TY - JOUR
T1 - Intervention enhancement strategies among adults with type 2 diabetes in a very low-carbohydrate web-based program
T2 - Evaluating the impact with a randomized trial
AU - Saslow, Laura R.
AU - Moskowitz, Judith Tedlie
AU - Mason, Ashley E.
AU - Daubenmier, Jennifer
AU - Liestenfeltz, Bradley
AU - Missel, Amanda L.
AU - Bayandorian, Hovig
AU - Aikens, James E.
AU - Kim, Sarah
AU - Hecht, Frederick M.
N1 - Funding Information:
The authors would like to thank their dedicated participants; Linda Collins, Marlene Otto, Gina Dahlem, and Alison O’Brien for their help; and the Consulting for Statistics, Computing, and Analytics Research group at the University of Michigan. The research was supported by a grant from the Carl Purcell Endowed Nursing Research Fellowship Fund to LS. LS was supported by a K01 award from the National Institutes of Health (NIH), DK107456, from the National Institute of Diabetes and Digestive and Kidney Diseases. AM was supported by a K award, K23HL133442, from the NIH’s National Heart, Lung, and Blood Institute. MO was supported by a P grant from the NIH’s National Institute of Nursing Research, P20NR015331. JM was supported by NIH grant K24 MH093225 from the National Institute of Mental Health. FH was supported by NIH grant K24 AT007827 from the National Center for Complementary and Integrative Health. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Publisher Copyright:
© 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. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/)
PY - 2020/7
Y1 - 2020/7
N2 - 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.
AB - 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.
KW - Diet
KW - Ketogenic
KW - Self-management
KW - Text messages
KW - Type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85096648543&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85096648543&partnerID=8YFLogxK
U2 - 10.2196/15835
DO - 10.2196/15835
M3 - Article
C2 - 32902391
AN - SCOPUS:85096648543
VL - 5
JO - JMIR Diabetes
JF - JMIR Diabetes
SN - 2371-4379
IS - 3
M1 - 15835
ER -
