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Translating the diabetes prevention program lifestyle intervention for weight loss into primary care: a randomized trial |
Ma J, Yank V, Xiao L, Lavori PW, Wilson SR, Rosas LG, Stafford RS |
JAMA Internal Medicine 2013 Jan 28;173(2):113-121 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; 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: The diabetes prevention program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes mellitus (DM) among high-risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care. METHODS: We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n = 79), (2) a self-directed DVD intervention (n = 81), or (3) usual care (n = 81). During a 3-month intensive intervention phase, the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) from baseline to 15 months. RESULTS: At baseline, participants had a mean (SD) age of 52.9 (10.6) years and a mean BMI of 32.0 (5.4); 47% were female; 78%, non-Hispanic white; and 17%, Asian/Pacific Islander. At month 15, the mean +/- SE change in BMI from baseline was -2.2 +/- 0.3 in the coach-led group versus -0.9 +/- 0.3 in the usual care group (p < 0.001) and -1.6 +/- 0.3 in the self-directed group versus usual care (p = 0.02). The percentages of participants who achieved the 7% DPP-based weight-loss goal were 37.0% (p = 0.003) and 35.9% (p = 0.004) in the coach-led and self-directed groups, respectively, versus 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level. CONCLUSION: Proven effective in a primary care setting, the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00842426.
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