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Phenotype tailored lifestyle intervention on weight loss and cardiometabolic risk factors in adults with obesity: a single-centre, non-randomised, proof-of-concept study.
Cifuentes, L, Ghusn, W, Feris, F, Campos, A, Sacoto, D, De la Rosa, A, McRae, A, Rieck, T, Mansfield, S, Ewoldt, J, et al
EClinicalMedicine. 2023;:101923
Abstract
BACKGROUND Lifestyle interventions for weight loss are currently not individualised to underlying pathophysiology and behavioral traits in obesity. We aim to compare the outcome of a standard lifestyle intervention (SLI) to phenotype-tailored lifestyle interventions (PLI) on weight loss, cardiometabolic risk factors and physiologic variables contributing to obesity. METHODS This 12-week, single-centre non-randomised proof-of-concept clinical trial including men and women aged 18-65 years with a body mass index (BMI) greater than 30 without history of any bariatric procedure, and current use of any medication known to affect weight. Participants lived anywhere in the United States, and underwent in-person testing in Rochester, MN at a teaching hospital. All participants completed in-person phenotype testing at baseline and after 12 weeks. Participants were assigned to their intervention based on their period of enrollment. In the first phase, participants were assigned to SLI with a low-calorie diet (LCD), moderate physical activity, and weekly behavioral therapy sessions. In the second phase, other participants were assigned to PLI according to phenotype: abnormal satiation (time-restricted volumetric LCD); abnormal postprandial satiety (LCD with pre-meal protein supplementation); emotional eating (LCD with intensive behavioral therapy); and abnormal resting energy expenditure (LCD with post-workout protein supplementation and high-intensity interval training). The primary outcome was total body weight loss in kg at 12 weeks using multiple imputation for missing data. Linear models estimated the association of study group allocation and study endpoints adjusting for age, sex, and baseline weight. This study was registered with ClinicalTrials.gov, NCT04073394. FINDINGS Between July 2020 and August 2021, 211 participants were screened, and 165 were assigned to one of the two treatments in the two phases: 81 SLI (mean [SD] age 42.9 [12] years; 79% women; BMI 38.0 [6.0]) and 84 PLI (age 44.8 [12.2] years; 83% women; BMI 38.7 [6.9]); 146 completed the 12-week programs. The weight loss was -7.4 kg (95%CI, -8.8, -6.0) with PLI vs. -4.3 kg (95%CI, -5.8, -2.7) with SLI (difference, -3.1 kg [95%CI, -5.1 to -1.1]; P = 0.004). No adverse events were reported in any group. INTERPRETATION Phenotype-tailored lifestyle interventions may result in significant weight loss, but a randomised controlled trial is required to confirm causality. FUNDING Mayo Clinic; NIH (K23-DK114460).
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Pilot Social Network Weight Loss Intervention With Two Immigrant Populations During the COVID-19 Pandemic.
Wieland, ML, Njeru, JW, Asiedu, GB, Zeratsky, KA, Clark, MM, Goetze, R, Patten, CA, Kelpin, SS, Novotny, P, Lantz, K, et al
American journal of health promotion : AJHP. 2022;(3):458-471
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PURPOSE To examine the feasibility and acceptability of a social network weight loss intervention delivered by lay health promoters (HPs) to immigrant populations. DESIGN Single-arm, non-randomized, pilot study of a social network weight loss intervention developed by a community-based participatory research partnership and delivered by HPs. SETTING Community-based setting in Southeastern Minnesota, United States. SAMPLE Somali and Hispanic immigrants to the United States: 4 social networks of adults (2 Hispanic and 2 Somali) with 39 network participants. INTERVENTION Twelve-week behavioral weight loss intervention delivered by HPs (4 weeks in-person and then 8 weeks virtual). MEASURES Feasibility was assessed by recruitment and retention rates. Acceptability was assessed by surveys and focus groups with HPs and participants. Behavioral measures included servings of fruits and vegetables, drinking soda, and physical activity. Physiologic measures included weight, blood pressure, glucose, cholesterol, and triglycerides. ANALYSIS Paired t-tests of pre- to post-intervention changes at the end of 12 weeks of treatment. RESULTS Recruitment was feasible and post-intervention was 100%. Participants highly rated the intervention on satisfaction, motivation, and confidence to eat a healthy diet, be physically active, and lose weight. Participants were motivated by group social support and cohesion of their social networks. On average, participants lost weight (91.6 ± 15.9 to 89.7 ± 16.6 kg, P < .0001), lowered their systolic blood pressure (133.9±16.9 to 127.2 ± 15.8 mm Hg; P < .001), lowered their diastolic blood pressure (81 ± 9.5 to 75.8 ± 9.6 mm Hg; P < .0001), had more servings of vegetables per day (1.9 ± 1.2 to 2.6 ± 1.4; P < .001), and increased their physical activity (2690 ± 3231 to 6595 ± 7322 MET-minutes per week; P = .02). CONCLUSION This pilot study of 2 immigrant communities who participated in a peer-led weight loss social network intervention delivered during the COVID-19 pandemic demonstrated high feasibility and acceptability. Participants lost weight, improved their health status, and improved their health behaviors.
