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

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 <i>t</i> 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 (<i>P</i>=.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; <i>P</i>=.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

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

10.2196/18614 ◽  
2020 ◽  
Vol 8 (11) ◽  
pp. e18614
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. Trial Registration ClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729

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

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.

scholarly journals EVALUASI INTERVENSI MEDIA BOOKLET TERHADAP TINGKAT PENGETAHUAN DAN KEPATUHAN PASIEN DIABETES MELITUS TIPE 2 DI PUSKESMAS BANJARBARU SELATAN

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Valentina Meta Srikartika ◽  
M. Rasyid Akbar ◽  
Herningtyas Nautika Lingga
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Level Of Knowledge ◽  
Diabetes Melitus

ABSTRAKKeberhasilan pengobatan diabetes melitus tidak hanya dipengaruhi oleh kualitas pelayanan kesehatan, keterampilan petugasnya, sikap, dan pola hidup pasien, tetapi dipengaruhi juga oleh kepatuhan pasien terhadap pengobatannya. Tingkat kepatuhan minum obat pasien diabetes mellitus di Indonesia mayoritas masih berada dibawah 50%. Tujuan dari penelitian ini adalah mengukur pengaruh edukasi melalui media booklet terhadap pengetahuan dan kepatuhan pasien diabetes melitus tipe 2. Jenis penelitian yang digunakan adalah Randomized Controlled Trial (RCT). Populasi yang didapat dari penelitian ini sebanyak 40 orang dengan kelompok kontrol 20 orang dan kelompok intervensi 20 orang. Kelompok kontrol merupakan kelompok yang tidak mendapatkan booklet, sedangkan kelompok intervensi adalah kelompok yang mendapatkan booklet sebagi media edukasi. Pengetahuan dan kepatuhan responden diukur melalui kuesioner yang diberikan sebelum (pretest) dan 2 minggu kemudian (posttest). Rata-rata skor pengetahuan dan kepatuhan pre-test dibandingkan dengan skor post-test dengan menggunakan uji Wilcoxon. Berdasarkan hasil analisis, terjadi perbedaan tingkat pengetahuan dan kepatuhan yang signifikan (p value < 0,001) antara sebelum dan sesudah pemberian booklet pada kelompok intervensi dan tidak ada perbedaan yang signifikan pada tingkat pengetahuan (p value = 0,83) dan kepatuhan (p value = 0,317) pada kelompok kontrol. Oleh karena itu, dapat disimpulkan bahwa media booklet dapat meningkatkan tingkat pengetahuan dan kepatuhan pada pasien diabetes melitus.Kata-kata kunci: Diabetes melitus, pengetahuan, kepatuhan, bookletABSTRACTThe success of a treatment of diabetes mellitus is not only influenced by the quality of health services, the skills of its officers, attitudes, and lifestyle of patients, but it is also influenced by patient adherence to treatment. The level of medication compliance among diabetes patients in Indonesia were still below 50%. The purpose of this study was to measure the effect of education through booklet media on the knowledge and compliance of patients with type 2 diabetes mellitus. The type of research used was Randomized Controlled Trial (RCT). The population obtained from this study were 40 people with a control group of 20 people and an intervention group of 20 people. The control group was the group that did not get the booklet, while the intervention group was the group that received the booklet as an educational medium. Knowledge and compliance of respondents was measured through questionnaires given before (pretest) and 2 weeks later (posttest). The average score of knowledge and adherence between pretest and posttest will be compared using Wilcoxon analysis. Based on the results of data analysis with the Wilcoxon test, there was a significant difference in the level of knowledge and compliance (p value < 0.001) between before and after booklet administration in the intervention group and no significant difference in knowledge level (p value = 0.83) and compliance (p value = 0.317) in the control group. It can be concluded that the booklet media can increase the level of knowledge and compliance in diabetes mellitus patients.Keywords: Diabetes mellitus, knowledge, compliance, booklet

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

2002 ◽  
Vol 32 (4) ◽  
pp. 699-706 ◽  
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.

scholarly journals Effectiveness of a Non-pharmacological Intervention to Control Diabetes Mellitus in a Primary Care Setting in Kerala: A Cluster-Randomized Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Arya Rahul ◽  
Sujatha Chintha ◽  
Thekkumkara Surendran Anish ◽  
Kannamkottapilly Chandrasekharan Prajitha ◽  
Pillaveetil Sathyadas Indu
Keyword(s):  
Diabetes Mellitus ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Glycemic Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Baseline Values ◽  
Cluster Randomized

