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Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial.

ABSTRACT: BACKGROUND:Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. OBJECTIVE:The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. METHODS:The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ?1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405 participants who qualify for the trial will complete surveys administered by blinded interviewers at baseline (randomization), 6, 12, 18, and 24 months. RESULTS:Data analysis is not yet complete, but we hypothesize that (1) TLC-GST > TLC-SCT > control at all follow-up time points for F&V consumption, and (2) intervention effects will be mediated by the theoretical constructs (eg, self-efficacy, goal pursuit, conflict, shielding, and facilitation). CONCLUSIONS:This study used a novel study design to initiate and then promote the maintenance of dietary behavior change through the use of an evidence-based fully automated telephony intervention. After the first 6 months (the acquisition phase), we will examine whether two telephony interventions built using different underlying behavioral theories were more successful than an assessment-only control group in helping participants maintain their newly acquired health behavior change. TRIAL REGISTRATION:Clinicaltrials.gov NCT00148525; http://clinicaltrials.gov/ct2/show/NCT00148525 (Archived by Webcite at http://www.webcitation.org/6TiRriJOs).

SUBMITTER: Wright JA

PROVIDER: S-EPMC4260007 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial.

Wright Julie A JA Quintiliani Lisa M LM Turner-McGrievy Gabrielle M GM Migneault Jeffrey P JP Heeren Timothy T Friedman Robert H RH

JMIR research protocols 20141110 4

<h4>Background</h4>Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation.<h4>Objective</h4>The objective of this p ...[more]

PMID: 25387065

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Project description:BACKGROUND:Many best practice smoking cessation programs use fully automated internet interventions designed for nonmobile personal computers (desktop computers, laptops, and tablets). A relatively small number of smoking cessation interventions have been designed specifically for mobile devices such as smartphones. OBJECTIVE:This study examined the efficacy and usage patterns of two internet-based best practices smoking cessation interventions. METHODS:Overall, 1271 smokers who wanted to quit were randomly assigned to (1) MobileQuit (designed for-and constrained its use to-mobile devices, included text messaging, and embodied tunnel information architecture) or (2) QuitOnline (designed for nonmobile desktop or tablet computers, did not include text messages, and used a flexible hybrid matrix-hierarchical information architecture). Primary outcomes included self-reported 7-day point-prevalence smoking abstinence at 3- and 6-month follow-up assessments. Program visits were unobtrusively assessed (frequency, duration, and device used for access). RESULTS:Significantly more MobileQuit participants than QuitOnline participants reported quitting smoking. Abstinence rates using intention-to-treat analysis were 20.7% (131/633) vs 11.4% (73/638) at 3 months, 24.6% (156/633) vs 19.3% (123/638) at 6 months, and 15.8% (100/633) vs 8.8% (56/638) for both 3 and 6 months. Using Complete Cases, MobileQuit's advantage was significant at 3 months (45.6% [131/287] vs 28.4% [73/257]) and the combined 3 and 6 months (40.5% [100/247] vs 25.9% [56/216]) but not at 6 months (43.5% [156/359] vs 34.4% [123/329]). Participants in both conditions reported their program was usable and helpful. MobileQuit participants visited their program 5 times more frequently than did QuitOnline participants. Consistent with the MobileQuit's built-in constraint, 89.46% (8820/9859) of its visits were made on an intended mobile device, whereas 47.72% (691/1448) of visits to QuitOnline used an intended nonmobile device. Among MobileQuit participants, 76.0% (459/604) used only an intended mobile device, 23.0% (139/604) used both mobile and nonmobile devices, and 0.1% (6/604) used only a nonmobile device. Among QuitOnline participants, 31.3% (137/438) used only the intended nonmobile devices, 16.7% (73/438) used both mobile and nonmobile devices, and 52.1% (228/438) used only mobile devices (primarily smartphones). CONCLUSIONS:This study provides evidence for optimizing intervention design for smartphones over a usual care internet approach in which interventions are designed primarily for use on nonmobile devices such as desktop computers, laptops. or tablets. We propose that future internet interventions should be designed for use on all of the devices (multiple screens) that users prefer. We forecast that the approach of designing internet interventions for mobile vs nonmobile devices will be replaced by internet interventions that use a single Web app designed to be responsive (adapt to different screen sizes and operating systems), share user data across devices, embody a pervasive information architecture, and complemented by text message notifications. TRIAL REGISTRATION:ClinicalTrials.gov NCT01952236; https://clinicaltrials.gov/ct2/show/NCT01952236 (Archived by WebCite at http://www.webcitation.org/6zdSxqbf8).

Project description:The Medical Research Councils' framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable.We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions.Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework.Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology.Clinical trials.gov: NCT02160249.

Project description:BackgroundAssessment of food intake is a cornerstone of nutritional research. However, the use of minimally validated dietary assessment methods is common and can generate misleading results. Thus, there is a need for valid, precise and cost-effective dietary assessment tools to be used in large cohort studies.The objective is to validate a newly developed automated self-administered web-based 24-h dietary recall (R24W), within a population of adults taking part in fully controlled feeding studies.MethodsSixty two adults completed the R24W twice while being fed by our research team. Actual intakes were precisely known, thereby allowing the analysis of the proportion of adequately self-reported items. Association between offered and reported portion sizes was assessed with correlation coefficients and agreement with the kappa score while systematics biases were illustrated with Bland-Altman Plot.ResultsParticipants received an average of 16 food items per testing day. They reported 89.3% of the items they received. The more frequently omitted food categories were vegetables included in recipes (40.0%) as well as side vegetables (20.0%) and represented less than 5% of the actual daily energy intake. Offered and self-reported portion sizes were significantly correlated (r = 0.80 P < 0.001) and demonstrated a strong agreement as assessed by the kappa score of 0.62. Reported portion sizes for individual food items were on average 3.2 g over the offered portion sizes. Portions of 100 g and above were on average underestimated by 2.4% (r = 0.68 P < 0.01; kappa score = 0.50) while small portions (less than 100 g) were overestimated by 17.1% (r = 0.46 P < 0.01; kappa score = 0.43). A nonsignificant underestimation (-13.9 kcal ± 646.3 kcal; P = 0.83) of energy intake was noted.ConclusionR24W performed well as participants were able to report the great majority of items they ate and selected portion size strongly related to the one they received. This suggests that food items are easily to find within the R24W and images of portion sizes used in this dietary assessment tool are adequate and can provide valid food intake evaluation.

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Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial.

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Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial.

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