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Baseline Characteristics Of Volunteers In The Smart Clinical Trial: Associations Between Habitual Physical Activity And Lifestyle Disease Risk Factors, Qingsheng Zhang, Jane E. O'Shea, Rebecca L. Thorne, Linda C. Tapsell, Marijka Batterham, Karen E. Charlton Nov 2012

Baseline Characteristics Of Volunteers In The Smart Clinical Trial: Associations Between Habitual Physical Activity And Lifestyle Disease Risk Factors, Qingsheng Zhang, Jane E. O'Shea, Rebecca L. Thorne, Linda C. Tapsell, Marijka Batterham, Karen E. Charlton

Dr Marijka Batterham

Physical Activity has been suggested to have favorable effects on various cardiovascular risk factors, and may serve as an intervening variable in life-style intervention studies. We aimed to examine the relationship between habitual physical activity and selected cardiovascular markers at baseline in a sample of overweight women who participated in the SMART clinical trial [ACTRN12608000425392]. A sub-sample of eighty-six overweight/obese women (mean age ± S.D.: 45 ± 7.9 years) were included in this analysis. Anthropometric and fasting blood data was collected at baseline (t = 0). Habitual physical activity was assessed by a validated questionnaire (Baecke questionnaire). Associations were examined …


Profiles Of Underreporting In Healthy Adults And Adults With Type Ii Diabetes Mellitus Participating In A Dietary Intervention Trial, Gina Martin, Linda C. Tapsell, Marijka Batterham Nov 2012

Profiles Of Underreporting In Healthy Adults And Adults With Type Ii Diabetes Mellitus Participating In A Dietary Intervention Trial, Gina Martin, Linda C. Tapsell, Marijka Batterham

Dr Marijka Batterham

Abstract from The Proceedings of the Nutrition Society of Australia, 2002.


A Randomized Controlled Trial Investigating The Effects Of A Low-Glycemic Index Diet On Pregnancy Outcomes In Gestational Diabetes Mellitus, Jennie Brand-Miller, Jimmy Chun Yu Louie, Peter Petocz, Tania Markovic, Nimalie Perera, Deborah Foote, Glynis Ross Nov 2012

A Randomized Controlled Trial Investigating The Effects Of A Low-Glycemic Index Diet On Pregnancy Outcomes In Gestational Diabetes Mellitus, Jennie Brand-Miller, Jimmy Chun Yu Louie, Peter Petocz, Tania Markovic, Nimalie Perera, Deborah Foote, Glynis Ross

Jimmy Chun Yu Louie

OBJECTIVE: The prevalence of gestational diabetes mellitus (GDM) is rising. There is little evidence to demonstrate the effectiveness of one dietary therapy over another. We aimed to investigate the effect of a low-glycemic index (LGI) versus a conventional high-fiber diet on pregnancy outcomes, neonatal anthropometry, and maternal metabolic profile in GDM.RESEARCH DESIGN AND METHODS: Ninety-nine women (age 26-42 years; mean ± SD prepregnancy BMI 24 ± 5 kg/m²) diagnosed with GDM at 20-32 weeks' gestation were randomized to follow either an LGI (n = 50; target glycemic index [GI] ~50) or a high-fiber moderate-GI diet (HF) (n = 49; target …


Study Protocol: A Randomized Controlled Trial Of A Computer-Based Depression And Substance Abuse Intervention For People Attending Residential Substance Abuse Treatment, Peter J. Kelly, Frances Kay-Lambkin, Amanda Baker, Frank P. Deane, Adam C. Brooks, Alexandra Mitchell, Sarah Marshall, Meredith Whittington, Genevieve A. Dingle Oct 2012

Study Protocol: A Randomized Controlled Trial Of A Computer-Based Depression And Substance Abuse Intervention For People Attending Residential Substance Abuse Treatment, Peter J. Kelly, Frances Kay-Lambkin, Amanda Baker, Frank P. Deane, Adam C. Brooks, Alexandra Mitchell, Sarah Marshall, Meredith Whittington, Genevieve A. Dingle

