Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial (Preprint)

BACKGROUND The evidence for the effectiveness of Web-based therapies comes mainly from nonclinical populations, with a few studies in primary care. There is little evidence from patients referred to secondary mental health care with depression. Adherence to Web-based therapies is often poor. One way to increase this is to create a new health service role of a coach to guide people through the therapy. OBJECTIVE This study aimed to test in people referred to secondary care with depression if a Web-based therapy (The Journal) supported by a coach plus usual care would be more effective in reducing depression compared with usual care plus an information leaflet about Web-based resources after 12 weeks. METHODS We conducted a randomized controlled trial with two parallel arms and a process evaluation that included structured qualitative interviews analyzed using thematic analysis. The coach had a background in occupational therapy. Participants were recruited face-to-face at community mental health centers. RESULTS We recruited 63 people into the trial (intervention 35, control 28). There were no statistically significant differences in the change from baseline in Patient Health Questionnaire-9 (PHQ-9) scores at 12 weeks comparing The Journal with usual care (mean change in PHQ-9 score 9.4 in the intervention group and 7.1 in the control group, t41=1.05, P=.30; mean difference=2.3, 95% CI −2.1 to 6.7). People who were offered The Journal attended on average about one less outpatient appointment compared with usual care, although this difference was not statistically significant (intervention mean number of visits 2.8 (SD 5.5) compared with 4.1 (SD 6.7) in the control group, t45=−0.80, P=.43; mean difference=1.3, 95% CI −4.5 to 2.0). The process evaluation found that the mean number of lessons completed in the intervention group was 2.5 (SD=1.9; range=0-6) and the number of contacts with the coach was a mean of 8.1 (SD=4.4; range=0-17). The qualitative interviews highlighted the problem of engaging clinicians in research and their resistance to recruitment: technical difficulties with The Journal, which prevented people logging in easily; difficulty accessing The Journal as it was not available on mobile devices; participants finding some lessons difficult; and participants saying they were too busy to complete the sessions. CONCLUSIONS The study demonstrated that it is feasible to use a coach in this setting, that people found it helpful, and that it did not conflict with other care that participants were receiving. Future trials need to engage clinicians at an early stage to articulate where Web-based therapies fit into existing clinical pathways; Web-based therapies should be available on mobile devices, and logging in should be easy. The role of the coach should be explored in larger trials. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ACTRN): 12613000015741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363351&isReview=true (Archived by WebCite at http://www.webcitation.org/6wEyCc6Ss).

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Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/mental.8510 ◽

2018 ◽

Vol 5 (1) ◽

pp. e5 ◽

Cited By ~ 5

Author(s):

Simon Hatcher ◽

Robyn Whittaker ◽

Murray Patton ◽

Wayne Sylvester Miles ◽

Nicola Ralph ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Qualitative Interviews ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

Randomized Controlled

Background The evidence for the effectiveness of Web-based therapies comes mainly from nonclinical populations, with a few studies in primary care. There is little evidence from patients referred to secondary mental health care with depression. Adherence to Web-based therapies is often poor. One way to increase this is to create a new health service role of a coach to guide people through the therapy. Objective This study aimed to test in people referred to secondary care with depression if a Web-based therapy (The Journal) supported by a coach plus usual care would be more effective in reducing depression compared with usual care plus an information leaflet about Web-based resources after 12 weeks. Methods We conducted a randomized controlled trial with two parallel arms and a process evaluation that included structured qualitative interviews analyzed using thematic analysis. The coach had a background in occupational therapy. Participants were recruited face-to-face at community mental health centers. Results We recruited 63 people into the trial (intervention 35, control 28). There were no statistically significant differences in the change from baseline in Patient Health Questionnaire-9 (PHQ-9) scores at 12 weeks comparing The Journal with usual care (mean change in PHQ-9 score 9.4 in the intervention group and 7.1 in the control group, t41=1.05, P=.30; mean difference=2.3, 95% CI −2.1 to 6.7). People who were offered The Journal attended on average about one less outpatient appointment compared with usual care, although this difference was not statistically significant (intervention mean number of visits 2.8 (SD 5.5) compared with 4.1 (SD 6.7) in the control group, t45=−0.80, P=.43; mean difference=1.3, 95% CI −4.5 to 2.0). The process evaluation found that the mean number of lessons completed in the intervention group was 2.5 (SD=1.9; range=0-6) and the number of contacts with the coach was a mean of 8.1 (SD=4.4; range=0-17). The qualitative interviews highlighted the problem of engaging clinicians in research and their resistance to recruitment: technical difficulties with The Journal, which prevented people logging in easily; difficulty accessing The Journal as it was not available on mobile devices; participants finding some lessons difficult; and participants saying they were too busy to complete the sessions. Conclusions The study demonstrated that it is feasible to use a coach in this setting, that people found it helpful, and that it did not conflict with other care that participants were receiving. Future trials need to engage clinicians at an early stage to articulate where Web-based therapies fit into existing clinical pathways; Web-based therapies should be available on mobile devices, and logging in should be easy. The role of the coach should be explored in larger trials. Trial Registration Australian New Zealand Clinical Trials Registry (ACTRN): 12613000015741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363351&isReview=true (Archived by WebCite at http://www.webcitation.org/6wEyCc6Ss).

