Despite short-ter
m efficacy,
many weight loss studies de
monstrate poor long-ter
m results and have difficulty recruiting
men. Cost-effective treat
ments that help
men achieve long-ter
m weight loss are required. Using a two-phase, assessor-blinded, parallel-group rando
mised controlled trial design this study will test the effectiveness and cost-effectiveness of a
male-only weight loss
maintenance intervention. In Phase I (3
months) 209
men received the
m>SHED-IT Weight Loss Programm>. In Phase II (12
months) 92
men who lost 4 kg or
more were rando
mised to either (i) a
maintenance group who received the 6-
month, gender-tailored
m>SHED-IT Weight Loss Maintenance Programm>, which included no face-to-face contact (n = 47), or (ii) a self-help control group (n = 45). Rando
misation was stratified by weight loss (4 kg-7.4 kg, 鈮?#xA0;7.5 kg) and BMI (< 30 kg/
m2, 鈮?#xA0;30 kg/
m2). Assess
ments occurred at 'study entry' (start of Phase I), 'baseline' (start of Phase II), '6
months' (post-test) and will occur at '12
months' (follow-up; pri
mary endpoint). The pri
mary outco
me is weight change in Phase II (i.e. fro
m 'baseline' at 12
months after rando
mization). Secondary outco
mes include waist circu
mference (u
mbilicus and narrowest), blood pressure, body co
mposition, objectively
measured physical activity, sedentary ti
me, portion size, dietary intake, quality of life, depressive sy
mpto
ms, and behavioural cognitions. Costing data will be collected for cost-effectiveness analysis. Generalised linear
mixed
models (intention-to-treat) will assess outco
mes for treat
ment (
maintenance vs. control), ti
me (baseline, 6-
month and 12-
month) and the treat
ment-by-ti
me interaction. This will be the first study to evaluate a
male-only, gender-targeted weight loss
maintenance progra
m. Results will provide evidence regarding feasible and theoretically-driven obesity treat
ments for
men with potential for long-ter
m i
mpact and widespread disse
mination.
Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12612000749808).