Background: Despite being the first Indian state with a dedicated Non-Communicable Disease (NCD) program, glycemic control among a large proportion of patients is low in Kerala. This study tries to find evidence for a standardized non-pharmacological strategy delivered through Junior Public Health Nurses (JPHNs) in achieving and maintaining glycemic control among diabetic patients registered with NCD clinics of primary health care settings.Design: A cluster randomized controlled trial was conducted among adult patients with Diabetes Mellitus attending NCD clinics of primary care settings of South Kerala, India. JPHNs of the intervention group received additional module-based training while standard management continued in the control group. Sequence generation was done by random permuted blocks method and a cluster of 12 patients was selected from each of the 11 settings by computer-generated random numbers. Patients were followed up for 6 months with monthly monitoring of Fasting Blood Sugar (FBS), Post-Prandial Blood Sugar (PPBS), blood pressure, Body Mass Index (BMI), and health-related behaviors. Knowledge and skills/practice of JPHNs were also evaluated. Analysis of Covariance was done to study the final outcome adjusting for the baseline values and a model for glycemic control was predicted using multilevel modeling.Results: We analyzed 72 participants in the intervention group and 60 participants in the control group according to the intention-to-treat principle. The intervention was associated with a significant reduction in FBS (p &lt; 0.001) and PPBS (p &lt; 0.001) adjusting for the baseline values. The achievement of glycemic control was 1.5 (95% CI: 1.05–2.3) times better with intervention and they showed a better trend of maintenance of glycemic control (FBS, p = 0.003 and PPBS, p = 0.039). Adjusting for clustering and the baseline values, the intervention showed a significant effect on FBS (B = −3.1, SE = 0.57; p &lt; 0.001) and PPBS (B = −0.81, SE = 0.3; p &lt; 0.001) with time. Drug adherence score (p &lt; 0.001), hours of physical activity (p &lt; 0.001), BMI (p = 0.002), fruit intake (p = 0.004), and green leafy vegetable intake (p = 0.01) were the major predictors of FBS control. The practice/skills score of the JPHNs significantly improved with intervention (p &lt; 0.001) adjusting for baseline values.Conclusion: A well-designed health worker intervention package incorporated into the existing health system can translate into attitude change and skill development in the health workers which can reflect in the improvement of glycemic control among the patients.Trial registration: [URL: http://www.ctri.nic.in], identifier [CTRI/2017/11/010622].

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

2018 ◽  
Vol 5 (1) ◽  
pp. e5 ◽  
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).

scholarly journals Improving gait adaptability in patients with hereditary spastic paraplegia (Move-HSP): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lotte van de Venis ◽  
Bart P. C. van de Warrenburg ◽  
Vivian Weerdesteyn ◽  
Bas J. H. van Lith ◽  
Alexander C. H. Geurts ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Hereditary Spastic Paraplegia ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Spastic Paraplegia ◽  
Randomized Controlled ◽  
Near Falls

Abstract Background People with hereditary spastic paraplegia (HSP) experience difficulties adapting their gait to meet environmental demands, a skill required for safe and independent ambulation. Gait adaptability training is possible on the C-Mill, a treadmill equipped with augmented reality, enabling visual projections to serve as stepping targets or obstacles. It is unknown whether gait adaptability can be trained in people with HSP. Aim The aim of Move-HSP is to study the effects of ten 1-h sessions of C-Mill training, compared with usual care, on gait adaptability in people with pure HSP. In addition, this study aims to identify key determinants of C-Mill training efficacy in people with pure HSP. Method Move-HSP is a 5-week, two-armed, open-label randomized controlled trial with a cross-over design for the control group. Thirty-six participants with pure HSP will be included. After signing informed consent, participants are randomized (1:1) to intervention or control group. All participants register (near) falls for 15 weeks, followed by the first assessment (week 16), and, thereafter, wear an Activ8 activity monitor for 7 days (week 16). The intervention group receives 10 sessions of C-Mill training (twice per week, 1-h sessions; weeks 17–21), whereas control group continues with usual care (weeks 17–21). Afterwards, both groups are re-assessed (week 22). Subsequently, the intervention group enter follow-up, whereas control group receives 10 sessions of C-Mill training (weeks 23–27), is re-assessed (week 28), and enters follow-up. During follow-up, both groups wear Activ8 activity monitors for 7 days (intervention group: week 23, control group: week 29) and register (near) falls for 15 weeks (intervention group: weeks 23–37, control group: weeks 29–43), before the final assessment (intervention group: week 38, control group: week 44). The primary outcome is the obstacle subtask of the Emory Functional Ambulation Profile. Secondary outcomes consist of clinical tests assessing balance and walking capacity, physical activity, and fall monitoring. Discussion Move-HSP will be the first RCT to assess the effects of C-Mill gait adaptability training in people with pure HSP. It will provide proof of concept for the efficacy of gait adaptability training in people with pure HSP. Trial registration Clinicaltrials.gov NCT04180098. Registered on November 27, 2019.