Frank Deane

"Background: A large proportion of people attending residential alcohol and other substance abuse treatment have a co-occurring mental illness. Empirical evidence suggests that it is important to treat both the substance abuse problem and co-occurring mental illness concurrently and in an integrated fashion. However, the majority of residential alcohol and other substance abuse services do not address mental illness in a systematic way. It is likely that computer delivered interventions could improve the ability of substance abuse services to address co-occurring mental illness. This protocol describes a study in which we will assess the effectiveness of adding a computer delivered …


Relationships Between Clinical Data And Baseline Eating Behaviours In A Sample Of Overweight Volunteers For A Dietary Intervention Trial, Lynette Mackey De Paiva, Lynda Gillen, Linda Tapsell, Marijka Batterham, Xu-Feng Huang, Rachel Cavanagh, Meredith Kennedy Sep 2012

Relationships Between Clinical Data And Baseline Eating Behaviours In A Sample Of Overweight Volunteers For A Dietary Intervention Trial, Lynette Mackey De Paiva, Lynda Gillen, Linda Tapsell, Marijka Batterham, Xu-Feng Huang, Rachel Cavanagh, Meredith Kennedy

Xu-Feng Huang

No abstract provided.


Dietary And Clinical Risk Profiles Of A Sample Of Healthy Overweight Adults Provide Targets For Dietary Advice In An Intervention Trial, Lynda Gillen, Linda Tapsell, Marijka Batterham, Xu-Feng Huang, Rachel Cavanagh, Meredith Kennedy Sep 2012

Dietary And Clinical Risk Profiles Of A Sample Of Healthy Overweight Adults Provide Targets For Dietary Advice In An Intervention Trial, Lynda Gillen, Linda Tapsell, Marijka Batterham, Xu-Feng Huang, Rachel Cavanagh, Meredith Kennedy

Xu-Feng Huang

No abstract provided.


Erythrocyte Biomarker-Based Validation Of A Diet History Method Used In A Dietary Intervention Trial, Craig S. Patch, Karen J Murphy, Jackie Mansour, Linda C. Tapsell, Barbara J. Meyer, Trevor A Mori, Manny Noakes, P Clifton, I Puddey, P Howe Jul 2012

Erythrocyte Biomarker-Based Validation Of A Diet History Method Used In A Dietary Intervention Trial, Craig S. Patch, Karen J Murphy, Jackie Mansour, Linda C. Tapsell, Barbara J. Meyer, Trevor A Mori, Manny Noakes, P Clifton, I Puddey, P Howe

L. C. Tapsell

No abstract provided.


Profiles Of Underreporting In Healthy Adults And Adults With Type Ii Diabetes Mellitus Participating In A Dietary Intervention Trial, Gina Martin, Linda C. Tapsell, Marijka Batterham Jul 2012

Profiles Of Underreporting In Healthy Adults And Adults With Type Ii Diabetes Mellitus Participating In A Dietary Intervention Trial, Gina Martin, Linda C. Tapsell, Marijka Batterham

L. C. Tapsell

Abstract from The Proceedings of the Nutrition Society of Australia, 2002.


Comparison Of Computerised Dietary Assessments With Diet History And Food Record Data At Baseline In An Australian Food-Based Clinical Trial, Yasmine Probst, Virva Sarmas, Linda C. Tapsell Jul 2012

Comparison Of Computerised Dietary Assessments With Diet History And Food Record Data At Baseline In An Australian Food-Based Clinical Trial, Yasmine Probst, Virva Sarmas, Linda C. Tapsell

L. C. Tapsell

Background: Food-based clinical trials are vital to advance the scientific evidence for the impact of food on health. These trials reqUire stringent dietary assessment to substantiate effects. We are evaluating the use of a self-administered computerised dietary assessment (DietAdvice) in a current food based weight loss trial. Objective: This cross sectional study aims to compare data from DietAdvice with diet history (DH) and food record (FR) dietary assessments measured at baseline. Materials and Methods: Baseline data for n=71 overweight (23-60 years, BMI 25-37 kg/m2) participants was utilised. Macronutrient data for matched dietary assessments from n=32 participants was obtained for the …