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Behavioral Interventions to Attenuate Driven Overeating and Weight Regain After Bariatric Surgery.
Ames, GE, Koball, AM, Clark, MM
Frontiers in endocrinology. 2022;:934680
Abstract
Weight regain after bariatric surgery is associated with problematic eating behaviors that have either recurred after a period of improvement or are new-onset behaviors. Problematic eating behaviors after bariatric surgery have been conceptualized in different ways in the literature, such as having a food addiction and experiencing a loss of control of eating. The intersection of these constructs appears to be driven overeating defined as patients' experiences of reduced control of their eating which results in overeating behavior. The purpose of this review is to define patient experiences of driven overeating through the behavioral expression of emotion-based eating, reward-based eating, and executive functioning deficits-namely impulsivity-which is associated with weight regain after having bariatric surgery. Delineating concepts in this way and determining treatment strategies accordingly may reduce distress related to the inevitable return of increased hunger, cravings, portion sizes, and tolerance for highly palatable foods after surgery. Along with standard behavioral weight maintenance strategies, topics including acceptance, motivation, emotion-based eating, reward-based/impulsive eating, physical activity, and self-compassion are discussed. These concepts have been adapted for patients experiencing weight regain after having bariatric surgery and may be particularly helpful in attenuating driven overeating and weight regain.
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GLP-1 Analog Modulates Appetite, Taste Preference, Gut Hormones, and Regional Body Fat Stores in Adults with Obesity.
Kadouh, H, Chedid, V, Halawi, H, Burton, DD, Clark, MM, Khemani, D, Vella, A, Acosta, A, Camilleri, M
The Journal of clinical endocrinology and metabolism. 2020;(5):1552-63
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PURPOSE Obesity is associated with alterations in appetite, gastrointestinal hormone levels and excessive fat mass. We previously published a double-blind, placebo-controlled, randomized, 16-week trial on effects of once-daily glucagon-like peptide-1 (GLP-1) analog, liraglutide on weight, satiation, and gastric functions in obese volunteers. The aim of this substudy is to compare to placebo the effects of liraglutide on appetite, taste preference, regional body fat stores, and anthropometric measurements. METHODS Forty obese adults received standard instruction for weight management, monthly behavioral intervention utilizing motivational interviews, and 16-week treatment of once-daily liraglutide (escalated to 3 mg SQ daily). At baseline and 16 weeks, the following were measured: appetite and taste preferences rated every 30 min for 5 h after ingesting 300 mL Ensure®; maximal tolerated volume (MTV) with a nutrient drink test; fasting and postprandial bioactive GLP-1 (7-36) and peptide YY (PYY) levels; total and regional body fat with dual-energy X-ray absorptiometry, and waist and hip circumference. RESULTS Thirty-five participants (17 liraglutide; 18 placebo) completed the trial. Compared to placebo group, liraglutide group had significant reductions in MTV; prospective food consumption score; desire to eat something sweet, salty, savory or fatty; and an increase in perceived fullness. Postprandial plasma levels of GLP-1 decreased and PYY levels increased with liraglutide relative to baseline. Significant reductions in total body, trunk, and upper and lower body fat without reduction in lean body mass were observed. CONCLUSION Liraglutide 3 mg SQ modulates appetite, taste preference, gut hormones, and regional body fat stores in adults with obesity without reduction in lean body mass.
