scholarly journals Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low–Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial

JMIR Diabetes ◽  
10.2196/15835 ◽  
2020 ◽  
Vol 5 (3) ◽  
pp. e15835
Author(s):  
Laura R Saslow ◽  
Judith Tedlie Moskowitz ◽  
Ashley E Mason ◽  
Jennifer Daubenmier ◽  
Bradley Liestenfeltz ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Effect Size ◽  
Text Messages ◽  
Self Monitoring ◽  
Web Based ◽  
Low Carbohydrate ◽  
The Mean ◽  
Diet And Lifestyle

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. Trial Registration ClinicalTrials.gov NCT02676648; http://clinicaltrials.gov/ct2/show/NCT02676648

scholarly journals Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low–Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial (Preprint)

2019 ◽  
Author(s):  
Laura R Saslow ◽  
Judith Tedlie Moskowitz ◽  
Ashley E Mason ◽  
Jennifer Daubenmier ◽  
Bradley Liestenfeltz ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Effect Size ◽  
Text Messages ◽  
Self Monitoring ◽  
Web Based ◽  
Low Carbohydrate ◽  
The Mean ◽  
Diet And Lifestyle

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 <i>ad libitum</i> 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/m<sup>2</sup>) with type 2 diabetes (glycated hemoglobin [HbA<sub>1c</sub>] ≥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 HbA<sub>1c</sub> and weight at baseline and at 4, 8, and 12 months. We evaluated whether each strategy exerted a differential impact on HbA<sub>1c</sub> and weight at 12 months against an a priori threshold of Cohen <i>d</i> 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 HbA<sub>1c</sub> 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 <i>P</i> 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 <i>d</i> 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. CLINICALTRIAL ClinicalTrials.gov NCT02676648; http://clinicaltrials.gov/ct2/show/NCT02676648

Acceptability of Self-regulation Theory based mHealth Behaviorial Intervention for Older Adults with Type 2 Diabetes and Obesity (Preprint)

2019 ◽  
Author(s):  
Yaguang Zheng ◽  
Katie Weinger ◽  
Jordan Greenberg ◽  
Lora E. Burke ◽  
Susan M. Sereika ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Older Adults ◽  
Weight Loss ◽  
Self Regulation ◽  
Self Monitoring ◽  
Regulation Theory ◽  
Régulation Theory ◽  
The Mean ◽  
Diabetes And Obesity

BACKGROUND Mobile health (mHealth) is routinely used in younger adults with diabetes for weight loss. However, it is not known if older adult can use mHealth successfully in making lifestyle changes. OBJECTIVE The aim of the study was to examine the acceptability of a self-regulation theory-based mHealth behaviorial intervention for older adults with type 2 diabetes and obesity. METHODS This was a one-group intervention study. Participants received an 8-week self-regulation theory-based intervention consisting of 5 group sessions. They also used the Lose It! App for daily self-monitoring of food intake, a Fitbit, Bluetooth-enabled glucose meters, and weighing scales. At the end of the 8-week intervention, participants were asked to continue use of these devices for daily self-monitoring for 4 more weeks, without additional group sessions. RESULTS The sample (N=9) was White (88.9%) and female (44.4%), with mean 76.4±6.0 years of age (range: 69-89), 15.7±2.0 years of education, 33.3±3.1 kg/m2 for BMI and 7.4%±0.8 for HbA1c. Mild cognitive impairment was observed in 44.4% of sample. Over the 84 days of self-monitoring, the mean % days of using the Lose It!, Fitbit, blood glucose meter, and scale were 82.7±17.6, 85.2±19.7, 65.3±30.1, and 53.0±34.5, respectively. The mean percent weight loss from baseline was 4.92%±0.25. The dose of oral hypoglycemic agents or insulin was reduced in 55.6% of participants. CONCLUSIONS Older adults are able to use mHealth to improve their lifestyle behaviors and clinical outcomes. CLINICALTRIAL NCT03398590

scholarly journals Efficacy and safety of low and very low carbohydrate diets for type 2 diabetes remission: systematic review and meta-analysis of published and unpublished randomized trial data

