scholarly journals A Feasible and Efficacious Mobile-Phone Based Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Melinda S Bender ◽  
Bruce A Cooper ◽  
Linda G Park ◽  
Sara Padash ◽  
Shoshana Arai
Keyword(s):  
Weight Loss ◽  
Controlled Trial ◽  
Phase 1 ◽  
Intervention Group ◽  
Filipino Americans ◽  
Phase 2 ◽  
Filipino American ◽  
Potential Efficacy

BACKGROUND Filipino Americans have a high prevalence of obesity, type 2 diabetes (T2D), and cardiovascular disease compared with other Asian American subgroups and non-Hispanic whites. Mobile health (mHealth) weight loss interventions can reduce chronic disease risks, but these are untested in Filipino Americans with T2D. OBJECTIVE The objective of this study was to assess feasibility and potential efficacy of a pilot, randomized controlled trial (RCT) of a culturally adapted mHealth weight loss lifestyle intervention (Pilipino Americans Go4Health [PilAm Go4Health]) for overweight Filipino Americans with T2D. METHODS This was a 2-arm pilot RCT of the 3-month PilAm Go4Health intervention (phase 1) with an active waitlist control and 3-month follow-up (phase 2). The waitlist control received the PilAm Go4Health in phase 2, whereas the intervention group transitioned to the 3-month follow-up. PilAm Go4Health incorporated a Fitbit accelerometer, mobile app with diary for health behavior tracking (steps, food/calories, and weight), and social media (Facebook) for virtual social support, including 7 in-person monthly meetings. Filipino American adults ≥18 years with T2D were recruited from Northern California. Feasibility was measured by rates of recruitment, engagement, and retention. Multilevel regression analyses assessed within and between group differences for the secondary outcome of percent weight change and other outcomes of weight (kg), body mass index (BMI), waist circumference, fasting plasma glucose, HbA1c, and steps. RESULTS A total of 45 Filipino American adults were enrolled and randomized. Mean age was 58 (SD 10) years, 62% (28/45) were women, and mean BMI was 30.1 (SD 4.6). Participant retention and study completion were 100%, with both the intervention and waitlist group achieving near-perfect attendance at all 7 intervention office visits. Groups receiving the PilAm Go4Health in phase 1 (intervention group) and phase 2 (waitlist group) had significantly greater weight loss, −2.6% (−3.9 to −1.4) and −3.3% (−1.8 to −4.8), respectively, compared with the nonintervention group, resulting in a moderate to small effect sizes (d=0.53 and 0.37, respectively). In phase 1, 18% (4/22) of the intervention group achieved a 5% weight loss, whereas 82% (18/22) maintained or lost 2% to 5% of their weight and continued to maintain this weight loss in the 3-month follow-up. Other health outcomes, including waist circumference, BMI, and step counts, improved when each arm received the PilAm Go4Health, but the fasting glucose and HbA1c outcomes were mixed. CONCLUSIONS The PilAm Go4Health was feasible and demonstrated potential efficacy in reducing diabetes risks in overweight Filipino Americans with T2D. This study supports the use of mHealth and other promising intervention strategies to reduce obesity and diabetes risks in Filipino Americans. Further testing in a full-scale RCT is warranted. These findings may support intervention translation to reduce diabetes risks in other at-risk diverse populations. CLINICALTRIAL Clinicaltrials.gov NCT02290184; https://clinicaltrials.gov/ct2/show/NCT02290184 (Archived by WebCite at http://www.webcitation.org/6vDfrvIPp)

scholarly journals Healthy Dads, Healthy Kids UK, a weight management programme for fathers: feasibility RCT

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e033534 ◽  
Author(s):  
Tania Griffin ◽  
Yongzhong Sun ◽  
Manbinder Sidhu ◽  
Peymane Adab ◽  
Adrienne Burgess ◽  
...  
Keyword(s):  
Weight Loss ◽  
Weight Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Management Programme ◽  
Feasibility Trial ◽  
Minority Ethnic Group ◽  
Weight Management Programme ◽  
Overweight Or Obesity

