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The SHED-IT randomized controlled trial: evaluation of an internet-based weight-loss program for men |
Morgan PJ, Lubans DR, Collins CE, Warren JM, Callister R |
Obesity 2009 Nov;17(11):2025-2032 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; 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* |
The aim of this study was to evaluate the efficacy of an internet-based weight-loss program for men in an assessor blinded randomized controlled trial. In total, 65 overweight/obese male staff and students at the University of Newcastle (mean (SD) age 35.9 (11.1) years; BMI 30.6 (2.8)) were randomly assigned to either (i) internet group (n = 34) or (ii) control group (information only) (n = 31). Both groups received one face-to-face information session and a program booklet. Internet group participants used the study website to self-monitor diet and activity with feedback provided based on participants' online entries on seven occasions over 3 months. Participants were assessed at baseline, 3-, and 6-month follow-up for weight, waist circumference, BMI, blood pressure, resting heart rate, objectively measured physical activity, and self-reported total daily kilojoules. Intention-to-treat analysis revealed significant weight loss of 5.3 kg (95% confidence interval (CI) -7.3 to -3.3) at 6 months for the internet group and 3.5 kg (95% CI -5.5 to -1.4) for the control group. A significant time effect was found for all outcomes but no between-group differences. Per-protocol analysis revealed a significant group-by-time interaction (p < 0.001), with compliers losing more weight at 6 months (-9.1 kg; 95% CI -11.8 to -6.5) than noncompliers (-2.7 kg; 95% CI -5.3 to -0.01) and the control group (-4.2 kg; 95% CI -6.2 to -2.2). Simple weight-loss interventions can be effective in achieving statistically and clinically significant weight loss in men. The internet is a feasible and effective medium for weight loss in men but strategies need to be explored to improve engagement in online programs.
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