BMJ ◽  
2021 ◽  
pp. m4743
Author(s):  
Joshua Z Goldenberg ◽  
Andrew Day ◽  
Grant D Brinkworth ◽  
Junko Sato ◽  
Satoru Yamada ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Type 2 Diabetes ◽  
Weight Loss ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Low Carbohydrate ◽  
Remission Of Diabetes

Abstract Objective To determine the efficacy and safety of low carbohydrate diets (LCDs) and very low carbohydrate diets (VLCDs) for people with type 2 diabetes. Design Systematic review and meta-analysis. Data sources Searches of CENTRAL, Medline, Embase, CINAHL, CAB, and grey literature sources from inception to 25 August 2020. Study selection Randomized clinical trials evaluating LCDs (<130 g/day or <26% of a 2000 kcal/day diet) and VLCDs (<10% calories from carbohydrates) for at least 12 weeks in adults with type 2 diabetes were eligible. Data extraction Primary outcomes were remission of diabetes (HbA 1c <6.5% or fasting glucose <7.0 mmol/L, with or without the use of diabetes medication), weight loss, HbA 1c , fasting glucose, and adverse events. Secondary outcomes included health related quality of life and biochemical laboratory data. All articles and outcomes were independently screened, extracted, and assessed for risk of bias and GRADE certainty of evidence at six and 12 month follow-up. Risk estimates and 95% confidence intervals were calculated using random effects meta-analysis. Outcomes were assessed according to a priori determined minimal important differences to determine clinical importance, and heterogeneity was investigated on the basis of risk of bias and seven a priori subgroups. Any subgroup effects with a statistically significant test of interaction were subjected to a five point credibility checklist. Results Searches identified 14 759 citations yielding 23 trials (1357 participants), and 40.6% of outcomes were judged to be at low risk of bias. At six months, compared with control diets, LCDs achieved higher rates of diabetes remission (defined as HbA 1c <6.5%) (76/133 (57%) v 41/131 (31%); risk difference 0.32, 95% confidence interval 0.17 to 0.47; 8 studies, n=264, I 2 =58%). Conversely, smaller, non-significant effect sizes occurred when a remission definition of HbA 1c <6.5% without medication was used. Subgroup assessments determined as meeting credibility criteria indicated that remission with LCDs markedly decreased in studies that included patients using insulin. At 12 months, data on remission were sparse, ranging from a small effect to a trivial increased risk of diabetes. Large clinically important improvements were seen in weight loss, triglycerides, and insulin sensitivity at six months, which diminished at 12 months. On the basis of subgroup assessments deemed credible, VLCDs were less effective than less restrictive LCDs for weight loss at six months. However, this effect was explained by diet adherence. That is, among highly adherent patients on VLCDs, a clinically important reduction in weight was seen compared with studies with less adherent patients on VLCDs. Participants experienced no significant difference in quality of life at six months but did experience clinically important, but not statistically significant, worsening of quality of life and low density lipoprotein cholesterol at 12 months. Otherwise, no significant or clinically important between group differences were found in terms of adverse events or blood lipids at six and 12 months. Conclusions On the basis of moderate to low certainty evidence, patients adhering to an LCD for six months may experience remission of diabetes without adverse consequences. Limitations include continued debate around what constitutes remission of diabetes, as well as the efficacy, safety, and dietary satisfaction of longer term LCDs. Systematic review registration PROSPERO CRD42020161795.

scholarly journals A Randomised Crossover Trial: Exploring the Dose-Response effect Of Carbohydrate restriction on glycaemia in people with type 2 diabetes (D-ROC2)

2021 ◽  
Author(s):  
Ebaa Al ozairi ◽  
Muhammad Abdul Ghani ◽  
Nick Oliver ◽  
Brandon Whitcher ◽  
Reem Al Awadi ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Dose Response ◽  
Dietary Protein ◽  
Crossover Trial ◽  
Carbohydrate Restriction ◽  
Low Carbohydrate Diet ◽  
Low Carbohydrate ◽  
Dietary Treatments

