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Weight-management interventions in primary care: a pilot randomised controlled trial [with consumer summary]
Nanchahal K, Townsend J, Letley L, Haslam D, Wellings K, Haines A
British Journal of General Practice 2009 May;59(562):e157-e166
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; 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*

BACKGROUND: There is a paucity of randomised controlled trials of weight management in primary care. AIM: To ascertain the feasibility of a full trial of a nurse-led weight-management programme in general practice. DESIGN OF STUDY: Factorial randomised control trial. SETTING: Primary care, UK. METHOD: A total of 123 adults (80.3% women, mean age 47.2 years) with body mass index >= 27 kg/m2, recruited from eight practices, were randomised to receive structured lifestyle support (n = 30), structured lifestyle support plus pedometer (n = 31), usual care (n = 31), or usual care plus pedometer (n = 31) for a 12-week period. RESULTS: A total of 103 participants were successfully followed up. The adjusted mean difference in weight in structured support compared to usual care groups was -2.63 kg (95% confidence interval (CI) -4.06 to -1.20 kg), and for pedometer compared to no pedometer groups it was -0.11 kg (95% CI -1.52 to 1.30 kg). One in three participants in the structured-support groups (17/50, 34.0%) lost 5% or more of their initial weight, compared to less than one in five (10/53, 18.9%) in usual-care groups; provision of a pedometer made little difference (14/48, 29.2% pedometer; 13/55, 23.6% no pedometer). Difference in waist circumference change between structured-support and usual-care groups was -1.80 cm (95% CI -3.39 to -0.20 cm), and between the pedometer and no pedometer groups it was -0.84 cm (95% CI -2.42 to 0.73 cm). When asked about their experience of study participation, most participants found structured support helpful. CONCLUSION: The structured lifestyle support package could make substantial contributions to improving weight-management services. A trial of the intervention in general practice is feasible and practicable.

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