weekly counseling calls. To estimate the impact of the program, the primary outcome was weight (kg) measured during face-to-face measurement visits by trained research staff. Pre and post differences in weight were analyzed with a one-way repeated measures analysis of variance. Differences by language preference at both time points were analyzed with t tests. Body mass index and weight management behaviors also were examined. Feasibility and acceptability were determined by recruitment success, adherence (ie, percentage of replies to interactive text messages and attrition), and participant satisfaction. RESULTS:Participants who completed the final assessment (N=18) decreased body weight by 1.85 kg (F1,17=10.80, P=.004, CI? 0.66-3.03, ?(2)=0.39). At both time points, there were no differences in weight by language preference. Participants responded to 88.04% (986/1120) of interactive text messages, attrition rate was 10% (2/20), and 94% (19/20) of participants reported satisfaction with the program. CONCLUSIONS:This fully automated text message based weight program was feasible with English and Spanish-speakers and may have promoted modest weight loss over an 8-week period. TRIAL REGISTRATION:Clinicaltrials.gov NCT01171586; http://clinicaltrials.gov/ct2/show/NCT01171586 (Archived by WebCite at http://www.webcitation.org/6Ksr6dl7n).