Cited by 487Pharmacology and Obesity TreatmentObesity and Health PracticesObesity, Physical Activity, Diet

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

Open access
Wadden, Thomas A., Volger, Sheri, Sarwer, David B., Vetter, Marion L., Tsai, Adam G., Berkowitz, Robert I., Kumanyika, Shiriki, Schmitz, Kathryn H. +4 more·2011·New England Journal of Medicine

Abstract

BACKGROUND: Calls for primary care providers (PCPs) to offer obese patients behavioral weight-loss counseling have not been accompanied by adequate guidance on how such care could be delivered. This randomized trial compared weight loss during a 2-year period in response to three lifestyle interventions, all delivered by PCPs in collaboration with auxiliary health professionals (lifestyle coaches) in their practices. METHODS: We randomly assigned 390 obese adults in six primary care practices to one of three types of intervention: usual care, consisting of quarterly PCP visits that included education about weight management; brief lifestyle counseling, consisting of quarterly PCP visits combined with brief monthly sessions with lifestyle coaches who instructed participants about behavioral weight control; or enhanced brief lifestyle counseling, which provided the same care as described for the previous intervention but included meal replacements or weight-loss medication (orlistat or sibutramine), chosen by the participants in consultation with the PCPs, to potentially increase weight loss. RESULTS: Of the 390 participants, 86% completed the 2-year trial, at which time, 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. Initial weight decreased at least 5% in 21.5%, 26.0%, and 34.9% of the participants in the three groups, respectively. Enhanced lifestyle counseling was superior to usual care on both these measures of success (P=0.003 and P=0.02, respectively), with no other significant differences among the groups. The benefits of enhanced lifestyle counseling remained even after participants given sibutramine were excluded from the analyses. There were no significant differences between the intervention groups in the occurrence of serious adverse events. CONCLUSIONS: Enhanced weight-loss counseling helps about one third of obese patients achieve long-term, clinically meaningful weight loss. (Funded by the National Heart, Lung, and Blood Institute; POWER-UP ClinicalTrials.gov number, NCT00826774.).

AI snapshot

Written from the paper’s full text.

TL;DR

In a two-year randomized trial in six primary care practices, enhanced brief lifestyle counseling—quarterly PCP visits, monthly lifestyle-coach sessions, plus meal replacements or weight-loss medication—produced greater weight loss than usual care in obese adults. Brief lifestyle counseling alone did not significantly outperform usual care.

Key findings

  • At 24 months, mean (±SE) weight loss was 1.7±0.7 kg with usual care, 2.9±0.7 kg with brief lifestyle counseling, and 4.6±0.7 kg with enhanced brief lifestyle counseling.
  • Initial weight decreased by at least 5% in 21.5%, 26.0%, and 34.9% of participants in the three groups, respectively.
  • Enhanced lifestyle counseling was superior to usual care on both weight loss and ≥5% weight loss (P=0.003 and P=0.02, respectively), with no other significant differences among groups.
  • There were no significant differences between intervention groups in serious adverse events; 73 hospitalizations occurred, with no deaths.

Methods

  • Randomized trial of 390 obese adults in six primary care practices; participants were ≥21 years old, had BMI 30 to 50, and had at least two of five metabolic syndrome components.
  • Participants were assigned to usual care (quarterly PCP visits), brief lifestyle counseling (quarterly PCP visits plus monthly lifestyle-coach sessions), or enhanced brief lifestyle counseling (same as brief counseling plus meal replacements, orlistat, or sibutramine chosen with the PCP).
  • Primary outcome was 24-month weight change; intention-to-treat analyses used repeated-measures linear mixed-effects models and generalized-estimating-equation models, controlling for initial weight, age, sex, race or ethnic group, and study site. The trial had 80% power to detect a 2.75-kg difference at month 24.

Limitations

  • The paper states that limitations included provision of free treatment enhancements, which may limit generalizability; need for longer follow-up; and withdrawal of sibutramine from the market, which clouded interpretation of findings for the enhanced-counseling group.
  • The text also makes evident that attendance declined from year 1 to year 2, brief lifestyle counseling did not significantly increase weight loss versus usual care, and the usual-care group lost more than expected, possibly because it received more weight-management support than typical primary care.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1056/nejmoa1109220

Cites

39 of 39 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 27 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    Initial weight decreased at least 5% in 21.5%, 26.0%, and 34.9% of participants in usual care, brief lifestyle counseling, and enhanced brief lifestyle counseling, respectively.

    “Initial weight decreased at least 5% in 21.5%, 26.0%, and 34.9% of the participants in the three groups, respectively.”
    Quote in the paperSubstantial claim
  • Findingown data

    There were no other significant differences among the three intervention groups in weight loss at 24 months.

