Randomised Controlled Feasibility Trial of an Evidence-Informed Behavioural Intervention for Obese Adults with Additional Risk Factors
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Mendeley | Further Information

{"title"=>"Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors", "type"=>"journal", "authors"=>[{"first_name"=>"Falko F.", "last_name"=>"Sniehotta", "scopus_author_id"=>"8550046900"}, {"first_name"=>"Stephan U.", "last_name"=>"Dombrowski", "scopus_author_id"=>"17345448300"}, {"first_name"=>"Alison", "last_name"=>"Avenell", "scopus_author_id"=>"7003819118"}, {"first_name"=>"Marie", "last_name"=>"Johnston", "scopus_author_id"=>"7402060418"}, {"first_name"=>"Suzanne", "last_name"=>"McDonald", "scopus_author_id"=>"50761228500"}, {"first_name"=>"Peter", "last_name"=>"Murchie", "scopus_author_id"=>"6602237545"}, {"first_name"=>"Craig R.", "last_name"=>"Ramsay", "scopus_author_id"=>"7005242161"}, {"first_name"=>"Kim", "last_name"=>"Robertson", "scopus_author_id"=>"56208986400"}, {"first_name"=>"Vera", "last_name"=>"Araujo-Soares", "scopus_author_id"=>"17345226300"}], "year"=>2011, "source"=>"PLoS ONE", "identifiers"=>{"pui"=>"362461758", "sgr"=>"80052286632", "pmid"=>"21897841", "scopus"=>"2-s2.0-80052286632", "isbn"=>"1932-6203", "doi"=>"10.1371/journal.pone.0023040", "issn"=>"19326203"}, "id"=>"089a5d9f-b0b5-32ae-bc9b-7d300ffb5794", "abstract"=>"BACKGROUND: Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.\\n\\nMETHOD: Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)≥30 kg/m2) adults (age≥18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.\\n\\nRESULTS: Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes.\\n\\nCONCLUSIONS: The intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified.\\n\\nTRIAL REGISTRATION: Controlled-Trials.com ISRCTN90101501.", "link"=>"http://www.mendeley.com/research/randomised-controlled-feasibility-trial-evidenceinformed-behavioural-intervention-obese-adults-addit-9", "reader_count"=>36, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>1, "Researcher"=>4, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>11, "Student > Postgraduate"=>3, "Student > Master"=>11, "Student > Bachelor"=>2, "Lecturer"=>1, "Professor"=>2}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>1, "Researcher"=>4, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>11, "Student > Postgraduate"=>3, "Student > Master"=>11, "Student > Bachelor"=>2, "Lecturer"=>1, "Professor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>1, "Nursing and Health Professions"=>6, "Mathematics"=>1, "Medicine and Dentistry"=>11, "Agricultural and Biological Sciences"=>3, "Sports and Recreations"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Psychology"=>8, "Social Sciences"=>2, "Economics, Econometrics and Finance"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>11}, "Social Sciences"=>{"Social Sciences"=>2}, "Sports and Recreations"=>{"Sports and Recreations"=>1}, "Psychology"=>{"Psychology"=>8}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>3}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>6}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}}, "reader_count_by_country"=>{"Malaysia"=>1}, "group_count"=>2}