Start Date May Predict Attrition 6 Months Into A 12mth Dietary Intervention Weight Loss Trial, Jane O'Shea, Linda C. Tapsell, Marijka Batterham, Karen Charlton, Yasmine Probst, Rebecca Thorne, Qingsheng Zhang, Holley Jones Jul 2012

Start Date May Predict Attrition 6 Months Into A 12mth Dietary Intervention Weight Loss Trial, Jane O'Shea, Linda C. Tapsell, Marijka Batterham, Karen Charlton, Yasmine Probst, Rebecca Thorne, Qingsheng Zhang, Holley Jones

L. C. Tapsell

Participant recruitment is a difficult and time consuming aspect of clinical trials, often resulting in delays and budget overruns. Having reached recruitment targets the next challenge is participant retention. Some weight-loss studies have attrition rates around 60% which may introduce bias in the results. It may be possible to reduce attrition rates if known predictors can be found but to date few studies produced consistent results. The aim of this exploratory study was to determine whether start date could be a predictor of attrition for participants involved in the SMART weight loss clinical trial (ACTRN12608000425392). Recruitment for the trial occurred …


Analysis Of The Costs Of A Large Prevention Trial, Nicole Urban, Steven Self, Larry Kessler, Ross Prentice, Maureen Henderson, Donald Iverson, Donovan Thompson, David Byar, William Insull, Sherwood Gorbach, C Clifford, Susan Goldman Jun 2012

Analysis Of The Costs Of A Large Prevention Trial, Nicole Urban, Steven Self, Larry Kessler, Ross Prentice, Maureen Henderson, Donald Iverson, Donovan Thompson, David Byar, William Insull, Sherwood Gorbach, C Clifford, Susan Goldman

Don C. Iverson

Total direct costs of the Women's Health Trial (WHT), alarge multicenter preventiontrial, were reduced by more than 50% by means of research costanalysis conducted during the trial design phase. The unit costs of specific trial activities were estimated so that total direct costs of the trial could be predicted from design parameters. The relative costs of screening, treatment, and follow-up, and the fixed costs associated with each clinical center in a multicenter preventiontrial were taken into account. Direct costs of the WHT were reduced from $195 million to $95 million by refinement of the trial protocol, selection of an efficient …


Statistical Design Of The Women's Health Trial, Steven Self, Ross Prentice, Donald Iverson, Maureen Henderson, Donovan Thompson, David Byar, William Insull, Sherwood Gorbach, Carolyn Clifford, Susan Goldman, Nicole Urban, Lianne Sheppard, Peter Greenwald Jun 2012

Statistical Design Of The Women's Health Trial, Steven Self, Ross Prentice, Donald Iverson, Maureen Henderson, Donovan Thompson, David Byar, William Insull, Sherwood Gorbach, Carolyn Clifford, Susan Goldman, Nicole Urban, Lianne Sheppard, Peter Greenwald

Don C. Iverson

The National Cancer Institute has initiated a randomized trial to determine whether a low fat diet can reduce the incidence of breast cancer among women at increased risk for this disease. A feasibility trial involving 303 women has been conducted to examine recruitment strategies, study short-term compliance and, more generally, develop and refine trial procedures. The feasibility trial group also developed a detailed full-scale trial design plan, and randomization of participants to such a trial is currently underway. The purpose of this report is to describe the major design features of this Women's Health Trial, with particular emphasis on the …


Trial Of Print And Telephone Delivered Interventions To Influence Walking, Nancy Humpel, Donald Iverson, A Marshall, Eva Leslie, Neville Owen Jun 2012

Trial Of Print And Telephone Delivered Interventions To Influence Walking, Nancy Humpel, Donald Iverson, A Marshall, Eva Leslie, Neville Owen

