Introduction: Stepped care is a type of adaptive intervention that adjusts an intervention according to an individual’s response to previous therapy. We aimed to determine whether a Stepped Care exercise intervention with a 24-week intervention and 6-month maintenance period, compared with a Comparator, achieved a difference in the proportion of individuals who attained target health outcomes (≥ 3% weight loss and/or HbA1c ≥ -0.4%), in people with central obesity and type 2 diabetes (T2D).
Methods: Previously inactive adults (n=30, 50% male, age 55±10yrs) with central obesity (waist circumference 112.8±15.3cm) and T2D (7.9±1.3% HbA1c) were randomised (2:1) to Stepped Care (SC, n=21) or Comparator (C, n=9). Body weight and HbA1c were measured at each step. Participants in SC who did not achieve target health outcomes were ‘stepped up’ while ‘responders’ maintained their prescription. The SC intervention had three 8-week ‘steps’ for ‘non-responders’ which increased in exercise duration and intensity. The C group received standard physical activity advice and were re-assessed at weeks 8, 16, 24 and six-months.
Results: There were 5 drop-outs (SC=4;C=1) during the intervention. Compared with C, SC had a 32% greater proportion of participants who achieved target health outcomes at week 8, 40% greater proportion at week 16, but only a 6% difference in proportion of response at week 24. C had a 10% greater response at six-month follow-up than SC. From baseline to six-months there were no between-group differences for change in HbA1c [-0.58% (95% CI, -1.71, 0.54), p=0.29)], nor weight loss [-3.26kg (95% CI, -23.3 to 16.8), p=0.74]. There was low adherence to the physical activity targets in both groups across all timepoints, especially in the SC group during the six-month maintenance period.
Conclusions: The stepped care approach employed in the present study was beneficial to improve early response to intervention; however, was not effective longer-term.