12‐Month Outcomes and Process Evaluation of the SHED‐IT RCT: An Internet‐Based Weight Loss Program Targeting Men

This article reports the 12‐month follow‐up results and process evaluation of the SHED‐IT (Self‐Help, Exercise, and Diet using Information Technology) trial, an Internet‐based weight loss program exclusively for men. Sixty‐five overweight/obese male staff and students at the University of Newcastle (Callaghan, Australia) (mean (s.d.) age = 35.9 (11.1) years; BMI = 30.6 (2.8)) were randomly assigned to either (i) Internet group (n = 34) or (ii) Information only control group (n = 31). Both received one face‐to‐face information session and a program booklet. Internet group participants were instructed to use the study website for 3 months. Participants were assessed at baseline, 3‐, 6‐, and 12‐month follow‐up for weight, waist circumference, BMI, blood pressure, and resting heart rate. Retention at 3‐ and 12‐months was 85% and 71%, respectively. Intention‐to‐treat (ITT) analysis using linear mixed models revealed significant and sustained weight loss of ?5.3 kg (95% confidence interval (CI): ?7.5, ?3.0) at 12 months for the Internet group and ?3.1 kg (95% CI: ?5.4, ?0.7) for the control group with no group difference. A significant time effect was found for all outcomes (P < 0.001). Per‐protocol analysis revealed a significant group‐by‐time interaction for weight, waist circumference, BMI, and systolic blood pressure. Internet group compliers (who self‐monitored as instructed) maintained greater weight loss at 12 months (?8.8 kg; 95% CI ?11.8, ?5.9) than noncompliers (?1.9 kg; 95% CI ?4.8, 1.0) and controls (?3.0 kg; 95% CI ?5.2, ?0.9). Qualitative analysis by questionnaire and interview highlighted the acceptability and satisfaction with SHED‐IT. Low‐dose approaches to weight loss are feasible, acceptable, and can achieve clinically important weight loss in men after 1‐year follow‐up.