Evaluation of a primary care-oriented brief counselling intervention for obesity with and without orlistat.

OBJECTIVE: There is a significant need for an obesity treatment model suitable for the primary care environment. We examined the effectiveness of a brief counselling intervention alone, in combination with orlistat, and drug-alone in a 12-month randomized-clinical trial at a medical school obesity centre. METHODS: Participants (N = 250) with body mass index (BMI) >or=27 were randomized. Changes in body weight, lipids, blood pressure and serum glucose were examined. Drug adherence and attendance were also evaluated. RESULTS: Completers analysis was conducted on 136 participants with data at baseline, 6 and 12 months and intention-to-treat analyses (ITT) for the total sample. Amongst completers, participants in the drug only (P = 0.012) and drug + brief counselling (P = 0.001) groups lost more weight (mean +/- SD: -3.8 +/- 5.8 kg and -4.8 +/- 4.4 kg, respectively) than participants in the brief counselling only group at 6 months (-1.7 +/- 3.3 kg), but there were no significant group differences at 12 months. ITT model results were similar to completers at 6 months and remained significant at 12 months, but the weight losses were more modest (<3 kg) for both groups receiving orlistat. For brief counselling alone, participants gained weight (1.7 +/- 4.2 kg). Cardiovascular disease (CVD) parameter changes were negligible. CONCLUSIONS: Pharmacotherapy alone or combined with brief counselling resulted in modest weight losses that had minimal impact on cardiovascular parameters, but were greater than brief counselling alone. Whilst brief interventions and primary pharmacotherapy have been suggested as viable treatments for implementation in primary care settings, our study suggests that such minimal interventions provide minimal benefits.

Weight loss with meal replacement and meal replacement plus snacks: a randomized trial.

OBJECTIVE: To evaluate whether snacking would improve weight loss and weight maintenance in overweight individuals within the context of a structured meal replacement (MR) weight loss program. DESIGN: A prospective 24 week, 2 (snacking vs nonsnacking) x 2 (MR vs meal replacement augmented with snacks (MRPS)) randomized trial. Participants were instructed to limit their total daily intake to 1200 (women) or 1500 (men) kcals. Those receiving the MR program were instructed not to snack while those in the MRPS program were told to snack three times per day. SUBJECTS: A total of 100 participants were block-randomized, based on prestudy snacking status (high vs low), to receive a standard meal replacement program (MR) or MRPS. MEASUREMENTS: Weight, height, blood pressure, lipid fractions, glucose, and insulin were assessed at the baseline, 12-, and 24 weeks. RESULTS: Completers analysis at 24 weeks demonstrated a significant time effect (F(1,46)=44.6, P<0.001), indicating that all participants lost significant amounts of weight regardless of group assignment. An intention-to-treat model resulted in similar results. By week 24, the average weight loss across groups was 4.6 kg. There also were significant improvements across all groups among completers for systolic blood pressure (P=0.047), cholesterol (P=0.001), LDL (P=0.001), glucose (P=0.004), and insulin (P=0.001) at week 12, and glucose (P=0.001) and insulin at week 24 (P=0.003). CONCLUSIONS: Our results suggest that a participant's preferences for snacking did not affect their response to treatment. Snackers and nonsnackers responded equally well whether they received a standard meal replacement program or one augmented with snacks.