Vitalum study design: RCT evaluating the efficacy of tailored print communication and telephone motivational interviewing on multiple health behaviors

Abstract Background A large proportion of adults fail to meet public health guidelines for physical activity as well as fruit, vegetable and fat intake. Interventions are needed to improve these health behaviors. Both computer tailoring and motivational interviewing have shown themselves to be promising techniques for health behavior change. The Vitalum project aims to compare the efficacy of these techniques in improving the health behaviors of adults aged 45–70. This paper describes the design of the Vitalum study. Methods/Design Dutch general medical practices (N = 23) were recruited via a registration network or by personal invitation. The participants were then enrolled through these general practices using an invitational letter. They (n = 2,881) received a written baseline questionnaire to assess health behaviors, and potential psychosocial and socio-demographic behavioral determinants. A power analysis indicated that 1,600 participants who were failing to meet the guidelines for physical activity and either fruit or vegetable consumption were needed. Eligible participants were stratified based on hypertension status and randomized into one of four intervention groups: tailored print communication, telephone motivational interviewing, combined, and control. The first two groups either received four letters or took part in four interviews, whereas the combined group received two letters and took part in two interviews in turns at 5, 13, 30 and 43 weeks after returning the baseline questionnaire. Each letter and interview focused on physical activity or nutrition behavior. The participants also took part in a telephone survey 25 weeks after baseline to gather new information for tailoring. There were two follow-up questionnaires, at 47 and 73 weeks after baseline, to measure short- and long-term effects. The control group received a tailored letter after the last posttest. The process, efficacy and cost-effectiveness of the interventions will be examined by means of multilevel mixed regression, cost-effectiveness analyses and process evaluation. Discussion The Vitalum study simultaneously evaluates the efficacy of tailored print communication and telephone motivational interviewing, and their combined use for multiple behaviors and people with different motivational stages and education levels. The results can be used by policymakers to contribute to evidence-based prevention of chronic diseases. Trial Registration Dutch Trial Register NTR1068http://deepblue.lib.umich.edu/bitstream/2027.42/112919/1/12889_2008_Article_1186.pd

Cost-effectiveness of tailored print communication, telephone motivational interviewing, and a combination of the two: results of an economic evaluation alongside the Vitalum randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>The aim of the present study was to evaluate the cost-effectiveness of tailored print communication (TPC), telephone motivational interviewing (TMI), a combination of the two, and no intervention on two outcomes in adults aged 45 to 70, half of them having hypertension: increasing the number of public health guidelines met for three behaviors (physical activity and fruit and vegetable consumption), and impact on quality adjusted life years (QALYs).</p> <p>Methods</p> <p>Participants (<it>n </it>= 1,629) from 23 Dutch general practices were randomized into one of four groups, which received 4 TPCs, 4 TMIs, 2 of each (combined), or no intervention (control), respectively. The self-reported outcomes, measured at baseline and 73 weeks follow-up (7 months after the last intervention component), were difference in total number of guidelines met at follow-up compared to baseline, and number of QALYs experienced over 73 weeks. The costs of implementing the intervention were estimated using a bottom-up approach.</p> <p>Results</p> <p>At 73 weeks follow-up participants showed increased adherence with 0.62 (TPC), 0.40 (TMI), 0.50 (combined), and 0.26 (control) guidelines compared to baseline, and experienced 1.09, 1.08, 1.08, and 1.07 QALYs, respectively. The costs for the control group were considered to be zero. TMI was more expensive (€107 per person) than both the combined intervention (€80) and TPC (€57). The control condition was most cost-effective for lower ceiling ratios, while TPC had the highest probability of being most cost-effective for higher ceiling ratios (more than €160 per additional guideline met, and €2,851 for each individual QALY).</p> <p>Conclusions</p> <p>For low society's willingness to pay, the control group was most cost-effective for the number of QALYs experienced over 73 weeks. This also applied to the increase in the number of guidelines met at lower ceiling ratios, whereas at higher ceiling ratios, TPC had a higher probability of being more cost-effective than the TMI, combined or control conditions. This also seemed to apply for QALYs experienced over 73 weeks. More research is needed on the long-term efficacy of both TPC and TMI, as well as on how to increase their cost-effectiveness.</p> <p>Trial registration</p> <p>Dutch Trial Register NTR1068</p

Systematically Developing a Web-Based Tailored Intervention Promoting HPV-Vaccination Acceptability Among Mothers of Invited Girls Using Intervention Mapping.

