Lifestyle Weight Loss Intervention Research Articles

A randomized controlled trial of an innovative, user-friendly, interactive smartphone app-based lifestyle intervention for weight loss.

ObjectivesMost electronically delivered lifestyle interventions are labor intensive, requiring logging onto websites and manually recording activity and diet. Cumbersome technology and lack of a human coach may have contributed to the limitations of prior interventions. In response, the current program of research created a comprehensive electronically delivered lifestyle intervention using a user‐friendly, interactive, smartphone app‐based model, and evaluated it in a randomized controlled trial.MethodsTwenty‐eight adults, body mass index 25–42 kg/m2, with smartphones and sedentary jobs, were randomized to the intervention, along with conventional outpatient weight‐management visits every 3 months, or to a wait‐listed control group that received only weight‐management visits. The intervention included wearable activity trackers, smartscales, food photography logs, physician‐driven app‐based behavioral coaching, and peer support via the app. The prespecified primary outcome was a comparison of change in weight in kilograms, in the intervention versus control group at 6 months.ResultsAt 6 months, the intervention group experienced a statistically significant weight change of −7.16 ± 1.78 kg (mean ± SE, 95% CI −11.05 to −3.26, p < 0.01), which differed from the weight change in controls by −4.16 ± 2.01 kg (95% CI −8.29 to −0.02, p < 0.05, prespecified primary outcome). Weight change in the control group was −3.00 ± 1.05 kg (95% CI −5.27 to −0.73, p < 0.05). Waist circumference and hemoglobin A1c significantly improved (intervention vs. control: p < 0.01, p < 0.05, respectively, prespecified secondary outcomes). Weight change in the intervention group correlated with numbers of food photographs participants shared (rho = −0.86, p < 0.01), numbers of their text messages (rho = −0.80, p < 0.01), number of times and days each participant stepped on the smartscale (rho = −0.73, p < 0.01; rho = −0.608, p < 0.05, respectively), and mean daily step counts (rho = −0.55, p < 0.05).ConclusionThis app‐based electronically delivered lifestyle intervention produced statistically significant, clinically meaningful weight loss and improved metabolic health. Engagement with the intervention correlated strongly with weight loss. Given the limited sample size, larger and longer studies of this intervention are needed.

Effect of Time-Restricted Feeding on Body Weight and Cardiometabolic Risks: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Introduction: Time-restricted eating (TRE) or time-restricted feeding (TRF), a form of intermittent fasting (IF) when food consumption is restricted to a 4–12 hour window, poses unique possible health benefits that allow the nutrient to work in harmony with circadian rhythm. Whether TRF is effective in weight loss and cardiometabolic profile compare to usual diet is controversial. We conducted a meta-analysis of randomized control trials to investigate the weight and metabolic effects of TRF in humans. Methods: The systematic review was conducted according to the PRISMA guidelines. The literature search was conducted in MEDLINE, EMBASE, and CENTRAL from database inception to November 30, 2020. The search terms included time restricting feeding, time-restricted eating, periodic fasting, intermittent fasting, and periodic fasting. The eligibility criteria included a randomized controlled trial (RCT) comparing the effect of TRF as an intervention and control diet on weight and cardiometabolic risks in individuals with overweight (BMI 23–26.9 kg/m2 in Asian and 25–29.9 kg/m2 in others) or obesity (BMI≥27 kg/m2 in Asian and ≥30 kg/m2 in others) with study duration of at least 8 weeks. The primary outcome is the change in body weight between preintervention and postintervention. The secondary outcome is the change in total fat mass and lean mass, HDL, LDL, and triglycerides. Pool mean differences (MD) with 95% confidence interval (CI) were calculated for each outcome. Results: Four articles met the inclusion criteria and were included in this systematic review and meta-analysis. There were 511 participants with BMI 24 kg/m2 and above and aged between 18 and 65. TRF was defined as a 4–8 hours ad-lib unrestricted eating in 24 hours. The control diet was defined as ad-lib eating per usual habits. There was a significant improvement in weight and body composition in the TRF group. The mean weight loss was -2.08 kg (95% CI: -3.49 to -0.68) greater among TRF group. There was a significant total fat mass and lean mass loss in the TRF group with the MD of -1.29 kg (95% CI: -2.04 to -0.54) and -0.59 kg (95% CI: -1.15 to -0.03), respectively. There was no significant change in HDL, LDL, or triglycerides comparing between TRF and control diet. Conclusion: This systematic review and meta-analysis of RCT showed that TRF with no calories restriction resulted in significant decreased in weight, fat mass, and a slight decreased in total lean mass compared with control diet. Our findings support TRF as an effective lifestyle intervention for weight loss.