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

2017 ◽  
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. 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).

scholarly journals Feasibility Randomized Controlled Trial of ImpulsePal: Smartphone App–Based Weight Management Intervention to Reduce Impulsive Eating in Overweight Adults (Preprint)

2018 ◽  
Author(s):  
Samantha B van Beurden ◽  
Jane R Smith ◽  
Natalia S Lawrence ◽  
Charles Abraham ◽  
Colin J Greaves
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Dual Process ◽  
Feasibility Trial ◽  
Smartphone App ◽  
Control Group ◽  
Eligibility Criteria ◽  
Management Intervention ◽  
Randomized Controlled

BACKGROUND ImpulsePal is a theory-driven (dual-process), evidence-informed, and person-centered smartphone app intervention designed to help people manage impulsive processes that prompt unhealthy eating to facilitate dietary change and weight loss. OBJECTIVE The aims of this study were to (1) assess the feasibility of trial procedures for evaluation of the ImpulsePal intervention, (2) estimate standard deviations of outcomes, and (3) assess usability of, and satisfaction with, ImpulsePal. METHODS We conducted an individually randomized parallel two-arm nonblinded feasibility trial. The eligibility criteria included being aged ≥16 years, having a body mass index of ≥25 kg/m2, and having access to an Android-based device. Weight was measured (as the proposed primary outcome for a full-scale trial) at baseline, 1 month, and 3 months of follow-up. Participants were randomized in a 2:1 allocation ratio to the ImpulsePal intervention or a waiting list control group. A nested action-research study allowed for data-driven refinement of the intervention across 2 cycles of feedback. RESULTS We screened 179 participants for eligibility, and 58 were randomized to the intervention group and 30 to the control group. Data were available for 74 (84%, 74/88) participants at 1 month and 67 (76%, 67/88) participants at 3 months. The intervention group (n=43) lost 1.03 kg (95% CI 0.33 to 1.74) more than controls (n=26) at 1 month and 1.01 kg (95% CI −0.45 to 2.47) more than controls (n=43 and n=24, respectively) at 3 months. Feedback suggested changes to intervention design were required to (1) improve receipt and understanding of instructions and (2) facilitate further engagement with the app and its strategies. CONCLUSIONS The evaluation methods and delivery of the ImpulsePal app intervention are feasible, and the trial procedures, measures, and intervention are acceptable and satisfactory to the participants. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 14886370; http://www.isrctn.com/ISRCTN14886370 (Archived by WebCite at http://www.webcitation.org/76WcEpZ51)

scholarly journals Fall and Balance Outcomes After an Intervention to Promote Leg Strength, Balance, and Walking in People With Diabetic Peripheral Neuropathy: “Feet First” Randomized Controlled Trial

2010 ◽  
Vol 90 (11) ◽  
pp. 1568-1579 ◽  
Author(s):  
Robin L. Kruse ◽  
Joseph W. LeMaster ◽  
Richard W. Madsen
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Lower Extremity ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Intervention Group ◽  
Control Group ◽  
Foot Care ◽  
Randomized Controlled ◽  
Lower Extremity Strength

Background Weight-bearing exercise has been discouraged for people with diabetes mellitus and peripheral neuropathy (DM+PN). However, people with diabetes mellitus and insensate feet have an increased risk of falling. Lower-extremity exercise and balance training reduce fall risk in some older adults. It is unknown whether those with neuropathy experience similar benefits. Objective As part of a study of the effects of weight-bearing exercise on foot ulceration in people with DM+PN, the effects of a lower-extremity exercise and walking intervention on balance, lower-extremity strength (force-generating capacity), and fall incidence were determined. Design The study was an observer-masked, 12-month randomized controlled trial. Setting Part 1 of the intervention took place in physical therapy offices, and part 2 took place in the community. Patients The participants were 79 people who were mostly sedentary, who had DM+PN, and who were randomly assigned to either a control group (n=38) or an intervention group (n=41). Intervention Part 1 included leg strengthening and balance exercises and a graduated, self-monitored walking program; part 2 included motivational telephone calls. Both groups received regular foot care, foot care education, and 8 sessions with a physical therapist. Measurements The measurements collected were strength, balance, and participant-reported falls for the year after enrollment. Results There were no statistically significant differences between the groups for falls during follow-up. At 12 months, there was a small increase in the amount of time that participants in the intervention group could stand on 1 leg with their eyes closed. No other strength or balance measurements differed between the groups. Limitations The study was designed to detect differences in physical activity, not falls. The intensity of the intervention was insufficient to improve strength and balance in this population. Conclusions The training program had a minimal effect on participants' balance and lower-extremity strength. Increasing weight-bearing activity did not alter the rate of falling for participants in the intervention group relative to that for participants in the control group. People who are sedentary and who have DM+PN appear to be able to increase activity without increasing their rate of falling.

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