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Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA.

ABSTRACT: OBJECTIVES:(1) To estimate weight change from a low-carbohydrate diabetes prevention programme (LC-DPP) and (2) to evaluate the feasibility and acceptability of an LC-DPP. RESEARCH DESIGN:Single-arm, mixed methods (ie, integration of quantitative and qualitative data) pilot study. SETTING:Primary care clinic within a large academic medical centre in the USA. PARTICIPANTS:Adults with pre-diabetes and Body Mass Index of ?25?kg/m2. INTERVENTION:We adapted the Centers for Disease Control and Prevention's National Diabetes Prevention Program (NDPP)-an evidence-based, low-fat dietary intervention-to teach participants to follow a very low-carbohydrate diet (VLCD). Participants attended 23 group-based classes over 1?year. OUTCOME MEASURES:Primary outcome measures were (1) weight change and (2) percentage of participants who achieved ?5%?wt loss. Secondary outcome measures included intervention feasibility and acceptability (eg, attendance and qualitative interview feedback). RESULTS:Our enrolment target was 22. One person dropped out before a baseline weight was obtained; data from 21 individuals were analysed. Mean weight loss in kilogram was 4.3 (SD 4.8) at 6 months and 4.9 (SD 5.8) at 12 months. Mean per?cent body weight changes were 4.5 (SD 5.0) at 6 months and 5.2 (SD 6.0) at 12 months; 8/21 individuals (38%) achieved ?5%?wt loss at 12 months. Mean attendance was 10.3/16 weekly sessions and 3.4/7 biweekly or monthly sessions. Among interviewees (n=14), three factors facilitated VLCD adherence: (1) enjoyment of low-carbohydrate foods, (2) diminished hunger and cravings and (3) health benefits beyond weight loss. Three factors hindered VLCD adherence: (1) enjoyment of high-carbohydrate foods, (2) lack of social support and (3) difficulty preplanning meals. CONCLUSIONS:An LC-DPP is feasible, acceptable and may be an effective option to help individuals with pre-diabetes to lose weight. Data from this pilot will be used to plan a fully powered randomised controlled trial of weight loss among NDPP versus LC-DPP participants. TRIAL REGISTRATION NUMBER:NCT03258918.

SUBMITTER: Hafez Griauzde D

PROVIDER: S-EPMC7045213 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA.

Hafez Griauzde Dina D Saslow Laura L Patterson Kaitlyn K Ansari Tahoora T Liestenfeltz Bradley B Tisack Aaron A Bihn Patti P Shopinski Samuel S Richardson Caroline R CR

BMJ open 20200121 1

<h4>Objectives</h4>(1) To estimate weight change from a low-carbohydrate diabetes prevention programme (LC-DPP) and (2) to evaluate the feasibility and acceptability of an LC-DPP.<h4>Research design</h4>Single-arm, mixed methods (ie, integration of quantitative and qualitative data) pilot study.<h4>Setting</h4>Primary care clinic within a large academic medical centre in the USA.<h4>Participants</h4>Adults with pre-diabetes and Body Mass Index of ≥25 kg/m<sup>2</sup>.<h4>Intervention</h4>We adap ...[more]