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Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/15001 ◽

2020 ◽

Vol 22 (6) ◽

pp. e15001

Author(s):

Sarah MacLean ◽

Daniel J Corsi ◽

Sadie Litchfield ◽

Julia Kucharski ◽

Kira Genise ◽

...

Keyword(s):

Quality Of Life ◽

Mental Health ◽

Health Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

Randomized Controlled

Background Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. Objective We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. Methods We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). Results A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. Conclusions The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. Trial Registration ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

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Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial (Preprint)

10.2196/preprints.15001 ◽

2019 ◽

Author(s):

Sarah MacLean ◽

Daniel J. Corsi ◽

Sadie Litchfield ◽

Julia Kucharski ◽

Kira Genise ◽

...

Keyword(s):

Quality Of Life ◽

Mental Health ◽

Health Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

Randomized Controlled

BACKGROUND Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. OBJECTIVE We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. METHODS We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). RESULTS A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. CONCLUSIONS The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. CLINICALTRIAL ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

Palliative & Supportive Care ◽

10.1017/s1478951518000901 ◽

2019 ◽

Vol 17 (1) ◽

pp. 46-53

Author(s):

Kaori Ichihara ◽

Sayako Ouchi ◽

Sachiko Okayama ◽

Fukiko Kinoshita ◽

Mitsunori Miyashita ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Usual Care ◽

Pain Assessment ◽

Spiritual Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

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Effects of an attachment-based parent intervention on mothers of children with autism spectrum disorder: preliminary findings from a non-randomized controlled trial

Child and Adolescent Psychiatry and Mental Health ◽

10.1186/s13034-021-00389-z ◽

2021 ◽

Vol 15 (1) ◽

Author(s):

Nobuyo Kubo ◽

Megumi Kitagawa ◽

Sayaka Iwamoto ◽

Toshifumi Kishimoto

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Self Efficacy ◽

Controlled Trial ◽

Intervention Group ◽

Children With Autism ◽

Autism Spectrum ◽

Control Group ◽

Randomized Controlled ◽

Children With Asd

Abstract Background Caregivers of children with autism spectrum disorders (ASD) often experience difficulties in responding appropriately to the needs of those children, who typically express attachment in distinct and nonconventional ways. This highlights the need for an attachment-based approach targeted at caregivers of children with ASD. Circle of Security Parenting (COSP), an attachment-based parenting program, is designed to increase caregivers’ sensitivity to children’s attachment needs. The aim of this study was to provide verification of the effectiveness of COSP in mothers of children with ASD. Methods This study was a non-randomized controlled trial. Sixty mothers of children with ASD aged 4–12 were recruited. Twenty mothers received the COSP intervention, while 40 did not. The characteristics of children in the control group were matched with those of the intervention group. To evaluate the outcomes of the intervention, changes in parental self-efficacy and mental health were assessed using the Tool to Measure Parenting Self-Efficacy (TOPSE) and the General Health Questionnaire-30 (GHQ-30). The children’s improvement in emotional and behavioral problems was assessed from the mothers’ perspective using the Child Behavior Checklist (CBCL). Both groups completed the assessments in parallel. Evaluations were compared between baseline (T1) and 6-month follow-up (T2). Results Scores for self-efficacy and mental health of mothers and behavior of children were significantly improved from T1 to T2 in the intervention group, but not in the control group. Participants’ mental health was markedly worsened in the control group. Conclusion This study demonstrated that the COSP program for mothers of children with ASD improved their parental self-efficacy and mental health, and reduced their subjective sense of difficulties related to their children’s behaviors. Our findings support the effectiveness of the attachment-based program for mothers of children with ASD, providing the groundwork for further studies of the attachment-based intervention for children with ASD and their families. Future studies with larger samples and randomization are also needed for direct evaluation of the improvement of children's attachment security, and for exploration of the synergistic relationship between various family support strategies and COSP. Trial Registration This trial was registered with the University Hospital Medical Information Network Clinical Trial Registry (No. UMIN000039574)

