Intensive Lifestyle Intervention Research Articles

Weight Change During the Postintervention Follow-up of Look AHEAD.

Patients with type 2 diabetes are encouraged to lose weight, but excessive weight loss in older adults may be a marker of poor health and subsequent mortality. We examined weight change during the postintervention period of Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) with diabetes support and education (DSE) (control) in overweight/obese individuals with type 2 diabetes and sought to identify predictors of excessive postintervention weight loss and its association with mortality. These secondary analyses compared postintervention weight change (year 8 to final visit; median 16 years) in ILI and DSE in 3,999 Look AHEAD participants. Using empirically derived trajectory categories, we compared four subgroups: weight gainers (n = 307), weight stable (n = 1,561), steady losers (n = 1,731), and steep losers (n = 380), on postintervention mortality, demographic variables, and health status at randomization and year 8. Postintervention weight change averaged -3.7 ± 9.5%, with greater weight loss in the DSE than the ILI group. The steep weight loss trajectory subgroup lost on average 17.7 ± 6.6%; 30% of steep losers died during postintervention follow-up versus 10-18% in other trajectories (P < 0001). The following variables distinguished steep losers from weight stable: baseline, older, longer diabetes duration, higher BMI, and greater multimorbidity; intervention, randomization to control group and less weight loss in years 1-8; and year 8, higher prevalence of frailty, multimorbidity, and depressive symptoms and lower use of weight control strategies. Steep weight loss postintervention was associated with increased risk of mortality. Older individuals with longer duration of diabetes and multimorbidity should be monitored for excessive unintentional weight loss.

Remission of type 2 diabetes depends on prompt comprehensive lifestyle changes upon diagnosis: How can this “Road to Damascus” experience be supported?

Theoretically, a new diagnosis of type 2 diabetes mellitus (T2DM) requires a dramatic change in an individual’s way of life. Weight loss and physical activity can lead to remission of diabetes, which has been associated with a lower risk of developing complications. Today, the importance of a healthy lifestyle is further highlighted by data showing that obesity and diabetes increase the risk of severe complications from coronavirus disease 2019. However, remission rarely occurs in reality, probably due to the inability of people with T2DM to adhere to the intensive lifestyle interventions that are necessary. The complexity of contributing factors may explain why making these changes is so challenging and underscore the fact that there is no magical solution for T2DM. Instead, hard work from both patients and health care providers is needed for the conversion to be achieved. This article calls for more research on the underlying reasons why adhering to a healthy way of life is so difficult for people with diabetes and obesity. Clearly defining these barriers would facilitate the planning of effective policies to promote the adoption of appropriate lifestyle changes early in the course of the disease.

Effects of Intensive Lifestyle Intervention on All-Cause Mortality in Older Adults With Type 2 Diabetes and Overweight/Obesity: Results From the Look AHEAD Study.

Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) and diabetes support and education (DSE) (control) in 5,145 individuals with overweight/obesity and type 2 diabetes, found no significant differences in all-cause or cardiovascular mortality or morbidity during 9.6 (median) years of intervention. Participants in ILI who lost ≥10% at 1 year had lower risk of composite cardiovascular outcomes relative to DSE. Since effects of ILI may take many years to emerge, we conducted intent-to-treat analyses comparing mortality in ILI over 16.7 years (9.6 years of intervention and then observation) to DSE. In a secondary exploratory analysis, we compared mortality by magnitude of weight loss in ILI relative to DSE. Primary outcome was all-cause mortality from randomization to 16.7 years. Other outcomes included cause-specific mortality, interactions by subgroups (age, sex, race/ethnicity, and cardiovascular disease history), and an exploratory analysis by magnitude of weight loss in ILI versus DSE as reference. Analyses used proportional hazards regression and likelihood ratio. The incidence of all-cause mortality did not differ significantly in ILI and DSE (549 and 589 participants, respectively) (hazard ratio [HR] 0.91 [95% CI 0.81, 1.02]; P = 0.11). There were no significant differences between treatments in cause-specific mortality or within prespecified subgroups. ILI participants who lost ≥10% at 1 year had a 21% reduced risk of mortality (HR 0.79 [95% CI 0.67, 0.94]; P = 0.007) relative to DSE. ILI focused on weight loss did not significantly affect mortality risk. However, ILI participants who lost ≥10% had reduced mortality relative to DSE.

