RESEARCH DESIGN AND METHODS: We randomized 230 patients with overweight/obesity, type 2 diabetes, and glycated hemoglobin (A1c) 7%-11% to receive usual care (UC) or UC with tDNA for 6 months. The tDNA intervention consisted of structured low-calorie meal plan, diabetes-specific meal replacements, and increased physical activity. Participants were counseled either through motivational interviewing (tDNA-MI) or conventional counseling (tDNA-CC). The UC group received standard dietary and exercise advice through conventional counseling. All patients were followed for another 6 months after intervention.
RESULTS: At 6 months, A1c decreased significantly in tDNA-MI (-1.1±0.1%, p<0.001) and tDNA-CC (-0.5±0.1%, p=0.001) but not in UC (-0.2±0.1%, p=NS). Body weight decreased significantly in tDNA-MI (-6.9±1.3 kg, p<0.001) and tDNA-CC (-5.3±1.2 kg, p<0.001) but not in UC (-0.8±0.5 kg, p=NS). tDNA-MI patients had significantly lower fasting plasma glucose (tDNA-MI: -1.1±0.3 mmol/L, p<0.001; tDNA-CC: -0.6±0.3 mmol/L, p=NS; UC: 0.1±0.3 mmol/L, p=NS) and systolic blood pressure (tDNA-MI: -9±2 mm Hg, p<0.001; tDNA-CC: -9±2 mm Hg, p=0.001; UC: -1±2 mm Hg, p=NS). At 1 year, tDNA-MI patients maintained significant reduction in A1c (tDNA-MI: -0.5±0.2%, p=0.006 vs tDNA-CC: 0.1±0.2%, p=NS and UC: 0.02±0.01%, p=NS) and significant weight loss (tDNA-MI: -5.8±1.3 kg, p<0.001 vs tDNA-CC: -3.3±1.2 kg, p=NS and UC: 0.5±0.6 kg, p=NS).
CONCLUSIONS: Structured lifestyle intervention through culturally adapted nutrition algorithm and motivational interviewing significantly improved diabetes control and body weight in primary care setting.
METHODS: Patients with T2D and overweight/obesity (n = 230) were randomized either into the tDNA group which included a structured low-calorie meal plan using normal foods, incorporation of diabetes-specific meal replacements, and an exercise prescription or usual T2D care (UC) for 6 months. Patients in the tDNA group also received either counseling with motivational interviewing (tDNA-MI) or conventional counseling (tDNA-CC). The UC group received standard dietary and exercise advice using conventional counseling. Eating self-efficacy was assessed using a locally validated Weight Efficacy Lifestyle (WEL) questionnaire. All patients were followed up for additional 6 months' post-intervention.
RESULTS: There was a significant change in WEL scores with intervention over one-year [Group X Time effect: F = 51.4, df = (3.4, 318.7), p<0.001]. Compared to baseline, WEL scores improved in both the tDNA groups with significantly higher improvement in the tDNA-MI group compared to the tDNA-CC and UC groups at 6 months (tDNA-MI: 25.4±2.1 vs. tDNA-CC: 12.9±2.8 vs. UC: -6.9±1.9, p<0.001). At 12 months' follow-up, both the tDNA groups maintained improvement in the WEL scores, with significantly higher scores in the tDNA-MI group than tDNA-CC group, and the UC group had decreased WEL scores (tDNA-MI: 28.9±3.1 vs. tDNA-CC: 11.6±3.6 vs. UC: -13.2±2.1, p<0.001). Patients in the tDNA-MI group with greater weight loss and hemoglobin A1C reduction also had a higher eating self-efficacy, with a similar trend observed in comparative groups.
CONCLUSION: Eating self-efficacy improved in patients with T2D and overweight/obesity who maintained their weight loss and glycemic control following a structured lifestyle intervention based on the Malaysian customized tDNA and the improvement was further enhanced with motivational interviewing.
CLINICAL TRIAL: This randomized clinical trial was registered under National Medical Research Registry, Ministry of Health Malaysia with registration number: NMRR-14-1042-19455 and also under ClinicalTrials.gov with registration number: NCT03881540.