Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial

Laura R Saslow, Judith Tedlie Moskowitz, Ashley E Mason, Jennifer Daubenmier, Bradley Liestenfeltz, Amanda L Missel, Hovig Bayandorian, James E Aikens, Sarah Kim, Frederick M Hecht, Laura R Saslow, Judith Tedlie Moskowitz, Ashley E Mason, Jennifer Daubenmier, Bradley Liestenfeltz, Amanda L Missel, Hovig Bayandorian, James E Aikens, Sarah Kim, Frederick M Hecht

Abstract

Background: Adults with type 2 diabetes may experience health benefits, including glycemic control and weight loss, from following a very low-carbohydrate, ketogenic (VLC) diet. However, it is unclear which ancillary strategies may enhance these effects.

Objective: This pilot study aims to estimate the effect sizes of 3 intervention enhancement strategies (text messages, gifts, and breath vs urine ketone self-monitoring) that may improve outcomes of a 12-month web-based ad libitum VLC diet and lifestyle intervention for adults with type 2 diabetes. The primary intervention also included other components to improve adherence and well-being, including positive affect and mindfulness as well as coaching.

Methods: Overweight or obese adults (n=44; BMI 25-45 kg/m2) with type 2 diabetes (glycated hemoglobin [HbA1c] ≥6.5%), who had been prescribed either no glucose-lowering medications or metformin alone, participated in a 12-month web-based intervention. Using a 2×2×2 randomized factorial design, we compared 3 enhancement strategies: (1) near-daily text messages about the intervention's recommended behaviors (texts n=22 vs no texts n=22), (2) mailed gifts of diet-relevant foods and cookbooks (6 rounds of mailed gifts n=21 vs no gifts n=23), and (3) urine- or breath-based ketone self-monitoring (urine n=21 vs breath n=23). We assessed HbA1c and weight at baseline and at 4, 8, and 12 months. We evaluated whether each strategy exerted a differential impact on HbA1c and weight at 12 months against an a priori threshold of Cohen d of 0.5 or greater.

Results: We retained 73% (32/44) of the participants at 12 months. The intervention, across all conditions, led to improvements in glucose control and reductions in body weight at the 12-month follow-up. In intent-to-treat (ITT) analyses, the mean HbA1c reduction was 1.0% (SD 1.6) and the mean weight reduction was 5.3% (SD 6.0), whereas among study completers, these reductions were 1.2% (SD 1.7) and 6.3% (SD 6.4), respectively, all with a P value of less than .001. In ITT analyses, no enhancement strategy met the effect size threshold. Considering only study completers, 2 strategies showed a differential effect size of at least a d value of 0.5 or greater.

Conclusions: Text messages, gifts of food and cookbooks, and urine-based ketone self-monitoring may potentially enhance the glycemic or weight loss benefits of a web-based VLC diet and lifestyle intervention for individuals with type 2 diabetes. Future research could investigate other enhancement strategies to help create even more effective solutions for the treatment of type 2 diabetes.

Trial registration: ClinicalTrials.gov NCT02676648; https://ichgcp.net/clinical-trials-registry/NCT02676648.

Keywords: diet, ketogenic; self-management; text messages; type 2 diabetes.

Conflict of interest statement

Conflicts of Interest: FH was on the Scientific Advisory Board for Virta Health during some of this research but is no longer on the Scientific Advisory Board. LS’s partner, HB, is an inventor of software used in this study, which purchased a software services agreement for its use. The other authors have no conflicts of interest to declare.

©Laura R Saslow, Judith Tedlie Moskowitz, Ashley E Mason, Jennifer Daubenmier, Bradley Liestenfeltz, Amanda L Missel, Hovig Bayandorian, James E Aikens, Sarah Kim, Frederick M Hecht. Originally published in JMIR Diabetes (http://diabetes.jmir.org), 09.09.2020.

Figures

Figure 1
Figure 1
Study participant flowchart. HbA1c: glycated hemoglobin.

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