Sex-specific associations of fat mass and muscle mass with cardiovascular disease risk factors in adults with type 2 diabetes living with overweight and obesity: secondary analysis of the Look AHEAD trial

BackgroundDistinguishable sex differences exist in fat mass and muscle mass. High fat mass and low muscle mass are independently associated with cardiovascular disease (CVD) risk factors in people living with type 2 diabetes; however, it is unknown if the association between fat mass and CVD risk is modified by muscle mass, or vice versa. This study examined the sex-specific interplay between fat mass and muscle mass on CVD risk factors in adults with type 2 diabetes living with overweight and obesity.MethodsDual-energy X-ray absorptiometry (DXA) measures were used to compute fat mass index (FMI) and appendicular muscle mass index (ASMI), and participants were separated into high-fat mass vs. low-fat mass and high-muscle mass vs. low-muscle mass. A two-way analysis of covariance (ANCOVA: high-FMI vs. low-FMI by high-ASMI vs. low-ASMI) was performed on CVD risk factors (i.e., hemoglobin A1C [A1C]; high-density lipoprotein cholesterol; low-density lipoprotein cholesterol; triglycerides; systolic and diastolic blood pressure; cardiorespiratory fitness, depression and health related-quality of life [HR-QoL]) at baseline and following a 1-year intensive lifestyle intervention (ILI) for females and males separately, with a primary focus on the fat mass by muscle mass interaction effects.ResultsData from 1,369 participants (62.7% females) who completed baseline DXA were analyzed. In females, there was a fat mass by muscle mass interaction effect on A1C (p = 0.016) at baseline. Post-hoc analysis showed that, in the low-FMI group, A1C was significantly higher in low-ASMI when compared to high-ASMI (60.3 ± 14.1 vs. 55.5 ± 13.5 mmol/mol, p = 0.023). In the high-FMI group, there was no difference between high-ASMI and low-ASMI (56.4 ± 12.5 vs. 56.5 ± 12.8 mmol/mol, p = 0.610). In males, only high-FMI was associated with higher A1C when compared to low-FMI (57.1 ± 14.4 vs. 54.2 ± 12.0 mmol/mol, p = 0.008) at baseline. Following ILI, there were significant fat mass by muscle mass interaction effects on changes in the mental component of HR-QoL in males.ConclusionConsidering that A1C predicts future CVD, strategies to lower A1C may be especially important in females with low fat and low muscle mass living with type 2 diabetes. Our results highlight the complicated and sex-specific contribution of fat mass and muscle mass to CVD risk factors.

Feasibility and Pilot Testing of Mobile Health Apps to Supplement 2 Healthy Lifestyle Interventions in Chronic Traumatic Brain Injury

To determine the feasibility of mobile health (mHealth) apps for enhancing participation of people with chronic traumatic brain injury (TBI) in the Group Lifestyle Balance (GLB-TBI) weight loss intervention and Brain Health Group (BHG-TBI) active control intervention. Community. n = 56 overweight/obese adults with moderate-severe TBI. The GLB-TBI is a 12-month group- and community-based program to promote healthy eating and physical activity. The BHG-TBI is a 12-month group- and community-based program to promote general brain health, designed as an active control condition matched on time, structure, and perceived benefit to the GLB-TBI. In a randomized controlled trial testing the efficacy of the GLB-TBI for weight loss, participants used a group-specific mHealth app providing daily tips customized according to their intervention allocation. Compliance (percentage of daily prompts read and completed) and participant-reported satisfaction and usability. In conjunction with relevant stakeholders, we developed the content and structure of the GLB-TBI and BHG-TBI apps based on core curriculum components. We incorporated cognitive strategies (app notifications) to address potential cognitive impairment common after TBI. Both apps delivered brief daily educational and motivational "tips" derived directly from their respective curricula. Daily use of the apps varied greatly across participants, with most participants who used the apps completing 10% to 50% of daily content. Participants found the apps to be easy to use, but only some found them helpful. App use was substantially different for those who participated in the intervention during (2020) versus before (2019) the COVID-19 pandemic. Although enhancing an intensive lifestyle intervention with mHealth technology may be helpful, further refinement is needed to optimize the frequency and delivery methods of mHealth content. Although one might expect remote app use to have been higher during the pandemic, we observed the opposite, potentially due to less hands-on training and ongoing support to use the app and/or general technology fatigue with social distancing.