Is it Time to Expand Glucagon-like Peptide-1 Receptor Agonist Use for Weight Loss in Patients Without Diabetes?

The obesity and type 2 diabetes mellitus epidemics demonstrate thatsimply emphasizing a healthy lifestyle is insufficient. While weight loss medications have historically been considered "cosmetic", glucagon-like peptide-1 receptor agonists (GLP1-RAs) also reduce cardiovascular risk in patients with type 2 diabetes. Therefore, we assessed whether GLP1-RAs warrant use in patients who are overweight (body mass index 27.0-29.9 kg/m2) without weight-related comorbidity. We reviewed trials of available GLP1-RAs with a natural GLP1 backbone given their trend toward cardiovascular benefit and excluded trials requiring concurrent antidiabetic agents associated with weight gain. We assessed 20 phase III trials of GLP1-RAs studied in cardiovascular outcome trials. The GLP1-RAs consistently produced weight loss. Hypoglycemia risk with GLP1-RAs was generally low without other precipitating factors, whereas gastrointestinal adverse effects were common. Dulaglutide 1.5 mg weekly did not produce sufficient weight loss to support its use specifically for weight loss, while data supporting dulaglutide 3.0 or 4.5 mg weekly were limited to a single trial. Weight loss was sufficient with liraglutide 1.8 mg daily in one trial and was consistently sufficient with liraglutide 3.0 mg daily. Oral and injectable semaglutide at both doses consistently produced weight loss, though demonstrated a potential increased risk for retinopathy. Overall, we suggest five GLP1-RAs can be used in the treatment of overweight (body mass index 27.0-29.9 kg/m2 without weight-related comorbidity) with shared decision making to address each medications' key limitation: liraglutide 1.8 mg daily (less demonstrated weight loss), liraglutide 3.0 mg daily (no cardiovascular outcome trial at this dose), and oral and injectable semaglutide at both doses (uncertain retinopathy risk and pending cardiovascular outcome trial of high-dose semaglutide). Use should be limited to patients who fail, refuse, or cannot access lifestyle interventions for weight loss, and should be accompanied by standard restrictions on and monitoring of weight loss medications. We expect additional and earlier use of weight loss therapies to help clinicians curb the obesity and type 2 diabetes epidemics.

Obesity and Cardiovascular Disease: A Scientific Statement From the American Heart Association.

The global obesity epidemic is well established, with increases in obesity prevalence for most countries since the 1980s. Obesity contributes directly to incident cardiovascular risk factors, including dyslipidemia, type 2 diabetes, hypertension, and sleep disorders. Obesity also leads to the development of cardiovascular disease and cardiovascular disease mortality independently of other cardiovascular risk factors. More recent data highlight abdominal obesity, as determined by waist circumference, as a cardiovascular disease risk marker that is independent of body mass index. There have also been significant advances in imaging modalities for characterizing body composition, including visceral adiposity. Studies that quantify fat depots, including ectopic fat, support excess visceral adiposity as an independent indicator of poor cardiovascular outcomes. Lifestyle modification and subsequent weight loss improve both metabolic syndrome and associated systemic inflammation and endothelial dysfunction. However, clinical trials of medical weight loss have not demonstrated a reduction in coronary artery disease rates. In contrast, prospective studies comparing patients undergoing bariatric surgery with nonsurgical patients with obesity have shown reduced coronary artery disease risk with surgery. In this statement, we summarize the impact of obesity on the diagnosis, clinical management, and outcomes of atherosclerotic cardiovascular disease, heart failure, and arrhythmias, especially sudden cardiac death and atrial fibrillation. In particular, we examine the influence of obesity on noninvasive and invasive diagnostic procedures for coronary artery disease. Moreover, we review the impact of obesity on cardiac function and outcomes related to heart failure with reduced and preserved ejection fraction. Finally, we describe the effects of lifestyle and surgical weight loss interventions on outcomes related to coronary artery disease, heart failure, and atrial fibrillation.

Return on Investment: Medical Savings of an Employer-Sponsored Digital Intensive Lifestyle Intervention, Weight Loss.

