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Preoperative lifestyle intervention in bariatric surgery: a randomized clinical trial.

ABSTRACT: Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed.To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period.Bariatric Center of Excellence at a large, urban medical center.Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual presurgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions, followed by 16 weeks of face-to-face and telephone sessions before surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted 6, 12, and 24 months after surgery.Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average body mass index was 47.5 kg/m(2) at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12-, and 24-month assessments, respectively. Percent weight loss from study enrollment to 6 and 12 months after surgery was comparable for both groups, but at 24 months after surgery, the lifestyle group had significantly smaller percent weight loss compared with the usual care group (26.5% versus 29.5%, respectively, P = .02).Presurgery lifestyle intervention did not improve weight loss at 24 months after surgery. The findings from this study raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients.

SUBMITTER: Kalarchian MA

PROVIDER: S-EPMC5041299 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Preoperative lifestyle intervention in bariatric surgery: a randomized clinical trial.

Kalarchian Melissa A MA Marcus Marsha D MD Courcoulas Anita P AP Cheng Yu Y Levine Michele D MD

Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery 20150508 1

<h4>Background</h4>Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed.<h4>Objective</h4>To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period.<h4>Setting</h4>Bariatric Center of Excellence at a large, urban medical center.<h4>Methods</h4>Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of us ...[more]

PMID: 26410538

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Project description:ImportanceQuestions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM).ObjectiveTo compare the remission of T2DM following surgical and nonsurgical treatments.Design, setting, and participantsIn this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population.InterventionsParticipants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3.Main outcomes and measuresPrimary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change.ResultsBody mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P < .001). Mean (SE) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0% (2.0%), followed by LAGB at 15.0% (2.0%) and lifestyle treatment at 5.7% (2.4%) (P < .01).Conclusions and relevanceAmong obese participants with T2DM, bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention resulted in more disease remission than did lifestyle intervention alone.Trial registrationclinicaltrials.gov Identifier: NCT01047735.

Project description:BackgroundHabitual physical activity (PA) may help to optimize bariatric surgery outcomes; however, objective PA measures show that most patients have low PA preoperatively and make only modest PA changes postoperatively. Patients require additional support to adopt habitual PA. The objective of this study was to test the efficacy of a preoperative PA intervention (PAI) versus standard presurgical care (SC) for increasing daily moderate-to-vigorous PA (MVPA) in bariatric surgery patients.MethodsOutcomes analysis included 75 participants (86.7% women; 46.0±8.9 years; body mass index [BMI]=45.0±6.5 kg/m2) who were randomly assigned preoperatively to 6 weeks of PAI (n=40) or SC (n=35). PAI received weekly individual face-to-face sessions with tailored instruction in behavioral strategies (e.g., self-monitoring, goal-setting) to increase home-based walking exercise. The primary outcome, pre- to postintervention change in daily bout-related (≥10 min bouts) and total (≥1 min bouts) MVPA minutes, was assessed objectively via a multisensor monitor worn for 7 days at baseline- and postintervention.ResultsRetention was 84% at the postintervention primary endpoint. In intent-to-treat analyses with baseline value carried forward for missing data and adjusted for baseline MVPA, PAI achieved a mean increase of 16.6±20.6 min/d in bout-related MVPA (baseline: 4.4±5.5 to postintervention: 21.0±21.4 min/d) compared to no change (-0.3±12.7 min/d; baseline: 7.9±16.6 to postintervention: 7.6±11.5 min/d) for SC (P=.001). Similarly, PAI achieved a mean increase of 21.0±26.9 min/d in total MVPA (baseline: 30.9±21.2 to postintervention: 51.9±30.0 min/d), whereas SC demonstrated no change (-0.1±16.3 min/d; baseline: 33.7±33.2 to postintervention: 33.6±28.5 minutes/d) (P=.001).ConclusionWith behavioral intervention, patients can significantly increase MVPA before bariatric surgery compared to SC. Future studies should determine whether preoperative increases in PA can be maintained postoperatively and contribute to improved surgical outcomes.