1 Year HIIT and Omega-3 Fatty Acids to Improve Cardiometabolic Risk in Stage-A Heart Failure

ObjectivesThis study aims to determine whether 1 year of high-intensity interval training (HIIT) and omega-3 fatty acid (n-3 FA) supplementation would improve fitness, cardiovascular structure/function, and body composition in obese middle-aged adults at high-risk of heart failure (HF) (stage A). BackgroundIt is unclear if intensive lifestyle interventions begun in stage A HF can improve key cardiovascular and metabolic risk factors. MethodsHigh-risk obese adults (n = 80; age 40 to 55 years; N-terminal pro–B-type natriuretic peptide >40 pg/mL or high-sensitivity cardiac troponin T >0.6 pg/mL; visceral fat >2 kg) were randomized to 1 year of HIIT exercise or attention control, with n-3 FA (1.6 g/daily omega-3-acid ethyl esters) or placebo supplementation (olive oil 1.6 g daily). Outcome variables were exercise capacity quantified as peak oxygen uptake (V.O2), left ventricular (LV) mass, LV volume, myocardial triglyceride content (magnetic resonance spectroscopy), arterial stiffness/function (central pulsed-wave velocity; augmentation index), and body composition (dual x-ray absorptiometry scan). ResultsFifty-six volunteers completed the intervention. There was no detectible effect of HIIT on visceral fat or myocardial triglyceride content despite a reduction in total adiposity (Δ: -2.63 kg, 95% CI: -4.08 to -0.46, P = 0.018). HIIT improved exercise capacity by ∼24% (ΔV.O2: 4.46 mL/kg per minute, 95% CI: 3.18 to 5.56; P < 0.0001), increased LV mass (Δ: 9.40 g, 95% CI: 4.36 to 14.44; P < 0.001), and volume (Δ: 12.33 mL, 95 % CI: 5.61 to 19.05; P < 0.001) and reduced augmentation index (Δ: -4.81%, 95% CI: -8.63 to -0.98; P = 0.009). There was no independent or interaction effect of n-3 FA on any outcome. ConclusionsOne-year HIIT improved exercise capacity, cardiovascular structure/function, and adiposity in stage A HF with no independent or additive effect of n-3 FA administration. (Improving Metabolic Health in Patients With Diastolic Dysfunction [MTG]; NCT03448185)

Abstract 009: Differential Effect Of An Intensive Lifestyle Intervention On Risk For Cardiovascular Events According To Baseline Level Of Glycated Hemoglobin

Introduction: A lack of effective interventions remains a major clinical gap in cardiovascular disease (CVD) prevention for individuals with type 2 diabetes (T2D) and high glycated hemoglobin (HbA1c). Our objective was to determine whether the effect of an intensive lifestyle intervention (ILI) on CVD prevention differed by baseline HbA1c among Action for Health in Diabetes (Look AHEAD) trial participants. Hypothesis: ILI will be associated with differential risk for CVD by HbA1c. Methods: Look AHEAD randomized 5145 adults, aged 45-76 years, with T2D and overweight/obesity, to ILI or a control of diabetes support and education (DSE) for a median of 9.6 years. ILI focused on weight loss through decreased caloric intake and increased physical activity. We assessed the parent trial’s pre-specified primary CVD outcome. We assessed for additive (Poisson regression) and multiplicative (Cox proportional hazards) heterogeneity of intervention effects on CVD risk by HbA1c adjusting for stratified randomization and using intention to treat analysis. Results: Baseline HbA1c ranged from 4.4% to 14.5% (mean 7.3, SD 1.2). We observed additive and multiplicative heterogeneity of effects (all p&lt;0.001) between ILI and HbA1c on CVD risk (Figure). Compared to DSE, ILI was associated with lower risk for CVD for HbA1c quintiles 1 and 2. The “ILI-CVD” association changed direction at HbA1c=7.7%; ILI was associated with higher risk of CVD than DSE within HbA1c quintile 5 (and when continuous, HbA1c ≥8.7%). Conclusion: Among adults with T2D and overweight/obesity, the effect of a lifestyle intervention on CVD risk differed by HbA1c. There is a critical need to identify effective CVD prevention strategies for individuals with T2D and high HbA1c.

