Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA

BMJ Open. 2020 Jan 21;10(1):e033397. doi: 10.1136/bmjopen-2019-033397.

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's National Diabetes Prevention Program (NDPP)-an evidence-based, low-fat dietary intervention-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.

Keywords: diabetes and endocrinology; nutrition and dietetics; preventive medicine.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Body Mass Index
  • Diabetes Mellitus / prevention & control*
  • Dietary Carbohydrates / pharmacology*
  • Exercise / physiology
  • Female
  • Humans
  • Life Style*
  • Male
  • Middle Aged
  • Pilot Projects
  • Prediabetic State / prevention & control*
  • Weight Loss / physiology*
  • Weight Reduction Programs / methods*

Substances

  • Dietary Carbohydrates

Associated data

  • ClinicalTrials.gov/NCT03258918