PMID: 31969366

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Project description:IntroductionThe prevalence of type 2 diabetes is rising steeply. National Health Service England (NHSE) is exploring the potential of a digital diabetes prevention programme (DDPP) and has commissioned a pilot with embedded evaluation.Methods and analysisThis study aims to determine whether, and if so, how, should NHSE implement a national DDPP, using a mixed-methods pretest and post-test design, underpinned by two theoretical frameworks: the Coventry, Aberdeen and London - Refined (CALO-RE) taxonomy of behavioural change techniques for the digital interventions and the Consolidated Framework for Implementation Research (CFIR) for implementation processes. In eight pilot areas across England, adults with non-diabetic hyperglycaemia (NDH) (glycated haemoglobin (HbA1c) 42-47 mmol/mol or fasting plasma glucose 5.5-6.9 mmol/L) and adults without NDH who are overweight (body mass index (BMI) >25 kg/m2) or obese (BMI >30 kg/m2) will be referred to one of five digitally delivered diabetes prevention interventions. The primary outcomes are reduction in HbA1c and weight (for people with NDH) and reduction in weight (for people who are overweight or obese) at 12 months. Secondary outcomes include use of the intervention, satisfaction, physical activity, patient activation and resources needed for successful implementation. Quantitative data will be collected at baseline, 6 months and 12 months by the digital intervention providers. Qualitative data will be collected through semistructured interviews with commissioners, providers, healthcare professionals and patients. Quantitative data will be analysed descriptively and using generalised linear models to determine whether changes in outcomes are associated with demographic and intervention factors. Qualitative data will be analysed using framework analysis, with data pertaining to implementation mapped onto the CFIR.Ethics and disseminationThe study has received ethical approval from the Public Health England Ethics and Research Governance Group (reference R&D 324). Dissemination will include a report to NHSE to inform future policy and publication in peer-reviewed journals.

Project description:IntroductionAll Veterans Affairs (VA) Medical Centers offer the MOVE! Weight Management Program to help patients achieve and maintain a healthy weight through a calorie-restricted, low-fat diet and increased physical activity. Yet, most MOVE! participants do not achieve clinically significant weight loss of ≥5%. A carbohydrate-restricted diet may help more Veterans to achieve ≥5% weight loss.MethodsThis was a single-arm explanatory sequential mixed methods pilot study conducted in one VA health care system. Veterans with prediabetes and body mass index ≥25 kg/m2 were invited to participate in a group-based, virtual, very low-carbohydrate Diabetes Prevention Program (VLC-DPP) consisting of 23 sessions over 12 months. Participants were taught to follow a very low-carbohydrate eating pattern, defined as 20-35 grams of net carbohydrates per day. The primary outcomes were measures of feasibility and acceptability, including program uptake and session attendance. Secondary outcomes included change in weight, hemoglobin A1c, lipids, and patient-reported measures of food cravings, stress eating, perceived health status, and motivation. Interviews were conducted at 6 months to identify factors that facilitated or hindered participants' achievement of ≥5% weight loss.ResultsAmong 108 screened Veterans, 21 enrolled in the study (19%), and 18 were included in the analytic cohort. On average, participants attended 12.4/16 weekly sessions and 3.6/8 bimonthly or monthly sessions. At 12 months, mean percent weight loss was 9.4% (SD = 10.7) with 9 participants (50%) achieving ≥5% weight loss. Three factors facilitated achievement of ≥5% weight loss among 10/16 interviewees: (1) enjoyment of low-carbohydrate foods; (2) careful monitoring of carbohydrate intake; and (3) reduced hunger and food cravings. Three factors hindered achievement of ≥5% weight loss among 6/16 interviewees: (1) food cravings, particularly for sweets; (2) challenges with maintaining a food log; and (3) difficulty with meal planning.ConclusionA VLC-DPP is feasible and acceptable and shows preliminary efficacy among Veterans with prediabetes. The program's weight loss effectiveness compared to standard MOVE! should be evaluated in a larger-scale trial. Such a program may be offered in addition to the standard MOVE! program to expand the menu of evidence-based lifestyle counseling options for Veterans.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04881890, identifier NCT04881890.

