@article {Hafez Griauzdee033397, author = {Dina Hafez Griauzde and Laura Saslow and Kaitlyn Patterson and Tahoora Ansari and Bradley Liestenfeltz and Aaron Tisack and Patti Bihn and Samuel Shopinski and Caroline R Richardson}, title = {Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA}, volume = {10}, number = {1}, elocation-id = {e033397}, year = {2020}, doi = {10.1136/bmjopen-2019-033397}, publisher = {British Medical Journal Publishing Group}, abstract = {Objectives (1) To estimate weight change from a low-carbohydrate diabetes prevention programme (LC-DPP) and (2) to evaluate the feasibility and acceptability of an LC-DPP.Research design Single-arm, mixed methods (ie, integration of quantitative and qualitative data) pilot study.Setting Primary care clinic within a large academic medical centre in the USA.Participants Adults with pre-diabetes and Body Mass Index of >=25 kg/m2.Intervention We adapted the Centers for Disease Control and Prevention{\textquoteright}s National Diabetes Prevention Program (NDPP){\textemdash}an evidence-based, low-fat dietary intervention{\textemdash}to teach participants to follow a very low-carbohydrate diet (VLCD). Participants attended 23 group-based classes over 1 year.Outcome measures Primary outcome measures were (1) weight change and (2) percentage of participants who achieved >=5\% wt loss. Secondary outcome measures included intervention feasibility and acceptability (eg, attendance and qualitative interview feedback).Results Our enrolment target was 22. One person dropped out before a baseline weight was obtained; data from 21 individuals were analysed. Mean weight loss in kilogram was 4.3 (SD 4.8) at 6 months and 4.9 (SD 5.8) at 12 months. Mean per cent body weight changes were 4.5 (SD 5.0) at 6 months and 5.2 (SD 6.0) at 12 months; 8/21 individuals (38\%) achieved >=5\% wt loss at 12 months. Mean attendance was 10.3/16 weekly sessions and 3.4/7 biweekly or monthly sessions. Among interviewees (n=14), three factors facilitated VLCD adherence: (1) enjoyment of low-carbohydrate foods, (2) diminished hunger and cravings and (3) health benefits beyond weight loss. Three factors hindered VLCD adherence: (1) enjoyment of high-carbohydrate foods, (2) lack of social support and (3) difficulty preplanning meals.Conclusions An LC-DPP is feasible, acceptable and may be an effective option to help individuals with pre-diabetes to lose weight. Data from this pilot will be used to plan a fully powered randomised controlled trial of weight loss among NDPP versus LC-DPP participants.Trial registration number NCT03258918.}, issn = {2044-6055}, URL = {https://bmjopen.bmj.com/content/10/1/e033397}, eprint = {https://bmjopen.bmj.com/content/10/1/e033397.full.pdf}, journal = {BMJ Open} }