ObjectiveThis study aimed to determine the medical cost impact and return on investment (ROI) of a large, commercial, digital, weight‐management intensive lifestyle intervention (ILI) program (Real Appeal).MethodsParticipants in this program were compared with a control group matched by age, sex, geographic region, health risk, baseline medical costs, and chronic conditions. Medical costs were defined as the total amount paid for all medical expenses, inclusive of both the insurers’ and the study participants’ responsibility.ResultsIn the 3 years following program registration, the intent‐to‐treat (ITT) cohort had significantly lower medical expenditures than the matched controls, with an average of −$771 or 12% lower costs (P = 0.002). Among 4,790 ITT participants, a total savings of $3,693,090 compared with total program costs of $1,639,961 translated into a 2.3:1 ROI. Program completers (n = 3,990), who attended more sessions than the overall ITT group, had greater mean weight loss (−4.4%), greater cost savings (−$956 or 14%), and an ROI of 2.0:1 over the 3‐year time frame compared with matched controls.ConclusionsThe findings demonstrated that the digital weight‐management ILI was associated with a significantly positive ROI. Employers and payers willing to cover the cost of an ILI that produces both weight loss and demonstrated cost benefits can improve health and save money for their population with overweight or obesity.

Lifestyle weight-loss intervention may attenuate methylation aging: the CENTRAL MRI randomized controlled trial

BackgroundDNA methylation age (mAge), a methylation biomarker for the aging process, might serve as a more accurate predictor of morbidity and aging status than chronological age. We evaluated the role of multiple factors, including fat deposition, cardiometabolic risk factors and lifestyle weight-loss intervention, on the deviation of mAge from chronological age (mAge deviation) or 18-month change in mAge (∆mAge). In this sub-study of the CENTRAL magnetic resonance imaging weight-loss trial, we evaluated mAge by a validated 240-CpG-based prediction formula at baseline and after 18-month intervention of either low fat (LF) or mediterranean/low carbohydrate (MED/LC) diets.ResultsAmong 120 CENTRAL participants with abdominal obesity or dyslipidemia, mAge (mean ± SD: 60.3 ± 7.5 years) was higher than the chronological age (48.6 ± 9.3 years) but strongly correlated (r = 0.93; p = 3.1 × 10–53). Participants in the lowest tertile of mAge deviation from their chronological age had significantly lower waist-circumference, visceral adipose tissue, intrahepatic fat (IHF) content, fasting-glucose and HOMA-IR, as compared with participants in the highest sex-specific residual tertile (p < 0.05 for all). IHF% remained associated with greater mAge deviation after further adjustments (β = 0.23; p = 0.02). After 18-month weight-loss lifestyle intervention, mAge remained significantly correlated with chronological age (r = 0.94, p = 1.5 × 10–55). mAging occurred, with no difference between lifestyle intervention groups (∆ = 0.9 ± 1.9 years in MED/LC vs. ∆ = 1.3 ± 1.9 years in LF; p = 0.2); however, we observed a mAging attenuation in successful weight losers (> 5% weight loss) vs. weight-loss failures ( ∆ = 0.6 years vs. ∆ = 1.1 years; p = 0.04), and in participants who completed the trial with healthy liver fat content (< 5% IHF) vs. participants with fatty liver (∆ = 0.6 years vs. ∆ = 1.8 years; p = 0.003). Overall, 18 months of weight-loss lifestyle intervention attenuated the mAging of the men, mainly the older, by 7.1 months than the expected (p < 0.05).ConclusionsLifestyle weight-loss intervention may attenuate mAging. Deviation of mAge from chronological age might be related to body fat distribution and glycemic control and could indicate biological age, health status and the risk for premature cardiometabolic diseases.Trial registration: ClinicalTrials.gov NCT01530724. Registered 10 February 2012, https://clinicaltrials.gov/ct2/show/study/NCT01530724.

Halo effect of a Mediterranean-lifestyle weight-loss intervention on untreated family members' weight and physical activity: a prospective study.

