A Two-Year Randomized Trial of Obesity Treatment in Primary Care Practice

In the paper

“the mean (±SE) weight loss with usual care, brief lifestyle counseling, and enhanced brief lifestyle counseling was 1.7±0.7, 2.9±0.7, and 4.6±0.7 kg, respectively.”

• Also stated in: § WEIGHT LOSS · plain

  “At month 24, the mean (±SE) weight loss among participants assigned to usual care, those assigned to brief lifestyle counseling, and those assigned to enhanced lifestyle counseling was 1.7±0.7, 2.9±0.7, and 4.6±0.7 kg, respectively.”

In the paper

“An analysis of weight loss in the 66 participants in the enhanced-lifestyle-counseling group who used meal replacements (without exposure to sibutramine) for most of the trial revealed a loss of 4.1±0.9 kg at month 24, which was significantly greater than that in the usual-care group (P = 0.04) but did not differ significantly from the weight loss in the brief-lifestyle- counseling group (P = 0.30”

In the paper

“Sibutramine was discontinued in five participants because of increases in blood pressure (≥10 mm Hg), in a sixth participant because of tachycardia, and in a seventh because of anxiety. Orlistat was discontinued in five participants because of gastrointestinal symptoms.”

In the paper

“At baseline, participants who received enhanced lifestyle counseling chose one of three additional treatment enhancements: meal replacements (67 participants), sibutramine (38), or orlistat (24).”

In the paper

“Participants who received enhanced lifestyle counseling had significantly greater improvements in waist circumference and in HDL cholesterol and triglyceride levels at one or more assessments, as compared with the other two groups (in the intention-to-treat population) (Table 2A in the Supplementary Appendix).”

In the paper

“Participants in the lifestyle-counseling group and those in the enhanced-lifestyle-counseling group attended 56.1±28.8% and 64.7±25.8% of the 25 scheduled coaching visits, respectively.”

In the paper

“The remaining 85 participants lost a mean of 4.3±0.8 kg at month 24, which was significantly greater than the loss for those who received usual care (1.7±0.7 kg) but did not differ significantly from the weight loss for those who received brief lifestyle counseling (2.9±0.7 kg).”

In the paper

“This included 21 events in 16 participants in the usual-care group, 26 events in 20 participants in the brief-lifestyle-counseling group, and 26 events in 22 participants in the enhanced-lifestyle-counseling group, with no significant differences between groups (P = 0.556).”

In the paper

“An intention-to-treat analysis, based on participants’initial choice of enhancement, revealed a mean weight loss of 3.9±1.0, 5.5±1.3, and 4.6±1.7 kg in these three subgroups, respectively, at month 24, with no significant differences among them.”

In the paper

“Eleven participants (16%) who initially chose meal replacements switched to a different enhancement, as did 15 participants (39%) who chose sibutramine (including 9 in whom the drug was withdrawn in response to the FDA’s actions) and 8 participants (33%) who chose orlistat.”

In the paper

“Long-term weight loss in the group that received enhanced lifestyle counseling (as well as in the group that received brief lifestyle counseling without enhancement) was greater than weight loss observed in other primary care trials,5–7,30,31 with the exception of a study involving extremely obese patients who were treated with intensive group lifestyle modification and weight-loss medications.32”

What the sources say

• Not checked yetcites [5] Martin PD Dutton GR Rhode PC Horswell RL Ryan DH Brantley PJ Weight loss maintenance following a primary care intervention for low-income minority women Obesity (Silver Spring) 2008 16 2462 2467 18787526 PMC2753427 source
• Not checked yetcites [6] Christian JG Bessesen DH Byers TE Christian KK Goldstein MG Bock BC Clinic-based support to help overweight patients with type 2 diabetes increase physical activity and lose weight Arch Intern Med 2008 168 141 146 18227359 source
• Not checked yetcites [7] Ockene IS Hebert JR Ockene JK Effect of physician-delivered nutrition counseling training and an office-support program on saturated fat intake, weight, and serum lipid measurements in a hyperlipidemic population: Worcester Area Trial for Counseling in Hyperlipidemia (WATCH) Arch Intern Med 1999 159 725 731 10218753 source
• Not checked yetcites [30] Cohen MD D’Amico FJ Merenstein JH Weight reduction in obese hypertensive patients Fam Med 1991 23 25 28 2001777
• Not checked yetcites [31] Kumanyika S Fassbender J Sarwer D One-year results of the Think Health! study of weight management in primary care practice Obesity (Silver Spring) (in press) 22051940 source
• Not checked yetcites [32] Ryan DH Johnson WD Myers VH Nonsurgical weight loss for extreme obesity in primary care settings: results of the Louisiana Obese Subjects Study Arch Intern Med 2010 170 146 154 20101009 source

In the paper

“The study had 80% power to detect a 2.75-kg difference in weight change at month 24 between the usual-care and brief-lifestyle-counseling groups and between the usual-care and enhanced-lifestyle-counseling groups.”