ObjectiveTo assess (1) the feasibility of delivering a culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK), for fathers with overweight or obesity and their primary school-aged children, and (2) the feasibility of conducting a definitive randomised controlled trial (RCT).DesignA two-arm, randomised feasibility trial with a mixed-methods process evaluation.SettingSocioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK.ParticipantsFathers with overweight or obesity and their children aged 4–11 years.InterventionParticipants were randomised in a 1:2 ratio to control (family voucher for a leisure centre) or intervention comprising 9 weekly healthy lifestyle group sessions.OutcomesFeasibility of the intervention and RCT was assessed according to prespecified progression criteria: study recruitment, consent and follow-up, ability to deliver intervention, intervention fidelity, adherence and acceptability, weight loss, using questionnaires and measurements at baseline, 3 and 6 months, and through qualitative interviews.ResultsThe study recruited 43 men, 48% of the target sample size; the mean body mass index was 30.2 kg/m2 (SD 5.1); 61% were from a minority ethnic group; and 54% were from communities in the most disadvantaged quintile for socioeconomic deprivation. Recruitment was challenging. Retention at follow-up of 3 and 6 months was 63%. Identifying delivery sites and appropriately skilled and trained programme facilitators proved difficult. Four programmes were delivered in leisure centres and community venues. Of the 29 intervention participants, 20 (69%) attended the intervention at least once, of whom 75% attended ≥5 sessions. Sessions were delivered with high fidelity. Participants rated sessions as ‘good/very good’ and reported lifestyle behavioural change. Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI −5.1 to −0.6).ConclusionsThe intervention was well received, but there were significant challenges in recruitment, programme delivery and follow-up. The HDHK-UK study was not considered feasible for progression to a full RCT based on prespecified stop–go criteria.Trial registration numberISRCTN16724454.

scholarly journals A Randomized Controlled Trial of an Educational Intervention to Promote Oral and Dental Health of Patients with Type 2 Diabetes Mellitus

2020 ◽  
Author(s):  
Maryam Mallekmahmoodi ◽  
Mohsen Shamsi ◽  
Nasrin Roozbahani ◽  
Rahmatollah Moradzadeh
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Type 2 Diabetes Mellitus ◽  
Dental Hygiene ◽  
Controlled Trial ◽  
Intervention Group ◽  
Randomized Controlled

Abstract Background: Diabetes is the most prevalent disease resulted from metabolic disorders. This study aimed to investigate the effect of training based on health belief model (HBM) on oral hygiene-related behaviors in patients with type 2 diabetes mellitus. Methods: This study was conducted as an educational randomized controlled trial (single blind) on 120 patients with type 2 diabetes referring to a diabetes clinic selected through systematic sampling, who were assigned to two groups of control (N=60) and intervention (N=60). The data collection tool was a valid and reliable questionnaire based on HBM which was completed by both groups before the intervention. Then, the intervention group received 4 sessions of educational program based on HBM in one month, and the same questionnaire was completed again after 3 months and the data were analyzed through SPSS version 20 software with inferential statistics, t-test, paired t-tests, Chi square, Mann-Whitney test, and Wilcoxon test analysis. Results: Three months after the intervention, awareness of the patients and perceived susceptibility, benefits, self-efficacy, internal cue to action, and performance in oral and dental hygiene-related behaviors had a significant increase in the intervention group (p<0.05). So that the performance of oral and dental hygiene in the intervention group increased from 2.16 ± 0.71 to 3.25 ± 0.49 (p=0.001) after the education. Conclusion: Our results suggest that training patients with diabetes based on HBM as well as through active follow-up can enhance their skills in oral and dental hygiene-related behaviors. Controlling, monitoring and follow-up during the program are also recommended.

scholarly journals Long-term weight loss following a randomised controlled trial of a weight management programme for men delivered through professional football clubs: the Football Fans in Training follow-up study

2018 ◽  
Vol 6 (9) ◽  
pp. 1-114 ◽  
Author(s):  
Cindy M Gray ◽  
Sally Wyke ◽  
Rachel Zhang ◽  
Annie S Anderson ◽  
Sarah Barry ◽  
...  
Keyword(s):  
Public Health ◽  
Weight Loss ◽  
Health Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Medical Record Linkage ◽  
Football Clubs ◽  
Portion Sizes