Obesity is subject to strong family clustering. The relatives of participants in weight-loss interventions may also modify their lifestyle and lose weight. The aim of this study was to examine the presence and magnitude of a halo effect in untreated family members of participants enrolled in a randomized, multi-component, lifestyle intervention. A total of 148 untreated adult family members of participants in an intensive weight-loss lifestyle intervention (the PREDIMED-Plus study) were included. Changes at 1 and 2 years in body weight, physical activity, and adherence to a traditional Mediterranean diet (MedDiet) were measured. Generalized linear mixed models were used to assess whether the change differed between family members of the intervention group compared to the control. Untreated family members from the intervention group displayed a greater weight loss than those from the control after 1 and 2 years: adjusted 2-year weight change difference between groups was -3.98 (SE 1.10) kg (p < 0.001). There was a halo effect with regard to adherence to the MedDiet at one year which was sustained at two years: 2-year adjusted difference in MedDiet score change +3.25 (SE 0.46) (p < 0.001). In contrast, no halo effect was observed with regard to physical activity, as the untreated family members did not substantially modify their physical activity levels in either group, and the adjusted difference at two years between the 2 groups was -272 (SE 624) METs.min/week (p = 0.665). In the first prospective study to assess the influence on untreated family members of a diet and physical activity weight-loss intervention, we found evidence of a halo effect in relatives on weight loss and improvement in adherence to a MedDiet, but not on physical activity. The expansion of MedDiet changes from individuals involved in a weight-loss intervention to their family members can be a facilitator for obesity prevention.

Effect of an Intensive Weight-Loss Lifestyle Intervention on Kidney Function: A Randomized Controlled Trial

Introduction: Large randomized trials testing the effect of a multifactorial weight-loss lifestyle intervention including Mediterranean diet (MedDiet) on renal function are lacking. Here, we evaluated the 1-year efficacy of an intensive weight-loss intervention with an energy-reduced MedDiet (erMedDiet) plus increased physical activity (PA) on renal function. Methods: Randomized controlled “PREvención con DIeta MEDiterránea-Plus” (PREDIMED-Plus) trial is conducted in 23 Spanish centers comprising 208 primary care clinics. Overweight/obese (n = 6,719) adults aged 55–75 years with metabolic syndrome were randomly assigned (1:1) to an intensive weight-loss lifestyle intervention with an erMedDiet, PA promotion, and behavioral support (intervention) or usual-care advice to adhere to an energy-unrestricted MedDiet (control) between September 2013 and December 2016. The primary outcome was 1-year change in estimated glomerular filtration rate (eGFR). Secondary outcomes were changes in urine albumin-to-creatinine ratio (UACR), incidence of moderately/severely impaired eGFR (<60 mL/min/1.73 m²) and micro- to macroalbuminuria (UACR ≥30 mg/g), and reversion of moderately (45 to <60 mL/min/1.73 m²) to mildly impaired GFR (60 to <90 mL/min/1.73 m²) or micro- to macroalbuminuria. Results: After 1 year, eGFR declined by 0.66 and 1.25 mL/min/1.73 m² in the intervention and control groups, respectively (mean difference, 0.58 mL/min/1.73 m²; 95% CI: 0.15–1.02). There were no between-group differences in mean UACR or micro- to macroalbuminuria changes. Moderately/severely impaired eGFR incidence and reversion of moderately to mildly impaired GFR were 40% lower (HR 0.60; 0.44–0.82) and 92% higher (HR 1.92; 1.35–2.73), respectively, in the intervention group. Conclusions: The PREDIMED-Plus lifestyle intervention approach may preserve renal function and delay CKD progression in overweight/obese adults.

Group versus one-to-one multi-component lifestyle interventions for weight management: a systematic review and meta-analysis of randomised controlled trials.

Multi-component lifestyle interventions that incorporate diet, physical activity and behaviour change are effective for weight management. However, it is not clear whether delivery in a group or one-to-one format influences weight loss efficacy. The present study aimed to systematically review the evidence of the effectiveness of group compared to one-to-one multi-component lifestyle interventions for weight management. MEDLINE, EMBASE, CINAHL, CENTRAL and ISRCTN databases were searched from inception up to February 2020 for randomised controlled trials comparing group versus one-to-one multi-component lifestyle interventions for weight loss in adults with a body mass index ≥25kgm-2 . The primary outcome was weight loss (kg) at 12months and the secondary outcome was attainment of ≥5% weight loss at 12months. Risk of bias was assessed using the Cochrane Risk of Bias Tool. Meta-analysis used random effects and estimated risk ratios and continuous inverse variance methods. Heterogeneity was investigated using I2 statistics and sensitivity analyses. Seven randomised controlled trials with 2576 participants were included. Group interventions were favoured over one-to-one interventions for weight loss at 12months (-1.9kg, 95% confidence interval=-1.3 to -2.6; I2 =99%). Participants of group interventions were more likely to attain ≥5% weight loss at 12months relative to one-to-one interventions (relative risk=1.58, 95% confidence interval=1.25-2.00; I2 =60%). Group multi-component lifestyle interventions are superior for weight loss compared to one-to-one interventions with respect to adult weight management. Further research is required to determine whether specific components of group interventions can explain the superiority of weight loss outcomes in group interventions.

