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Development of a salutogenic intervention for healthy eating among Dutch type 2 diabetes mellitus patients.

ABSTRACT: Healthy eating can be challenging for type 2 diabetes mellitus (T2DM) patients. The theory of salutogenesis, which focuses on the resources required to organize behavioural changes in everyday life, was used to develop an intervention for healthy eating. The aim was to describe the development, structure and content of this salutogenic intervention. The development consisted of two phases that were based on the operationalization of important key principles of salutogenesis. In Phase 1 (Exploration and synthesis), a systematic review and three qualitative studies were performed to explore important characteristics to enable healthy eating in everyday life. The results were used to develop the draft intervention. In Phase 2 (Validation and adjustment), interviews and workshops were conducted with T2DM patients, healthcare providers and scientists. Based on this, the draft intervention was modified into its final form. The developmental process resulted in a 12-week, group-based intervention that aimed to enable important resources for healthy eating via self-examination, reflection, setting goals and sharing experiences. Attention was also paid to disease information, disease acceptance, food literacy, stress management, self-identity and social support. The group sessions began following an individual intake session, with a booster session held 3 months after the intervention. The researcher's translation of the stakeholders' priorities into an intervention was corrected for and approved by the stakeholders concerned. This comprehensive salutogenic intervention was developed based on practical and scientific evidence. Providing transparency in developmental processes and content is important because it determines the scientific integrity and credibility of an intervention.

SUBMITTER: Polhuis KCMM

PROVIDER: S-EPMC8827024 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Development of a salutogenic intervention for healthy eating among Dutch type 2 diabetes mellitus patients.

Polhuis Kristel C M M KCMM Vaandrager Lenneke L Soedamah-Muthu Sabita S SS Koelen Maria A MA

Health promotion international 20211201 6

Healthy eating can be challenging for type 2 diabetes mellitus (T2DM) patients. The theory of salutogenesis, which focuses on the resources required to organize behavioural changes in everyday life, was used to develop an intervention for healthy eating. The aim was to describe the development, structure and content of this salutogenic intervention. The development consisted of two phases that were based on the operationalization of important key principles of salutogenesis. In Phase 1 (Explorat ...[more]

PMID: 33667316

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Project description:BackgroundHealthy eating can improve the course of type 2 diabetes mellitus (T2DM) considerably. As changing eating behaviors in everyday is challenging, there is a need for a nutritional strategy with an eye for everyday life of people with T2DM. A theory centered around the everyday life context is salutogenesis. Salutogenic principles have been operationalized in a new nutritional program for T2DM on food literacy and well-being: the Salutogenic Intervention for Type 2 Diabetes (SALUD) program.ObjectiveThis study aims to describe the protocol of the invention study that will examine the quantitative and qualitative effects of the SALUD program.MethodsA semiblinded randomized controlled trial will be performed in the Netherlands. A sample size of 56 (including a 30% dropout rate) people with T2DM has been calculated, of whom half (n=28, 50%) will follow the SALUD program (intervention) and half (n=28, 50%) will receive usual care (control). Recruitment strategies consist of advertisement via local health care professionals, posters, social media, and local newspapers. The SALUD program consists of 12 weekly web-based group sessions under the supervision of a certified lifestyle coach. Fidelity of the delivery is guaranteed by selecting a salutogenic coach, use of an intervention manual, training of the coach, weekly evaluation forms, and recording several sessions. The theoretical salutogenic principle of the intervention is mobilizing 2 important psychosocial resources required for organizing healthy eating in everyday life: self-identity and social support. Measurements will be performed at 3 times: at baseline (T0), after 12 weeks (postintervention; T1), and after 24 weeks (follow-up; T2). The primary outcome is food literacy, measured with the self-perceived food literacy scale questionnaire (expected effect size=0.9). Secondary outcomes are self-efficacy, quality of life, sense of coherence, diet quality, body weight, BMI, and waist-hip ratio. All outcomes will be tested with linear mixed models, following an intention-to-treat approach and standard principles of randomized controlled trials. In addition, a qualitative analysis will be performed.ResultsThe proposed study will provide useful information on the effects of a salutogenic program on healthy eating and well-being in people with T2DM in everyday life. Recruitment started on October 1, 2021. The intervention participants followed the SALUD program between January and August, 2022. The acquisition of the data was completed on August 1, 2022; publications are expected in 2023.ConclusionsThis study will be one of the first salutogenic interventions for T2DM, which will provide valuable information on what salutogenic intervention entail. The SALUD program may serve as a concrete, web-based tool. The combination of quantitative and qualitative measures allows a comprehensive evaluation of effects. These insights can be used for further optimalization of T2DM interventions.Trial registrationNetherlands Trial Registry, NL8963; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8963.International registered report identifier (irrid)DERR1-10.2196/40490.