Background Rising levels of obesity require interventions that support people in long-term weight loss. The Football Fans in Training (FFIT) programme uses loyalty to football teams to engage men in weight loss. In 2011/12, a randomised controlled trial (RCT) found that the FFIT programme was effective in helping men lose weight up to 12 months. Objectives To investigate the long-term weight, and other physical, behavioural and psychological outcomes up to 3.5 years after the start of the RCT; the predictors, mediators and men’s qualitative experiences of long-term weight loss; cost-effectiveness; and the potential for long-term follow-up via men’s medical records. Design A mixed-methods, longitudinal cohort study. Setting Thirteen professional Scottish football clubs from the RCT and 16 additional Scottish football clubs that delivered the FFIT programme in 2015/16. Participants A total of 665 men who were aged 35–65 years at the RCT baseline measures and who consented to follow-up after the RCT (intervention group, n = 316; comparison group, n = 349), and 511 men who took part in the 2015/16 deliveries of the FFIT programme. Interventions None as part of this study. Main outcome measures Objectively measured weight change from the RCT baseline to 3.5 years. Results In total, 488 out of 665 men (73.4%) attended 3.5-year measurements. Participants in the FFIT follow-up intervention group sustained a mean weight loss from baseline of 2.90 kg [95% confidence interval (CI) 1.78 to 4.02 kg; p < 0.001], and 32.2% (75/233) weighed ≥ 5% less than at baseline. Participants in the FFIT follow-up comparison group (who participated in routine deliveries of the FFIT programme after the RCT) lost a mean of 2.71 kg (95% CI 1.65 to 3.77 kg; p < 0.001), and 31.8% (81/255) achieved ≥ 5% weight loss. Both groups showed long-term improvements in body mass index, waist circumference, percentage body fat, blood pressure, self-reported physical activity (PA) (including walking), the consumption of fatty and sugary foods, fruit and vegetables and alcohol, portion sizes, self-esteem, positive and negative affect, and physical and mental health-related quality of life (HRQoL). Mediators included self-reported PA (including walking) and sitting time, the consumption of fatty and sugary foods and fruit and vegetables, portion sizes, self-esteem, positive affect, physical HRQoL, self-monitoring of weight, autonomous regulation, internal locus of control, perceived competence, and relatedness to other FFIT programme participants and family members. In qualitative interviews, men described continuing to self-monitor weight and PA. Many felt that PA was important for weight control, and walking remained popular; most were still aware of portion sizes and tried to eat fewer snacks. The FFIT programme was associated with an incremental cost-effectiveness of £10,700–15,300 per quality-adjusted life-year (QALY) gained at 3.5 years, and around £2000 per QALY gained in the lifetime analysis. Medical record linkage provided rich information about the clinical health outcomes of the FFIT RCT participants, and 90% of men (459/511) who took part in the 2015/16 FFIT programme gave permission for future linkage. Conclusions Participation in the FFIT programme under both research (during the FFIT RCT) and routine (after the FFIT RCT) delivery conditions led to significant long-term weight loss. Further research should investigate (1) how to design programmes to improve long-term weight loss maintenance, (2) longer-term follow-up of FFIT RCT participants and (3) very long-term follow-up via medical record linkage. Trial registration Current Controlled Trials ISRCTN32677491. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 6, No. 9. See the NIHR Journals Library website for further project information. The Scottish Executive Health Department Chief Scientist Office (CSO) funded the feasibility pilot that preceded the FFIT RCT (CZG/2/504). The Medical Research Council (MRC) funded Kate Hunt and additional developmental research through the MRC/CSO Social and Public Health Sciences Unit Gender and Health programme (5TK50/25605200-68094).

scholarly journals A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial

10.2196/22147 ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. e22147
Author(s):  
Karen Lim ◽  
Shiao-Yng Chan ◽  
Su Lin Lim ◽  
Bee Choo Tai ◽  
Cammy Tsai ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Weight Loss ◽  
Controlled Trial ◽  
Intervention Group ◽  
Caloric Intake ◽  
First Trimester ◽  
Control Group ◽  
Optimal Weight ◽  
Randomized Controlled

Background Women with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited. Objective This trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes. Methods In this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group. Results In total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%). Conclusions Although a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management. Trial Registration ClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7691-3

scholarly journals Testing the effectiveness of a weight loss intervention to enhance self-regulation in adults who are obese: protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031572 ◽  
Author(s):  
Kerstin Frie ◽  
Jamie Hartmann-Boyce ◽  
Susan A Jebb ◽  
Paul Aveyard
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Self Regulation ◽  
Intervention Group ◽  
The Self ◽  
Regulatory Processes ◽  
Process Outcomes ◽  
Randomised Controlled

