Evidence map›Paper›PMID 23197844›Full record

Trial reportPsychosomatic medicine2013

Can attention control conditions have detrimental effects on behavioral medicine randomized trials?

Sherry L Pagoto, Mary M McDermott, George Reed, Philip Greenland, Kathy M Mazor, Judith K Ockene, Matt Whited, Kristin Schneider, Brad Appelhans, Kathy Leung and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychosomatic medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00217919 (Reducing Risk Factors in Peripheral Arterial Disease), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
0.4field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00217919 nacompletednot on this map

Reducing Risk Factors in Peripheral Arterial Disease

TypeinterventionalSponsorNorthwestern UniversityRan2006 to 2009Enrolled355ConditionsCardiovascular Diseases, Peripheral Vascular DiseasesArmsHealth-Counselor Mediated Telephone Counseling Intervention
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Pooled it
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  3. Systematic review of control groups in nutrition education intervention research.The international journal of behavioral nutrition and physical activity · 2017
    Pooled it
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  15. Considerations of Control Conditions Designs in Randomized Controlled Trials of Exercise Interventions for Cancer Survivors.The Canadian journal of nursing research = Revue canadienne de recherche en sciences infirmieres · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 1 institution in 1 country.

Sherry L PagotoDivision of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01760, USA. Sherry.pagoto@umassmed.edu
Mary M McDermott
George Reed
Philip Greenland
Kathy M Mazor
Judith K Ockene
Matt Whited
Kristin Schneider
Brad Appelhans
Kathy Leung
Philip Merriam
Ira Ockene
University of Massachusetts Chan Medical School · US

Funding

Multidisciplinary Clinical and Translational Science (MCTS) Program (UL1)UL1TR000150 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LLOYD-JONES, DONALD M · 2012 to 2013
$10.1M
Reducing Risk Factors in Peripheral Arterial DiseaseR01HL073912 · NHLBI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MCDERMOTT, MARY MCGRAE · 2005 to 2010
$3.0M
Depression treatment and risk for cardiovascular diseaseK23HL109620 · NHLBI · EAST CAROLINA UNIVERSITY · PI WHITED, MATTHEW CHARLES · 2012 to 2016
$646k
NCATS NIH HHS UL1 TR000150NHLBI NIH HHS K23 HL109620NHLBI NIH HHS R01 HL073912NHLBI NIH HHS R01-HL073912
6 · The paper itself

Abstract

objectiveAttention control (AC) conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance about which behavioral interventions and outcomes merit AC is available in the literature. The primary aim of the present study is to demonstrate a scenario in which use of AC in a behavioral randomized trial was unnecessary and possibly detrimental.

methodsExploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered counseling intervention reduced low-density lipoprotein cholesterol levels in 355 participants with peripheral arterial disease, compared with AC and usual care (UC) conditions. The patient-centered counseling intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched telephone-delivered health education, and the UC condition consisted of an educational pamphlet.

resultsAt 12-month follow-up, the mean low-density lipoprotein cholesterol changes were -11.1 and -6.8 mg/dL in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased the use or dose intensity of medication was significantly lower in AC than in UC: 17.5% versus 30.5% (p=.03). No significant difference in other outcomes was observed between AC and UC.

conclusionsAC has significantly worse medication outcomes, and there is no indication of a therapeutic effect on other end points. Implications for the use of AC in behavioral randomized trials are discussed.

trial registrationclinicaltrials.gov Identifier: NCT00217919.

Indexed as

AttentionBehavioral MedicineCounselingHealth Knowledge, Attitudes, PracticeAgedAnalysis of VarianceAnticholesteremic AgentsAnticipation, PsychologicalCholesterol, LDLControl GroupsDietary FatsFemaleHumansMaleMedication AdherencePatient Education as TopicAnticholesteremic AgentsCholesterol, LDLDietary Fats

Identifiers

PMID23197844
PMCPMC3570637
OpenAlexW2076871327

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.