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Discussing Weight Management With Type 2 Diabetes Patients in Primary Care Using the Small Talk Big Difference Intervention: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Guidelines for the management of type 2 diabetes universally recommend that adults with type 2 diabetes and obesity be offered individualized interventions to encourage weight loss. Yet despite the existing recommendations, provision of weight management services is currently patchy around the United Kingdom and where services are available, high attrition rates are often reported. In addition, individuals often fail to take up services, that is, after discussion with a general practitioner or practice nurse, individuals are referred to the service but do not attend for an appointment. Qualitative research has identified that the initial discussion raising the issue of weight, motivating the patient, and referring to services is crucial to a successful outcome from weight management. OBJECTIVE:Our aim was to evaluate the effectiveness of an Internet-based training program and practice implementation toolkit with or without face-to-face training for primary care staff. The primary outcome is the change in referral rate of patients with type 2 diabetes to National Health Service adult weight management programs, 3 months pre- and postintervention. METHODS:We used the Behavior Change Wheel to develop an intervention for staff in primary care consisting of a 1-hour Internet-based eLearning package covering the links between obesity, type 2 diabetes, and the benefits of weight management, the treatment of diabetes in patients with obesity, specific training in raising the issue of weight, local services and referral pathways, overview of weight management components/ evidence base, and the role of the referrer. The package also includes a patient pamphlet, a discussion tool, a practice implementation checklist, and an optional 2.5-hour face-to-face training session. We have randomly assigned 100 practices in a 1:1 ratio to either have immediate access to all the resources or have access delayed for 4 months. An intention-to-treat statistical analysis will be performed. RESULTS:Recruitment to the study is now complete. We will finalize follow-up in 2018 and publish in early 2019. CONCLUSIONS:This protocol describes the development and randomized evaluation of the effectiveness of an intervention to improve referral and uptake rates of weight management programs for adults with type 2 diabetes. At a time when many new dietary and pharmacological weight management interventions are showing large clinical benefits for people with type 2 diabetes, it is vital that primary care practitioners are willing, skilled, and able to discuss weight and make appropriate referrals to services. TRIAL REGISTRATION:ClinicalTrials.gov NCT03360058; https://clinicaltrials.gov/ct2/show/NCT03360058 (Archived by WebCite at http://www.webcitation.org/74HI8ULfn). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12162.

SUBMITTER: Brooksbank K

PROVIDER: S-EPMC6396071 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Discussing Weight Management With Type 2 Diabetes Patients in Primary Care Using the Small Talk Big Difference Intervention: Protocol for a Randomized Controlled Trial.

Brooksbank Katriona K O'Donnell Joanne J Corbett Vicky V Shield Sarah S Ainsworth Rachel R Shearer Ross R Montgomery Susan S Gallagher Andrew A Duncan Hannah H Hamilton Lorna L Laszlo Valerie V Noone Rhonda R Baxendale Anna A Blane David D Logue Jennifer J

JMIR research protocols 20190215 2

<h4>Background</h4>Guidelines for the management of type 2 diabetes universally recommend that adults with type 2 diabetes and obesity be offered individualized interventions to encourage weight loss. Yet despite the existing recommendations, provision of weight management services is currently patchy around the United Kingdom and where services are available, high attrition rates are often reported. In addition, individuals often fail to take up services, that is, after discussion with a genera ...[more]

PMID: 30767902

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Project description:BackgroundObesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss weight management with patients or support behavior change. Evidence shows that commercial weight management services, that most primary care trusts have 'on prescription', are more effective than primary care treatment.Methods/designWe propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress, or advice to lose weight on medical grounds. The primary outcome will be weight change at 12-months. Other questions are: what actions do people take to manage their weight in response to the two GP intervention types? How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type? How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention? What is the cost per kg/m2 lost for each intervention? Research assistants visiting GP practices in England (n?=?60) would objectively measure weight and height prior to GP consultations and randomize willing patients (body mass index 30+, excess body fat, 18+ years) using sealed envelopes. Full recruitment (n?=?1824) is feasible in 46 weeks, requiring six sessions of advice-giving per GP. Participants will be contacted at 3 months (postintervention) via telephone to identify actions they have taken to manage their weight. We will book appointments for participants to be seen at their GP practice for a 12-month follow-up.DiscussionTrial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop Smoking Service. Likewise, the intervention could be introduced in the Quality and Outcomes Framework and influence practice worldwide.Trial registrationCurrent Controlled Trials ISRCTN26563137.