IntroductionPrevious trials finding an effect of self-monitoring on weight loss have considered the effect to be mediated by self-regulatory processes. However, a qualitative think-aloud study asking people to record thoughts and feelings during weighing showed that self-regulation occurs only rarely without further instruction. The aim of this trial is to test a novel intervention guiding people through the self-regulatory processes to see whether it facilitates weight loss.Methods and analysesA parallel group, randomised controlled trial will be conducted to test the concept that a self-regulation intervention for weight loss increases weight loss compared with daily self-weighing without further support. One hundred participants with a body mass index ≥30 kg/m2will be randomised to either the control or intervention group. The control group will be asked to weigh themselves daily for 8 weeks, the intervention group will be encouraged to follow the self-regulation intervention. They will be prompted to weigh daily, track their weight using an app, plan daily actions for weight loss and reflect on their action plans on a weekly basis. This self-regulation cycle will allow them to experiment with different weight loss strategies and identify effective and sustainable actions. Primary and process outcomes will be measured at baseline and 8 weeks’ follow-up. Linear regression analysis of the primary outcome, weight change, will assess the early effectiveness of the intervention. The process outcomes liking, perceived effectiveness, as well as usage and barriers with regard to the self-regulation intervention, will be assessed through qualitative analysis of follow-up interviews and quantitative analysis of adherence rates and responses to a final questionnaire.Ethics and disseminationThis trial was reviewed and approved by the NHS National Research Ethics Committee and the Health Research Authority (reference number: 18/SC/0482). The findings of the trial will be published in peer reviewed journals and presented at conferences.Trial registration numberISRCTN14148239, prerecruitment.Protocol versionVersion 1.1, 7 December 2018.

scholarly journals The Effect on Health Outcomes of Post-Intervention Transtheoretical Model-Based Motivational Interview in Adults with Type 2 Diabetes Mellitus: Follow up a Cross-Sectional Study

2019 ◽  
Vol 8 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Alime Selçuk-Tosun ◽  
Handan Zincir
Keyword(s):  
Diabetes Mellitus ◽  
Self Efficacy ◽  
Motivational Interview ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Self ◽  
Cross Sectional ◽  
Randomized Controlled

Introduction: The individuals with type 2 diabetes mellitus were supported with the individual motivational interview in the previous randomized controlled trial. The aim of this study was to assess whether the effect of motivational interview persists relative to the self-efficacy, metabolic control, and health-behavioral change of them. Methods: This study was contacted a cross-sectional design. This study was the follow-up to the previous randomized controlled trial. Total of 32 participants, including 18 from the intervention group and 14 from the control group, were contacted. No new intervention was performed to previous groups (control and intervention). The participants in the intervention and control groups were contacted by phone in the 18th month, and their self-efficacy, metabolic control and health behaviors were assessed. Results: The intergroup comparisons showed that the difference between the sixth month and 18th month was statistically significant except for medical treatment self-efficacy subscale score, postprandial blood glucose and waist circumference. The groups were similar in terms of their use of medicine, nutrition and physical activity behavior stages according to the 18th-month follow-up. Conclusion: This study found that the self-efficacy scores of the intervention group decreased negatively, and their metabolic values increased negatively in the 18th months, compared with the sixth month. In this respect, it is recommended that motivational interviews should be carried out at certain intervals assessing the characteristics of participants without discontinuing them after the intervention.

scholarly journals A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial

10.2196/15448 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e15448
Author(s):  
Emily Staite ◽  
Adam Bayley ◽  
Ebaa Al-Ozairi ◽  
Kurtis Stewart ◽  
David Hopkins ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Diabetes Prevention Program ◽  
Mean Difference ◽  
Control Group ◽  
Web Based ◽  
The Mean

Background Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. Objective This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. Methods We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. Results We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. Conclusions This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. Trial Registration ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397

scholarly journals Low-energy total diet replacement intervention in patients with type 2 diabetes mellitus and obesity treated with insulin: a randomized trial

2020 ◽  
Vol 8 (1) ◽  
pp. e001012 ◽  
Author(s):  
Adrian Brown ◽  
Anne Dornhorst ◽  
Barbara McGowan ◽  
Omar Omar ◽  
Anthony R Leeds ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Glycemic Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Low Energy ◽  
Control Group ◽  
Total Diet ◽  
Diabetes And Obesity