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A randomized controlled trial of a brief educational and psychological intervention for patients presenting to a cardiac clinic with palpitation

Psychological Medicine ◽

10.1017/s0033291702005536 ◽

2002 ◽

Vol 32 (4) ◽

pp. 699-706 ◽

Cited By ~ 11

Author(s):

R. MAYOU ◽

D. SPRIGINGS ◽

J. BIRKHEAD ◽

J. PRICE

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Educational Intervention ◽

Psychological Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Number Needed To Treat ◽

Treatment Needs ◽

Randomized Controlled

Background. We sought to determine whether a brief psycho-educational intervention reduced disability in patients with benign palpitation.Method. In a pragmatic randomized controlled trial within a cardiology clinic at a district general hospital, 80 consecutive patients diagnosed as having benign palpitation – either palpitation due to awareness of extrasystoles or sinus rhythm – with associated distress or disability were randomized to an intervention group (usual care plus nurse-delivered intervention based on cognitive-behavioural principles) or to a control group (usual care). Principal outcome was difference in proportion of participants with good or excellent researcher-rated activity levels at 3 months. Subsidiary outcomes were self-rated symptoms, distress and disability, researcher-rated unmet treatment needs.Results. The principal outcome showed a statistically and clinically significant benefit for the intervention group, with a number needed to treat of 3 (95% CIs 2 to 7). All but one subsidiary outcomes also showed a difference in favour of the intervention group, and several differences reached statistical significance. Significantly more of the control group had unmet treatment needs at 3 months.Conclusions. A brief, nurse-delivered, psycho-educational intervention, was an effective treatment for benign palpitation. Further evaluation, including assessment of cost-effectiveness, is needed. The findings have application to the care of patients presenting with other types of ‘unexplained’ medical symptoms.

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The effectiveness of a web-based psycho-education program in a community in Selangor, Malaysia: A randomized controlled trial (Preprint)

10.2196/preprints.10472 ◽

2020 ◽

Author(s):

Sherina Mohd-Sidik ◽

Siti Fatimah Kader Maideen ◽

Lekhraj Rampal ◽

Firdaus Mukhtar

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Health Literacy ◽

Mental Health Literacy ◽

Controlled Trial ◽

Control Group ◽

Depression And Anxiety ◽

Web Based ◽

Randomized Controlled ◽

Significant Difference

BACKGROUND Background Mental health problems namely depression and anxiety are the most common problems in the community. Often patients do not seek professional care due to the stigma attached to it. OBJECTIVE The study aimed to determine the effectiveness of a web-based psycho-education program in managing mild depression and anxiety. Methods METHODS A two-arm randomized controlled trial of a single blinded, parallel study comparing a four weeks of web-based psycho-education intervention program versus a wait list control group was carried out. The intervention program consisted of four sessions, with each session accessed on a weekly basis. Participants aged 18 years and above, who have participated in the first phase of this study, having access to internet and who are internet literate were invited to participate in the study. By using a random number table, 119 eligible and consented participants were randomly assigned to either the intervention or the control group using random number table. The primary outcomes were depression and anxiety score while the secondary outcome was mental health literacy score, which were all assessed at baseline, week 5 and week 12. Analysis was based on intention to treat analysis. RESULTS Significant difference in the mental health literacy score between the intervention and the control group was observed, F (1,117) = 20.149, p<0.001, n2=0.142. No significant difference was found in the depression (p= 0.361) and anxiety scores (p= 0.797). CONCLUSIONS The psycho-education intervention was effective in increasing the mental health literacy of the participants. CLINICALTRIAL The trial is registered in International Standard Randomized Controlled Trial, ISRCTN 39656144.

