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.
DESIGN: Cross-sectional.
SETTING: Jakarta, Indonesia and Kuala Lumpur, Malaysia.
PARTICIPANTS: A convenience sample of 504 non-pregnant women 18-40 years.
MAIN MEASURES: Plasma 25-hydroxyvitamin D and PTH.
RESULTS: The mean 25-hydroxyvitamin D concentration was 48 nmol/l. Less than 1% of women had a 25-hydroxyvitamin D concentration indicative of vitamin D deficiency (<17.5 nmol/l); whereas, over 60% of women had a 25-hydroxyvitamin D concentration indicative of insufficiency (<50 nmol/l). We estimate that 52 nmol/l was the threshold concentration for plasma 25-hydroxyvitamin D above which no further suppression of PTH occurred. Below and above this concentration the slopes of the regression lines were -0.18 (different from 0; P=0.003) and -0.01 (P=0.775), respectively. The relation between vitamin D status and parathyroid hormone concentration did not differ between women with low, medium or high calcium intakes (P=0.611); however, even in the highest tertile of calcium intake, mean calcium intake was only 657 mg/d.
CONCLUSION: On the basis of maximal suppression of PTH we estimate an optimal 25-hydroxyvitamin D concentration of approximately 50 nmol/l. Many women had a 25-hydroxyvitamin D below this concentration and may benefit from improved vitamin D status.