Don C. Iverson

Both self-help print materials and telephone-assisted counseling have generally proved useful strategies to increase physical activity. This study examined their effectiveness in an intervention aimed specifically at promoting walking for specific purposes. Methods: Participants (n = 399) were randomly allocated to one of two 3-week intervention programs. The Print program comprised multiple mailing of brochures that emphasized walking within the local community environments. The Print plus Telephone program received the same brochures plus three telephone calls. Data collected via mailed self-completed surveys were analyzed by exploring outcomes related to walking for specific purposes. Results: There were no significant differences between …


Healthy Beginnings Trial Phase 2 Study: Follow-Up And Cost-Effectiveness Analysis, Li Ming Wen, Louise A. Baur, Chris Rissel, Vicki Flood, Judy M. Simpson, Alison Hayes, Louise L. Hardy, Karen Wardle Jan 2012

Healthy Beginnings Trial Phase 2 Study: Follow-Up And Cost-Effectiveness Analysis, Li Ming Wen, Louise A. Baur, Chris Rissel, Vicki Flood, Judy M. Simpson, Alison Hayes, Louise L. Hardy, Karen Wardle

Faculty of Health and Behavioural Sciences - Papers (Archive)

Background: In 2007, we commenced the Healthy Beginnings Trial (HBT) Phase 1 study, which is the first randomised controlled trial (RCT) to test the effectiveness of an early childhood obesity intervention in children aged up to 2 years. The results were promising with significant improvements in infant feeding practices and a lower mean body mass index (BMI). The aims of this proposed Phase 2 study are to determine if the early intervention will lead to a lower mean BMI, lower screen time, improved dietary behaviours and demonstrated costeffectiveness of the intervention, in children aged 3½ and 5 years. Methods/design: In …


Effectiveness Of Home Based Early Intervention On Children's Bmi At Age 2: Randomised Controlled Trial, Li Ming Wen, Louise A. Baur, Judy M. Simpson, Chris Rissel, Karen Wardle, Victoria M. Flood Jan 2012

Effectiveness Of Home Based Early Intervention On Children's Bmi At Age 2: Randomised Controlled Trial, Li Ming Wen, Louise A. Baur, Judy M. Simpson, Chris Rissel, Karen Wardle, Victoria M. Flood

Faculty of Health and Behavioural Sciences - Papers (Archive)

Objectives: To assess the effectiveness of a home-based early intervention on children’s BMI at age two. Design: Randomised controlled trial Setting: The Healthy Beginnings Trial was conducted in socially and economically disadvantaged areas of Sydney, Australia during 2007-2010. Participants: A total of 667 first-time mothers and their infants. Intervention: The intervention consisted of eight home visits from specially trained community nurses delivering a staged home-based intervention, one in the antenatal period, and seven at 1, 3, 5, 9, 12, 18 and 24 months after birth. Timing of the visits was designed to coincide with early childhood developmental milestones. …


Study Protocol For A Randomized Controlled Trial Of Humor Therapy In Residential Care: The Sydney Multisite Intervention Of Laughterbosses And Elderclowns (Smile), Belinda Goodenough, Lee-Fay Low, Anne-Nicole Casey, Lynn Chenoweth, Richard Fleming, Peter Spitzer, Jean-Paul Bell, Henry Brodaty Jan 2012

Study Protocol For A Randomized Controlled Trial Of Humor Therapy In Residential Care: The Sydney Multisite Intervention Of Laughterbosses And Elderclowns (Smile), Belinda Goodenough, Lee-Fay Low, Anne-Nicole Casey, Lynn Chenoweth, Richard Fleming, Peter Spitzer, Jean-Paul Bell, Henry Brodaty

Faculty of Health and Behavioural Sciences - Papers (Archive)