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Transoral outlet reduction with full thickness endoscopic suturing for weight regain after gastric bypass: a large multicenter international experience and meta-analysis.
Vargas, EJ, Bazerbachi, F, Rizk, M, Rustagi, T, Acosta, A, Wilson, EB, Wilson, T, Neto, MG, Zundel, N, Mundi, MS, et al
Surgical endoscopy. 2018;(1):252-259
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BACKGROUND AND AIMS Many patients who undergo bariatric surgery will experience weight regain and effective strategies are needed to help these patients. A dilated gastrojejunal anastomosis (GJA) has been associated with weight recidivism after Roux-en-Y gastric bypass surgery (RYGB). Endoscopic transoral outlet reduction (TORe) with a full thickness endoscopic suturing device (Overstitch, Apollo Endosurgery, Austin, TX) is a minimally invasive therapeutic option. The primary aim of this project was to examine the safety and long-term efficacy data from three bariatric surgery centers and to conduct a systematic review and meta-analysis of the existing literature. METHODS Patients who underwent TORe with the Overstitch device from Jan 2013 to Nov 2016 at 3 participating bariatric surgery centers were included in the multicenter analysis. For the systematic review and meta-analysis, a comprehensive search of multiple English databases was conducted. Random effects model was used. RESULTS 130 consecutive patients across three centers underwent TORe with an endolumenal suturing device. These patients (mean age 47; mean BMI 36.8) had experienced 24.6% weight regain from nadir weight after RYGB. Average weight lost at 6, 12, and 18 months after TORe was 9.31 ± 6.7 kg (N = 84), 7.75 ± 8.4 kg (N = 70), 8 ± 8.8 kg (N = 46) (p < 0.01 for all three time points), respectively. The meta-analysis included 330 patients. The pooled weight lost at 12 months was 8.4 kg (95% CI 6.5-10.3) with no significant heterogeneity across included studies (p = 0.07). Overall, 14% of patients experienced nausea, 18% had pain and 8% required a repeat EGD. No serious adverse events reported. CONCLUSION When implemented as part of a multidisciplinary intervention, TORe using endolumenal suturing is safe, reproducible, and effective approach to manage weight recidivism after RYGB and should be utilized early in the management algorithm of these patients.
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Healthy Immigrant Families: Randomized Controlled Trial of a Family-Based Nutrition and Physical Activity Intervention.
Wieland, ML, Hanza, MMM, Weis, JA, Meiers, SJ, Patten, CA, Clark, MM, Sloan, JA, Novotny, PJ, Njeru, JW, Abbenyi, A, et al
American journal of health promotion : AJHP. 2018;(2):473-484
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PURPOSE To evaluate a healthy eating and physical activity intervention for immigrant families, derived through community-based participatory research. DESIGN The Healthy Immigrant Families study was a randomized controlled trial with delayed intervention control group, with families as the randomization unit. SETTING US Midwest city. PARTICIPANTS Participants were recruited by community partners from Hispanic, Somali, and Sudanese immigrant communities. INTERVENTION Family health promoters from participating communities delivered 6 healthy eating modules, 4 physical activity modules, and 2 modules synthesizing information in 12 home visits (60-90 minutes) within the first 6 months. Up to 12 follow-up phone calls to each participant occurred within the second 6 months. MEASURES Primary measures were dietary quality measured with weekday 24-hour recall and reported as Healthy Eating Index score (0-100) and physical activity measured with accelerometers (14 wear days) at baseline, 6, 12, and 24 months. RESULTS In total, 151 persons (81 adolescents and 70 adults; 44 families) were randomly assigned. At 12 months, significant improvement occurred in Healthy Eating Index scores for adults in the intervention group compared with controls (change, +8.6 vs -4.4; P < .01) and persisted at 24 months (+7.4 from baseline; P < .01). No differences were observed for adolescents and no significant differences occurred between groups for physical activity. CONCLUSION This intervention produced sustained dietary quality improvement among adults but not among adolescents. Program outcomes are relevant to communities working to decrease cardiovascular risk among immigrant populations.