Youth with type 2 diabetes have a high rate of treatment failure after discontinuation of insulin: A Pediatric Diabetes Consortium study.

Insulin is commonly used to reverse gluco-toxicity in youth with newly diagnosed type 2 diabetes (T2D), but many are subsequently weaned off insulin. We analyzed Pediatric Diabetes Consortium (PDC) data to determine how long glycemic control is maintained after termination of initial insulin treatment. Youth with T2D who had previously been on insulin but were on either an intensive lifestyle intervention alone or metformin alone upon enrollment in the PDC T2D Registry were studied (N=183). The primary outcome was time to treatment failure, defined by need to restart insulin or metformin or another diabetes medication. Data were analyzed using logistic regression to assess risk factors for treatment failure. Of the 183 participants studied (mean age 15 years, diabetes duration 1.7 years), 54% experienced treatment failure (median follow-up time 1.7 years). In the subgroup on metformin monotherapy (N=140), 45% subsequently required restart of insulin. Moreover, of participants in the subgroup treated with an intensive lifestyle intervention alone (N=43), 81% restarted insulin or were treated with metformin or other diabetes medication. In both groups, median time to treatment failure was 1.2 years. Higher HbA1c at enrollment was significantly associated with treatment failure (p < 0.001). Youth with T2D who are initially treated with insulin have a high rate of treatment failure when switched to intensive lifestyle alone or metformin alone. Our data highlight the severe and progressive nature of youth onset T2D, hence patients should be monitored closely for deteriorating glycemic control after being weaned off insulin.

Body Weight Variability and Risk of Cardiovascular Outcomes and Death in the Context of Weight Loss Intervention Among Patients With Type 2 Diabetes

Body weight fluctuation is associated with greater risks of adverse health outcomes. Whether intensive weight loss interventions affect the association of variability in adiposity measures with adverse health outcomes in individuals with type 2 diabetes has not been studied previously. To evaluate the associations of long-term variability in adiposity indices with cardiovascular disease (CVD) outcomes and whether these associations are affected by an intensive lifestyle intervention among adults with type 2 diabetes. This prospective cohort study included participants in the Action for Health in Diabetes (Look AHEAD) trial without CVD at baseline (August 2001 to April 2004). The Look AHEAD study included 16 centers in the United States. Data analysis was performed from December 2020 to June 2021. Variability of body mass index (BMI) and waist circumference (WC) across 4 annual visits, assessed using the coefficient of variation (CV), variability independent of the mean (VIM), and standard deviation (SD). Main outcomes were (1) all-cause mortality, (2) cardiovascular deaths (deaths from myocardial infarction [MI] or stroke), and (3) CVD events (MI, stroke, and/or death from cardiovascular causes). Among 3604 study participants (mean [SD] age, 58.4 [6.6] years; 2240 [62.3%] women; 1364 [37.7%] Black participants; 2404 [66%] White participants), there were 216 CVD events, 33 CVD deaths, and 166 deaths over a median of 6.7 years. In the control group, the hazard ratios (HRs) for the highest quartile (quartile 4) compared with the lowest quartile (quartile 1) of CV of BMI were 4.06 (95% CI, 2.17-7.57), 15.28 (95% CI, 2.89-80.90), and 2.16 (95% CI, 1.21-3.87) for all-cause mortality, CVD mortality, and cardiovascular events, respectively. In the intervention group, the corresponding HRs were 0.99 (95% CI, 0.45-2.16), 1.14 (95% CI, 0.12-10.53), and 0.77 (95% CI, 0.40-1.49) for quartile 4 vs quartile 1. Regarding WC, in the control group, HRs for quartile 4 vs quartile 1 were 1.84 (95% CI, 1.01-3.35), 6.46 (95% CI, 1.16-36.01), and 1.28 (95% CI, 0.72-2.29). In the intervention group, HRs were 1.23 (95% CI, 0.61-2.46), 0.55 (95% CI, 0.15-2.11), and 0.70 (95% CI, 0.39-1.25) for quartile 4 vs quartile 1. In this cohort study of individuals with type 2 diabetes, higher variability of adiposity indices was associated with significantly increased risk of CVD outcomes and death in the control group but not in the intensive lifestyle intervention group.