Project description:ImportanceIdiopathic intracranial hypertension (IIH) causes headaches, vision loss, and reduced quality of life. Sustained weight loss among patients with IIH is necessary to modify the disease and prevent relapse.ObjectiveTo compare the effectiveness of bariatric surgery with that of a community weight management (CWM) intervention for the treatment of patients with active IIH.Design, setting, and participantsThis 5-year randomized clinical trial (Idiopathic Intracranial Hypertension Weight Trial) enrolled women with active IIH and a body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or higher at 5 National Health Service hospitals in the UK between March 1, 2014, and May 25, 2017. Of 74 women assessed for eligibility, 6 did not meet study criteria and 2 declined to participate; 66 women were randomized. Data were analyzed from November 1, 2018, to May 14, 2020.InterventionsBariatric surgery (n = 33) or CWM intervention (Weight Watchers) (n = 33).Main outcomes and measuresThe primary outcome was change in intracranial pressure measured by lumbar puncture opening pressure at 12 months, as assessed in an intention-to-treat analysis. Secondary outcomes included lumbar puncture opening pressure at 24 months as well as visual acuity, contrast sensitivity, perimetric mean deviation, and quality of life (measured by the 36-item Short Form Health Survey) at 12 and 24 months. Because the difference in continuous outcomes between groups is presented, the null effect was at 0.ResultsOf the 66 female participants (mean [SD] age, 32.0 [7.8] years), 64 (97.0%) remained in the clinical trial at 12 months and 54 women (81.8%) were included in the primary outcome analysis. Intracranial pressure was significantly lower in the bariatric surgery arm at 12 months (adjusted mean [SE] difference, -6.0 [1.8] cm cerebrospinal fluid [CSF]; 95% CI, -9.5 to -2.4 cm CSF; P = .001) and at 24 months (adjusted mean [SE] difference, -8.2 [2.0] cm CSF; 95% CI, -12.2 to -4.2 cm CSF; P < .001) compared with the CWM arm. In the per protocol analysis, intracranial pressure was significantly lower in the bariatric surgery arm at 12 months (adjusted mean [SE] difference, -7.2 [1.8] cm CSF; 95% CI, -10.6 to -3.7 cm CSF; P < .001) and at 24 months (adjusted mean [SE] difference, -8.7 [2.0] cm CSF; 95% CI, -12.7 to -4.8 cm CSF; P < .001). Weight was significantly lower in the bariatric surgery arm at 12 months (adjusted mean [SE] difference, -21.4 [5.4] kg; 95% CI, -32.1 to -10.7 kg; P < .001) and at 24 months (adjusted mean [SE] difference, -26.6 [5.6] kg; 95% CI, -37.5 to -15.7 kg; P < .001). Quality of life was significantly improved at 12 months (adjusted mean [SE] difference, 7.3 [3.6]; 95% CI, 0.2-14.4; P = .04) and 24 months (adjusted mean [SE] difference, 10.4 [3.8]; 95% CI, 3.0-17.9; P = .006) in the bariatric surgery arm.Conclusions and relevanceIn this randomized clinical trial, bariatric surgery was superior to a CWM intervention in lowering intracranial pressure. The continued improvement over the course of 2 years shows the impact of this intervention with regard to sustained disease remission.Trial registrationClinicalTrials.gov Identifier: NCT02124486.

