Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour

Šilarova, Barbora; Lucas, Joanne; Butterworth, Adam S.; Angelantonio, Emanuele Di; Girling, Christine; Lawrence, Kathryn; Mackintosh, Stuart; Moore, Carmel; Payne, Rupert; Sharp, Stephen J.; Shefer, Guy; Tolkien, Zoe; Usher‐Smith, Juliet A.; Walker, Matthew R.; Danesh, John; Griffin, Simon J.

doi:10.1186/s12889-015-2192-5

Cited by 14 publications

(21 citation statements)

References 55 publications

(53 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The INFORM (Information and Risk Modification) trial was a parallel-group, open randomised controlled trial in England that sought to quantify the short term effects of providing information about CVD risk and lifestyle advice on health-related behaviours; the protocol has been reported previously [ 28 ]. A convenience sample of 932 participants recruited from the INTERVAL blood donation trial [ 29 ] was randomised 1:1:1:1, with stratification by age (older or younger than 60 years) and sex, to one of the following trial arms: control with no intervention; web-based lifestyle advice only; lifestyle advice plus phenotypic coronary heart disease (CHD) risk score information; or lifestyle advice plus phenotypic and genetic CHD risk score information.…”

Section: Methodsmentioning

confidence: 99%

The association between psychosocial factors and change in lifestyle behaviour following lifestyle advice and information about cardiovascular disease risk

et al. 2018

View full text Add to dashboard Cite

BackgroundPhysical activity (PA) and fruit and vegetable intake (FVI) are two key modifiable risk factors for cardiovascular disease (CVD). Achieving change in these behaviours is challenging and affected by many variables including psychosocial factors. We aimed to investigate the association between social support, stress and mood, and change in PA and FVI following provision of CVD risk information and web-based lifestyle advice.MethodsSeven hundred sixteen blood donors (56% male; mean age 57 years) from the intervention arms of the Information and Risk Modification (INFORM) trial, a randomised controlled trial to assess the impact of providing CVD risk and web-based lifestyle information, were analysed as a prospective cohort. We used linear and logistic regression analyses to quantify the association between social support, stress and mood at baseline and behaviour change following the intervention. We modelled objective (average acceleration measured by Axivity AX3 wrist-worn accelerometers and plasma carotenoid levels) and subjective (self-reported recreational PA and FVI) outcomes as change between baseline and 12 weeks follow-up.ResultsThere was no clear association between social support and change in objective or subjective PA. Higher levels of stress and, to a lesser extent, depression symptoms were associated with smaller improvement in self-reported PA (β -1.53 h/week vigorous PA, 95% confidence interval (CI) -2.30 to -0.75, p < 0.001 for stress; β -1.64 h/week, 95% CI -3.50 to 0.21, p = 0.082 for little interest). Higher social support was associated with greater odds and higher stress was associated with lower odds of increasing self-reported FVI to five portions per day (odds ratio (OR) 1.33, 95% CI 1.05 to 1.69, p = 0.020 for social support; OR 0.57, 95% CI 0.43 to 0.76, p < 0.001 for stress). The associations between psychosocial factors and objective FVI were not statistically significant.ConclusionsHigh stress and low mood may reduce the likelihood and extent of reported change in PA and FVI following CVD risk information and advice. Greater social support may be associated with increased FVI. The role of psychosocial factors should be considered when developing, tailoring and evaluating future interventions.Trial registrationCurrent Controlled Trials ISRCTN17721237. Registered 12 January 2015.Electronic supplementary materialThe online version of this article (10.1186/s12889-018-5655-7) contains supplementary material, which is available to authorized users.

show abstract

Section: Methodsmentioning

confidence: 99%

The association between psychosocial factors and change in lifestyle behaviour following lifestyle advice and information about cardiovascular disease risk

et al. 2018

View full text Add to dashboard Cite

show abstract

“…This study is a secondary analysis of data collected as part of the INFORM trial. Details of that trial are reported elsewhere [ 22 ]. In brief, INFORM was a parallel group randomized controlled trial that aimed to explore the short-term effects on health-related behaviors of giving people different types of information online about their estimated risk of CHD in the subsequent 10 years, together with Web-based lifestyle advice.…”

Section: Methodsmentioning

confidence: 99%

“…The first session then began with education on either diet, physical activity, or smoking cessation alongside tips on how to overcome self-identified barriers to risk reduction and the creation of steps toward self-identified actionable goals. The second and third sessions included similar content, with participants beginning by reviewing their progress toward goals, continuing with education, and tips to overcome barriers, and then finishing with identification of new goals [ 22 ].…”

