Dataset Information

Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity Intervention for Pregnant Women With Diabetes: The Fit for Two Pilot Study.

ABSTRACT:

Background

Diabetes during pregnancy poses serious health risks to both mother and child. Regular physical activity can reduce these risks, yet few clinic-based interventions of physical activity for pregnant women with diabetes have been attempted.

Objective

The purpose of this single-arm pilot trial is to assess the feasibility and acceptability, and explore the potential efficacy of a counseling- and mobile health-based physical activity intervention for pregnant women with diabetes.

Methods

Participants (N=17) who had type 2 or gestational diabetes, could read and speak in English or Spanish, and were between 10 and 27 weeks of gestation were recruited from the University of California San Diego Diabetes and Pregnancy Program. Participants engaged in a one-on-one counseling and goal-setting session immediately following a clinic visit with their physician. They were given a Fitbit and shown how to use the Fitbit app, including entering personalized step goals, and were encouraged to build up to 10,000 daily steps. Daily steps were recorded for 12 weeks, until they were 36 weeks' gestation, or until 1 week before they gave birth, whichever came first. Feasibility was measured by recruitment, retention, and adherence, and acceptability was measured using consumer satisfaction questionnaires and follow-up interviews. Potential efficacy was explored by examining changes in daily steps over time.

Results

The participants were primarily Hispanic (13/17, 76%), had public insurance (15/17, 88%), and had type 2 diabetes (12/17, 71%). Of the 17 patients who began the intervention, 76% (13/17) completed a follow-up visit, and 71% (12/17) continued wearing the Fitbit regularly after 8 weeks in the intervention. Adherence in wearing the Fitbit was relatively high, with a median wear adherence of 90% of days. The intervention was generally well accepted, with 85% (11/13) indicating that they were motivated to exercise more following the counseling session, 85% (11/13) indicating that the Fitbit helped increase their activity, and 92% (12/13) recommending the program overall. Mean daily steps increased from baseline (mean 6122, SD 2439) to week 3 (mean 6269, SD 2166) and then decreased through week 12 (mean 4191, SD 2228).

Conclusions

High acceptability, retention, and adherence suggest that this may be a promising approach to delivering a simple, low-burden intervention in a clinical setting to a high-risk, underserved population. A randomized controlled trial is needed to determine whether this approach is effective in slowing the reduction in activity typically seen throughout pregnancy.

Trial registration

ClinicalTrials.gov NCT03302377; https://clinicaltrials.gov/ct2/show/NCT03302377.

SUBMITTER: Larsen B

PROVIDER: S-EPMC7641781 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity Intervention for Pregnant Women With Diabetes: The Fit for Two Pilot Study.

Larsen Britta B Micucci Stephanie S Hartman Sheri J SJ Ramos Gladys G

JMIR mHealth and uHealth 20201021 10

<h4>Background</h4>Diabetes during pregnancy poses serious health risks to both mother and child. Regular physical activity can reduce these risks, yet few clinic-based interventions of physical activity for pregnant women with diabetes have been attempted.<h4>Objective</h4>The purpose of this single-arm pilot trial is to assess the feasibility and acceptability, and explore the potential efficacy of a counseling- and mobile health-based physical activity intervention for pregnant women with dia ...[more]

PMID: 33084584

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Project description:BackgroundNonpharmacological and accessible therapies that engage individuals in self-management are needed to address depressive symptoms in pregnancy. The 12-week "Mindful Moms" intervention was designed to empower pregnant women with depressive symptomatology to create personal goals and engage in mindful physical activity using prenatal yoga.ObjectivesThis longitudinal pilot study evaluated the feasibility, acceptability, and preliminary effects of the "Mindful Moms" intervention in pregnant women with depressive symptoms.MethodsWe evaluated enrollment and retention data (feasibility) and conducted semistructured interviews (acceptability). We evaluated the intervention's effects over time on participants' depressive symptoms, anxiety, perceived stress, self-efficacy, and maternal-child attachment, and we compared findings to an archival comparison group, also assessed longitudinally.ResultsEnrollment and retention rates and positive feedback from participants support the intervention's acceptability and feasibility. "Mindful Moms" participants experienced decreases in depressive symptoms, perceived stress, anxiety, ruminations, and maternal-child attachment and no change in physical activity self-efficacy from baseline to postintervention. Comparisons of the "Mindful Moms" intervention to the comparison groups over time indicated differences in depressive symptoms between all groups and a trend in differences in perceived stress.DiscussionResults support the feasibility and acceptability of "Mindful Moms" for pregnant women with depressive symptoms and suggest that further research is warranted to evaluate this intervention for reducing depressive and related symptoms. Lack of a concurrent control group, with equivalent attention from study staff, and no randomization limit the generalizability of this study; yet, these preliminary findings support future large-scale randomized controlled trials to further evaluate this promising intervention.