Efficacy of Residential, Group-Based, Intensive Holistic Lifestyle Intervention Among Type-2 Diabetes Patients - A Single Group Pre- And Post-intervention Study.

BackgroundThe present study assessed the efficacy of the residential, group-based, intensive holistic lifestyle intervention on glycaemic control.Materials and methodsA one-group pre and post-intervention study was conducted among 145 people with diabetes for a period of one year from February 2019 to January 2020. The study population underwent "Brahma Kumaris Raja Yoga lifestyle" intervention. Outcome variables were changes in HbA1c levels and anthropometric parameters (like weight, BMI, etc.). Paired t-test was used to compare normally distributed numeric variables.ResultsThe mean age was 52.39±5.79 years, with a male-female ratio close to 1:1. Mean HbA1c at baseline was 9.06±2.1%. The mean weight and BMI were 71.03±12.84 kg and 28.28±4.83kg/m2, respectively. Mean HbA1c value had shown a reduction of 1.60% (95%CI 1.17 to 1.90, p <0.001) at three months and 1.58% (95% CI 1.13-1.87, p<0.001) reduction at a six-month follow-up. Between the third and sixth months, there was no significant change in the HbA1c value. Mean weight reduced by 0.79 kg (95% CI 0.08-1.08, p=0.023) at six-month follow-up and mean BMI decreased by 0.31 units from baseline to three months (95% CI 0.05-0.56, p=0.017). A statistically significant reduction was observed in waist circumference at the third month (MD=1.61 95% CI =0.95 to 2.28, P<0.001) and sixth month (MD=1.53, 95% CI 0.82-2.25, p<0.001) follow-up.ConclusionThis residential, group-based, intensive holistic lifestyle intervention showed a significant decrease in HbA1c levels and anthropometric parameters at three- and six-months follow-up, thereby improving the overall health and wellbeing of people with diabetes.

Cardiorespiratory Fitness, BMI, Mortality, and Cardiovascular Disease in Adults with Overweight/Obesity and Type 2 Diabetes.

We estimated the effects of cardiorespiratory fitness (CRF) and body mass index (BMI) at baseline on mortality and cardiovascular disease events in people with type 2 diabetes who participated in the Look AHEAD randomized clinical trial. Look AHEAD compared effects of an intensive lifestyle intervention with diabetes support and education on cardiovascular disease events in 5145 adults age 45-76 yr with overweight/obesity and type 2 diabetes. In 4773 participants, we performed a secondary analysis of the association of baseline CRF during maximal treadmill test (expressed as metabolic equivalents (METs)) on mortality and cardiovascular disease events during a mean follow-up of 9.2 yr. The mean (SD) CRF was 7.2 (2.0) METs. Adjusted for age, sex, race/ethnicity, BMI, intervention group, and β-blocker use, all-cause mortality rate was 30% lower per SD greater METs (hazard ratio (HR) = 0.70 (95% confidence interval, 0.60 to 0.81); rate difference (RD), -2.71 deaths/1000 person-years (95% confidence interval, -3.79 to -1.63)). Similarly, an SD greater METs predicted lower cardiovascular disease mortality (HR, 0.45; RD, -1.65 cases/1000 person-years) and a composite cardiovascular outcome (HR, 0.72; RD, -6.38). Effects of METs were homogeneous on the HR scale for most baseline variables and outcomes but heterogeneous for many on the RD scale, with greater RD in subgroups at greater risk of the outcomes. For example, all-cause mortality was lower by 7.6 deaths/1000 person-years per SD greater METs in those with a history of cardiovascular disease at baseline but lower by only 1.6 in those without such history. BMI adjusted for CRF had little or no effect on these outcomes. Greater CRF is associated with reduced risks of mortality and cardiovascular disease events.

Feasibility of an Adapted Community-Based Lifestyle Intervention to Prevent Cancer in the Rural South: Healthy Living Partnerships to Prevent Cancer (HELP PC).