Scopus | Further Information

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  • {"files"=>["https://ndownloader.figshare.com/files/374095", "https://ndownloader.figshare.com/files/374153", "https://ndownloader.figshare.com/files/374218", "https://ndownloader.figshare.com/files/374259", "https://ndownloader.figshare.com/files/374300", "https://ndownloader.figshare.com/files/374342", "https://ndownloader.figshare.com/files/374438", "https://ndownloader.figshare.com/files/374480", "https://ndownloader.figshare.com/files/374535", "https://ndownloader.figshare.com/files/374638", "https://ndownloader.figshare.com/files/374718", "https://ndownloader.figshare.com/files/374943", "https://ndownloader.figshare.com/files/375096", "https://ndownloader.figshare.com/files/375236", "https://ndownloader.figshare.com/files/375385", "https://ndownloader.figshare.com/files/375597"], "description"=>"<div><h3>Background</h3><p>Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.</p> <h3>Method</h3><p>Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI)≥30 kg/m2) adults (age≥18 y) with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.</p> <h3>Results</h3><p>Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44); mean-BMI = 36.73(6.06)) with 2.35(1.47) co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD) was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation). Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes.</p> <h3>Conclusions</h3><p>The intervention procedures were found to be acceptable and feasible. Attrition rates were unacceptably high and areas for improvements of trial procedures were identified.</p> <h3>Trial Registration</h3><p>Controlled-Trials.com <a href=\"http://www.controlled-trials.com/ISRCTN90101501\">ISRCTN90101501</a></p> </div>", "links"=>[], "tags"=>["randomised", "controlled", "feasibility", "evidence-informed", "behavioural", "obese", "adults", "factors"], "article_id"=>133873, "categories"=>["Biotechnology"], "users"=>["Falko F. Sniehotta", "Stephan U. Dombrowski", "Alison Avenell", "Marie Johnston", "Suzanne McDonald", "Peter Murchie", "Craig R. Ramsay", "Kim Robertson", "Vera Araujo-Soares"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0023040.s001", "https://dx.doi.org/10.1371/journal.pone.0023040.s002", "https://dx.doi.org/10.1371/journal.pone.0023040.s003", "https://dx.doi.org/10.1371/journal.pone.0023040.s004", "https://dx.doi.org/10.1371/journal.pone.0023040.s005", "https://dx.doi.org/10.1371/journal.pone.0023040.s006", "https://dx.doi.org/10.1371/journal.pone.0023040.s007", "https://dx.doi.org/10.1371/journal.pone.0023040.s008", "https://dx.doi.org/10.1371/journal.pone.0023040.s009", "https://dx.doi.org/10.1371/journal.pone.0023040.s010", "https://dx.doi.org/10.1371/journal.pone.0023040.s011", "https://dx.doi.org/10.1371/journal.pone.0023040.s012", "https://dx.doi.org/10.1371/journal.pone.0023040.s013", "https://dx.doi.org/10.1371/journal.pone.0023040.s014", "https://dx.doi.org/10.1371/journal.pone.0023040.s015", "https://dx.doi.org/10.1371/journal.pone.0023040.s016"], "stats"=>{"downloads"=>90, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Randomised_Controlled_Feasibility_Trial_of_an_Evidence_Informed_Behavioural_Intervention_for_Obese_Adults_with_Additional_Risk_Factors/133873", "title"=>"Randomised Controlled Feasibility Trial of an Evidence-Informed Behavioural Intervention for Obese Adults with Additional Risk Factors", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2011-08-29 01:04:33"}
  • {"files"=>["https://ndownloader.figshare.com/files/741312"], "description"=>"<p>CONSORT Study Flowchart.</p>", "links"=>[], "tags"=>["public health and epidemiology"], "article_id"=>411682, "categories"=>["Biotechnology"], "users"=>["Falko F. Sniehotta", "Stephan U. Dombrowski", "Alison Avenell", "Marie Johnston", "Suzanne McDonald", "Peter Murchie", "Craig R. Ramsay", "Kim Robertson", "Vera Araujo-Soares"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023040.g001", "stats"=>{"downloads"=>1, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_CONSORT_Study_Flowchart_/411682", "title"=>"CONSORT Study Flowchart.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2011-08-29 00:28:02"}