In the paper

“Overweight patients who received eight brief counseling sessions (and met quarterly with their PCP to manage coexisting illnesses) lost 4.4 kg in 6 months, as compared with 0.9 kg for the patients in the control group, who were limited to quarterly PCP visits.”

What the sources say

• Not checked yetcites [9] Tsai AG Wadden TA Rogers MA Day SC Moore RH Islam BJ A primary care intervention for weight loss: results of a randomized controlled pilot study Obesity (Silver Spring) 2010 18 1614 1618 20019680 source

In the paper

“Participants were randomly assigned to interventions (in equal numbers) with the use of a computer-generated algorithm that was operated by the Investigational Drug Service at the University of Pennsylvania.”

In the paper

“All providers were certified in intervention delivery at baseline and were recertified at 6-month intervals, according to previously described methods.27”

What the sources say

• Not checked yetcites [27] Wadden TA West DS Delahanty L The Look AHEAD study: a description of the lifestyle intervention and the evidence supporting it Obesity (Silver Spring) 2006 14 737 752 16855180 PMC2613279

In the paper

“Approximately 86% of the participants in each group had their weight measured at 24 months (Fig. 1).”

In the paper

“Weight was measured by a certified staff member at baseline and at 6, 12, 18, and 24 months with the use of a digital scale (Tanita BWB-800).”

In the paper

“Both orlistat (GlaxoSmithKline) and sibutramine (Abbott) increase weight loss by approximately 3 to 5 kg, as compared with placebo,12–14”

What the sources say

• Not checked yetcites [12] Davidson MH Hauptman J DiGirolamo M Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial JAMA 1999 281 235 242 [Erratum, JAMA 1999;281:1174.] 9918478 source
• Not checked yetcites [13] James WP Astrup A Finer N Effect of sibutramine on weight maintenance after weight loss: a randomised trial Lancet 2000 356 2119 2125 11191537 source
• Not checked yetcites [14] Li Z Maglione M Tu W Meta-analysis: pharmacologic treatment of obesity Ann Intern Med 2005 142 532 546 15809465 source

In the paper

“Changes in weight in the intention-to-treat population were compared with the use of repeated-measures linear mixed-effects models (for continuous outcomes) and generalized-estimating-equation models (for categorical outcomes), which controlled for initial weight, age, sex, race or ethnic group, and study site.”

In the paper

“Assignments were stratified by clinic, with randomly varied block sizes (3, 6, or 9).”

In the paper

“a difference addressed in the analyses by the a priori decision to control for initial weight.”

In the paper

“which is a common criterion for clinically meaningful weight loss.11,29”

What the sources say

• Not checked yetcites [11] National Heart Lung and Blood Institute (NHLBI) Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: the evidence report: National Institutes of Health Obes Res 1998 6 Suppl 2 51S 209S [Erratum, Obes Res 1998;6:464.] 9813653
• Not checked yetcites [29] Wing RR Lang W Wadden TA Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes Diabetes Care 2011 34 1481 1486 21593294 PMC3120182 source

In the paper

“Holm’s procedure28 was used to adjust for multiple comparisons and to identify significant differences in at least one of the two between-group comparisons (P = 0.025).”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  cites [28] Holm S A simple sequentially rejective multiple test procedure Scand J Stat 1979 6 65 70

In the paper

“The strengths of this study include the randomized design”

In the paper

“the provision of free treatment enhancements (which may limit the generalizability of the results)”

In the paper

“Our data support the screening by PCPs of all adults for obesity, as well as efforts to help patients understand the health consequences of excess weight and the benefits of modest weight loss; these practices are consistent with prior recommendations.1,11”

What the sources say

• Not checked yetcites [1] Preventive Services Task Force Screening for obesity in adults: recommendations and rationale Ann Intern Med 2003 139 930 932 14644896 source
• Not checked yetcites [11] National Heart Lung and Blood Institute (NHLBI) Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: the evidence report: National Institutes of Health Obes Res 1998 6 Suppl 2 51S 209S [Erratum, Obes Res 1998;6:464.] 9813653