@Article{info:doi/10.2196/jmir.5806,
author="Saslow, Laura R
and Mason, Ashley E
and Kim, Sarah
and Goldman, Veronica
and Ploutz-Snyder, Robert
and Bayandorian, Hovig
and Daubenmier, Jennifer
and Hecht, Frederick M
and Moskowitz, Judith T",
title="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",
journal="J Med Internet Res",
year="2017",
month="Feb",
day="13",
volume="19",
number="2",
pages="e36",
keywords="eHealth; diet; weight loss; type 2 diabetes mellitus",
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://clinicaltrials.gov/ct2/show/NCT01967992 (Archived by WebCite at http://www.webcitation.org/6o0fI9Mkq) ",
issn="1438-8871",
doi="10.2196/jmir.5806",
url="http://www.jmir.org/2017/2/e36/",
url="https://doi.org/10.2196/jmir.5806",
url="http://www.ncbi.nlm.nih.gov/pubmed/28193599"
}