Project description:BackgroundDespite bariatric surgery showing significant weight loss trajectories for many patients, a substantial proportion regain weight after the first year following surgery. The addition of telemedicine to standard care could support patients with engaging in a more active lifestyle and thus improve clinical outcomes.ObjectiveOur aim was to evaluate a telemedicine intervention program dedicated to the promotion of physical activity including digital devices, teleconsultation, and telemonitoring the first 6 months following bariatric surgery.MethodsThis study employed a mixed methods design based on an open-label randomized controlled trial. Patients were included during the first week after bariatric surgery; then, they were randomized into 2 intervention groups: The TelePhys group received a monthly telemedicine consultation focusing on physical activity coaching, while the TeleDiet group received a monthly telemedicine consultation involving diet coaching. Data were collected using a watch pedometer and body weight scale, both of which were connected wirelessly. The primary outcome was the difference between the 2 groups in the mean numbers of steps at the first and sixth postoperative months. Weight change was also evaluated, and focus groups and interviews were conducted to enrich the results and capture perceptions of the telemedicine provided.ResultsAmong the 90 patients (mean age 40.6, SD 10.4 years; 73/90, 81% women; 62/90, 69% gastric bypass), 70 completed the study until the sixth month (n=38 TelePhys; n=32 TeleDiet), and 18 participants agreed to be interviewed (n=8 Telephys; n=10 TeleDiet). An increase in the mean number of steps between the first and sixth months was found in both groups, but this change was significant only in the TeleDiet group (P=.01). No difference was found when comparing both intervention groups. Interviewed participants reported having appreciated the teleconsultations, as the individualized tailored counseling helped them to make better choices about behaviors that could increase their likelihood of a daily life in better health. Weight loss followed by social factors (such as social support) were identified as the main facilitators to physical activity. Family responsibilities, professional constraints as well as poor urban policies promoting physical activity, and lack of accessibility to sport infrastructure were their major barriers to postoperative lifestyle adherence.ConclusionsOur study did not show any difference in mobility recovery after bariatric surgery related to a telemedicine intervention dedicated to physical activity. The early postoperative timing for our intervention may explain the null findings. eHealth interventions aiming to change behaviors and carried out by clinicians require support from structured public health policies that tackle patients' obesogenic environment in order to be efficient in their struggle against sedentary lifestyle-related pathologies. Further research will need to focus on long-term interventions.Trial registrationClinicalTrials.gov NCT02716480, https://clinicaltrials.gov/ct2/show/NCT02716480.

Project description:BACKGROUND: Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. OBJECTIVE: It is not known whether a program of moderate intervention might effectively reduce metabolic abnormalities in the general population. DESIGN: Two-arm randomized controlled 1-year trial. PATIENTS: Three hundred and thirty-five patients participated from a dysmetabolic population-based cohort of 375 adults aged 45-64 years in northwestern Italy. MEASUREMENTS: We compared the effectiveness of a general recommendation-based program of lifestyle intervention carried out by trained professionals versus standard unstructured information given by family physicians at reducing the prevalence of multiple metabolic and inflammatory abnormalities. RESULTS: At baseline, clinical/anthropometric/laboratory and lifestyle characteristics of the intervention (n = 169) and control (n = 166) groups were not significantly different. The former significantly reduced total/saturated fat intake and increased polyunsaturated fat/fiber intake and exercise level compared to the controls. Weight, waist circumference, high-sensitivity C-reactive protein, and most of the metabolic syndrome components decreased in the intervention group and increased in the controls after 12 months. Lifestyle intervention significantly reduced metabolic syndrome (odds ratio [OR] = 0.28; 95% CI 0.18-0.44), with a 31% (21-41) absolute risk reduction, corresponding to 3.2 (2-5) patients needing to be treated to prevent 1 case after 12 months. The intervention significantly reduced the prevalence of central obesity (OR = 0.33; 0.20-0.56), and hypertriglyceridemia (OR = 0.48; 0.31-0.75) and the incidence of diabetes (OR = 0.23; 0.06-0.85). CONCLUSION: A lifestyle intervention based on general recommendations was effective in reducing multiple metabolic/inflammatory abnormalities. The usual care by family physicians was ineffective at modifying progressive metabolic deterioration in high-risk individuals.

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Preoperative lifestyle intervention in bariatric surgery: a randomized clinical trial.

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Preoperative lifestyle intervention in bariatric surgery: a randomized clinical trial.

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