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Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes mellitus: study protocol of myDIDeA.

ABSTRACT: The potential of web-based interventions in dietary behaviour modification of the diabetics has not been fully explored. We describe the protocol of a 12-month match-design randomised controlled trial of a web-based dietary intervention for type 2 diabetic patients with primary aim to evaluate the effect of the intervention on their dietary knowledge, attitude and behaviour (KAB). The secondary objective of this study is to improve the participants' dietary practices, physical measurements and biomarkers.A minimum total sample of 82 Type 2 diabetics will be randomised, either to the control group, who will receive the standard diabetes care or the e-intervention group, who will participate in a 6-month web-based dietary intervention in addition to the standard care. The dietary recommendations are based on existing guidelines, but personalised according to the patients' Stages of Change (SOC). The participants will be followed up for 6 months post-intervention with data collection scheduled at baseline, 6-month and 12-month.We are aiming for a net improvement in the KAB score in participants of the e-intervention group, besides investigating the impact of the e-intervention on the dietary practices, physical measurements and blood biomarkers of those patients. The successful outcome of this study can be a precursor for policy makers to initiate more rigorous promotion of such web-based programmes in the country.Clinicaltrials.gov NCT01246687.

SUBMITTER: Ramadas A

PROVIDER: S-EPMC3123593 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature

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Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes mellitus: study protocol of myDIDeA.

Ramadas Amutha A Quek Kia Fatt KF Chan Carina K Y CK Oldenburg Brian B Hussein Zanariah Z

BMC public health 20110521

<h4>Background</h4>The potential of web-based interventions in dietary behaviour modification of the diabetics has not been fully explored. We describe the protocol of a 12-month match-design randomised controlled trial of a web-based dietary intervention for type 2 diabetic patients with primary aim to evaluate the effect of the intervention on their dietary knowledge, attitude and behaviour (KAB). The secondary objective of this study is to improve the participants' dietary practices, physical ...[more]

PMID: 21599990

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Project description:BACKGROUND:Increasing prevalence and disease burden has led to an increasing demand of programs and studies focused on dietary and lifestyle habits, and chronic diseases such as type 2 diabetes mellitus (T2DM). We evaluated the effects of a 6-month web-based dietary intervention on Dietary Knowledge, Attitude and Behaviour (DKAB), Dietary Stages of Change (DSOC), fasting blood glucose (FBG) and glycosylated haemoglobin (HbA1c) in patients with uncontrolled HbA1c (>?7.0%) in a randomised-controlled trial (myDIDeA) in Malaysia. METHODS:The e-intervention group (n =?62) received a 6-month web-delivered intensive dietary intervention while the control group (n =?66) continued with their standard hospital care. Outcomes (DKAB and DSOC scores, FBG and HbA1c) were compared at baseline, post-intervention and follow-up. RESULTS:While both study groups showed improvement in total DKAB score, the margin of improvement in mean DKAB score in e-intervention group was larger than the control group at post-intervention (11.1?±?0.9 vs. 6.5?±?9.4,p <?0.001) and follow-up (19.8?±?1.1 vs. 7.6?±?0.7,p <?0.001), as compared to the baseline. Although there was no significant difference between intervention and control arms with respect to DSOC score and glycaemic control, the e-intervention group showed improved DSOC score (199.7?±?18.2 vs193.3?±?14.6,p =?0.046), FBG (7.9?±?2.5 mmol/L vs. 8.9?±?3.9 mmol/L,p =?0.015) and HbA1c (8.5?±?1.8% vs. 9.1?±?2.0%,p =?0.004) at follow-up compared to the baseline, whereas such improvement was not seen in the control group. CONCLUSIONS:Most important impact of myDIDeA was on the overall DKAB score. This study is one of the first to demonstrate that an e-intervention can be a feasible method for implementing chronic disease management in developing countries. Concerns such as self-monitoring, length of intervention, intense and individualized intervention, adoption of other domains of Transtheoretical Model and health components, and barriers to change have to be taken into consideration in the development of future intervention programs. TRIAL REGISTRATION:ClinicalTrials.gov NCT01246687 .

