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| Development of Alive! (A Lifestyle Intervention Via Email), and its effect on health-related quality of life, presenteeism, and other behavioral outcomes: randomized controlled trial |
| Block G, Sternfeld B, Block CH, Block TJ, Norris J, Hopkins D, Quesenberry CP Jr, Husson G, Clancy HA |
| Journal of Medical Internet Research 2008 Oct-Dec;10(4):e43 |
| clinical trial |
| 4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; 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* |
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BACKGROUND: Cost-effective interventions to improve diet and physical activity are a public health priority. Alive! is an email-based intervention to increase physical activity, reduce saturated and trans fats and added sugars, and increase fruit and vegetable consumption. It was shown to improve these behaviors in a large randomized controlled trial. OBJECTIVE: (1) To describe the components and behavioral principles underlying Alive!, and (2) to report effects of the intervention on the secondary outcomes: health-related quality of life, presenteeism, self-efficacy, and stage of change. METHODS: The Alive! behavior change model is designed to elicit healthy behaviors and promote their maintenance. Behavioral strategies include assessments followed by individualized feedback, weekly goal-setting, individually tailored goals and tips, reminders, and promotion of social support. Alive! was tested among non-medical employees of Kaiser Permanente of Northern California, who were randomized to either the intervention group or the wait-list control group. After randomization, intervention group participants chose one topic to undertake for the intervention period: increasing physical activity, increasing fruits and vegetables, or decreasing saturated and trans fats and added sugars. Pre-post questionnaires assessed changes in SF-8 health-related quality of life, presenteeism, self-efficacy, and stage of change. Mixed effects multiple linear regression and ordinal logistic regression models were used, with department as a random effect factor. Analyses were by intention to treat: the 30% (238/787) who did not respond to the follow-up questionnaires were assigned change scores of zero. RESULTS: Participants were 19 to 65 years (mean 44.0 +/- 10.6), and 74.3% (585/787) were female. Mean SF-8 Physical quality of life score increased significantly more in the intervention group than in the control group, 1.84 (95% CI 0.96 to 2.72) versus 0.72 (95% CI -0.15 to 1.58) respectively, p = 0.02. SF8 Mental score also improved significantly more in the intervention group than in the control group (p = 0.02). The odds ratio for improvement in self-assessed health status was 1.57 (95% CI 1.21 to 2.04, p < 0.001) for the intervention group compared to the control group. The odds ratio for having a reduction in difficulty accomplishing work tasks because of physical or emotional problems, a measure of presenteeism, was 1.47 (95% CI 1.05 to 2.05, p = 0.02) for the intervention group compared to the control group. The odds of having an improvement in self-efficacy for changing diet was 2.05 (95% CI 1.44 to 2.93) for the intervention versus the control group (p < 0.001). Greater improvement in stage of change for physical activity (p = 0.05), fats (p = 0.06), and fruits/vegetables (p = 0.006) was seen in the intervention group compared to the control group. Significant effects on diet and physical activity behavior change are reported elsewhere. CONCLUSIONS: Cost-effective methods that can reach large populations with science-based interventions are urgently needed. Alive! is a fully automated low-cost intervention shown to effect significant improvements in important health parameters. TRIAL REGISTRATION: ClinicalTrials.gov NCT00607009; http://ClinicalTrials.gov/ct2/show/NCT00607009.
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