Journal Article

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

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

2017

Overview

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. 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. In this pilot feasibility study, we randomized overweight adults (body mass index ≥25) with type 2 diabetes (glycated hemoglobin [HbA ] 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. At 32 weeks, participants in the intervention group reduced their HbA 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 HbA 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). 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. ClinicalTrials.gov NCT01967992; https://clinicaltrials.gov/ct2/show/NCT01967992 (Archived by WebCite at http://www.webcitation.org/6o0fI9Mkq).

• Publisher: Journal of Medical Internet Research,Gunther Eysenbach MD MPH, Associate Professor,JMIR Publications
• Subject: Adults / Analysis / Body mass index / Body weight / Carbohydrates / Chronic diseases / Chronic illnesses / Clinical trials / Control groups / Diabetes / Diabetes Mellitus, Type 2 - blood / Diabetes Mellitus, Type 2 - diet therapy / Diabetes Mellitus, Type 2 - therapy / Diabetes therapy / Diabetics / Diet / Diet, Ketogenic - methods / Dropping out / Exercise / Feasibility / Feasibility Studies / Female / Flexibility / Glycated Hemoglobin - metabolism / Glycemic control / Groups / Health status / Healthy Lifestyle / Hemoglobin / Humans / Internet / Internet resources / Intervention / Life Style / Lifestyles / Low-carbohydrate diet / Male / Middle Aged / Mindfulness / Obesity / Original Paper / Overweight / Overweight persons / Physical activity / Physical fitness / Pilot Projects / Positive emotions / Prediabetic state / Recipes / Registration / Self Care - methods / Selfmanagement / Sleep / Social aspects / Social support / Stress management / Training / Triglycerides / Type 2 diabetes / Type 2 diabetes mellitus / Weight loss