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).