Project description:Background and objectivesDorzagliatin is a first-in-class small molecule glucokinase activator (GKA) that improves pancreatic insulin secretion behavior and regulates hepatic glucose conversion in a glucose concentration-dependent manner. The primary objective of this study was to develop a population pharmacokinetic model of dorzagliatin to evaluate the influence of covariates, such as demographic characteristics and liver and kidney function, on the pharmacokinetics of dorzagliatin and provide a basis for medication guidance.MethodThe pharmacokinetic data of dorzagliatin in this study came from six clinical trials. Based on the combined data, a population pharmacokinetic model of dorzagliatin was established using NONMEM software (ICON, MD, USA, version 7.4.3). The algorithm used was first-order conditional estimation with interaction (FOCEI). The dorzagliatin population pharmacokinetic modeling analysis included 1062 subjects and 7686 observable concentrations. Covariates, including age (AGE), sex (GEND), body weight (TBW), body mass index (BMI), body surface area (BSA), albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (CR), creatinine clearance (CRCL), and total bilirubin (TBIL), were screened using the forward-backward method. Model evaluation was performed using goodness-of-fit plots, prediction corrected visual prediction check (pcVPC), and bootstrap.ResultsConcentration data of dorzagliatin in the dose range were best characterized by a two-compartment model with sequential zero-order then first-order absorption and first-order elimination. The final model estimated dorzagliatin data for typical male subjects (69 kg body weight, 18 U/L AST and 55 years old); the apparent total clearance (CL/F) was 10.4 L/h, apparent volume of central compartment distribution (Vc/F) was 80.6 L, inter-compartmental clearance (Q/F) was 3.02 L/h, apparent volume of peripheral compartment distribution (Vp/F) was 26.5 L, absorption rate constant (Ka) was 3.29 h-1, and duration of zero-order absorption (D1) was 0.418 h. The inter-individual variation of CL/F, Vc/F, Vp/F, and D1 was 22.5%, 14.9%, 48.8%, and 82.8%, respectively.ConclusionThe two-compartment linear pharmacokinetic model with zero- and first-order sequential absorption adequately described the pharmacokinetic characteristics of dorzagliatin. Body weight, aspartate aminotransferase, and age had a statistically significant effect on the CL/F of dorzagliatin. Body weight and sex had a statistically significant effect on Vc/F. However, considering the clinically insignificant changes in the magnitude of steady-state exposure caused by these covariates, as well as the minimal changes in the steady-state exposure for individuals with mild and moderate impaired hepatic function and all stages of renal impairment, dose adjustments based on the tested covariates or for specific populations are deemed unnecessary.

Project description:BackgroundPeople of low socioeconomic position (SEP) are disproportionately affected by type 2 diabetes (T2D), partly due to unhealthy eating patterns that contribute to inadequate disease self-management and prognosis. Digital technologies have the potential to provide a suitable medium to facilitate diabetes education, support self-management, and address some of the barriers to healthy eating, such as lack of nutritional knowledge or shopping or cooking skills, in this target group.ObjectiveThis study aims to test the feasibility, appeal, and potential effectiveness of EatSmart, a 12-week, evidence-based, theoretically grounded, fully automated web-based and mobile-delivered healthy eating behavior change program to help disadvantaged people living with T2D to eat healthily on a budget and improve diabetes self-management.MethodsEatSmart is a mixed methods (quantitative and qualitative) pre-post design pilot study. Sixty socioeconomically disadvantaged people with T2D aged 18 to 75 years will be recruited. Participants will complete self-reported baseline assessments of their basic demographic and clinical data, dietary intake, dietary self-efficacy, and barriers to healthy eating. They will be provided with login access to the EatSmart web program, which includes six progressive skill-based modules covering healthy eating planning; smart food budgeting and shopping; time-saving meal strategies, healthy cooking methods, modifying recipes; and a final reinforcement and summary module. Over the 3-month intervention, participants will also receive 3 text messages weekly, encouraging them to review goals, continue to engage with different components of the EatSmart web program, and eat healthily. Participants will undertake follow-up assessments directly following the intervention 3 months post baseline and again after a 6-month postintervention follow-up period (9 months post baseline). Feasibility will be evaluated using the number of participants recruited and retained and objective indicators of engagement with the website. Program appeal and potential effects on primary and secondary outcomes will be assessed via the same surveys used at baseline, with additional questions asking about experience with and perceptions of the program. In-depth qualitative interviews will also be conducted 6 months post intervention to provide deeper insight into experiences with EatSmart and a more comprehensive description of the program's appeal.ResultsThe EatSmart website has been developed, and all participants have viewed the modules as of May 2020. Results are expected to be submitted for publication in December 2020.ConclusionsThis study will provide data to address the currently limited evidence regarding whether disadvantaged populations with T2D may benefit from digitally delivered behavior change programs that facilitate eating healthily on a budget.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12619001111167; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001111167.International registered report identifier (irrid)DERR1-10.2196/19488.

