Figure 1. Trial Flow Diagram .

The moderate intervention involved a food-based diet with a 25% to 35% energy restriction for a total of 12 months (52 weeks). The severe intervention involved total diet replacement with 65% to 75% energy restriction for 4 months (16 weeks) or until a body mass index (calculated as weight in kilograms divided by height in meters squared) of no lower than 20 was reached, whichever came first, followed by moderate energy restriction until 12 months (52 weeks).