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Effects of the Satir Model on Mental Health: A Randomized Controlled Trial

Research on Social Work Practice ◽

10.1177/1049731518819829 ◽

2018 ◽

Vol 29 (7) ◽

pp. 775-785 ◽

Cited By ~ 1

Author(s):

Way Kwok-Wai Lau ◽

Pamela Pui-Yu Leung ◽

Catherine Lai-Ping Chung

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Mental Health Problems ◽

Controlled Trial ◽

Intervention Group ◽

Health Problems ◽

Control Group ◽

Mediation Analyses ◽

Randomized Controlled ◽

The Relationship

Objective: This randomized controlled trial examined the effect of an intensive experiential workshop based on the Satir growth model (SGM) that aims at cultivating self-transformation. Method: Ninety-six adult participants were randomly assigned to the intervention group (52 participants) or the wait-list control group. The role of self-transformation, measured by the Perceived Self-Transformation Scale, in the relationship between affects and mental health problems was examined using mediation analyses. Results: After the workshop, the intervention group demonstrated higher levels of self-transformation (η2 = .308, p < .001), as well as significant improvement ( p < .001) in positive (η2 = .557) and negative (η2 = .293) affects, self-esteem (η2 = .538), spirituality (η2 = .473), and mental health problems (η2 = .386). Importantly, increased self-transformation after the workshop partially mediated the relationship between reduced negative affect and mental health problems in the intervention group (indirect effect: β = 0.163, 95% confidence interval [0.035, 0.343]). Conclusion: Findings of this study suggest that the SGM-based intervention can be effective in ameliorating mental health problems.

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Effect of the Pregnant+ Smartphone App on the Dietary Behavior of Women With Gestational Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial (Preprint)

10.2196/preprints.18614 ◽

2020 ◽

Author(s):

Lisa Garnweidner-Holme ◽

Lena Henriksen ◽

Liv Elin Torheim ◽

Mirjam Lukasse

Keyword(s):

Diabetes Mellitus ◽

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Intervention Group ◽

Dietary Behavior ◽

Smartphone App ◽

Control Group ◽

Food Frequency ◽

Randomized Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. A healthy diet and stable blood glucose levels during pregnancy can prevent adverse health outcomes for the mother and the newborn child. Mobile health may be a useful supplement to prenatal care, providing women with targeted dietary information concerning GDM. OBJECTIVE We analyzed secondary data from a two-arm, multicentered, nonblinded randomized controlled trial to determine if a smartphone app with targeted dietary information and blood glucose monitoring had an effect on the dietary behavior of women with GDM. METHODS Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L were individually randomized to either the intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only. Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017. The Pregnant+ app promoted 10 GDM-specific dietary recommendations. A healthy dietary score for Pregnant+ (HDS-P+) was constructed from a 41-item food frequency questionnaire and used to assess the intervention effect on the dietary behavior completed at trial entry and at around gestation week 36. Dietary changes from baseline to week 36 were examined by a paired sample two-tailed t test. Between-group dietary differences after the intervention were estimated with analysis of covariance, with adjustment for baseline diet. RESULTS A total of 238 women participated: 115 were allocated to the intervention group and 123 to the control group. Of the 238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36. All the participants showed improvements in their HDS-P+ from baseline. However, the Pregnant+ app did not have a significant effect on their HDS-P+. The control group reported a higher weekly frequency of choosing fish meals (P=.05). No other significant differences were found between the intervention and control groups. There were no significant demographic baseline differences between the groups, except that more women in the intervention group had a non-Norwegian language as their first language (61 vs 46; P=.02). CONCLUSIONS Our findings do not support the supplementation of face-to-face follow-up of women with GDM with a smartphone app in the presence of high-standard usual care, as the Pregnant+ app did not have a beneficial effect on pregnant women’s diet. CLINICALTRIAL ClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729

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