Association of counselor weight status and demographics with participant weight loss in a structured lifestyle intervention

ObjectiveThere is substantial variability in the effectiveness of group lifestyle interventions for weight loss. We examined associations between intervention weight loss counselors and participant weight loss and program engagement in a structured lifestyle intervention. MethodsData were from 575 adults (87% female, 51 (12) years, baseline BMI: 32.4 (7.2) kg/m2) in an 11-week structured group lifestyle program. Participants self-enrolled in groups led by 11 weight loss counselors based on meeting times. All weight loss counselors received the same training. Linear mixed models were used to evaluate counselor predictors of participant percent (%) weight loss and program engagement (weight reporting throughout 11 weeks). ResultsOf the 575 participants, 415 (72%) defined as complete reporters, i.e. reported weight weekly, lost a mean 7.3% weight (range: +3.1% to 16.2%). Participant weight loss differed between weight loss counselors (p = 0.003), and adjusted mean participant weight loss by weight loss counselor ranged from 6% to 9%. Weight loss was greater for weight loss counselors with a graduate degree in nutrition than weight loss counselors with another graduate degree (8.3% versus 6.4%, p = 0.05), but was not different between weight loss counselors with and without graduate degrees. Higher counselor BMI was associated with higher participant weight loss (p = 0.005). ConclusionsThese results demonstrate the potential for quantitatively important effects of weight loss counselor characteristics on participant success and engagement in structured lifestyle interventions, indicating a need for research in this area.

Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort

ObjectivesDiabetes Intervention Accentuating Diet and Enhancing Metabolism-I (DIADEM-I) is the first randomised controlled trial (RCT) in the Middle East and North Africa (MENA) region testing the effectiveness of an intensive...

Associations of Intensive Lifestyle Intervention in Type 2 Diabetes With Health Care Use, Spending, and Disability

Intensive lifestyle interventions focused on diet and exercise can reduce weight and improve diabetes management. However, the long-term effects on health care use and spending are unclear, especially for public payers. To estimate the association of effective intensive lifestyle intervention for weight loss with long-term health care use and Medicare spending. This ancillary study used data from the Look AHEAD randomized clinical trial, which randomized participants with type 2 diabetes to an intensive lifestyle intervention or control group (ie, diabetes support and education), provided ongoing intervention from 2001 to 2012, and demonstrated improved diabetes management and reduced health care costs during the intervention. This study compared Medicare data between study arms from 2012 to 2015 to determine whether the intervention was associated with persistent reductions in health care spending. Starting in 2001, Look AHEAD's intervention group participated in sessions with lifestyle counselors, dieticians, exercise specialists, and behavioral therapists with the goal of reducing weight 7% in the first year. Sessions occurred weekly in the first 6 months of the intervention and decreased over the intervention period. The controls participated in periodic group education sessions that occurred 3 times per year in the first year and decreased to 1 time per year later in the trial. Outcomes included total Medicare spending, Part D prescription drug costs, Part A and Part B Medicare spending, hospital admissions, emergency department visits, and disability-related Medicare eligibility. This study matched Medicare administrative records for 2796 Look AHEAD study participants (54% of 5145 participants initially randomized and 86% of 3246 participants consenting to linkages). Linked intervention and control participants were of a similar age (mean [SD] age, 59.6 [5.4] years vs 59.6 [5.5] years at randomization) and sex (818 [58.1%] women vs 822 [59.3%] women). There was no statistically significant difference in total Medicare spending between groups (difference, -$133 [95% CI, -$1946 to $1681]; P = .89). In the intervention group, compared with the control group, there was statistically significantly higher Part B spending (difference, $513 [95% CI, $70 to $955]; P = .02) but lower prescription drug costs (difference, -$803 [95% CI, -$1522 to -$83]; P = .03). This ancillary study of a randomized clinical trial found that reductions in health care use and spending associated with an intensive lifestyle intervention for type 2 diabetes diminished as participants aged. Intensive lifestyle interventions may need to be sustained to reduce long-term health care spending. ClinicalTrials.gov Identifier: NCT03952728.

Neighbourhood walkability and physical activity: moderating role of a physical activity intervention in overweight and obese older adults with metabolic syndrome.