    “with no other significant differences among the groups.”
    • Also stated in: § WEIGHT LOSS · plain
      “whereas other between-group differences were not significant.”
    Quote in the paperSubstantial claim
  • Findingown data

    The enhanced lifestyle counseling group had significantly smaller reductions in LDL cholesterol levels at month 24.

    “However, this group had significantly smaller reductions in LDL cholesterol levels at month 24.”
    Quote in the paperNot a substantial claim
  • Findingown data

    For each intervention group, higher attendance generally was associated with greater weight loss.

    “Figure 3 in the Supplementary Appendix shows that for each intervention group, higher attendance generally was associated with greater weight loss.”
    Quote in the paperNot a substantial claim
  • Findingown data

    PCPs collaborating with medical assistants helped one group of their obese patients lose an average of 4.7% of initial weight at 24 months.

    “The principal finding of this study was that PCPs, collaborating with medical assistants, helped one group of their obese patients lose an average of 4.7% of their initial weight at 24 months.”
    Quote in the paperSubstantial claim
  • May combine two claims. 18
  • Classified as probably not a substantial claim. 13
  • May combine two claims.

    Findingown data

    At month 24, mean weight loss was 1.7 kg with usual care, 2.9 kg with brief lifestyle counseling, and 4.6 kg with enhanced brief lifestyle counseling.

    “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.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Among the 66 participants in the enhanced-lifestyle-counseling group who used meal replacements without sibutramine for most of the trial, mean weight loss at month 24 was 4.1 kg, significantly greater than usual care (P = 0.04) but not significantly different from brief lifestyle counseling (P = 0.30).

    “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”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Sibutramine was discontinued in five participants because of increases in blood pressure, in a sixth because of tachycardia, and in a seventh because of anxiety; orlistat was discontinued in five participants because of gastrointestinal symptoms.

    “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.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    At baseline, participants who received enhanced lifestyle counseling chose meal replacements (67), sibutramine (38), or orlistat (24).

    “At baseline, participants who received enhanced lifestyle counseling chose one of three additional treatment enhancements: meal replacements (67 participants), sibutramine (38), or orlistat (24).”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    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.

    “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).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Participants in lifestyle counseling and enhanced lifestyle counseling attended 56.1% and 64.7% of the 25 scheduled coaching visits, respectively.

    “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.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Among the 85 participants who received enhanced lifestyle counseling without sibutramine, mean weight loss at month 24 was 4.3 kg, significantly greater than usual care (1.7 kg) but not significantly different from brief lifestyle counseling (2.9 kg).

    “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).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    There were 21 serious adverse events in 16 usual-care participants, 26 events in 20 brief-lifestyle-counseling participants, and 26 events in 22 enhanced-lifestyle-counseling participants, with no significant differences between groups (P = 0.556).

    “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).”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    In an intention-to-treat analysis based on initial choice of enhancement, mean weight loss at month 24 was 3.9 kg for meal replacements, 5.5 kg for sibutramine, and 4.6 kg for orlistat, with no significant differences among them.

    “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.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Among participants who initially chose meal replacements, 16% switched to a different enhancement; among those who chose sibutramine, 39% switched; among those who chose orlistat, 33% switched.

    “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.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationcitation

    Long-term weight loss in the enhanced lifestyle counseling group and in the brief lifestyle counseling group was greater than weight loss observed in other primary care trials, with the exception of a study involving extremely obese patients treated with intensive group lifestyle modification and weight-loss medications.

    “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”
    Quote in the paperSubstantial claim0 of 6 sources checked
    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [30] Cohen MD D’Amico FJ Merenstein JH Weight reduction in obese hypertensive patients Fam Med 1991 23 25 28 2001777

      Not checked in the free run.

    • cites [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 in the free run.

    • cites [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

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

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

    “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.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Premisecitation

    Overweight patients who received eight brief counseling sessions and quarterly PCP visits lost 4.4 kg in 6 months, compared with 0.9 kg for control patients limited to quarterly PCP visits.

    “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.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductown data

    Participants were randomly assigned to interventions in equal numbers with a computer-generated algorithm operated by the Investigational Drug Service at the University of Pennsylvania.

    “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.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductcitation

    All providers were certified in intervention delivery at baseline and recertified at 6-month intervals.

    “All providers were certified in intervention delivery at baseline and were recertified at 6-month intervals, according to previously described methods.27”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [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

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Approximately 86% of participants in each group had their weight measured at 24 months.

