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.