  • {"files"=>["https://ndownloader.figshare.com/files/741511"], "description"=>"<p>Note. Intention and subjective norm measures were based on single items; The psychometrically shortened version of the IPQ-R was used.</p>", "links"=>[], "tags"=>["self-reported", "measures", "behaviour"], "article_id"=>411877, "categories"=>["Biotechnology"], "users"=>["Falko F. Sniehotta", "Stephan U. Dombrowski", "Alison Avenell", "Marie Johnston", "Suzanne McDonald", "Peter Murchie", "Craig R. Ramsay", "Kim Robertson", "Vera Araujo-Soares"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023040.t003", "stats"=>{"downloads"=>7, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_self_reported_measures_of_behaviour_and_psychological_variables_available_data_at_Time_2_and_3_for_all_participants_and_Cronbach_s_alphas_/411877", "title"=>"Baseline self-reported measures of behaviour and psychological variables, available data at Time 2 and 3 for all participants and Cronbach's alphas.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-29 00:31:17"}
  • {"files"=>["https://ndownloader.figshare.com/files/741566"], "description"=>"<p><i>Note</i>. GP practice A indicates proportion of sample recruited from the GP practice located in the more deprived area. Differences between groups were not tested for significance as allocation was randomised.</p>", "links"=>[], "tags"=>["pre-randomisation", "baseline", "characteristics"], "article_id"=>411927, "categories"=>["Biotechnology"], "users"=>["Falko F. Sniehotta", "Stephan U. Dombrowski", "Alison Avenell", "Marie Johnston", "Suzanne McDonald", "Peter Murchie", "Craig R. Ramsay", "Kim Robertson", "Vera Araujo-Soares"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023040.t002", "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Means_standard_deviation_of_pre_randomisation_baseline_characteristics_in_control_and_intervention_group_/411927", "title"=>"Means (standard deviation) of pre-randomisation baseline characteristics in control and intervention group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-29 00:32:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/741479"], "description"=>"<p><i>Note</i>. The regression model did not differ significantly from the intercept only model (<i>χ</i><sup>2</sup>(1) = 20.614, p = .081). However, rather than to better predict the outcome, the focus was to examine associations between independent and dependent variables as well as the predictive abilities of independent variables on dependent variables.</p>", "links"=>[], "tags"=>["public health and epidemiology"], "article_id"=>411848, "categories"=>["Biotechnology"], "users"=>["Falko F. Sniehotta", "Stephan U. Dombrowski", "Alison Avenell", "Marie Johnston", "Suzanne McDonald", "Peter Murchie", "Craig R. Ramsay", "Kim Robertson", "Vera Araujo-Soares"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023040.t001", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Predictors_of_consent_to_participate_in_the_study_n_8202_8202_806_/411848", "title"=>"Predictors of consent to participate in the study (n = 806).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-29 00:30:48"}
  • {"files"=>["https://ndownloader.figshare.com/files/741441"], "description"=>"<p>Note. Only n = 9 participants in the control and n = 16 participants in the intervention condition completed the Food Frequency Questionnaire and n = 11 controls and n = 20 intervention participants completed the Godin physical activity index. Due to these limited sample sizes, no <i>F</i> statistics for these measures are reported.</p>", "links"=>[], "tags"=>["measures", "baseline", "deviation", "intention-to-treat", "completing", "ancova", "controlled"], "article_id"=>411800, "categories"=>["Biotechnology"], "users"=>["Falko F. Sniehotta", "Stephan U. Dombrowski", "Alison Avenell", "Marie Johnston", "Suzanne McDonald", "Peter Murchie", "Craig R. Ramsay", "Kim Robertson", "Vera Araujo-Soares"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0023040.t004", "stats"=>{"downloads"=>1, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Changes_in_outcome_measures_from_baseline_Time_1_to_six_month_Time_3_in_control_and_intervention_group_with_standard_deviation_SD_intention_to_treat_for_all_participants_completing_the_study_and_ANCOVA_statistics_controlled_for_sex_height_and_baseline_ou/411800", "title"=>"Changes in outcome measures from baseline (Time 1) to six month (Time 3) in control and intervention group with standard deviation (SD), intention-to-treat for all participants completing the study and ANCOVA statistics controlled for sex, height and baseline outcome measure.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-29 00:30:00"}

PMC Usage Stats | Further Information

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