Obesity increases risk of cancer onset and promulgates cancer mortality. Healthy Living Partnerships to Prevent Cancer (HELP PC) is an adapted intensive lifestyle intervention that is facilitated by community health workers (CHWs). The primary objective of this one-arm pilot study was to test the feasibility of evaluating HELP PC in a rural community by assessing participant recruitment, retention, and adherence to the intervention. The secondary objectives of this study were to evaluate the feasibility of collecting study measures and analyze intervention effects to inform future studies. Adults of all races and a BMI ≥ 25 kg/m2 who resided in the Dan River Region of Southern Virginia were recruited. Participants received 24 weekly (hour-long) group sessions led by a CHW and two consultations with a registered dietitian (RDN). Seventy-five percent (21/28) of eligible subjects were enrolled (n = 21; mean age = 46 years; 67% African American; 90% female; median BMI = 36.1), and recruitment was completed in 2 weeks. Fifty-two percent (11/21) of participants attended >70% of group sessions (adherence) and 98% of RDN consultations were attended. Eighty-six percent (n=18) of participants completed the 6-month follow-up visit (retention), and showed improvements in moderate physical activity, health literacy, general health, energy, and emotional well-being. Feasibility of HELP PC was established through efficient participant recruitment, modest attendance, high retention, and execution of data collection procedures. Importantly, findings can be applied to advance cancer prevention lifestyle interventions in rural communities.

Eating breakfast is associated with weight loss during an intensive lifestyle intervention for overweight/obesity.

This study examined whether breakfast consumption frequency (BCF) is associated with weight-loss outcomes in the Look AHEAD (Action for Health in Diabetes) trial. Data from a subset of participants (n = 3,915) from Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) to diabetes support and education (DSE) in adults with overweight/obesity and type 2 diabetes, were analyzed. BCF was collected by yearly questionnaire. Multivariable linear regression models were used to estimate the association between average BCF and percentage weight change over 4 years, controlling for baseline sociodemographic, anthropometric, and diabetes-related variables. In separate models, adjustment for diet (n = 915) and physical activity level (n = 837) was performed in a subset of participants. Four-year average BCF was similar in DSE (n = 1,916) and ILI (n = 1,999) arms (p = 0.14). Each 1-day higher average BCF was associated with an additional 0.5% weight loss in the ILI arm (p < 0.0001) but not in the DSE arm (p = 0.58). This association in the ILI arm remained significant after adjustment for diet (p = 0.02) but not after adjustment for physical activity (p = 0.36). Breakfast consumption was associated with greater weight loss in the active treatment group of an ILI, which may be mediated by increased physical activity.

Effects of preconception lifestyle intervention in infertile women with obesity: The FIT-PLESE randomized controlled trial.

BackgroundWomen with obesity and infertility are counseled to lose weight prior to conception and infertility treatment to improve pregnancy rates and birth outcomes, although confirmatory evidence from randomized trials is lacking. We assessed whether a preconception intensive lifestyle intervention with acute weight loss is superior to a weight neutral intervention at achieving a healthy live birth.Methods and findingsIn this open-label, randomized controlled study (FIT-PLESE), 379 women with obesity (BMI ≥ 30 kg/m2) and unexplained infertility were randomly assigned in a 1:1 ratio to 2 preconception lifestyle modification groups lasting 16 weeks, between July 2015 and July 2018 (final follow-up September 2019) followed by infertility therapy. The primary outcome was the healthy live birth (term infant of normal weight without major anomalies) incidence. This was conducted at 9 academic health centers across the United States. The intensive group underwent increased physical activity and weight loss (target 7%) through meal replacements and medication (Orlistat) compared to a standard group with increased physical activity alone without weight loss. This was followed by standardized empiric infertility treatment consisting of 3 cycles of ovarian stimulation/intrauterine insemination. Outcomes of any resulting pregnancy were tracked. Among 191 women randomized to standard lifestyle group, 40 dropped out of the study before conception; among 188 women randomized to intensive lifestyle group, 31 dropped out of the study before conception. All the randomized women were included in the intent-to-treat analysis for primary outcome of a healthy live birth. There were no significant differences in the incidence of healthy live births [standard 29/191(15.2%), intensive 23/188(12.2%), rate ratio 0.81 (0.48 to 1.34), P = 0.40]. Intensive had significant weight loss compared to standard (−6.6 ± 5.4% versus −0.3 ± 3.2%, P < 0.001). There were improvements in metabolic health, including a marked decrease in incidence of the metabolic syndrome (baseline to 16 weeks: standard: 53.6% to 49.4%, intensive 52.8% to 32.2%, P = 0.003). Gastrointestinal side effects were significantly more common in intensive. There was a higher, but nonsignificant, first trimester pregnancy loss in the intensive group (33.3% versus 23.7% in standard, 95% rate ratio 1.40, 95% confidence interval [CI]: 0.79 to 2.50). The main limitations of the study are the limited power of the study to detect rare complications and the design difficulty in finding an adequate time matched control intervention, as the standard exercise intervention may have potentially been helpful or harmful.ConclusionsA preconception intensive lifestyle intervention for weight loss did not improve fertility or birth outcomes compared to an exercise intervention without targeted weight loss. Improvement in metabolic health may not translate into improved female fecundity.Trial registrationClinicalTrials.gov NCT02432209.