Project description:BACKGROUND:Diabetes is a major contributor to global death and disability. Text-messaging interventions hold promise for improving diabetes outcomes through better knowledge and self-management. OBJECTIVE:The aim of this study was to examine the implementation and impact of a diabetes text-messaging program targeted primarily for low-income Latino patients receiving care at 2 federally qualified health centers (FQHCs). METHODS:A mixed-methods, quasi-experimental research design was employed for this pilot study. A total of 50 Spanish or English-speaking adult patients with diabetes attending 2 FQHC sites in Los Angeles from September 2015 to February 2016 were enrolled in a 12-week, bidirectional text-messaging program. A comparison group (n=160) was constructed from unexposed, eligible patients. Demographic data and pre/post clinical indicators were compared for both the groups. Propensity score weighting was used to reduce selection bias, and over-time differences in clinical outcomes between groups were estimated using individual fixed-effects regression models. Population-averaged linear models were estimated to assess differential effects of patient engagement on each clinical indicator among the intervention participants. A sample of intervention patients (n=11) and all implementing staff (n=8) were interviewed about their experiences with the program. Qualitative data were transcribed, translated, and analyzed to identify common themes. RESULTS:The intervention group had a mean glycated hemoglobin (HbA1c) reduction of 0.4 points at follow-up, relative to the comparison group (P=.06). Patients who were more highly engaged with the program (response rate ≥median of 64.5%) experienced a 2.2 point reduction in HbA1c, relative to patients who were less engaged, controlling for demographic characteristics (P<.001). Qualitative analyses revealed that many participants felt supported, as though "someone was worrying about [their] health." Participants also cited learning new information, setting new goals, and receiving helpful reminders. Staff and patients highlighted strategies to improve the program, including incorporating patient responses into in-person clinical care and tailoring the messages to patient knowledge. CONCLUSIONS:A diabetes text-messaging program provided instrumental and emotional support for participants and may have contributed to clinically meaningful improvements in HbA1c. Patients who were more engaged demonstrated greater improvement. Program improvements, such as linkages to clinical care, hold potential for improving patient engagement and ultimately, improving clinical outcomes.

Project description:BackgroundThe Healthier You National Health Service Digital Diabetes Prevention Programme (NHS-digital-DPP) is a 9-month digital behavior change intervention delivered by 4 independent providers that is implemented nationally across England. No studies have explored the design features included by service providers of digital diabetes prevention programs to promote engagement, and little is known about how participants of nationally implemented digital diabetes prevention programs such as this one make use of them.ObjectiveThis study aimed to understand engagement with the NHS-digital-DPP. The specific objectives were to describe how engagement with the NHS-digital-DPP is promoted via design features and strategies and describe participants' early engagement with the NHS-digital-DPP apps.MethodsMixed methods were used. The qualitative study was a secondary analysis of documents detailing the NHS-digital-DPP intervention design and interviews with program developers (n=6). Data were deductively coded according to an established framework of engagement with digital health interventions. For the quantitative study, anonymous use data collected over 9 months for each provider representing participants' first 30 days of use of the apps were obtained for participants enrolled in the NHS-digital-DPP. Use data fields were categorized into 4 intervention features (Track, Learn, Coach Interactions, and Peer Support). The amount of engagement with the intervention features was calculated for the entire cohort, and the differences between providers were explored statistically.ResultsData were available for 12,857 participants who enrolled in the NHS-digital-DPP during the data collection phase. Overall, 94.37% (12,133/12,857) of those enrolled engaged with the apps in the first 30 days. The median (IQR) number of days of use was 11 (2-25). Track features were engaged with the most (number of tracking events: median 46, IQR 3-22), and Peer Support features were the least engaged with, a median value of 0 (IQR 0-0). Differences in engagement with features were observed across providers. Qualitative findings offer explanations for the variations, including suggesting the importance of health coaches, reminders, and regular content updates to facilitate early engagement.ConclusionsAlmost all participants in the NHS-digital-DPP started using the apps. Differences across providers identified by the mixed methods analysis provide the opportunity to identify features that are important for engagement with digital health interventions and could inform the design of other digital behavior change interventions.

