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

Griauzde, Dina H.; Saslow, Laura R.; Patterson, Kaitlyn; Ansari, Tahoora; Liestenfeltz, Bradley; Tisack, Aaron; Bihn, Patti; Shopinski, Samuel; Richardson, Caroline R.

doi:10.1136/bmjopen-2019-033397

Cited by 18 publications

(55 citation statements)

References 43 publications

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“…The New American Diabetes Association care guidelines [ 4 ] state that low-carbohydrate diet plans may result in improved glycemia [ 5 ] and help patients with prediabetes in decreasing postprandial glucose spikes that are frequently followed by crashes and cravings. Low-carbohydrate diets have shown positive effects for the prevention of prediabetes [ 6 , 7 ] and management of T2DM [ 8 , 9 ]. However, patients with prediabetes may lack sufficient motivation and support [ 7 ] or knowledge to adopt and maintain a low-carbohydrate diet.…”

Section: Introductionmentioning

confidence: 99%

“…Low-carbohydrate diets have shown positive effects for the prevention of prediabetes [ 6 , 7 ] and management of T2DM [ 8 , 9 ]. However, patients with prediabetes may lack sufficient motivation and support [ 7 ] or knowledge to adopt and maintain a low-carbohydrate diet. Although limited, research has supported the use of health coaching interventions for adults with prediabetes and type 2 diabetes to increase knowledge, increase motivation, and support long-term behavioral changes.…”

Section: Introductionmentioning

confidence: 99%

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Continuous Glucose Monitoring With Low-Carbohydrate Diet Coaching in Adults With Prediabetes: Mixed Methods Pilot Study

Yost¹,

DeJonckheere²,

Stonebraker³

et al. 2020

JMIR Diabetes

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Background: Type 2 diabetes mellitus (T2DM) is preventable; however, few patients with prediabetes participate in prevention programs. The use of user-friendly continuous glucose monitors (CGMs) with low-carbohydrate diet coaching is a novel strategy to prevent T2DM. Objective: This study aims to determine the patient satisfaction and feasibility of an intervention combining CGM use and low-carbohydrate diet coaching in patients with prediabetes to drive dietary behavior change. Methods: We conducted a mixed methods, single-arm pilot and feasibility study at a suburban family medicine clinic. A total of 15 adults with prediabetes with hemoglobin A 1c (HbA 1c) levels between 5.7% and 6.4% and a BMI >30 kg/m 2 were recruited to participate. The intervention and assessments took place during 3 in-person study visits and 2 qualitative phone interviews (3 weeks and 6 months after the intervention). During visit 1, participants were asked to wear a CGM and complete a food intake and craving log for 10 days. During visit 2, the food intake and craving log along with the CGM results of the participants were reviewed and the participants received low-carbohydrate diet coaching, including learning about carbohydrates and personalized feedback. A second CGM sensor, with the ability to scan and record glucose trends, was placed, and the participants logged their food intake and cravings as they attempted to reduce their total carbohydrate intake (<100 g/day). During visit 3, the participants reviewed their CGM and log data. The primary outcome was satisfaction with the use of CGM and low-carbohydrate diet. The secondary outcomes included feasibility, weight, and HbA 1c change, and percentage of time spent in hyperglycemia. Changes in attitudes and risk perception of developing diabetes were also assessed. Results: The overall satisfaction rate of our intervention was 93%. The intervention induced a weight reduction of 1.4 lb (P=.02) and a reduction of HbA 1c levels by 0.71% (P<.001) since enrollment. Although not significantly, the percentage of time above glucose goal and average daily glucose levels decreased slightly during the study period. Qualitative interview themes indicated no major barriers to CGM use; the acceptance of a low-carbohydrate diet; and that CGMs helped to visualize the impact of carbohydrates on the body, driving dietary changes. Conclusions: The use of CGMs and low-carbohydrate diet coaching to drive dietary changes in patients with prediabetes is feasible and acceptable to patients. This novel method merits further exploration, as the preliminary data indicate that combining CGM use with low-carbohydrate diet coaching drives dietary changes, which may ultimately prevent T2DM.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Continuous Glucose Monitoring With Low-Carbohydrate Diet Coaching in Adults With Prediabetes: Mixed Methods Pilot Study

Yost¹,

DeJonckheere²,

Stonebraker³

et al. 2020

JMIR Diabetes

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“…Additionally, low-to-moderate carbohydrate diets are effective at reducing HbA1c among individuals with T2DM (26). However, research focused on effects of low-carbohydrate diets on glycemic outcomes among individuals with prediabetes are limited to pilot or non-randomized studies (32)(33)(34)(35).…”

Section: Discussionmentioning

confidence: 99%

“…In an non-randomized study, participants with IGT who participated in a 7-day in-hospital program (consisting of education and eating a low-carbohydrate diet) had reduced weight, HbA1c, and other glycemic outcomes at 12 months (32). A small, singlearm pilot study of a low-carbohydrate DPP found a reduction in HbA1c at 6 months that was not sustained at 12 months (33). A randomized pilot trial of overweight or obese individuals with T2D or prediabetes found that a very low-carbohydrate diet improved HbA1c, led to higher medication discontinuation, and more weight loss compared with a low-fat diet (34,35).…”

Section: Background and Rationale {6a}mentioning

confidence: 99%

Low-carbohydrate Dietary Pattern on Glycemic Outcomes Trial (ADEPT) among Individuals with Elevated Hemoglobin A1c: Study Protocol for a Randomized Controlled Trial