Project description:BackgroundElectronic health (eHealth) and mobile health (mHealth) interventions have the potential to tackle the worldwide problem of physical inactivity. However, they often suffer from large attrition rates. Consequently, feasibility and acceptability of interventions have become important matters in the creation of e- and mHealth interventions. The aim of this study was to evaluate participants' opinions regarding acceptability and feasibility of a self-regulation, app-based intervention called 'MyDayPlan'. 'MyDayPlan' provides an innovative daily cycle providing several self-regulation techniques throughout the day that guide users towards an active lifestyle via various self-regulation techniques.MethodsSemi-structured interviews were conducted with 20 adults after using the app for 2 weeks. A directed content analysis was performed using NVivo Software.Results'MyDayPlan' was well-received and seems to be feasible and acceptable with inactive adults. The straightforward lay out and ease of use of the app were appreciated. Furthermore, the incorporation of the techniques 'action planning', and 'prompting review of behavioral goals' was positively evaluated. However, the users gave some recommendations: implementation of activity trackers to self-monitor physical activity could be of added value. Furthermore, increasing intuitiveness by minimizing text input and providing more preprogrammed options could further increase the ease of use. Finally, users indicated that they would benefit from more guidance during the "coping planning" component (barrier identification/problem solving), for example by receiving more tailored examples.ConclusionsBased on these findings, adaptations will be made to the 'MyDayPlan' app before evaluating its effectiveness. Furthermore, involving potential end users and evaluating acceptability and feasibility during the development of an e- and mHealth intervention is key. Also, creating interventions with a large ease of use and straightforward layout that provides tailored support during action and coping planning is key.

Project description:BackgroundAs adults age, their physical activity decreases and sedentary behavior increases, leading to increased risk of negative health outcomes. Wearable electronic activity monitors have shown promise for delivering effective behavior change techniques. However, little is known about the feasibility and acceptability of non-Fitbit wearables (Fitbit, Inc, San Francisco, California) combined with telephone counseling among adults aged more than 55 years.ObjectiveThe purpose of our study was to determine the feasibility, acceptability, and effect on physical activity of an intervention combining a wearable physical activity monitor, tablet device, and telephone counseling among adults aged 55-79 years.MethodsAdults (N=40, aged 55-79 years, body mass index=25-35, <60 min of activity per week) were randomized to receive a 12-week intervention or to a wait list control. Intervention participants received a Jawbone Up24 monitor, a tablet with the Jawbone Up app installed, and brief weekly telephone counseling. Participants set daily and weekly step goals and used the monitor's idle alert to notify them when they were sedentary for more than 1 h. Interventionists provided brief counseling once per week by telephone. Feasibility was measured using observation and study records, and acceptability was measured by self-report using validated items. Physical activity and sedentary time were measured using ActivPAL monitors following standard protocols. Body composition was measured using dual-energy x-ray absorptiometry scans, and fitness was measured using a 6-min walk test.ResultsParticipants were 61.48 years old (SD 5.60), 85% (34/40) female, 65% (26/40) white. Average activity monitor wear time was 81.85 (SD 3.73) of 90 days. Of the 20 Up24 monitors, 5 were reported broken and 1 lost. No related adverse events were reported. Acceptability items were rated at least 4 on a scale of 1-5. Effect sizes for most outcomes were small, including stepping time per day (d=0.35), steps per day (d=0.26), sitting time per day (d=0.21), body fat (d=0.17), and weight (d=0.33).ConclusionsThe intervention was feasible and acceptable in this population. Effect sizes were similar to the sizes found using other wearable electronic activity monitors, indicating that when combined with telephone counseling, wearable activity monitors are a potentially effective tool for increasing physical activity and decreasing sedentary behavior.Trial registrationClinicaltrials.gov NCT01869348; https://clinicaltrials.gov/ct2/show/NCT01869348 (Archived by WebCite at http://www.webcitation.org/6odlIolqy).