Background: Humor therapy is a non-pharmacological intervention with potential to improve mood and quality of life for institutionalized older persons, including those with dementia. The primary aims of the Sydney Multisite Intervention of LaughterBosses and ElderClowns (SMILE) are to examine the effects of humor therapy on residents' mood, quality of life, social engagement, and agitation. Methods: SMILE is a single-blinded cluster-randomized controlled trial where 398 consented residents in 35 residential aged care facilities will be allocated to receive humor therapy or usual care. Residents allocated to the intervention group will engage in humor therapy with professional performers (ElderClowns) and trained …


Comparison Of The Dietadvice Website In The Clinical Trial And Primary Healthcare Contexts, Yasmine Probst, Kathryn Boyd, Virva Walkington, Linda C. Tapsell Jan 2012

Comparison Of The Dietadvice Website In The Clinical Trial And Primary Healthcare Contexts, Yasmine Probst, Kathryn Boyd, Virva Walkington, Linda C. Tapsell

Faculty of Health and Behavioural Sciences - Papers (Archive)

The aim of this study was to evaluate the use of the DietAdvice website, a self-administered online dietary assessment, in the context of a dietary intervention randomized controlled trial [ACTRN 12608000425392]. Data available from a total of n=118 volunteers recruited to the dietary trial and using the website in the clinic at t=0, 3 and 12mo was compared with that obtained from diet histories (DH) and 3-day food record (FR). Fasting blood samples from these time points were also correlated with the macronutrient values obtained. Complete web based records were obtained for 65% of participants at t=0, 83% at t=3 …


Study Protocol: A Randomized Controlled Trial Of A Computer-Based Depression And Substance Abuse Intervention For People Attending Residential Substance Abuse Treatment, Peter J. Kelly, Frances Kay-Lambkin, Amanda Baker, Frank P. Deane, Adam C. Brooks, Alexandra Mitchell, Sarah Marshall, Meredith Whittington, Genevieve A. Dingle Jan 2012

Study Protocol: A Randomized Controlled Trial Of A Computer-Based Depression And Substance Abuse Intervention For People Attending Residential Substance Abuse Treatment, Peter J. Kelly, Frances Kay-Lambkin, Amanda Baker, Frank P. Deane, Adam C. Brooks, Alexandra Mitchell, Sarah Marshall, Meredith Whittington, Genevieve A. Dingle

Faculty of Health and Behavioural Sciences - Papers (Archive)

"Background: A large proportion of people attending residential alcohol and other substance abuse treatment have a co-occurring mental illness. Empirical evidence suggests that it is important to treat both the substance abuse problem and co-occurring mental illness concurrently and in an integrated fashion. However, the majority of residential alcohol and other substance abuse services do not address mental illness in a systematic way. It is likely that computer delivered interventions could improve the ability of substance abuse services to address co-occurring mental illness. This protocol describes a study in which we will assess the effectiveness of adding a computer delivered …


Seven Out Of Ten Most Popular Vegetables Remain Top Choice During First 3 Months Of A 12 Month Weight Loss Dietary Intervention Trial, Jane O'Shea, Yasmine Probst, Rebecca Thorne, Sara Grafenauer, Linda Tapsell Jan 2012

Seven Out Of Ten Most Popular Vegetables Remain Top Choice During First 3 Months Of A 12 Month Weight Loss Dietary Intervention Trial, Jane O'Shea, Yasmine Probst, Rebecca Thorne, Sara Grafenauer, Linda Tapsell

Faculty of Health and Behavioural Sciences - Papers (Archive)

Increasing vegetable consumption is part of dietary advice for weight loss, but how this converts to vegetable choices is not known. In this context, our aim was to identify the main vegetable groups reported by the study sample in the Healthy Eating and Lifestyle Trial [ACTRN1260000784011] at baseline (Oct 2010-Feb 2011) and after 3mo (Feb - May 2011). Data from diet histories (DH) were analyzed using the AUSNUT 2007 database in Foodworks (Xyris, version 6.0.2562) to determine the average daily amount (g) of vegetables consumed by the study sample. Baseline DH (n=113 subjects; 85 female) exposed 32 vegetable categories. The …