    “Approximately 86% of the participants in each group had their weight measured at 24 months (Fig. 1).”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Study design and conductnone given

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

    “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).”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Premisecitation

    Both orlistat and sibutramine increase weight loss by approximately 3 to 5 kg, as compared with placebo.

    “Both orlistat (GlaxoSmithKline) and sibutramine (Abbott) increase weight loss by approximately 3 to 5 kg, as compared with placebo,12–14”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [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 in the free run.

    • cites [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 in the free run.

    • cites [14] Li Z Maglione M Tu W Meta-analysis: pharmacologic treatment of obesity Ann Intern Med 2005 142 532 546 15809465 source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductown data

    Weight changes in the intention-to-treat population were compared with repeated-measures linear mixed-effects models and generalized-estimating-equation models that controlled for initial weight, age, sex, race or ethnic group, and study site.

    “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.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

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

    “Assignments were stratified by clinic, with randomly varied block sizes (3, 6, or 9).”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The baseline weight difference was addressed in the analyses by the a priori decision to control for initial weight.

    “a difference addressed in the analyses by the a priori decision to control for initial weight.”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim.

    Premisecitation

    A 5% or greater reduction in initial weight is a common criterion for clinically meaningful weight loss.

    “which is a common criterion for clinically meaningful weight loss.11,29”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [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 in the free run.

    • cites [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

      Not checked in the free run.

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductcitation

    Holm's procedure 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).

    “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).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [28] Holm S A simple sequentially rejective multiple test procedure Scand J Stat 1979 6 65 70

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

  • Classified as probably not a substantial claim.

    Study design and conductown data

    The study had a randomized design.

    “The strengths of this study include the randomized design”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationnone given

    The provision of free treatment enhancements may limit the generalizability of the results.

    “the provision of free treatment enhancements (which may limit the generalizability of the results)”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim. May combine two claims.

    Interpretationown data

    The data support 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.

    “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”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [1] Preventive Services Task Force Screening for obesity in adults: recommendations and rationale Ann Intern Med 2003 139 930 932 14644896 source

      Not checked in the free run.

    • cites [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 in the free run.

    • Rests on an assumption: The trial participants are representative of obese adults in primary care practice.
26 of 26
  • The paper relies on this without support.

    The trial participants are representative of obese adults in primary care practice.

    “Enhanced weight-loss counseling helps about one third of obese patients achieve long-term, clinically meaningful weight loss.”
    “By providing enhanced lifestyle counseling, as described here, PCPs could help a considerable minority of obese persons achieve clinically meaningful weight loss,11,29 which they might not achieve if they were simply told to reduce their weight on their own.”
  • The paper relies on this without support.

    The primary care practices and staff in the trial are typical of primary care practices generally.

    “Enhanced lifestyle counseling offers a model for treating obesity in primary care practices with the help of regular staff members (PCPs and medical assistants).”
2 of 2

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Cites

Flagged first, then by citations

Research works printed but not linked: 2

  1. Holm S, 1979, Scand J Stat, 6, 65
  2. Cohen MD, 1991, Fam Med, 23, 25

Cited by

Sorted by citations

Authors
Wadden, T. A., Volger, S., Sarwer, D. B., Vetter, M. L., Tsai, A. G., Berkowitz, R. I., Kumanyika, S., Schmitz, K. H., Diewald, L. K., Barg, R., Chittams, J., & Moore, R. H.
Affiliations
  • University of Pennsylvania (US)
  • University of Colorado Anschutz (US)
  • Children's Hospital of Philadelphia (US)
  • University of Pennsylvania Health System (US)
Venue
New England Journal of Medicine
Published
2011-11-24
Volume
365
Issue
21
Pages
1969-1979
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2137765752
Cited by
487
References
39
Citations by year
2026: 5 · 2025: 8 · 2024: 13 · 2023: 28 · 2022: 24 · 2021: 31 · 2020: 38 · 2019: 30 · 2018: 27 · 2017: 34 · 2016: 41 · 2015: 49 · 2014: 49 · 2013: 61 · 2012: 45
FWCI
37.24
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (5u01hl087072-05)
  • National Heart, Lung, and Blood Institute (U01-HL087072)
Topics
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Health Sciences › Health Professions › Pharmacy › Obesity and Health Practices
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
Keywords
obesity, weight loss, lifestyle intervention, primary care, meal replacement, orlistat, sibutramine, weight management, long-term weight maintenance
MeSH terms
Adult, Behavior Therapy, Cardiovascular Diseases, Counseling, Diet, Reducing, Female, Humans, Life Style, Male, Middle Aged, Obesity, Primary Health Care, Risk Factors, Weight Loss, Exercise, Risk Reduction Behavior, Intention to Treat Analysis

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