Abstract
BackgroundEnsuring treatment adherence is important for the internal validity of clinical trials. In intervention studies where touch points decrease over time, there is even more of an adherence challenge. Trials with multiple cohorts offer an opportunity to innovate on ways to increase treatment adherence without compromising the integrity of the study design, and previous cohorts can serve as historical controls. Electronically delivered nudges offer low-cost opportunities to increase treatment adherence.ObjectiveThis study aimed to evaluate the effectiveness of electronic messages (e-messages) on treatment adherence to the last cohort of a parent weight loss intervention during the second half of a year-long trial, when intervention checkpoint frequency decreases. Treatment adherence is measured by intervention class attendance and adherence to the intervention diet.MethodsAll participants in the last cohort (cohort 5, n=128) of a large randomized weight loss study were offered an e-message intervention to improve participant adherence during the last 6 months of a 1-year weight loss program. Overall, 3 to 4 electronic weekly messages asked participants about intervention diet adherence. A propensity score model was estimated using 97 participants who opted to receive e-messages and 31 who declined in cohort 5 and used to pair match cohort 5 e-message participants to a historical control group from cohorts 1 to 4. Moreover, 88 participants had complete data, yielding 176 participants in the final analyses. After matching, intervention and matched control groups were compared on (1) proportion of class attendance between the 6 and 12 month study endpoints, (2) diet adherence, as measured by total carbohydrate grams for low-carbohydrate (LC) and total fat grams for low-fat (LF) diets at 12 months, and (3) weight change from 6 to 12 months. The dose-response relationship between the proportion of text messages responded to and the 3 outcomes was also investigated.ResultsCompared with matched controls, receiving e-messages had no effect on (1) treatment adherence; class attendance after 6 months +4.6% (95% CI −4.43 to 13.68, P=.31), (2) adherence; LC −2.5 g carbohydrate, 95% CI −29.9 to 24.8, P=.85; LF +6.2 g fat, 95% CI −4.1 to 17.0, P=.26); or on (3) the secondary outcome of weight change in the last 6 months; +0.3 kg (95% CI −1.0 to 1.5, P=.68). There was a positive significant response correlation between the percentage of messages to which participants responded and class attendance (r=.45, P<.001).ConclusionsAlthough this e-message intervention did not improve treatment adherence, future studies can learn from this pilot and may incorporate more variety in the prompts and more interaction to promote more effective user engagement. Uniquely, this study demonstrated the potential for innovating within a multicohort trial using propensity score–matched historical control subjects.Trial RegistrationClinicalTrials.gov NCT01826591; https://clinicaltrials.gov/ct2/show/NCT01826591International Registered Report Identifier (IRRID)RR2-10.1016/j.cct.2016.12.021
Highlights
BackgroundAn important challenge of behavioral interventions is treatment adherence
Conclusions: this e-message intervention did not improve treatment adherence, future studies can learn from this pilot and may incorporate more variety in the prompts and more interaction to promote more effective user engagement
This study demonstrated the potential for innovating within a multicohort trial using propensity score–matched historical control subjects
Summary
Treatment adherence strategies increase participants’ enactment of the intervention delivered, thereby increasing the internal validity of the results and accuracy of conclusions drawn from the study [1,2]. In large trials with multiple cohorts or staggered enrollment, there is an opportunity to utilize lessons learned from early enrollees to design protocol modifications to increase treatment adherence in later enrollees. This would be the case for the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) study, which contrasted healthy low-carbohydrate (LC) versus healthy low-fat (LF) diets for a sample of 609 generally healthy, free-living adults with body mass index 28 to 40 kg/m2 [7]. Delivered nudges offer low-cost opportunities to increase treatment adherence
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