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The effect of a structured behavioral intervention on poorly controlled diabetes: a randomized controlled trial
Weinger K, Beverly EA, Lee Y, Sitnokov L, Ganda OP, Caballero AE
Archives of Internal Medicine 2011 Dec 12;171(22):1990-1999
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Although maintaining nearly normal glycemia delays onset and slows progression of diabetes complications, many patients with diabetes and their physicians struggle to achieve glycemic targets. The best methods to support patients as they follow diabetes prescriptions and recommendations are unclear. METHODS: To test the efficacy of a behavioral diabetes intervention in improving glycemia in long-duration, poorly controlled diabetes, we randomized 222 adults with diabetes (49% type 1) (mean (SD) age 53 (12) years; mean (SD) disease duration 18 (12) years; mean (SD) hemoglobin A1c (HbA1c) concentration 9.0% (1.1%)) to attend (1) a 5-session manual-based, educator-led structured group intervention with cognitive behavioral strategies (structured behavioral arm); (2) an educator-led attention control group education program (group attention control); or (3) unlimited individual nurse and dietitian education sessions for 6 months (individual control). Outcomes were baseline and 3-, 6-, and 12-month postintervention HbA1c levels (primary) and frequency of diabetes self-care, 3-day pedometer readings, 24-hour diet recalls, average number of glucose checks, physical fitness, depression, coping style, self-efficacy, and quality of life (secondary). RESULTS: Linear mixed modeling found that all groups showed improved HbA1c levels (p < 0.001). However, the structured behavioral arm showed greater improvements than the group and individual control arms (3-month HbA1c concentration changes -0.8% versus -0.4% and -0.4%, respectively (p = 0.04 for group x time interaction). Furthermore, participants with type 2 disease showed greater improvement than those with type 1 (p = 0.04 for type of diabetes x time interaction). Quality of life, glucose monitoring, and frequency of diabetes self-care did not differ by intervention over time. CONCLUSIONS: A structured, cognitive behavioral program is more effective than 2 control interventions in improving glycemia in adults with long-duration diabetes. Educators can successfully use modified psychological and behavioral strategies. (TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT000142922).

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