Background: Currently, the eHealth field calls for detailed descriptions of theory-based interventions in order to support improved design of such interventions. This article aims to provide a systematic description of the design rationale behind an interactive web-based tailored intervention promoting HPV-vaccination acceptability. Methods: The 6-step Intervention Mapping (IM) protocol was used to describe the design rationale. After the needs assessment in Step 1, intervention objectives were formulated in Step 2. In Step 3, we translated theoretical methods into practical applications, which were integrated into a coherent intervention in Step 4. In Step 5, we anticipated future implementation and adoption, and finally, an evaluation plan was generated in Step 6. Results: Walking through the various steps of IM resulted in a detailed description of the intervention. The needs assessment indicated HPV-vaccination uptake remaining lower than expected. Mothers play the most important role in decision-making about their daughter's immunization. However, they generally feel ambivalent after they made their decisions, and their decisions are based on rather unstable grounds. Therefore, intervention objectives were to improve HPV-vaccination uptake and informed decision-making, and to decrease decisional conflict among mothers of invited girls. Computer-tailoring was chosen as the main method; virtual assistants were chosen as a practical application to deliver interactive tailored feedback. To maximize compatibility with the needs of the target group, a user-centered design strategy by means of focus groups and online experiments was applied. In these, prototypes were tested and sequentially refined. Finally, efficacy, effectiveness, and acceptability of the intervention were tested in a randomized controlled trial. Results showed a significant positive effect of the intervention on informed decision-making, decisional conflict, and nearly all determinants of HPV-vaccination uptake (P < 0.001). Mothers evaluated the intervention as highly positive. Discussion: Using IM led to an innovative effective intervention for promoting HPV-vaccination acceptability. The intervention maps will aid in interpreting the results of our evaluation studies. Moreover, it will ease the comparison of design rationales across interventions, and may provide leads for the development of other eHealth interventions. This paper adds to the plea for systematic reporting of design rationales constituting the process of developing interventions

LA PRESA DE AYAGAURES EN CONSTRUCCIÓN [Material gráfico]

Copia digital. Madrid : Ministerio de Educación, Cultura y Deporte. Subdirección General de Coordinación Bibliotecaria, 201

Tailored Print Communication and Telephone Motivational Interviewing Are Equally Successful in Improving Multiple Lifestyle Behaviors in a Randomized Controlled Trial

Background: Computer tailoring and motivational interviewing show promise in promoting lifestyle change, despite few head-to-head comparative studies. Purpose: Vitalum is a randomized controlled trial in which the efficacy of these methods was compared in changing physical activity and fruit and vegetable consumption in middle-aged Dutch adults. Methods: Participants (n?=?1,629) were recruited via 23 general practices and randomly received either four tailored print letters, four motivational telephone calls, two of each type of intervention, or no information. The primary outcomes were absolute change in self-reported physical activity and fruit and vegetable consumption. Results: All three intervention groups (i.e., the tailored letters, the motivational calls, and the combined version) were equally and significantly more effective than the control group in increasing physical activity (hours/day), intake of fruit (servings/day), and consumption of vegetables (grams/day) from baseline to the intermediate measurement (week 25), follow-up 1 (week 47) and 2 (week 73). Effect sizes (Cohen's d) ranged from 0.15 to 0.18. Participants rated the interventions positively; interviews were more positively evaluated than letters. Conclusions: Tailored print communication and telephone motivational interviewing or their combination are equally successful in changing multiple behaviors. © 2010 The Author(s)

Intervention Fidelity of Telephone Motivational Interviewing On Physical Activity, Fruit Intake, and Vegetable Consumption in Dutch Outpatients With and Without Hypertension.

BACKGROUND: In theory, Motivational Interviewing (MI) fidelity should be associated with client outcomes. Nevertheless, this fidelity-effectiveness association is rarely investigated. This study evaluated the extent to which Telephone Motivational Interviewing (TMI) fidelity is associated with change in self-reported physical activity (PA), fruit intake, and vegetable consumption. METHOD: Adults in primary care (45-70 years) participated in a study that compared the effect of tailor print communication, telephone motivational interviewing (TMI), and a combination of the two on PA, fruit intake, and vegetable consumption. MI fidelity was assessed using the behavioral coding method "Motivational Interviewing Treatment Integrity Code (MITI)" in 409 randomly selected audio-recorded sessions, representing 232 participants of the TMI group. The associations between MI fidelity scores and the behavioral changes from baseline to 47-week follow-up were examined using backward multiple linear regression analyses (adjusted for covariates). RESULTS: A significant and positive association between the percentage of MI adherent responses and improvements in PA and fruit consumption was found with respectively a small and medium effect size. The global rating "Spirit" (which resembles an all-at-once appraisal of the interviewer's MI competence) was significantly, but inversely associated with progress in vegetable intake with a medium effect size. CONCLUSION: The finding that relatively lower MI competency was associated with higher vegetable consumption went against our expectations. Findings suggest that practicing MI-consistent skills was beneficial in promoting PA and fruit consumption, but moderated vegetable intake. This study contributes to the scientific confidence that TMI enables change in PA and fruit intake

The effect of emotion regulation strategies on decision-making about the maternal pertussis vaccination among pregnant women in the Netherlands: an experimental study