The role of carbohydrate restriction in the management of glycemia in type 2 diabetes (T2D) has been a subject of immense debate and controversy partly due to low-carbohydrate trials being confounded by multiple factors including degree of calorie restriction, dietary protein content, and by no clear definition of a low-carbohydrate diet. The current study sought to provide insight into the relationship between carbohydrate restriction and glycemia by testing the effect of varying doses of carbohydrate on continuous glucose concentrations within a range of intakes defined as low-carbohydrate while controlling for confounding factors. This was a randomised crossover trial in participants with T2D testing 5 different 6-day eucaloric, isocaloric dietary treatments with varying carbohydrate contents (10%, 15%, 20%, 25%, and 30% kcal). Diets were kept isocaloric by exchanging %kcal from carbohydrate with predominantly unsaturated fat, keeping protein constant at 15% kcal. Daily self-weighing was employed to ensure participants maintained their weight throughout each treatment arm. Between dietary treatments, participants underwent a washout period of at least 7 days and were advised to maintain their habitual diet. Glycemic control was assessed using a continuous glucose monitoring device that was placed while the participant was on their normal diet, and was worn for the 6 days of each treatment. 12 participants completed the study. There were no differences in 24-hour and postprandial sensor glucose concentrations between the 30%kcal and 10%kcal doses (7.4 +/- 1.1mmol/L vs 7.6 +/- 1.4mmol/L (P=0.28) and 8.0 +/- 1.4mmol/L vs 8.3 +/- 1.3mmol/L (P=0.28) respectively). In our exploratory analyses we did not find any dose-response relationship between carbohydrate intake and glyaemia. A small amount of weight loss occurred in each treatment arm (range: 0.4 to 1.1kg over the 6 days) but adjusting for these differences did not influence the primary or secondary outcomes. Modest changes in dietary carbohydrate content in the absence of weight loss while keeping dietary protein intake constant do not appear to influence glucose concentrations in people with T2D.

The Impact of Self-monitoring of Blood Glucose on a Behavioral Weight Loss Intervention for Patients With Type 2 Diabetes

2012 ◽  
Vol 39 (3) ◽  
pp. 397-405 ◽  
Author(s):  
Lisa M. McAndrew ◽  
Melissa A. Napolitano ◽  
Leonard M. Pogach ◽  
Karen S. Quigley ◽  
Kerri Leh Shantz ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Blood Glucose ◽  
Weight Loss Intervention ◽  
Behavioral Weight Loss ◽  
Self Monitoring ◽  
Behavioral Weight Loss Intervention ◽  
The Impact

scholarly journals Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial

2020 ◽  
Vol 8 (1) ◽  
pp. e001115 ◽  
Author(s):  
Eri Wada ◽  
Takeshi Onoue ◽  
Tomoko Kobayashi ◽  
Tomoko Handa ◽  
Ayaka Hayase ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Blood Glucose ◽  
Glycemic Control ◽  
Glucose Monitoring ◽  
Analysis Of Covariance ◽  
Self Monitoring ◽  
Flash Glucose Monitoring ◽  
Baseline Values ◽  
The Mean

IntroductionThe present study aimed to evaluate the effects of flash glucose monitoring (FGM) and conventional self-monitoring of blood glucose (SMBG) on glycemic control in patients with non-insulin-treated type 2 diabetes.Research design and methodsIn this 24-week, multicenter, open-label, randomized (1:1), parallel-group study, patients with non-insulin-treated type 2 diabetes at five hospitals in Japan were randomly assigned to the FGM (n=49) or SMBG (n=51) groups and were provided each device for 12 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) level, and was compared using analysis of covariance model that included baseline values and group as covariates.ResultsForty-eight participants in the FGM group and 45 in the SMBG group completed the study. The mean HbA1c levels were 7.83% (62.1 mmol/mol) in the FGM group and 7.84% (62.2 mmol/mol) in the SMBG group at baseline, and the values were reduced in both FGM (−0.43% (−4.7 mmol/mol), p<0.001) and SMBG groups (−0.30% (−3.3 mmol/mol), p=0.001) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM: −0.46% (−5.0 mmol/mol), p<0.001; SMBG: −0.17% (−1.8 mmol/mol), p=0.124); a significant between-group difference was also observed (difference −0.29% (−3.2 mmol/mol), p=0.022). Diabetes Treatment Satisfaction Questionnaire score was significantly improved, and the mean glucose levels, SD of glucose, mean amplitude of glycemic excursions and time in hyperglycemia were significantly decreased in the FGM group compared with the SMBG group.ConclusionsGlycemic control was better with FGM than with SMBG after cessation of glucose monitoring in patients with non-insulin-treated type 2 diabetes.Trial registration numberUMIN000026452, jRCTs041180082.