BackgroundWhile urban built environments might promote active ageing, an infrequently studied question is how the neighbourhood walkability modulates physical activity changes during a physical activity intervention programme in older adults. We assessed the influence of objectively assessed neighbourhood walkability on the change in physical activity during the intervention programme used in the ongoing PREvención con DIeta MEDiterránea (PREDIMED)-Plus trial.MethodThe present study involved 228 PREDIMED-Plus senior participants aged between 55 and 75, recruited in Palma de Mallorca (Spain). Overweight/obese older adults with metabolic syndrome were randomised to an intensive weight-loss lifestyle intervention or a control group. A walkability index (residential density, land use mix, intersections density) was calculated using geographic information systems (1 km sausage-network buffer). Physical activity was assessed using accelerometer and a validated questionnaire, at baseline and two follow-up visits (6-months and 1-year later). Generalised additive mixed models were fitted to estimate the association between the neighbourhood walkability index and changes in physical activity during follow-up.ResultsHigher neighbourhood walkability (1 z-score increment) was associated with moderate-to-vigorous accelerometer assessed physical activity duration, (β = 3.44; 95% CI = 0.52; 6.36 min/day). When analyses were stratified by intervention arm, the association was only observed in the intervention group (β = 6.357; 95% CI = 2.07;10.64 min/day) (P for interaction = 0.055).ConclusionsThe results indicate that the walkability of the neighbourhood could support a physical activity intervention, helping to maintain or increase older adults’ physical activity.

Older age does not influence the success of weight loss through the implementation of lifestyle modification.

ObjectiveAge is sometimes a barrier for acceptance of patients into a hospital‐based obesity service. Our aim was to explore the effect of age on the ability to lose weight through lifestyle interventions, implemented within a hospital‐based obesity service.DesignRetrospective study.PatientsWe included a cohort of randomly selected patients with morbid obesity (n = 242), who attended our hospital‐based obesity service during 2005‐2016 and received only lifestyle weight loss interventions.MeasurementsPrimary outcome measures were percentage weight loss (%WL) and percentage reduction in body mass index (%rBMI) following implemented lifestyle interventions. Data were stratified according to patient age at referral: group 1 (age < 60 years, n = 167) and group 2 (age ≥ 60 years, n = 75). Weight loss was compared between groups, and correlations with age at referral were explored.ResultsThe duration of hospital‐based weight loss interventions ranged between 1 and 143 months (mean: 38.9 months; SD: 32.3). Baseline BMI at referral differed significantly between groups 1 and 2 (49.7 kgm−2 [SD: 8.7] vs 46.9 kgm−2 [SD: 6.1], respectively; P < .05). Following implemented lifestyle interventions, between groups 1 and 2 there were no differences in %WL (6.9% [SD: 16.7] vs 7.3% [SD: 11.60], respectively; P = NS) or %rBMI (8.1% [SD: 14.9] vs 7.8% [SD: 11.7], respectively; p = NS). Overall, there was no significant correlation between patient age at referral and %WL (r = −.13, p = NS).ConclusionsOlder age does not influence the success of weight loss through the implementation of lifestyle modification within a hospital‐based obesity service. Therefore, age per se should not influence clinical decisions regarding acceptance of patients to hospital‐based obesity services.

Effects of Weight Loss on Obstructive Sleep Apnea Severity. Ten-Year Results of the Sleep AHEAD Study.

Rationale: Weight loss is recommended to treat obstructive sleep apnea (OSA).Objectives: To determine whether the initial benefit of intensive lifestyle intervention (ILI) for weight loss on OSA severity is maintained at 10 years.Methods: Ten-year follow-up polysomnograms of 134 of 264 adults in Sleep AHEAD (Action for Health in Diabetes) with overweight/obesity, type 2 diabetes mellitus, and OSA were randomized to ILI for weight loss or diabetes support and education (DSE).Measurements and Main Results: Change in apnea-hypopnea index (AHI) was measured. Mean ± SE weight losses of ILI participants of 10.7 ± 0.7, 7.4 ± 0.7, 5.1 ± 0.7, and 7.1 ± 0.8 kg at 1, 2, 4, and 10 years, respectively, were significantly greater than the 1-kg weight loss at 1, 2, and 4 years and 3.5 ± 0.8 kg weight loss at 10 years for the DSE group (P values ≤ 0.0001). AHI was lower with ILI than DSE by 9.7, 8.0, and 7.9 events/h at 1, 2, and 4 years, respectively (P values ≤ 0.0004), and 4.0 events/h at 10 years (P = 0.109). Change in AHI over time was related to amount of weight loss, baseline AHI, visit year (P values < 0.0001), and intervention independent of weight change (P = 0.01). OSA remission at 10 years was more common with ILI (34.4%) than DSE (22.2%).Conclusions: Participants with OSA and type 2 diabetes mellitus receiving ILI for weight loss had reduced OSA severity at 10 years. No difference in OSA severity was present between ILI and DSE groups at 10 years. Improvement in OSA severity over the 10-year period with ILI was related to change in body weight, baseline AHI, and intervention independent of weight change.

