METHODS AND ANALYSIS: The study will be modelled according to the Capability, Opportunity, Motivation and Behaviour and Behaviour Change Wheel techniques, and use the DoTTI framework to identify needs, solutions and testing of a preliminary mobile app, respectively. In phase 1 (design and development), a focus group discussion (FGDs) of 5-8 individuals will be conducted with an estimated 60 women with GDM and 40 HCPs (doctors, dietitians and nurses). Synthesised data from the FGDs will then be combined with content from an expert committee to inform the development of the mobile app. In phase 2 (testing of early iterations), a preview of the mobile app will undergo alpha testing among the team members and the app developers, and beta testing among 30 women with GDM or with a history of GDM, and 15 HCPs using semi-structured interviews. The outcome will enable us to optimise an intervention using the mobile app as a diabetes prevention intervention which will then be evaluated in a randomised controlled trial.
ETHICS AND DISSEMINATION: The project has been approved by the Malaysia Research Ethics Committee. Informed consent will be obtained from all participants. Outcomes will be presented at both local and international conferences and submitted for publications in peer-reviewed journals.
OBJECTIVE: The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation.
METHODS: This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health's Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212).
RESULTS: Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022.
CONCLUSIONS: To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37288.
METHODS: We evaluated the effects of a novel natural food adjuvant combining mulberry leaf extract (MLE) with other bioactive ingredients, in people with type 2 diabetes (T2D) originating from Asia, on improving PP glucometabolic response in a randomized controlled exploratory crossover, two-center study (USA, Singapore). A 2-g blend of 250 mg MLE [containing 12.5 mg of 1-deoxynojirimycin (DNJ)], fiber (1.75 g), vitamin D3 (0.75 μg), and chromium (75 μg), compared with a similar blend without the MLE, was sprinkled over a 350-kcal breakfast meal (55.4 g carbs) and PP blood glucose (primary exploratory endpoint), insulin, and incretin hormones (GLP-1, GIP) were evaluated in blood samples over 3 h. Changes in incremental areas under the concentration curve (iAUC) and maximum concentrations (Cmax) were compared.
RESULTS: Thirty individuals (12 women, mean age 59 years, HbA1c 7.1%, BMI 26.5 kg/m2) were enrolled and the MLE-based blend relative to the blend without MLE significantly reduced glucose iAUC at 1 h (- 20%, p
SUBJECTS/METHODS: This study included 259 pregnant women within the Seremban Cohort Study (SECOST). Blood samples at < 14 weeks of gestation were drawn to determine serum 25(OH)D levels. GDM diagnosis was made at 24 to 32 weeks of gestation using a standard procedure. Association between serum vitamin D and GDM was tested using binary logistic regression.
RESULTS: Nearly all women (90%) had mild (68.3%) or severe (32.2%) vitamin D deficiency (VDD). Non-GDM women with mild VDD had a significantly higher mean vitamin D intake than GDM women with mild VDD (t = 2.04, p < 0.05). Women with higher early pregnancy serum vitamin D levels had a greater risk of GDM. However, this significant association was only identified among those with a family history of type 2 diabetes mellitus (T2DM) and in women with a body mass index indicating overweight or obese status.
CONCLUSIONS: The high prevalence of VDD in this sample of pregnant women underscores the need for effective preventive public health strategies. Further investigation of this unexpected association between serum vitamin D level and GDM risk in predominantly VDD pregnant women and the potential effects of adiposity and family history of T2DM on that association is warranted.
METHODS: We searched MEDLINE (via PubMed) and Science Direct databases for articles that included the component of nutrition for adult patients with type 2 diabetes (T2D), published in English between 2010 and 2020.
RESULTS: Fourteen studies met the criteria. Eight of 14 studies had an intervention with a control arm. In comparison to the control group, all studies (n = 8) showed a reduction in hypoglycemic events. However, only half of these studies (n = 4) had shown at least one positive clinical outcome. Features of nutrition therapy that appeared to have favorable clinical outcomes include individualized caloric prescription; distributing carbohydrates equally between Suhoor, Iftar and snacks; providing meal plans; adjusting food intake to suit Ramadan; and incorporating diabetes-specific formula as part of Suhoor or snack.
CONCLUSIONS: The review provides evidence for the effectiveness of Ramadan-focused nutrition therapy among people with T2D and identifies key features of nutrition therapy that may provide favourable clinical outcomes. Additional data on dietary quality and adequacy during Ramadan fasting warrants further studies.
METHODS: This was a prospective cohort study of 452 pregnant women recruited from 3 health clinics in a southern state of Peninsular Malaysia. PA levels at the first, second, and third trimester were assessed using the Pregnancy Physical Activity Questionnaire. GDM was diagnosed at 24-28 weeks of gestation following the Ministry of Health Malaysia criteria. Group-based trajectory modeling was used to identify PA trajectories. Three multivariate logistic models were used to estimate the odds of trajectory group membership and GDM.
RESULTS: Two distinct PA trajectories were identified: low PA levels in all intensity of PA and sedentary behavior (Group 1: 61.1%, n = 276) and high PA levels in all intensity of PA as well as sedentary behavior (Group 2: 38.9%, n = 176). Moderate and high intensity PA decreased over the course of pregnancy in both groups. Women in group 2 had significantly higher risk of GDM in two of the estimated logistic models. In all models, significant associations between PA trajectories and GDM were only observed among women with excessive gestational weight gain in the second trimester.
CONCLUSIONS: Women with high sedentary behavior were significantly at higher risk of GDM despite high PA levels by intensity and this association was significant only among women with excessive GWG in the second trimester. Participation in high sedentary behavior may outweigh the benefit of engaging in high PA to mitigate the risk of GDM.
METHODS: This was an 8-week, parallel-group, non-randomised study of 60 type 2 diabetes patients who opted for structured Ramadan Nutrition Therapy (sRNT; n = 38) or standard care (SC; n = 22) group. The sRNT group received a structured Ramadan Nutrition Plan incorporated with diabetes-specific formula throughout the study, while SC received standard nutrition care. The 3-day food records assessed dietary intake at three-time points.
RESULTS: At baseline, dietary characteristics were comparable; both groups had macronutrient intakes within the recommended range, but inadequate intakes of fiber and 11 essential micronutrients. After 8 weeks, the sRNT group significantly reduced intakes of carbohydrate, dietary glycemic index, glycemic load, and increased percentage of total energy intake from protein, fiber, pyridoxine, vitamin C, vitamin D, calcium, and chromium compared with the SC group. In the sRNT group, compliance to diabetes-specific formula predicted changes in HbA1c (p = 0.024), while fiber intake predicted fasting plasma glucose (p = 0.035), after adjusting for age, sex, weight changes and other dietary variables.
CONCLUSION: Intakes of certain nutrients improved significantly in sRNT group after 8 weeks of receiving a structured Ramadan Nutrition Plan compared to the standard care. The structured Ramadan Nutrition Plan with the incorporation of diabetes-specific formula significantly improved glycemic control and dietary adequacy during Ramadan fasting.