ObjectivesThe management of patients with long-standing type 2 diabetes and obesity receiving insulin therapy (IT) is a substantial clinical challenge. Our objective was to examine the effect of a low-energy total diet replacement (TDR) intervention versus standardized dietetic care in patients with long-standing type 2 diabetes and obesity receiving IT.Research design and methodsIn a prospective randomized controlled trial, 90 participants with type 2 diabetes and obesity receiving IT were assigned to either a low-energy TDR (intervention) or standardized dietetic care (control) in an outpatient setting. The primary outcome was weight loss at 12 months with secondary outcomes including glycemic control, insulin burden and quality of life (QoL).ResultsMean weight loss at 12 months was 9.8 kg (SD 4.9) in the intervention and 5.6 kg (SD 6.1) in the control group (adjusted mean difference −4.3 kg, 95% CI −6.3 to 2.3, p<0.001). IT was discontinued in 39.4% of the intervention group compared with 5.6% of the control group among completers. Insulin requirements fell by 47.3 units (SD 36.4) in the intervention compared with 33.3 units (SD 52.9) in the control (−18.6 units, 95% CI −29.2 to –7.9, p=0.001). Glycated Hemoglobin (HbA1c) fell significantly in the intervention group (4.7 mmol/mol; p=0.02). QoL improved in the intervention group of 11.1 points (SD 21.8) compared with 0.71 points (SD 19.4) in the control (8.6 points, 95% CI 2.0 to 15.2, p=0.01).ConclusionsPatients with advanced type 2 diabetes and obesity receiving IT achieved greater weight loss using a TDR intervention while also reducing or stopping IT and improving glycemic control and QoL. The TDR approach is a safe treatment option in this challenging patient group but requires maintenance support for long-term success.Trial registration numberISRCTN21335883.

scholarly journals The use of cardiac rehabilitation services to aid the recovery of patients with bowel cancer: a pilot randomised controlled trial with embedded feasibility study

2016 ◽  
Vol 4 (24) ◽  
pp. 1-232 ◽  
Author(s):  
Gill Hubbard ◽  
Julie Munro ◽  
Ronan O’Carroll ◽  
Nanette Mutrie ◽  
Lisa Kidd ◽  
...  
Keyword(s):  
Cardiac Rehabilitation ◽  
Controlled Trial ◽  
Phase 1 ◽  
Bowel Cancer ◽  
Phase 2 ◽  
Future Trial ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

BackgroundColorectal cancer (CRC) survivors are not meeting the recommended physical activity levels associated with improving their chances of survival and quality of life. Rehabilitation could address this problem.ObjectivesThe aims of the Cardiac Rehabilitation In Bowel cancer study were to assess whether or not cardiac rehabilitation is a feasible and acceptable model to aid the recovery of people with CRC and to test the feasibility and acceptability of the protocol design.DesignIntervention testing and feasibility work (phase 1) and a pilot randomised controlled trial with embedded qualitative study (phase 2), supplemented with an economic evaluation. Randomisation was to cardiac rehabilitation or usual care. Outcomes were differences in objective measures of physical activity and sedentary behaviour, self-reported measures of quality of life, anxiety, depression and fatigue. Qualitative work involved patients and clinicians from both cancer and cardiac specialties.SettingThree colorectal cancer wards and three cardiac rehabilitation facilities.ParticipantsInclusion criteria were those who were aged > 18 years, had primary CRC and were post surgery.ResultsPhase 1 (single site) – of 34 patient admissions, 24 (70%) were eligible and 4 (17%) participated in cardiac rehabilitation. Sixteen clinicians participated in an interview/focus group. Modifications to trial procedures were made for further testing in phase 2. Additionally, 20 clinicians in all three sites were trained in cancer and exercise, rating it as excellent. Phase 2 (three sites) – screening, eligibility, consent and retention rates were 156 (79%), 133 (67%), 41 (31%) and 38 (93%), respectively. Questionnaire completion rates were 40 (97.5%), 31 (75%) and 25 (61%) at baseline, follow-up 1 and follow-up 2, respectively. Forty (69%) accelerometer data sets were analysed; 20 (31%) were removed owing to invalid data.Qualitative studyCRC and cardiac patients and clinicians were interviewed. Key themes were benefits and barriers for people with CRC attending cardiac rehabilitation; generic versus disease-specific rehabilitation; key concerns of the intervention; and barriers to participation (CRC participants only).Economic evaluationThe average out-of-pocket expenses of attending cardiac rehabilitation were £50. The costs of cardiac rehabilitation for people with cancer are highly dependent on whether it involves accommodating additional patients in an already existing service or setting up a completely new service.Limitations and conclusionsThe main limitation is that this is a small feasibility and pilot study. The main novel finding is that cardiac rehabilitation for cancer and cardiac patients together is feasible and acceptable, thereby challenging disease-specific rehabilitation models.Future workThis study highlighted important challenges to doing a full-scale trial of cardiac rehabilitation but does not, we believe, provide sufficient evidence to reject the possibility of such a future trial. We recommend that any future trial must specifically address the challenges identified in this study, such as suboptimal consent, completion, missing data and intervention adherence rates and recruitment bias, and that an internal pilot trial be conducted. This should have clear ‘stop–proceed’ rules that are formally reviewed before proceeding to the full-scale trial.Trial registrationCurrent Controlled Trials ISRCTN63510637.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 4, No. 24. See the NIHR Journals Library website for further project information.

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