1991-P: Intensive Lifestyle Intervention Does Not Reduce Racial and Ethnic Disparities in Achievement of Optimal Glycemic Control

African Americans and Hispanics with type 2 diabetes have worse glycemic control relative to non-Hispanic whites. The Look AHEAD randomized trial demonstrated that an intensive lifestyle intervention for weight loss (ILI), versus diabetes support and education (DSE), improved HbA1c among overweight/obese adults with type 2 diabetes. We examined whether ILI reduced racial/ethnic disparities in achieving optimal glycemic control (HbA1c &amp;lt;7%). We used a GEE model to examine the effects of race/ethnicity, treatment arm, and their interaction on achieving HbA1c &amp;lt;7% over 8 years. Among 4,889 participants (16% African American, 14% Hispanic), more achieved HbA1c &amp;lt;7% in ILI vs. DSE in years 1-4 (p&amp;lt;0.001). However, significantly fewer Hispanic and African Americans achieved HbA1c &amp;lt;7% (p&amp;lt;0.001). The race by treatment interaction was not significant at any time point. These findings demonstrate persistent racial/ethnic disparities in glycemic control in a clinical trial population over eight years, which were not reduced by an effective lifestyle intervention. More research is needed to develop interventions that improve diabetes outcomes while reducing disparities. Disclosure J.F. Hayes: None. A. Bertoni: None. S.J. Pilla: None. R.R. Wing: None. Funding National Institutes of Health

2007-P: Weight Change and Intentionality of Weight Loss Relate to Mortality Risk in the Postintervention (Years 8-16) Phase of Look AHEAD

The health effects of weight loss in older individuals with diabetes is unclear, perhaps related to intentionality of the weight loss. Look AHEAD (LA) is a randomized trial comparing intensive lifestyle intervention for intentional weight loss with diabetes support and education (control) in 5145 individuals (age 45-76 at baseline) with overweight/obesity and type 2 diabetes. We examined the association of weight change trajectories post-intervention (i.e., yrs 8 to 16; M± SD percent weight change= -3.10% ±10.1), and concurrent risk of mortality by comparing weight gainers (N=226), maintainers (N=1459), modest losers (N=2206), and steep losers (N=415). Both weight loss groups were older, more likely to be in DSE, and lost less weight in yrs 1-8. In Cox proportional hazards regression models, adjusted for sex, race, baseline obesity, age, and treatment, mortality risk among the 4 weight change categories differed significantly (p&amp;lt;0.0001). Relative to maintainers, the hazard ratio for death was non-significantly lower in gainers (HR= .58, 95%CI 0.30,1.11) but significantly higher in modest losers (HR=1.49, 95%CI 1.20,1.36) and steep losers (HR=1.87, 95%CI 1.39,2.53). Adjusting for weight change baseline to year 8 did not alter the associations. Subsequent analyses examined the difference in the hazard ratios for death in those who reported having lost &amp;gt;10 lb over 2 most recent 6-month assessments intentionally, unintentionally, or through the combination (intentional + unintentional), relative to maintainers (no weight loss&amp;gt;10 lb). Adjusted analyses showed that the HR for mortality was significantly greater in both the unintentional (HR=3.26, 95%CI 2.35,5.01) and the combination (HR=2.63, 95%CI 1.28,5.39), but not different in the intentional weight loss group (HR=1.05, 95%CI 0.61,1.81) relative to maintainers. These data suggest that unintentional weight loss is associated with increased risk of mortality in older individuals with diabetes. Disclosure R.R. Wing: None. J. Clark: None. M. Espeland: Other Relationship; Self; Boehringer Ingelheim International GmbH, Ironwood Pharmaceuticals. J.O. Hill: Stock/Shareholder; Self; Gelesis, Shakabuku LLC. R.W. Jeffery: None. K.C. Johnson: None. W.C. Knowler: None. R.H. Neiberg: None. K. Olson: None. H.O. Steinberg: None. H. Wyatt: Research Support; Self; National Cattleman’s Association, Novo Nordisk Inc. Stock/Shareholder; Self; Shakabuku LLC. Other Relationship; Self; FoodMinds. Funding National Institutes of Health