OBJECTIVE: To assess whether cognitive reappraisal and acceptance are effective emotion regulation strategies to decrease the influence of negative affect on intention to accept maternal pertussis vaccination (MPV) among pregnant women in the Netherlands. METHODS: An experimental study with baseline and two follow-up measurements was conducted. Participants selected after baseline (N = 382) were randomized into two experimental groups (cognitive reappraisal, acceptance) and a control group. The effect of the experimental manipulations on negative affect was examined with multilevel analyses. A moderation analysis was performed to examine whether the manipulations moderated the association between negative affect and intention. RESULTS: All groups showed a decrease in negative affect (all p's < 0.001), with no differences between groups. A small decrease in the influence of negative affect on intention was found among those who used acceptance. CONCLUSION: No additional value of the emotion regulation strategies was found compared to the control group. However, exploratory analyses showed that acceptance seemed a promising strategy to decrease the influence of negative affect on intention to accept MPV. PRACTICE IMPLICATIONS: This study stressed the relevance for communication strategies to consider the emotions pregnant women experience during the decision-making process about the MPV

The effect of emotion regulation strategies on decision-making about the maternal pertussis vaccination among pregnant women in the Netherlands:an experimental study

OBJECTIVE: To assess whether cognitive reappraisal and acceptance are effective emotion regulation strategies to decrease the influence of negative affect on intention to accept maternal pertussis vaccination (MPV) among pregnant women in the Netherlands. METHODS: An experimental study with baseline and two follow-up measurements was conducted. Participants selected after baseline (N = 382) were randomized into two experimental groups (cognitive reappraisal, acceptance) and a control group. The effect of the experimental manipulations on negative affect was examined with multilevel analyses. A moderation analysis was performed to examine whether the manipulations moderated the association between negative affect and intention. RESULTS: All groups showed a decrease in negative affect (all p's < 0.001), with no differences between groups. A small decrease in the influence of negative affect on intention was found among those who used acceptance. CONCLUSION: No additional value of the emotion regulation strategies was found compared to the control group. However, exploratory analyses showed that acceptance seemed a promising strategy to decrease the influence of negative affect on intention to accept MPV. PRACTICE IMPLICATIONS: This study stressed the relevance for communication strategies to consider the emotions pregnant women experience during the decision-making process about the MPV

Dose-Response Relationship of a Web-Based Tailored Intervention Promoting Human Papillomavirus Vaccination: Process Evaluation of a Randomized Controlled Trial

BACKGROUND: In the Netherlands, HPV vaccination uptake remains low. To improve informed decision making (IDM) and HPV vaccination acceptability, we systematically developed an interactive, Web-based tailored intervention for mothers of Dutch girls to-be-invited. OBJECTIVE: The aim of this study is to provide insight into the intervention's working mechanisms by evaluating (1) program use, (2) program acceptability, and (3) the relationship of program use with (a) program acceptability, and (b) intervention effects (i.e., dose-response). METHODS: Only mothers from the intervention arm of a randomized controlled study (RCT) that assessed the effectiveness of the Web-based, tailored intervention were included. They were invited to visit the Web-based intervention between baseline (January 2015, just before access to the intervention) and follow-up (March 2015, prior to the first HPV vaccination). Indicators for program use were time of website use (i.e., duration of intervention exposure) and completeness (i.e., the proportion of all available webpages visited). HPV vaccination uptake registered by Praeventis was used as the primary outcome. Secondary outcomes were informed decision-making (IDM), decisional conflict, and social psychological determinants of HPV vaccination uptake. RESULTS: From the 3995 invited mothers, 2509 mothers (62.80%) logged in. Of these, 2239 mothers (89.24%) visited at least one page of the intervention components. On average, mothers spent 21.39 minutes on the website (SD = 12.41 minutes) and completed 50.04% (SD = 26.18%) of the website. Participants rated the website with a 7.64 on a 10-point scale (SD = 1.39). Program acceptability was significantly associated with completeness (β = 4.36, P < .001), but not with time of website use (β = -.07, P =.77). Intention-to-treat analysis (N = 3,995) showed a significant positive effect of completeness on all outcome measures (P's <.003; Bonferroni corrected alpha=.05/15 factors), including on HPV vaccination uptake. Time of website use had a significant positive effect on all outcomes (P's <.003), except for uptake (P = .195), risk perception when not vaccinated (P = .144), subjective norms (P = .032), and habit (P = .013). CONCLUSIONS: Program use and acceptability of the intervention was adequate. Completeness was positively associated with acceptability. Furthermore, positive effects (i.e., dose-response effects) were found of completeness and time of website use on the mothers IDM, decisional conflict, and almost all of the social-psychological determinants of HPV vaccination acceptability. In addition, the extent to which mothers completed the intervention had a positive impact on their daughters' vaccination uptake. This indicates that the Web-based, tailored intervention fits well with the mothers' needs, and that completeness of use is essential for improving HPV vaccination uptake, acceptability, and IDM. Program use should therefore be promoted. CLINICALTRIAL: Trialregister.nl NTR4795; https://www.trialregister.nl/trial/4795