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.
abstract: 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 [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.
  
  
  
  At 32 weeks, participants in the intervention group reduced their HbA1clevels 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 HbA1cto 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).
authors.affiliation: Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, United States.
authors.forename: Laura R
authors.identifier: 0000-0003-3991-3205
authors.initials: LR
authors.lastname: Saslow
authors.affiliation: Osher Center for Integrative Medicine, School of Medicine, University of California, San Francisco, San Francisco, CA, United States.
authors.forename: Ashley E
authors.identifier: 0000-0002-8744-0185
authors.initials: AE
authors.lastname: Mason
authors.affiliation: School of Medicine, University of California, San Francisco, San Francisco, CA, United States.
authors.forename: Sarah
authors.identifier: 0000-0002-3599-5509
authors.initials: S
authors.lastname: Kim
authors.affiliation: Osher Center for Integrative Medicine, School of Medicine, University of California, San Francisco, San Francisco, CA, United States.
authors.forename: Veronica
authors.identifier: 0000-0001-9402-0800
authors.initials: V
authors.lastname: Goldman
authors.affiliation: Applied Biostatistics Laboratory, School of Nursing, University of Michigan, Ann Arbor, MI, United States.
authors.forename: Robert
authors.identifier: 0000-0002-8503-2073
authors.initials: R
authors.lastname: Ploutz-Snyder
authors.affiliation: University of California, Berkeley, Berkeley, CA, United States.
authors.forename: Hovig
authors.identifier: 0000-0003-4596-0323
authors.initials: H
authors.lastname: Bayandorian
authors.affiliation: Institute of Holistic Health, Department of Health Education, San Francisco State University, San Francisco, CA, United States.
authors.forename: Jennifer
authors.identifier: 0000-0001-5678-4068
authors.initials: J
authors.lastname: Daubenmier
authors.affiliation: Osher Center for Integrative Medicine, School of Medicine, University of California, San Francisco, San Francisco, CA, United States.
authors.forename: Frederick M
authors.identifier: 0000-0002-5782-1171
authors.initials: FM
authors.lastname: Hecht
authors.affiliation: Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.
authors.forename: Judith T
authors.identifier: 0000-0002-1399-3318
authors.initials: JT
authors.lastname: Moskowitz
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000178:diet therapy / Q000628:therapy*; D055423:Diet, Ketogenic / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D000070497:Healthy Lifestyle; D006801:Humans; D020407:Internet; D008019:Life Style; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012648:Self Care / Q000379:methods*
chemical_list: D006442:Glycated Hemoglobin
keywords: diet; eHealth; type 2 diabetes mellitus; weight loss