Effects on body weight of strict or liberal adherence to an initial period of VLCD treatment. A randomised, one-year clinical trial of obese subjects.

ABSTRACT

OBJECTIVES: To examine the impact on early and late weight loss of three different, initial very low calorie diet (VLCD) approaches in a one-year obesity treatment program. DESIGN: Randomised clinical trial. SUBJECTS: 121 obese subjects, aged 21-60y, BMI > or = 30.0kg/m2. INTERVENTIONS: The VLCD-strict group was prescribed a strict outpatient VLCD for 16 weeks, followed by a 36-week hypocaloric diet. The VLCD-mw group received the same treatment, but were hospitalised in a metabolic ward for the initial week. The VLCD-plus group was allowed two small meals weekly, but received otherwise the same recommendations as the VLCD-strict group. RESULTS: After 16 weeks, there was no difference in weight loss between the treatment groups in the intent-to-treat population, while among completers, the weight loss was about 7 kg larger in the VLCD-strict group compared to the VLCD-plus group (P < 0.05). At one year, these groups differed by approximately 4 kg, both according to intention-to-treat and among completers (P < 0.05, both differences). These differences were more prominent among females. The weight reduction in the VLCD-mw group was generally not superior to the VLCD-strict group. CONCLUSIONS: In the short-term, strict VLCD only reduced weight better than a liberal VLCD approach among completers. However, after one year, a strict VLCD regimen seemed beneficial compared to a liberal VLCD for all patients. There was no extra weight loss if the VLCD period was initiated on a metabolic ward.