Project description:ObjectiveThe purpose of this study was to examine the feasibility and acceptability of a wearable device and telehealth counseling physical activity intervention early after lumbar spine surgery.MethodsSixteen patients were randomized to an 8-session physical activity intervention or to usual postoperative care after surgery. The intervention included a wearable device (ie, Fitbit) and telehealth counseling by a licensed physical therapist. The feasibility of study procedures was assessed through recruitment, randomization, retention, and participation rates. Acceptability was assessed through a satisfaction survey and median within-participant change in objective physical activity (steps per day and time spent in moderate-to-vigorous physical activity [MVPA]) and patient-reported outcomes.ResultsOf 64 participants who were eligible, recruitment and randomization rates were 41 and 62%, respectively. Retention for objective physical activity and patient-reported outcomes was 94 and 100%, respectively, at 6-month follow-up. Seven (88%) participants in the intervention group completed all telehealth sessions, and 6 (75%) met step goals over the 8 sessions. All participants in the intervention group found the wearable device and telehealth counseling to be helpful and reported it much or somewhat more important than other postoperative services. Median within-participant change for steps per day improved from baseline (preoperative) to 6 months after surgery for both the intervention (1070) and usual care (679) groups, while MVPA only improved for the intervention group (2.2. minutes per day). Improvements in back and leg pain and disability were noted for both groups. No adverse events were reported in the study.ConclusionCombining wearable technology and telehealth counseling is a feasible approach to promote the physical activity during the early postoperative period after spine surgery. Future randomized controlled trials are needed to investigate the efficacy of leveraging wearables and telehealth during postoperative rehabilitation.ImpactThis study has implications for the clinical dissemination of physical activity strategies in the rehabilitation setting.

Project description:BackgroundUntreated perinatal mood and anxiety disorders (PMAD) have short- and long-term health and social consequences; online cognitive behavioral therapy (CBT) interventions can reduce symptoms. Despite partner support being protective online interventions rarely target couples. This study builds on research on an existing CBT-based intervention, the Mothers and Babies Online Course (eMB), by testing its feasibility with prenatal couples.MethodsWe conducted a pilot, randomized, controlled feasibility trial using a 1:1 parallel design. To be eligible, participant dyads were pregnant people (between 13-30 weeks gestation and with a score of 10 or greater on either the GAD-7 or PHQ-9 scale indicating elevated symptoms of anxiety or depression) and their cohabitating partners, living in Missouri, with access to the internet; both in the dyad consented to participate. Recruitment occurred via Facebook ads, flyers, and a snowball approach. The intervention group received eMB, and the control group received a list of community resources. We examined retention and adherence data extracted from eMB analytics and study databases. All participants were given depression and anxiety scales at baseline, 4 and 8 weeks to test preliminary efficacy; satisfaction and acceptability were measured at trial end (i.e., eight weeks) and via interview.ResultsThere were 441 people who responded to recruitment materials, 74 pregnant people were screened; 19 partners did not complete enrolment, and 25 dyads were ineligible. There were 15 dyads per group (N = 30) who enrolled; all completed the study. The survey response rate was 90% but partners required nearly twice the number of reminders. No participant completed all lessons. Mean depression and anxiety scores dropped over time for dyads in control (M = -1.99, -1.53) and intervention (M = -4.80, -1.99). Intervention pregnant people's anxiety significantly decreased (M = -4.05; 95% CI [0.82, 7.27]) at time two compared to control. Twelve pregnant people and four partners participated in post-intervention interviews and suggested improvements for eMB.ConclusionOnline dyadic interventions can potentially reduce PMAD symptoms. However, to feasibly study eMB with couples, strategies to increase program adherence are necessary. Tailoring interventions to overtly include partners may be advantageous.Trial registrationClinicalTrials.gov NCT05867680, 19/05/2023.

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Dataset Information

Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity Intervention for Pregnant Women With Diabetes: The Fit for Two Pilot Study.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

Feasibility and Acceptability of a Counseling- and mHealth-Based Physical Activity Intervention for Pregnant Women With Diabetes: The Fit for Two Pilot Study.

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