Effect of a Behavioral Intervention Strategy for Adoption and Maintenance of a Physically Active Lifestyle: The Italian Diabetes and Exercise Study 2 (IDES_2): A Randomized Controlled Trial

Diabetes Care. 2017 Nov;40(11):1444-1452. doi: 10.2337/dc17-0594. Epub 2017 Aug 18.

Abstract

Objective: Adherence to physical activity (PA) recommendations is hampered by the lack of effective strategies to promote behavior change. The Italian Diabetes and Exercise Study 2 (IDES_2) is a randomized controlled trial evaluating a novel behavioral intervention strategy for increasing PA and decreasing sedentary time (SED-time) in patients with type 2 diabetes.

Research design and methods: The study randomized 300 physically inactive and sedentary patients with type 2 diabetes 1:1 to receive theoretical and practical counseling once yearly for 3 years (intervention group [INT]) or standard care (control group [CON]). Here, we report the 4-month effects on objectively (accelerometer) measured daily light-intensity PA (LPA), moderate-to-vigorous-intensity PA (MVPA), and SED-time, and cardiovascular risk factors.

Results: LPA and MVPA both increased, and SED-time decreased in both groups, although changes were significantly more marked in INT participants (approximately twofold for LPA and SED-time and approximately sixfold for MVPA). A significant reduction in HbA1c was observed only in INT subjects. An increase in LPA >0.92 h · day-1 and in MVPA >7.33 min · day-1 and a decrease in SED-time >1.05 h · day-1 were associated with an average decrease in HbA1c of ∼1% and also with significant improvements in fasting glucose, body weight, waist circumference, and hs-CRP. Changes in PA and SED-time were independent predictors of improvements in HbA1c.

Conclusions: This behavioral intervention is effective in the short term for increasing LPA and MVPA and reducing SED-time. Significant improvements in cardiometabolic risk profiles were observed in subjects experiencing the most pronounced changes in PA and SED-time, even if below the recommended level.

Trial registration: ClinicalTrials.gov NCT01600937.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Accelerometry
  • Adult
  • Aged
  • Aged, 80 and over
  • Cardiovascular Diseases / etiology
  • Cardiovascular Diseases / prevention & control
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / therapy*
  • Endpoint Determination
  • Exercise*
  • Female
  • Follow-Up Studies
  • Health Behavior*
  • Humans
  • Italy
  • Life Style*
  • Male
  • Middle Aged
  • Risk Factors
  • Sedentary Behavior
  • Treatment Outcome
  • Waist Circumference

Associated data

  • ClinicalTrials.gov/NCT01600937