Project description:IntroductionObesity and physical inactivity are major societal challenges and significant contributors to the global burden of disease and healthcare costs. Information and communication technologies are increasingly being used in interventions to promote behaviour change in diet and physical activity. In particular, social networking platforms seem promising for the delivery of weight control interventions.We intend to pilot test an intervention involving the use of a social networking mobile application and tracking devices (Fitbit Flex 2 and Fitbit Aria scale) to promote the social comparison of weight and physical activity, in order to evaluate whether mechanisms of social influence lead to changes in those outcomes over the course of the study.Methods and analysisMixed-methods study involving semi-structured interviews and a pre-post quasi-experimental pilot with one arm, where healthy participants in different body mass index (BMI) categories, aged between 19 and 35 years old, will be subjected to a social networking intervention over a 6-month period. The primary outcome is the average difference in weight before and after the intervention. Secondary outcomes include BMI, number of steps per day, engagement with the intervention, social support and system usability. Semi-structured interviews will assess participants' expectations and perceptions regarding the intervention.Ethics and disseminationEthics approval was granted by Macquarie University's Human Research Ethics Committee for Medical Sciences on 3 November 2016 (ethics reference number 5201600716).The social network will be moderated by a researcher with clinical expertise, who will monitor and respond to concerns raised by participants. Monitoring will involve daily observation of measures collected by the fitness tracker and the wireless scale, as well as continuous supervision of forum interactions and posts. Additionally, a protocol is in place to monitor for participant misbehaviour and direct participants-in-need to appropriate sources of help.

Project description:BackgroundBlack men are more likely to be diagnosed with type 2 diabetes (T2D) compared to non-Hispanic White men, and this disparity increases among men over the age of 55. A growing body of literature demonstrates the critical role of gender in the management of health behaviors such as T2D and shows that male gender norms can conflict with healthy behaviors. These studies suggest that tailoring diabetes self-management interventions to address the needs of Black men may be critical to helping them to achieve optimal health outcomes. Further, our own research on Blacks with T2D found gender disparities in participation in diabetes interventions, with males participating at significantly lower rates than females. Peer leaders are trained lay individuals who are used to provide ongoing diabetes self-management support to people with diabetes, particularly in minority communities. However, despite studies showing that diabetes management interventions using peer leaders have been successful, the majority of peer leaders as well as the participants in those studies are women. The limited studies to date suggest that Black men with T2D prefer peer-led, male-to-male T2D programs, however, this research consists primarily of nonrandomized, small sample feasibility studies calling for additional studies to establish the efficacy of these approaches. The proposed study will develop and preliminarily validate the effectiveness of an adapted peer leader diabetes self-management support (PLDSMS) intervention designed to improve diabetes-related lifestyle and self-management behaviors in Black men (over 55) with T2D.MethodWe propose to tailor an existing intervention by 1) our using male peers and 2) modifying the peer leader training content to focus on material appropriate for men. The proposed study includes a developmental phase (development of the intervention with expert feedback, followed by feasibility testing with Black men) and a validation phase [randomized clinical trial (RCT)].DiscussionIf successful, this study will lead to the development and dissemination of an intervention that will address the unique needs of Black men with T2D, helping them to achieve optimal diabetes self-management and health outcomes.Trial registrationRegistered at ClinicalTrials.gov with an ID NCT04760444 on February 17, 2021.

Dataset Information

Discussing Weight Management With Type 2 Diabetes Patients in Primary Care Using the Small Talk Big Difference Intervention: Protocol for a Randomized Controlled Trial.

Publications

Discussing Weight Management With Type 2 Diabetes Patients in Primary Care Using the Small Talk Big Difference Intervention: Protocol for a Randomized Controlled Trial.

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