Section: Methodsmentioning

confidence: 99%

“…The Information and Risk Modification (INFORM) Trial [ 22 ] was a randomized controlled trial comparing the impact of providing phenotypic and genetic CHD risk scores alongside a Web-based lifestyle intervention. In additional to behavioral outcomes, INFORM included quantitative measurements of engagement with the Web-based lifestyle intervention and a nested qualitative study with face-to-face individual interviews with participants throughout the trial [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

“…A complete list of investigators and contributors to the INTERVAL trial is provided elsewhere [ 23 ]. A complete list of investigators and contributors to the INFORM study is also provided elsewhere [ 22 ]. NHS Blood and Transplant, the sponsor of the INTERVAL trial, assisted with the involvement of blood donors in INFORM.…”

mentioning

confidence: 99%

See 2 more Smart Citations

Factors Associated With Engagement With a Web-Based Lifestyle Intervention Following Provision of Coronary Heart Disease Risk: Mixed Methods Study

Usher‐Smith¹,

Winther²,

Shefer³

et al. 2017

J Med Internet Res

Self Cite

View full text Add to dashboard Cite

BackgroundWeb-based interventions provide the opportunity to combine the tailored approach of face-to-face interventions with the scalability and cost-effectiveness of public health interventions. This potential is often limited by low engagement. A number of studies have described the characteristics of individuals who engage more in Web-based interventions but few have explored the reasons for these variations.ObjectiveWe aimed to explore individual-level factors associated with different degrees of engagement with a Web-based behavior change intervention following provision of coronary heart disease (CHD) risk information, and the barriers and facilitators to engagement.MethodsThis study involved the secondary analysis of data from the Information and Risk Modification Trial, a randomized controlled trial of a Web-based lifestyle intervention alone, or alongside information on estimated CHD risk. The intervention consisted of three interactive sessions, each lasting up to 60 minutes, delivered at monthly intervals. Participants were characterized as high engagers if they completed all three sessions. Thematic analysis of qualitative data from interviews with 37 participants was combined with quantitative data on usage of the Web-based intervention using a mixed-methods matrix, and data on the views of the intervention itself were analyzed across all participants.ResultsThirteen participants were characterized as low engagers and 24 as high engagers. There was no difference in age (P=.75), gender (P=.95), or level of risk (P=.65) between the groups. Low engagement was more often associated with: (1) reporting a negative emotional reaction in response to the risk score (P=.029), (2) perceiving that the intervention did not provide any new lifestyle information (P=.011), and (3) being less likely to have reported feeling an obligation to complete the intervention as part of the study (P=.019). The mixed-methods matrix suggested that there was also an association between low engagement and less success with previous behavior change attempts, but the statistical evidence for this association was weak (P=.16). No associations were seen between engagement and barriers or facilitators to health behavior change, or comments about the design of the intervention itself. The most commonly cited barriers related to issues with access to the intervention itself: either difficulties remembering the link to the site or passwords, a perceived lack of flexibility within the website, or lack of time. Facilitators included the nonjudgmental presentation of lifestyle information, the use of simple language, and the personalized nature of the intervention.ConclusionsThis study shows that the level of engagement with a Web-based intervention following provision of CHD risk information is not influenced by the level of risk but by the individual’s response to the risk information, their past experiences of behavior change, the extent to which they consider the lifestyle information helpful, and whether they felt obliged to complete t...

show abstract

Risk scoring for the primary prevention of cardiovascular disease

Karmali

Persell

Perel

et al. 2017

Cochrane Database of Systematic Reviews

107

View full text Add to dashboard Cite

There is uncertainty whether current strategies for providing CVD risk scores affect CVD events. Providing CVD risk scores may slightly reduce CVD risk factor levels and may increase preventive medication prescribing in higher-risk people without evidence of harm. There were multiple study limitations in the identified studies and substantial heterogeneity in the interventions, outcomes, and analyses, so readers should interpret results with caution. New models for implementing and evaluating CVD risk scores in adequately powered studies are needed to define the role of applying CVD risk scores in primary CVD prevention.

show abstract

Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour

Cited by 14 publications

References 55 publications

The association between psychosocial factors and change in lifestyle behaviour following lifestyle advice and information about cardiovascular disease risk

The association between psychosocial factors and change in lifestyle behaviour following lifestyle advice and information about cardiovascular disease risk

Factors Associated With Engagement With a Web-Based Lifestyle Intervention Following Provision of Coronary Heart Disease Risk: Mixed Methods Study

Risk scoring for the primary prevention of cardiovascular disease

Contact Info

Product

Resources

About