Project description:BACKGROUND:Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. OBJECTIVE:The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. METHODS:We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. RESULTS:General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. CONCLUSIONS:Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).

Project description:BackgroundLifestyle change is probably the most important single action to prevent type 2 diabetes mellitus. The purpose of this study was to assess the effects of a low-intensity individual lifestyle intervention by a physician and compare this to the same physician intervention combined with an interdisciplinary, group-based approach in a real-life setting.MethodsThe "Finnish Diabetes Risk score" (FINDRISC) was used by GPs to identify individuals at high risk. A randomised, controlled design and an 18 month follow-up was used to assess the effect of individual lifestyle counselling by a physician (individual physician group, (IG)) every six months, with emphasis on diet and exercise, and compare this to the same individual lifestyle counselling combined with a group-based interdisciplinary program (individual and interdisciplinary group, (IIG)) provided over 16 weeks. Primary outcomes were changes in lifestyle indicated by weight reduction ≥ 5%, improvement in exercise capacity as assessed by VO2 max and diet improvements according to the Smart Diet Score (SDS).Results213 participants (104 in the IG and 109 in the IIG group, 50% women), with a mean age of 46 and mean body mass index 37, were included (inclusion rate > 91%) of whom 182 returned at follow-up (drop-out rate 15%). There were no significant differences in changes in lifestyle behaviours between the two groups. At baseline 57% (IG) and 53% (IIG) of participants had poor aerobic capacity and after intervention 35% and 33%, respectively, improved their aerobic capacity at least one metabolic equivalent. Unhealthy diets according to SDS were common in both groups at baseline, 61% (IG) and 60% (IIG), but uncommon at follow-up, 17% and 10%, respectively. At least 5% weight loss was achieved by 35% (IG) and 28% (IIG). In the combined IG and IIG group, at least one primary outcome was achieved by 93% while all primary outcomes were achieved by 6%. Most successful was the 78% reduction in the proportion of participants with unhealthy diet (almost 50% absolute reduction).ConclusionIt is possible to achieve important lifestyle changes in persons at risk for type 2 diabetes with modest clinical efforts. Group intervention yields no additional effects. The design of the study, with high inclusion and low dropout rates, should make the results applicable to ordinary clinical settings.Trial registrationClinicalTrials.gov: NCT00202748.

Project description:Intimate partner violence (IPV) and its associated negative mental health consequences are significant for women in New Zealand and internationally. One of the most widely recommended interventions is safety planning. However, few women experiencing violence access specialist services for safety planning. A safety decision aid, weighing the dangers of leaving or staying in an abusive relationship, gives women the opportunity to prioritise, plan and take action to increase safety for themselves and their children. This randomised controlled trial is testing the effectiveness of an innovative, interactive web-based safety decision aid. The trial is an international collaborative concurrent replication of a USA trial (IRIS study NCT01312103), regionalised for the Aotearoa New Zealand culture and offers fully automated online trial recruitment, eligibility screening and consent.In a fully automated web-based trial (isafe) 340 abused women will be randomly assigned in equal numbers to a safety decision aid intervention or usual safety planning control website. Intervention components include: (a) safety priority setting, (b) danger assessment and (c) an individually tailored safety action plan. Self-reported outcome measures are collected at baseline and 3, 6, and 12-months post-baseline. Primary outcomes are depression (measured by Center for Epidemiologic Studies Depression Scale, Revised) and IPV exposure (measured by Severity Violence Against Women Scale) at 12 months post-baseline. Secondary outcomes include PTSD, psychological abuse, decisional conflict, safety behaviors and danger in the relationship.This trial will provide much-needed information on the potential relationships among safety planning, improved mental health, reduced violence as well as decreased decisional conflict related to safety in the abusive relationship. The novel web-based safety decision aid intervention may provide a cost-effective, easily accessed safety-planning resource that can be translated into clinical and community practice by multiple health disciplines and advocates. The trial will also provide information about how women in abusive relationships safely access safety information and resources through the Internet. Finally, the trial will inform other research teams on the feasibility and acceptability of fully automated recruitment, eligibility screening, consent and retention procedures.Trial registered on 03 July 2012 on the Australian New Zealand Clinical Trials Registry ACTRN12612000708853 .