Patient-Centered Care for Obesity: How Health Care Providers Can Treat Obesity While Actively Addressing Weight Stigma and Eating Disorder Risk

Patient-Centered Care for Obesity: How Health Care Providers Can Treat Obesity While Actively Addressing Weight Stigma and Eating Disorder Risk

Association Between Change in Accelerometer-Measured and Self-Reported Physical Activity and Cardiovascular Disease in the Look AHEAD Trial.

To conduct post hoc secondary analysis examining the association between change in physical activity. Measured with self-report and accelerometry, from baseline to 1 and 4 years and cardiovascular disease (CVD) outcomes in the Look AHEAD Trial. Participants were adults with overweight/obesity and type 2 diabetes with physical activity. Data at baseline and year 1 or 4 (n = 1,978). Participants were randomized to diabetes support and education or intensive lifestyle intervention. Measures included accelerometry-measured moderate-to-vigorous physical activity (MVPA), self-reported physical activity, and composite (morbidity and mortality) CVD outcomes. In pooled analyses of all participants, using Cox proportional hazards models, each 100 MET-min/week increase in accelerometry-measured MVPA from baseline to 4 years was associated with decreased risk of the subsequent primary composite outcome of CVD. Results were consistent for changes in total MVPA (hazard ratio 0.97 [95% CI 0.95, 0.99]) and MVPA accumulated in ≥10-min bouts (hazard ratio 0.95 [95% CI 0.91, 0.98]), with a similar pattern for secondary CVD outcomes. Change in accelerometry-measured MVPA at 1 year and self-reported change in physical activity at 1 and 4 years were not associated with CVD outcomes. Increased accelerometry-measured MVPA from baseline to year 4 is associated with decreased risk of CVD outcomes. This suggests the need for long-term engagement in MVPA to reduce the risk of CVD in adults with overweight/obesity and type 2 diabetes.

A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with Prediabetes.

Aims Prediabetes has been proved as an important risk factor of both diabetes and cardiovascular disease (CVD). Previous studies have shown that both lifestyle intervention and pioglitazone may delay the development of diabetes in patients with prediabetes. However, no study has ever explored whether these interventions could revert prediabetes to normal glycemic status as the primary outcome. Interventions that may revert prediabetes back to normal glucose status would be of great clinical importance. Materials and Methods We conducted a randomized, multicenter, 2 × 2 factorial designed study to examine whether intensive lifestyle intervention and/or pioglitazone could revert prediabetes to normal glucose tolerance. The participants were followed up for three years unless they reverted to normal glucose state or developed diabetes at the annual oral glucose tolerance test (OGTT). Reversion to normal glucose tolerance was confirmed on the basis of the results of OGTT. Results In our study, 1945 eligible patients were ultimately randomized into four groups. In this three-year follow-up study, overall, 60.0%, 50.3%, 56.6% and 65.1% reverted back to normoglycemic state over 3 years of follow-up in the conventional lifestyle intervention plus placebo, intensive lifestyle intervention plus placebo, conventional lifestyle intervention plus pioglitazone, and intensive lifestyle intervention plus pioglitazone groups, respectively. Compared to the conventional lifestyle intervention plus placebo group, all the other three groups did not show any significant benefit in terms of reverting back to normoglycemic state. Conclusion In our study, for patients with prediabetes, neither intensive lifestyle intervention nor pioglitazone had led to a higher reversion rate to normal glucose state. Trail registration.http://www.chictr.org.cn: ChiCTR-PRC-06000005.