Project description:BackgroundGlobally, the prevalence of type 1 diabetes mellitus (T1DM) is rising. In 2020, a total of 124,652 Australians had T1DM. Maintaining optimal glycemic control (hemoglobin A1c ≤7.0%, ≤53 mmol/mol) on a standard carbohydrate diet can be a challenge for people living with T1DM. The Diabetes Complications and Control Trial established that macrovascular and microvascular complications could be reduced by improving glycemic control. Recent studies have found that a very low or low carbohydrate diet can improve glycemic control. However, the overall evidence relating to an association between a very low or low carbohydrate diet and glycemic control in people living with T1DM is both limited and mixed. In addition, research has suggested that a reduced quality of life due to anxiety and depression adversely influences glycemic control. Despite a potential link between a very low or low carbohydrate diet and optimal glycemic control, to our knowledge, no research has examined an association between a low carbohydrate diet, quality of life, and glycemic control, making this study unique in its approach.ObjectiveThe study aims to develop a validated diabetes-specific quality of life questionnaire for use in Australian adults with T1DM and to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in Australian adults living with T1DM.MethodsThis cross-sectional study will be conducted in a tertiary hospital outpatient setting and will consist of 3 phases: phase 1, online Australian diabetes-specific quality of life questionnaire development and piloting (25-30 adults with T1DM); phase 2, questionnaire validation (364 adults with T1DM); and phase 3, a 12-week dietary intervention to determine if an association exists between a low carbohydrate diet, quality of life, and glycemic control in adults with T1DM (16-23 adults with T1DM). The validation of the study-developed Australian diabetes-specific quality of life questionnaire, and changes in hemoglobin A1c and quality of life in adults with T1DM while undertaking a low carbohydrate diet over 12 weeks will be the primary outcomes of this study.ResultsPhase 1 of the study is currently open for recruitment and has recruited 12 participants to date. It is anticipated that the first results will be submitted for publication in November 2021. Presently, no results are available.ConclusionsThis study is the first of its kind in that it will be the first to generate a new validated instrument, which could be used in evidence-based practice and research to understand the quality of life of Australian adults with T1DM. Second, the low carbohydrate dietary intervention outcomes could be used to inform clinicians about an alternative approach to assist T1DM adults in improving their quality of life and glycemic control. Finally, this study could warrant the development of an evidence-based low carbohydrate dietary guideline for adults living with T1DM with the potential to have a profound impact on this population.Trial registrationClinicalTrials.gov NCT04213300; https://clinicaltrials.gov/ct2/show/NCT04213300.International registered report identifier (irrid)PRR1-10.2196/25085.

Project description:INTRODUCTION:Urban living has been shown to affect health in various ways. As the world is becoming more urbanised and almost two-thirds of people with diabetes now live in cities, research into the relationship between urban living, health and diabetes is key to improving the lives of many. The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through the Cities Changing Diabetes (CCD) partnership programme. METHODS AND ANALYSIS:A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. ETHICS AND DISSEMINATION:The protocol steers the collection of primary and secondary data across the study sites. Research ethics board approval has been sought and obtained in each site. Findings from each of the local studies as well as the result from combined multisite (global) analyses will be reported in a series of core scientific journal papers.

Project description:INTRODUCTION:Successful competitive employment has been found to be related to enhanced self-esteem, higher quality of life and reduced mental health service use for individuals living with serious mental illnesses (SMIs) including schizophrenia, bipolar disorder and major depression. The effectiveness of the individual placement and support model has been demonstrated in multiple randomised controlled trials in many countries. The management of stress, depression and anxiety in the workplace may be effectively enhanced through digital mental health interventions. The WorkingWell mobile support tool ('app') is specifically designed to meet the need for illness management support for individuals with SMI in the workplace, as an adjunct to professional treatment. METHODS AND ANALYSIS:The WorkingWell app, grounded in evidence-based supported employment, is informed by user experience design. It will be tested in a pre-post design, mixed-methods pilot study to explore issues of feasibility, acceptability and usefulness, and to provide preliminary data on the impact of use. Putative mediators of improved job tenure and psychological well-being, including postintervention changes in social support, self-efficacy and work-related motivation, will be investigated. Forty individuals at least 18 years of age, meeting the eligibility requirements for supported employment services (ie, diagnosed with a mental illness meeting the criteria for severity, duration and treatment), working a minimum of 10 hours per week at study enrolment, and speaking, reading and writing in English will be recruited for the pilot study. Research staff will recruit individuals at community-based mental health agencies; provide orientation to the study, the study smartphones and the WorkingWell app; conduct research interviews including standardised measures as well as semistructured items; and provide technical assistance in telephone calls and inperson meetings. A sample of 10 agency staff will be recruited to obtain further information on the feasibility, acceptability and usefulness of WorkingWell. ETHICS AND DISSEMINATION:The study design and procedures are approved by the Dartmouth-Hitchcock Medical Center Committee for the Protection of Human Subjects, the Massachusetts Department of Mental Health Central Office Research Review Committee and the Vermont Agency of Human Services Institutional Review Board. Study findings will be disseminated to agency partners, state agencies and funders, and to the research and technology development communities. Findings from the study will inform the design, data collection procedures and protocol for future full-scale randomised controlled trial testing of the effectiveness of the WorkingWell app, as well as investigations of work-related variables as mediators of psychological well-being and quality of life for individuals with SMI.

