Impact of Skills for Change Program on metabolic control, diet and physical activity levels in adults with type 2 diabetes: A cluster randomized trial.

ABSTRACT

BACKGROUND: Type 2 diabetes mellitus is highly prevalent in the Arab Gulf countries. Despite this, limited culturally-adapted lifestyle intervention studies have been conducted in this region. METHODS: In this culturally adapted 12-month cluster randomized trial, 382 patients with type 2 diabetes, aged 20-70 years were recruited from 6 public healthcare centers (3 interventions and 3 controls) in Al Ain, United Arab Emirates. The primary outcome of this study was a change in hemoglobin A1c (HbA1c). The secondary outcomes were Body Mass Index (BMI), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, total cholesterol, dietary intake, and physical activity levels. A diet and physical activity intervention, guided by the social cognitive theory, was delivered individually and in group format to the intervention group. The control group continued receiving only their usual diabetes management care. The data were collected at baseline and 1 year after participation. RESULTS: The mean baseline HbA1c levels of the control and the intervention groups were 7.45 ± 0.11% and 7.81 ± 0.11%, respectively. At the end of the 12-month intervention, there was no significant difference in the changes of mean HbA1c between the intervention and the control groups. On the other hand, BMI and daily caloric intake were significantly decreased in the intervention compared to the control group by 1.18 kg/m2 (95% CI -1.78 - -0.60) and 246 kcal (95% CI -419.52 - -77.21), respectively, after controlling for age, gender, education, marital status, duration since diabetes diagnosis, diabetes treatment, treatment clinic, and baseline values. Sitting time during the week-end was significantly lower, difference 52.53 minutes (95% CI 93.93 - -11.14). CONCLUSIONS: This community-based lifestyle intervention for patients with baseline HbA1c <8% did not result in a significant decrease of HbA1c but reduced caloric intake, body weight, and weekend inactivity after controlling for the covariates. TRIAL REGISTRATION This trial was registered on February 11, 2020 with Clinicaltrials.gov (NCT04264793).