In-person and virtual multidisciplinary intensive lifestyle interventions are equally effective in patients with type 2 diabetes and obesity.

Background:Intensive lifestyle intervention (ILI) is essential for diabetes management. The Weight Achievement and Intensive Treatment (Why WAIT) program is a 12-week multidisciplinary weight management program that has been implemented in real-world clinical practice since 2005 and has shown long-term maintenance of weight reduction for 5 and 10 years. During the COVID-19 pandemic, the program went virtual using telemedicine and mobile health applications.Aims:This retrospective pilot study aims to evaluate the effectiveness of a virtual model of an already established and successful in-person program for diabetes and weight management since 2005.Methods:We evaluated 38 patients with diabetes and obesity enrolled in the Why WAIT program between February 2019 and December 2020. Sixteen participants were enrolled in virtual program (VP) and were compared with 22 participants who completed the latest two physical programs (PPs) before COVID-19. We evaluated changes in body weight, A1C, blood pressure (BP), and lipid profile after 12 weeks of ILI.Results:Body weight decreased by −7.4 ± 3.6 kg from baseline in VP compared with −6.8 ± 3.5 kg in PP (p = 0.6 between groups). A1C decreased by −1.03% ± 1.1% from baseline in VP, and by −1.0% ± 1.2% in PP (p = 0.9 between groups). BP, lipid profile, and all other parameters improved in both groups with no significant difference between them.Conclusion:Virtual multidisciplinary ILI is as effective as the in-person intervention program in improving body weight, A1C, BP, and lipid profile, and in reducing the number of anti-hyperglycemic medications. Results from our study suggest that scaling the Why WAIT program in a virtual format to a larger population of patients with diabetes and obesity is feasible and is potentially as successful as the in-person program.

Impact of intensive lifestyle intervention on gut microbiota composition in type 2 diabetes: a post-hoc analysis of a randomized clinical trial

ABSTRACT Type 2 diabetes (T2D) management is based on combined pharmacological and lifestyle intervention approaches. While their clinical benefits are well studied, less is known about their effects on the gut microbiota. We aimed to investigate if an intensive lifestyle intervention combined with conventional standard care leads to a different gut microbiota composition compared to standard care alone treatment in individuals with T2D, and if gut microbiota is associated with the clinical benefits of the treatments. Ninety-eight individuals with T2D were randomized to either an intensive lifestyle intervention combined with standard care group (N = 64), or standard care alone group (N = 34) for 12 months. All individuals received standardized, blinded, target-driven medical therapy, and individual counseling. The lifestyle intervention group moreover received intensified physical training and dietary plans. Clinical characteristics and fecal samples were collected at baseline, 3-, 6-, 9-, and 12-month follow-up. The gut microbiota was profiled with 16S rRNA gene amplicon sequencing. There were no statistical differences in the change of gut microbiota composition between treatments after 12 months, except minor and transient differences at month 3. The shift in gut microbiota alpha diversity at all time windows did not correlate with the change in clinical characteristics, and the gut microbiota did not mediate the treatment effect on clinical characteristics. The clinical benefits of intensive lifestyle and/or pharmacological interventions in T2D are unlikely to be explained by, or causally related to, changes in the gut microbiota composition.

Prediction of remission of type 2 diabetes mellitus after bariatric surgery

Type 2 diabetes prevalence is increasing dramatically worldwide. Conservative therapy doesn’t bring stable effect and is often insufficient, not to mention the lack of prospects to cure the disease. Fortunately, accumulating evidence points towards the notion that a complete remission of type 2 diabetes is feasible following a choice of surgical interventions. The efficacy of bariatric surgery in particular for achieving glycemic control has highlighted surgery as a candidate curative intervention for type 2 diabetes. When compared to intensive medical therapy and lifestyle intervention, metabolic surgery has shown superiority in achieving reducing number of medications and metabolic factors improvement, which translates in long-term benefits on diabetes progression and complications. Understanding factors that predict diabetes remission can help to select patients who will benefit most from bariatric surgery and to choose the most effective type of operation. This literature review analyzes studies of the most significant clinical and biochemical predictors of remission of type 2 diabetes mellitus after bariatric interventions, as well as highlights well-known mathematical prediction models.