Primary care referral to a commercial provider for XXXX treatment versus standard care: a randomised controlled trial.

@entity1 @entity353 @entity28
BACKGROUND: The increasing prevalence of @entity28 needs effective approaches for @entity353 in primary care and community settings. We compared @entity353 with standard treatment in primary care with that achieved after referral by the primary care team to a commercial provider in the community. METHODS: In this parallel group, non-blinded, randomised controlled trial, 772 overweight and @entity28 adults were recruited by primary care practices in Australia, Germany, and the UK. @entity1 were randomly assigned with a computer-generated simple randomisation sequence to receive either 12 months of standard care as defined by national treatment guidelines, or 12 months of free membership to a commercial programme (Weight Watchers), and followed up for 12 months. The primary outcome was weight change over 12 months. Analysis was by intention to treat (last observation carried forward [LOCF] and baseline observation carried forward [BOCF]) and in the population who completed the 12-month assessment. This trial is registered, number ISRCTN85485463. FINDINGS: 377 @entity1 were assigned to the commercial programme, of whom 230 (61%) completed the 12-month assessment; and 395 were assigned to standard care, of whom 214 (54%) completed the 12-month assessment. In all analyses, @entity1 in the commercial programme group lost twice as much weight as did those in the standard care group. Mean weight change at 12 months was -5  06 kg (SE 0  31) for those in the commercial programme versus -2  25 kg (0  21) for those receiving standard care (adjusted difference -2  77 kg, 95% CI -3  50 to -2  03) with LOCF; -4  06 kg (0  31) versus -1  77 kg (0  19; adjusted difference -2  29 kg, -2  99 to -1  58) with BOCF; and -6  65 kg (0  43) versus -3  26 kg (0  33; adjusted difference -3  16 kg, -4  23 to -2  11) for those who completed the 12-month assessment. @entity1 reported no adverse events related to trial participation. INTERPRETATION: Referral by a primary health-care professional to a commercial @entity353 programme that provides regular weighing, advice about diet and physical activity, motivation, and group support can offer a clinically useful early intervention for weight management in overweight and @entity28 @entity1 that can be delivered at large scale. FUNDING: Weight Watchers International, through a grant to the UK Medical Research Council.
