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 performed a systematic search using PubMed, Scopus, Cochrane Library, Web of Science for randomised controlled trials (RCTs), published until March 17, 2021. The quality assessment was carried out using the Cochrane Collaboration risk of bias tool. The Q-test and I 2 tests were used for the determination of heterogeneity of the included studies. Data were pooled using a random-effects model, and weighted mean difference (WMD) was used for the overall effect size.
RESULTS: Pooled findings of the five RCTs demonstrated that ginger supplementations had significantly reduced hs-CRP (WMD -0.42 mg/L; 95% CI, -0.78, -0.05, P = 0.03), TNF-α (-2.13 pg/mL; 95% CI: -3.41, -0.86, P = 0.001), and IL-6 (WMD: -0.61 pg/mL; 95% CI: -0.92, -0.30, P = 0.001) levels in patients with T2DM. The quality assessment of the studies showed that all of the included studies were at high risk of bias.
CONCLUSIONS: The meta-analysis shows that ginger supplementations reduced inflammatory parameters in patients with T2DM. Nonetheless, the reduction is relatively small, and its meaningful clinical effects are unknown. Future high-quality RCTs are needed to confirm the beneficial effects of ginger supplementation in patients with T2DM.
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: We randomized 108 overweight and obese patients with T2D (46 M/62F; age 60 ± 10 years; HbA1c 8.07 ± 1.05%; weight 101.4 ± 21.1 kg and BMI 35.2 ± 7.7 kg/m2) into three groups. Group A met with RDN to develop an individualized eating plan. Group B met with RDN and followed a structured meal plan. Group C did similar to group B and received weekly phone support by RDN.
RESULTS: After 16 weeks, all three groups had a significant reduction of their energy intake compared to baseline. HbA1c did not change from baseline in group A, but decreased significantly in groups B (- 0.66%, 95% CI -1.03 to - 0.30) and C (- 0.61%, 95% CI -1.0 to - 0.23) (p value for difference among groups over time
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.