An Online Intervention Comparing a Very Low-Carbohydrate Ketogenic Diet and Lifestyle Recommendations Versus a Plate Method Diet in Overweight Individuals With Type 2 Diabetes: A Randomized Controlled Trial

Laura R Saslow, Ashley E Mason, Sarah Kim, Veronica Goldman, Robert Ploutz-Snyder, Hovig Bayandorian, Jennifer Daubenmier, Frederick M Hecht, Judith T Moskowitz, Laura R Saslow, Ashley E Mason, Sarah Kim, Veronica Goldman, Robert Ploutz-Snyder, Hovig Bayandorian, Jennifer Daubenmier, Frederick M Hecht, Judith T Moskowitz

Abstract

Background: Type 2 diabetes is a prevalent, chronic disease for which diet is an integral aspect of treatment. In our previous trial, we found that recommendations to follow a very low-carbohydrate ketogenic diet and to change lifestyle factors (physical activity, sleep, positive affect, mindfulness) helped overweight people with type 2 diabetes or prediabetes improve glycemic control and lose weight. This was an in-person intervention, which could be a barrier for people without the time, flexibility, transportation, social support, and/or financial resources to attend.

Objective: The aim was to determine whether an online intervention based on our previous recommendations (an ad libitum very low-carbohydrate ketogenic diet with lifestyle factors; "intervention") or an online diet program based on the American Diabetes Associations' "Create Your Plate" diet ("control") would improve glycemic control and other health outcomes among overweight individuals with type 2 diabetes.

Methods: In this pilot feasibility study, we randomized overweight adults (body mass index ≥25) with type 2 diabetes (glycated hemoglobin [HbA1c] 6.5%-9.0%) to a 32-week online intervention based on our previous recommendations (n=12) or an online diet program based around a plate method diet (n=13) to assess the impact of each intervention on glycemic control and other health outcomes. Primary and secondary outcomes were analyzed by mixed-effects linear regression to compare outcomes by group.

Results: At 32 weeks, participants in the intervention group reduced their HbA1c levels more (estimated marginal mean [EMM] -0.8%, 95% CI -1.1% to -0.6%) than participants in the control group (EMM -0.3%, 95% CI -0.6% to 0.0%; P=.002). More than half of the participants in the intervention group (6/11, 55%) lowered their HbA1c to less than 6.5% versus 0% (0/8) in the control group (P=.02). Participants in the intervention group lost more weight (EMM -12.7 kg, 95% CI -16.1 to -9.2 kg) than participants in the control group (EMM -3.0 kg, 95% CI -7.3 to 1.3 kg; P<.001). A greater percentage of participants lost at least 5% of their body weight in the intervention (10/11, 90%) versus the control group (2/8, 29%; P=.01). Participants in the intervention group lowered their triglyceride levels (EMM -60.1 mg/dL, 95% CI -91.3 to -28.9 mg/dL) more than participants in the control group (EMM -6.2 mg/dL, 95% CI -46.0 to 33.6 mg/dL; P=.01). Dropout was 8% (1/12) and 46% (6/13) for the intervention and control groups, respectively (P=.07).

Conclusions: Individuals with type 2 diabetes improved their glycemic control and lost more weight after being randomized to a very low-carbohydrate ketogenic diet and lifestyle online program rather than a conventional, low-fat diabetes diet online program. Thus, the online delivery of these very low-carbohydrate ketogenic diet and lifestyle recommendations may allow them to have a wider reach in the successful self-management of type 2 diabetes.

Trial registration: ClinicalTrials.gov NCT01967992; https://ichgcp.net/clinical-trials-registry/NCT01967992 (Archived by WebCite at http://www.webcitation.org/6o0fI9Mkq).

Keywords: diet; eHealth; type 2 diabetes mellitus; weight loss.

Conflict of interest statement

Conflicts of Interest: Frederick Hecht is on the Scientific Advisory Board for Virta Health. No other author declares any conflict of interest.

©Laura R Saslow, Ashley E Mason, Sarah Kim, Veronica Goldman, Robert Ploutz-Snyder, Hovig Bayandorian, Jennifer Daubenmier, Frederick M Hecht, Judith T Moskowitz. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 13.02.2017.

Figures

Figure 1
Figure 1
Study participant flowchart for online study.
Figure 2
Figure 2
Mean and individual body weight (in kilograms) for the intervention and control groups at baseline and at 16 and 32 weeks. Bars represent 95% confidence intervals of the mean. Dashed lines reflect individual participants; darker lines represent each group mean.
Figure 3
Figure 3
Mean and individual body weight (in kilograms) for the intervention and control groups at baseline and at 16 and 32 weeks. Bars represent 95% confidence intervals of the mean. Dashed lines reflect individual participants; darker lines represent each group mean.
Figure 4
Figure 4
Body weight and HbA1c plotted for each participant separately for each of the three time periods (0, 16, and 32 weeks). Red lines represent the intervention participants; blue lines represent the control participants. Lines that end in an O reflect dropouts (and missing data). Lines that end in an arrow show participants who completed the study.

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