1526-P: Time-Dependent Effect of Kidney Disease on All-Cause and CVD Mortality in Adults with Type 2 Diabetes: A Secondary Analysis of the Look AHEAD Clinical Trial

The Look AHEAD trial compared an intensive lifestyle intervention (ILI) for weight loss with diabetes support and education in adults with T2DM and BMI ≥ 25 kg/m2. During 10 years of follow-up, ILI had no significant effect on mortality or incidence of CVD. Here we present a secondary analysis of urine albumin/creatinine ratio (ACR) and estimated glomerular filtration rate (eGFR) as predictors of all-cause mortality (361 deaths among 4865 participants) using time varying covariates proportional hazards models adjusted for age, sex, race/ethnicity, and ILI. Both ACR and eGFR predicted mortality (Figure 1a/b, respectively). In a joint analysis of ACR and eGFR, mortality was highest among groups with low eGFR and high ACR. Interestingly, high eGFR was also associated with higher mortality (Figure 1c). Effects of eGFR on mortality were nonlinear, but in each eGFR group, ACR was positively associated with mortality. In each analysis, ILI was beneficial, but not significantly so. There were no significant interactions between ACR or eGFR and insulin treatment, history of CVD, beta-blocker treatment, or age at baseline on mortality. In conclusion, ACR and eGFR predicted mortality in time varying models. Results were similar for CVD mortality (106 deaths) and for the primary trial outcome of fatal or nonfatal CVD (796 events). Disclosure A.C. Wills: None. W.C. Knowler: None.

1998-P: Waist Circumference Change in the First Year of the Look AHEAD Trial Is Associated with Risk for Cardiovascular Morbidity and Mortality

Look AHEAD found no difference between intensive lifestyle intervention (ILI) for weight loss and diabetes support and education (DSE; control) in cardiovascular (CVD) outcomes among individuals with overweight or obesity and type 2 diabetes (T2DM). This secondary analysis evaluated the association between change in weight and waist circumference (WC), a possible proxy for visceral adiposity, and risk for CVD outcomes. We classified Look AHEAD participants (n=4590) into one of four categories based on change in weight and WC from baseline to Year 1 (increase/increase, etc.) to examine the association between the categories and primary (myocardial infarction, stroke, hospitalized angina, CVD death) and secondary (primary outcomes and CABG/PTCA, hospitalized congestive heart failure, carotid endarterectomy, PVD, and total mortality) CVD outcomes from Year 1 to end of active treatment (median of 9 years). Cox proportional-hazards regression models were used to 1) compare ILI participants in the four categories to DSE and 2) evaluate the four categories within treatment groups using the group that decreased WC and weight as the reference. Compared to DSE, individuals in ILI who increased WC and weight and individuals who increased WC but decreased weight both had greater risk of secondary CVD outcomes (HR[95%CI]: 1.95 [1.33, 2.86] and 1.35 [1.02, 1.80] respectively). In analyses stratified by randomization group, DSE participants did not differ in cardiovascular events across categories. Individuals in ILI who gained WC (regardless of weight loss or gain), had increased risk of primary and secondary CVD outcomes compared to individuals in ILI who decreased weight and WC. Increased WC during weight loss treatment, regardless of weight loss or gain, is associated with greater risk for CVD outcomes in individuals with T2DM. This emphasizes the importance of measuring WC in clinical practice and testing interventions focused on decreasing WC. Disclosure K.L. Olson: None. R.H. Neiberg: None. M. Espeland: Other Relationship; Self; Boehringer Ingelheim International GmbH, Ironwood Pharmaceuticals. K.C. Johnson: None. W.C. Knowler: None. A.E. Staiano: None. L.E. Wagenknecht: None. R.R. Wing: None. Funding National Institutes of Health

Abstract #806735: Acceptability and Feasibility of an Innovative, User-Friendly, Interactive Technology-Based Lifestyle Intervention for Weight Loss

Abstract #806735: Acceptability and Feasibility of an Innovative, User-Friendly, Interactive Technology-Based Lifestyle Intervention for Weight Loss