Dorans

Bazzano

et al. 2020

Preprint

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• Background: Type 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality globally. Strong evidence supports the importance of diet and other lifestyle factors in preventing T2DM. Among individuals with T2DM, low-carbohydrate diets lead to decreases in hemoglobin A1c (HbA1c). However, research on the effects of low-carbohydrate diets on glycemic outcomes among individuals not currently on glucose-lowering medications who have elevated HbA1c is limited.• Methods: The objective of this randomized controlled trial is to study the effect of a healthy low-carbohydrate diet achieved through behavioral intervention and key food supplementation compared with usual diet on HbA1c and other metabolic risk factors among individuals with HbA1c from 6.0 to 6.9% who are not on glucose-lowering medications. In this parallel trial, 150 participants will be randomized to the intervention or control group for 6 months. The healthy low-carbohydrate diet target is <40 grams of net carbohydrates during the first 3 months and <40 to 60 net grams for months 3 to 6. This diet is characterized by abundant unsaturated fat and protein, high-fiber foods such as non-starchy vegetables and nuts, and minimal refined carbohydrates. The primary outcome is the difference in HbA1c change from baseline to 6 months in the intervention compared with usual diet group. Secondary outcomes include differences between groups in 6-month changes in fasting glucose, systolic blood pressure, total-to high-density lipoprotein cholesterol ratio, and body weight. Exploratory outcomes include differences in 6-month changes in fasting insulin, homeostasis model assessment of insulin resistance, diastolic blood pressure, waist circumference, and 10-year cardiovascular disease risk. An intention-to-treat analysis will be used. • Discussion: We expect that the results from this study will lead to new approaches for developing and implementing dietary approaches (other than the most commonly used reduced fat diet) that will substantially reduce risk of cardiometabolic disease among adults with or at high risk of T2DM. The study intervention involves behavioural counselling and promotes consumption of dietary components thought to reduce risk of cardiometabolic disease and has expected applicability in clinical practice.• Trial registration: Clinicaltrials.gov registry: https://clinicaltrials.gov/ct2/show/NCT03675360. Registered on September 18, 2018 (prior to enrolment of the first participant).

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“…Dietary and/or another lifestyle intervention has been listed as effective strategies in the international guidelines on the management of prediabetes [ 5 , 6 , 7 ]. As a kind of food rich in bioactive compounds, berries are considered “promising functional fruits” and have been widely studied in recent years [ 8 , 9 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

Effect of Sea Buckthorn on Plasma Glucose in Individuals with Impaired Glucose Regulation: A Two-Stage Randomized Crossover Intervention Study

Ren

Gong

Zhao

et al. 2021

Foods

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Sea buckthorn (SB) has been indicated to have hypoglycemic potential, but its effects on glucose in people with impaired glucose regulation (IGR) are still unclear. This work presents a randomized, double-blinded, two-way crossover study. A total of 38 subjects with IGR completed the intervention of consuming sea buckthorn fruit puree (SBFP, 90 mL/day, five weeks), washing out (four weeks), and then consuming placebo (90 mL/day, five weeks) or in reverse order. In our methodology, a unified questionnaire was used to gather information on physical activity and dietary intakes, and physical examinations were performed to measure blood pressure, height, and weight. Fasting blood samples were collected to detect the fasting plasma glucose (FPG) and glycated serum protein (GSP). To calculate the area under the curve of 2 h postprandial plasma glucose (2 h PG-AUC), blood samples at t = 30, 60, and 120 min were also collected and analyzed. Effects of the intervention were evaluated by paired-sample Wilcoxon test and mixed model analyses. Our results show that the FPG in subjects with IGR decreased by a median reduction of 0.14 mmol/L after five weeks’ consumption of SBFP, but increased by a median of 0.07 mmol/L after placebo intervention, and the comparison of these two interventions was statistically significant (p = 0.045). During the wash-out period, a similar difference was observed as the FPG decreased in the group that received SBFP intervention first, but increased in another group (p = 0.043). Both SBFP and placebo significantly raised GSP during the intervention period, but lowered it in the wash-out period (p < 0.05), while no significant difference was found between the two interventions. The 2 h PG-AUC remained relatively stable throughout the study. Our results indicated that consumption of SBFP for five weeks showed a slight downward trend on FPG in subjects with IGR.

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

Cited by 18 publications

References 43 publications

Continuous Glucose Monitoring With Low-Carbohydrate Diet Coaching in Adults With Prediabetes: Mixed Methods Pilot Study

Continuous Glucose Monitoring With Low-Carbohydrate Diet Coaching in Adults With Prediabetes: Mixed Methods Pilot Study

Low-carbohydrate Dietary Pattern on Glycemic Outcomes Trial (ADEPT) among Individuals with Elevated Hemoglobin A1c: Study Protocol for a Randomized Controlled Trial

Effect of Sea Buckthorn on Plasma Glucose in Individuals with Impaired Glucose Regulation: A Two-Stage Randomized Crossover Intervention Study

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

Cited by 18 publications

References 43 publications

Continuous Glucose Monitoring With Low-Carbohydrate Diet Coaching in Adults With Prediabetes: Mixed Methods Pilot Study

Continuous Glucose Monitoring With Low-Carbohydrate Diet Coaching in Adults With Prediabetes: Mixed Methods Pilot Study

Low-carbohydrate Dietary Pattern on Glycemic Outcomes Trial (ADEPT) among Individuals with Elevated Hemoglobin A1c:&nbsp;Study Protocol for a Randomized Controlled Trial

Effect of Sea Buckthorn on Plasma Glucose in Individuals with Impaired Glucose Regulation: A Two-Stage Randomized Crossover Intervention Study

Contact Info

Product

Resources

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Low-carbohydrate Dietary Pattern on Glycemic Outcomes Trial (ADEPT) among Individuals with Elevated Hemoglobin A1c: Study Protocol for a Randomized Controlled Trial