Project description:IntroductionAfrican American women (AA), particularly those living in the Southeastern USA, experience disproportionately high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool that may circumvent barriers to traditional HIV prevention tools, such as condom use; however, very little is known about how to improve PrEP access and uptake among AA women who may benefit from PrEP use. This project aims to understand how to increase PrEP access among AA women in the rural Southern USA, which may ultimately affect HIV incidence in this population.Methods and analysisThe goal of the current study is to systematically adapt a patient-provider communication tool to increase PrEP uptake among AA women receiving care at a federally qualified health centre in Alabama. We will use an iterative implementation process, by assessing the feasibility, acceptability and preliminary impact of the tool on PrEP uptake, using a pilot preintervention/postintervention design (N=125). We will evaluate women's reasons for declining a referral to a PrEP provider, reasons for incomplete referrals, reasons for not initiating PrEP after a successful referral and ongoing PrEP use at 3 and 12 months after PrEP initiation among our sample. The proposed work will significantly contribute to our understanding of factors impacting PrEP uptake and use among AA women, particularly in underserved areas in the Deep South that are heavily impacted by the HIV epidemic and experience worse HIV-related health outcomes relative to other areas in the USA.Ethics and disseminationThis protocol has been approved by the Institutional Review Board (IRB) at University of Alabama at Birmingham (Birmingham, AL; protocol 300004276). All participants will review a detailed informed consent form approved by the IRB and will provide written or verbal informed consent prior to enrolment. Results will be disseminated through peer-reviewed manuscripts, reports, and local, national and international presentations.Trial registration numberNCT04373551.

Project description:PurposeTo evaluate the ability of participants of a falls prevention programme to set and achieve goals.MethodsThe study used a prospective longitudinal design and a mixed-methods approach to data collection. Study participants were (1) 220 older adults participating in a 15-week combined exercise and education falls prevention programme and (2) 9 practitioners (3 home-care nurses, 5 community workers, and an exercise physiologist) involved in delivering the programme. Data from goal-setting forms were analyzed, and descriptive statistics were used to determine the number of appropriate goals set and achieved. Data were analyzed according to programme setting (home- or group-based) and whether or not participants were classified as being from a Culturally and Linguistically Diverse (CALD) background in the Australian context. Semi-structured interviews with programme practitioners were thematically analyzed.ResultsA total of 144 respondents (n=75 CALD group, n=41 non-CALD group, n=6 CALD home, n=22 non-CALD home) set 178 goals. Only 101 (57%) goals could be evaluated according to achievement, because participants set goals that focused on health state instead of behaviour, set goals not relevant to falls prevention, used inappropriate constructs to measure goal achievement, and either did not review their goals or dropped out of the programme before goal review. Of these 101 goals, 64 were achieved. Practitioners described their own difficulties in understanding the process of setting health behaviour goals along with communication, cultural, and logistic difficulties.ConclusionsBoth CALD and non-CALD participants and those participating in both group- and home-based programmes experienced difficulty in setting and achieving goals to facilitate behaviour change for falls prevention. Data suggest that home-based participants had more difficulty in setting goals than their group-based counterparts and, to a lesser extent, that CALD participants experienced more difficulty in setting goals than their non-CALD counterparts. The use of a guided approach to goal setting and the need for more specific practitioner training and follow-up support regarding goal setting in the context of a falls prevention programme should be considered.

Dataset Information

Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA.

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Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA.

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