scholarly journals Frequency of self-monitoring of blood glucose in relation to weight loss and A1C during intensive multidisciplinary weight management in patients with type 2 diabetes and obesity

2019 ◽  
Vol 7 (1) ◽  
pp. e000659 ◽  
Author(s):  
Shaheen Tomah ◽  
Noor Mahmoud ◽  
Adham Mottalib ◽  
David M Pober ◽  
Mhd Wael Tasabehji ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Body Weight ◽  
Blood Glucose ◽  
Weight Management ◽  
Average Frequency ◽  
Baseline Body Mass Index ◽  
Self Monitoring ◽  
Median Change

ObjectiveWe evaluated the relationship between frequency of self-monitoring of blood glucose (SMBG) and body weight, A1C, and cardiovascular risk factors in patients with type 2 diabetes (T2D) and obesity enrolled in a 12-week intensive multidisciplinary weight management (IMWM) program.Research design and methodsWe conducted a retrospective analysis of 42 patients who electronically uploaded their SMBG data over 12 weeks of an IMWM program and divided them into tertiles based on their average frequency of SMBG per day. Mean (range) SMBG frequencies were 2.3 (1.1–2.9) times/day, 3.4 (3–3.9) times/day, and 5 (4–7.7) times/day in the lowest, middle, and highest tertiles, respectively. Anthropometric and metabolic parameters were measured at baseline and after 12 weeks of intervention.ResultsParticipants in the highest tertile achieved a median change (IQR) in body weight of −10.4 kg (−7.6 to −14.4 kg) compared with −8.3 kg (−5.2 to −12.2 kg), and −6.9 kg (−4.2 to −8.9 kg) in the middle and lowest tertiles, respectively (p=0.018 for trend). Participants in the highest tertile had a median change (IQR) in A1C of −1.25% (−0.6 to −3.1%) compared with −0.8% (−0.3% to −2%) and −0.5% (−0.2% to −1.2%) in the middle and lowest tertiles, respectively (p=0.048 for trend). The association between change in body weight and SMBG frequency remained significant after adjusting for age, sex, baseline body mass index, diabetes duration, and use of insulin therapy.ConclusionsIncreased frequency of SMBG during IMWM is associated with significantly better weight loss and improvement of A1C in patients with T2D and obesity. These findings may suggest future clinical recommendations aimed at increasing SMBG frequency to achieve the most favorable outcomes.

scholarly journals Overweight and diabetes prevention: is a low-carbohydrate–high-fat diet recommendable?

2018 ◽  
Vol 57 (4) ◽  
pp. 1301-1312 ◽  
Author(s):  
Fred Brouns
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Carbohydrate Content ◽  
Food Sources ◽  
Long Term Effects ◽  
High Fat ◽  
Functional Changes ◽  
Low Carbohydrate

Abstract In the past, different types of diet with a generally low-carbohydrate content (< 50–< 20 g/day) have been promoted, for weight loss and diabetes, and the effectiveness of a very low dietary carbohydrate content has always been a matter of debate. A significant reduction in the amount of carbohydrates in the diet is usually accompanied by an increase in the amount of fat and to a lesser extent, also protein. Accordingly, using the term “low carb–high fat” (LCHF) diet is most appropriate. Low/very low intakes of carbohydrate food sources may impact on overall diet quality and long-term effects of such drastic diet changes remain at present unknown. This narrative review highlights recent metabolic and clinical outcomes of studies as well as practical feasibility of low LCHF diets. A few relevant observations are as follows: (1) any diet type resulting in reduced energy intake will result in weight loss and related favorable metabolic and functional changes; (2) short-term LCHF studies show both favorable and less desirable effects; (3) sustained adherence to a ketogenic LCHF diet appears to be difficult. A non-ketogenic diet supplying 100–150 g carbohydrate/day, under good control, may be more practical. (4) There is lack of data supporting long-term efficacy, safety and health benefits of LCHF diets. Any recommendation should be judged in this light. (5) Lifestyle intervention in people at high risk of developing type 2 diabetes, while maintaining a relative carbohydrate-rich diet, results in long-term prevention of progression to type 2 diabetes and is generally seen as safe.

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