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Background: Excess sugar consumption has been linked to numerous negative health outcomes, such as obesity and type II diabetes. Reducing sugar-sweetened beverage (SSB) consumption may reduce sugar intake and thus improve health. The aim of the study was to test the impact of the potentially different rewarding nature of water or diet drinks as replacements for SSB, using a habit and implementation intention–based intervention. Method: An online randomised, two-arm parallel design was used. One hundred and fifty-eight participants (mainly from the UK and USA) who regularly consumed SSBs (Mage = 31.5, 51% female) were advised to create implementation intentions to substitute their SSB with either water or a diet drink. Measures of SSB consumption, habit strength and hedonic liking were taken at baseline and at 2 months. Water or diet drink consumption was only measured at 2 months. Results: There was a large and significant reduction in SSB consumption and self-reported SSB habits for both the water and diet drink groups, but no difference between groups. There were no differences in hedonic liking for the alternative drink, alternative drink consumption and alternative drink habit between the two groups. Reduction in SSB hedonic liking was associated with reduced SSB consumption and habit. Conclusion: This study demonstrates that an implementation intention–based intervention achieved substantial reductions in SSB consumption and habits. It also indicates that hedonic liking for SSBs and alternative drinks are associated with changes in consumption behaviour. Substituting SSBs with water or diet drinks was equally as effective in reducing SSB consumption. [ABSTRACT FROM AUTHOR]

Background: The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled, prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo). At the time of the trial's development, NIH had invested substantial resources in evaluating the potential benefits of these antioxidants. To capitalize on the knowledge gained from following a large cohort of healthy, aging males on the effects of selenium and/or vitamin E, ancillary studies with other disease endpoints were solicited.Methods: Four ancillary studies were added. Each drew from the same population but had independent objectives and an endpoint other than prostate cancer. These studies fell into two categories: those prospectively enrolling and following participants (studies of Alzheimer's disease and respiratory function) and those requiring a retrospective medical record review after a reported event (cataracts/age-related macular degeneration and colorectal screening). An examination of the challenges and opportunities of adding ancillary studies is provided. The impact of the ancillary studies on adherence to SELECT was evaluated using a Cox proportional hazards model.Results: While the addition of ancillary studies appears to have improved participant adherence to the primary trial, this did not come without added complexity. Activation of the ancillary studies happened after the SELECT randomizations had begun resulting in accrual problems to some of the studies. Study site participation in the ancillary trials varied greatly and depended on the interest of the study site principal investigator. Procedures for each were integrated into the primary trial and all monitoring was done by the SELECT Data and Safety Monitoring Committee. The impact of the early closure of the primary trial was different for each of the ancillary trials.Conclusions: The ancillary studies allowed study sites to broaden the research opportunities for their participants. Their implementation was efficient because of the established infrastructure of the primary trial. Implementation of these ancillary trials took substantial planning and coordination but enriched the overall primary trial.Trial Registration: NCT00006392-S0000 : Selenium and Vitamin E in Preventing Prostate Cancer (SELECT) (4 October 2000). NCT00780689-S0000A :  Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE) (25 June 2002). NCT00784225-S0000B : Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000 (SEE) (31 October 2008). NCT00706121-S0000D : Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000 (ACP) (26 June 2008). NCT00063453-S0000C : Vitamin E and/or Selenium in Preventing Loss of Lung Function in Older Men Enrolled on SELECT Clinical Trial SWOG-S0000 (26 June 2003). [ABSTRACT FROM AUTHOR]