Project description:BackgroundMobile health solutions aimed at monitoring tasks among people with diabetes mellitus (DM) have been broadly applied. However, virtual coaches (VCs), embedded or not in mobile health, are considered valuable means of improving patients' health-related quality of life and ensuring adherence to self-care recommendations in diabetes management. Despite the growing need for effective, healthy coping digital interventions to support patients' self-care and self-management, the design of psychological digital interventions that are acceptable, usable, and engaging for the target users still represents the main challenge, especially from a psychosocial perspective.ObjectiveThis study primarily aims to test VC interventions based on psychoeducational and counseling approaches to support and promote healthy coping behaviors in adults with DM. As a preliminary study, university students have participated in it and have played the standardized patients' (SPs) role with the aim of improving the quality of the intervention protocol in terms of user acceptability, experience, and engagement. The accuracy of users' role-playing is further analyzed.MethodsThis preliminary study is based on the Obesity-Related Behavioral Intervention Trial model, with a specific focus on its early phases. The healthy coping intervention protocol was initially designed together with a team of psychologists following the main guidelines and recommendations for psychoeducational interventions for healthy coping in the context of DM. The protocol was refined with the support of 3 experts in the design of behavioral intervention technologies for mental health and well-being, who role-played 3 SPs' profiles receiving the virtual coaching intervention in a Wizard of Oz setting via WhatsApp. A refined version of the healthy coping protocol was then iteratively tested with a sample of 18 university students (mean age 23.61, SD 1.975 years) in a slightly different Wizard of Oz evaluation setting. Participants provided quantitative and qualitative postintervention feedback by reporting their experiences with the VC. Clustering techniques on the logged interactions and dialogs between the VC and users were collected and analyzed to identify additional refinements for future VC development.ResultsBoth quantitative and qualitative analyses showed that the digital healthy coping intervention was perceived as supportive, motivating, and able to trigger self-reflection on coping strategies. Analyses of the logged dialogs showed that most of the participants accurately played the SPs' profile assigned, confirming the validity and usefulness of this testing approach in preliminary assessments of behavioral digital interventions and protocols.ConclusionsThis study outlined an original approach to the early development and iterative testing of digital healthy coping interventions for type 2 DM. Indeed, the intervention was well-accepted and proved its effectiveness in the definition and refinement of the initial protocol and of the user experience with a VC before directly involving real patients in its subsequent use and testing.

Project description:Preclinical models of type 1 diabetes mellitus exhibit marked declines in skeletal muscle health including significant impairments in muscle repair. The present study investigated, for the first time, whether muscle repair was altered in young adults with uncomplicated type 1 diabetes (T1D) following damaging exercise.In this cohort study, eighteen physically-active young adults (M=22.1, SEM=0.9 years) with T1D (n, male/female=4/5; MHbA1c= 58, SEMHbA1c=5.9 mmol/mol) and without T1D (n, male/female=4/5) performed 300 unilateral eccentric contractions (90°s-1) of the knee extensors. Prior to exercise, at 48-hours and at 96-hours after exercise, participants gave a venous blood sample and vastus lateralis biopsy and performed a maximal voluntary isometric knee extension. Skeletal muscle extracellular matrix content, and satellite cell content/proliferation were assessed by immunofluorescence. Transmission electron microscopy was used to quantify ultrastructural damage.Maximal isometric strength was comparable between T1D and their sex-matched control group prior to exercise for both sexes. Immediately following damaging exercise, strength was decreased in both groups but there was a moderate effect size for lower strength during recovery in the T1D group at both 48-hours and 96-hours. Serum creatine kinase, an indicator of muscle damage, was moderately higher in T1D participants compared to controls at rest, and exhibited a small elevation 96-hours after exercise. Immunofluorescence analyses showed satellite cell content was lower at all timepoints in those with type 1 diabetes. T1D participants demonstrated a moderate delay in satellite cell proliferation (as assessed by Pax7+/Ki67+ nuclei counts) after exercise, reaching peak levels of proliferation 48-hours after control participants. Despite these differences, those with T1D did not exhibit greater ultrastructural muscle damage than controls as assessed by electron microscopy. Finally, a transcriptomic investigation of T1D muscle revealed several networks of dysregulated genes involving RNA translation as well as mitochondrial respiration function, providing potential explanations for previous observations of mitochondrial dysfunction in similar T1D cohorts. Our novel findings indicate that skeletal muscle from physically active, young adults with moderately controlled T1D may have a reduced ability to handle, and repair from, damaging exercise. While larger cohort studies are clearly needed, these results suggest that those with T1D may require longer recovery times following damaging exercise.

Dataset Information

Development of a salutogenic intervention for healthy eating among Dutch type 2 diabetes mellitus patients.

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Development of a salutogenic intervention for healthy eating among Dutch type 2 diabetes mellitus patients.

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