Project description:IntroductionApproximately 35% of patients with cancer experience clinically significant distress, and unmet psychological supportive care needs are prevalent. This study describes the protocol for a randomised controlled trial (RCT) to assess the efficacy and cost-effectiveness of an internet-based psychological intervention for distressed patients with cancer.Methods and analysisIn phase I, the intervention was developed on an interactive web platform and pilot tested for acceptability using a qualitative methodology with 21 patients with cancer. Phase II is an RCT underway with patients with or at risk of elevated psychological distress comparing: (1) static patient education website with (2) individualised web-delivered cognitive behavioural intervention (CancerCope). Participants were recruited through the Queensland Cancer Registry and Cancer Council Helpline and met the following inclusion criteria: (1) recently diagnosed with cancer; (2) able to read and speak English; (3) no previous history of head injury, dementia or psychiatric illness; (4) no other concurrent cancer; (5) phone and internet access; (5) scored ?4 on the Distress Thermometer. Participants are assessed at four time points: baseline/recruitment and 2, 6 and 12 months after recruitment and intervention commencement. Of the 163 participants recruited, 50% met caseness for distress. The area of highest unmet supportive care needs were psychological followed by physical and daily living needs. Primary outcomes are psychological and cancer-specific distress and unmet psychological supportive care needs. Secondary outcomes are positive adjustment, quality of life and cost-effectiveness.Ethics and disseminationEthical approval was obtained from the Griffith University Human Research Ethics Committee (Approval: PSY/70/13/HREC) and the Metro South Human Research Ethics Committee (HREC/13/QPAH/601). All participants provide informed consent prior to taking part in the study. Once completed, this study will provide recommendations about the efficacy of web-based cognitive behavioural interventions to facilitate better psychosocial adjustment for people with cancer.Trial registration numberANZCTR (ACTRN12613001026718).

Project description:IntroductionGestational diabetes mellitus (GDM) is a glucose intolerance occurring in 3%-10% of pregnant women and being a risk factor for multiple maternal and fetal complications. The risk of perinatal complications is proportional to the level of maternal hyperglycaemia. Proper glycaemic control is therefore one of the key elements of GDM therapy. Until recently, determination of blood glucose concentration was performed using glucose meters, which involved multiple fingerpricks. Nowadays, due to the flash glucose monitoring (FGM) availability, it is possible to collect measurements at any time without routine puncturing. The aim of the presented study is to assess the impact of FGM on the efficacy of treatment in population of patients diagnosed with GDM.Methods and analysisThis is a prospective, randomised study, that will recruit 100 women at 24-28 weeks of gestation at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland. Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomised to the FGM or self-monitoring of blood glucose groups. Further on, clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy. Primary outcome is mean glycaemia result in each group after 1 month analysis and percentage of results in the target glycaemic range. The secondary objectives will be to compare the two groups for maternal and neonatal outcomes in conjunction with long-term glycaemic control using blood glycated haemoglobin and fructosamine serum concentrations.Ethics and disseminationThe study is exempt from regional ethics review due to its nature of quality improvement in patient care. The study has been approved by the Bioethics Committee at the Medical University of Warsaw and the patient privacy protection boards governing over the recruitment sites. Results of the study will be presented in peer-reviewed journals and at conferences.Trial registration numberNCT04422821.

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Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes mellitus: study protocol of myDIDeA.

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Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes mellitus: study protocol of myDIDeA.

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