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Supervised, Vigorous Intensity Exercise Intervention for Depressed Female Smokers: A Pilot Study.
Patten, CA, Bronars, CA, Vickers Douglas, KS, Ussher, MH, Levine, JA, Tye, SJ, Hughes, CA, Brockman, TA, Decker, PA, DeJesus, RS, et al
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. 2017;(1):77-86
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INTRODUCTION Few studies have evaluated exercise interventions for smokers with depression or other psychiatric comorbidities. This pilot study evaluated the potential role of supervised vigorous exercise as a smoking cessation intervention for depressed females. METHODS Thirty adult women with moderate-severe depressive symptoms were enrolled and randomly assigned to 12 weeks of thrice weekly, in person sessions of vigorous intensity supervised exercise at a YMCA setting (EX; n = 15) or health education (HE; n = 15). All participants received behavioral smoking cessation counseling and nicotine patch therapy. Assessments were done in person at baseline, at the end of 12 weeks of treatment, and at 6 months post-target quit date. Primary end points were exercise adherence (proportion of 36 sessions attended) and biochemically confirmed 7-day point prevalence abstinence at Week 12. Biomarkers of inflammation were explored for differences between treatment groups and between women who smoked and those abstinent at Week 12. RESULTS Treatment adherence was high for both groups (72% for EX and 66% for HE; p = .55). The Week 12 smoking abstinence rate was higher for EX than HE (11/15 [73%] vs. 5/15 [33%]; p = .028), but no significant differences emerged at 6-month follow-up. Interleukin-6 levels increased more for those smoking than women abstinent at Week 12 (p = .040). CONCLUSIONS Vigorous intensity supervised exercise is feasible and enhances short-term smoking cessation among depressed female smokers. Innovative and cost-effective strategies to bolster long-term exercise adherence and smoking cessation need evaluation in this population. Inflammatory biomarkers could be examined in future research as mediators of treatment efficacy. IMPLICATIONS This preliminary study found that vigorous intensity supervised exercise is feasible and enhances short-term smoking cessation among depressed female smokers. This research addressed an important gap in the field. Despite decades of research examining exercise interventions for smoking cessation, few studies were done among depressed smokers or those with comorbid psychiatric disorders. A novel finding was increases in levels of a pro-inflammatory biomarker observed among women who smoked at the end of the intervention compared to those who did not.
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Healthy immigrant families: Participatory development and baseline characteristics of a community-based physical activity and nutrition intervention.
Wieland, ML, Weis, JA, Hanza, MM, Meiers, SJ, Patten, CA, Clark, MM, Sloan, JA, Novotny, PJ, Njeru, JW, Abbenyi, A, et al
Contemporary clinical trials. 2016;:22-31
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BACKGROUND US immigrants often have escalating cardiovascular risk. Barriers to optimal physical activity and diet have a significant role in this risk accumulation. METHODS We developed a physical activity and nutrition intervention with immigrant and refugee families through a community-based participatory research approach. Work groups of community members and health scientists developed an intervention manual with 12 content modules that were based on social-learning theory. Family health promoters from the participating communities (Hispanic, Somali, Sudanese) were trained to deliver the intervention through 12 home visits during the first 6 months and up to 12 phone calls during the second 6 months. The intervention was tested through a randomized community-based trial with a delayed-intervention control group, with measurements at baseline, 6, 12, and 24 months. Primary measurements included accelerometer-based assessment of physical activity and 24-hour dietary recall. Secondary measures included biometrics and theory-based instruments. RESULTS One hundred fifty-one individuals (81 adolescents, 70 adults; 44 families) were randomized. At baseline, mean (SD) time spent in moderate-to-vigorous physical activity was 64.7 (30.2) minutes/day for adolescents and 43.1 (35.4) minutes/day for adults. Moderate dietary quality was observed in both age groups. Biometric measures showed that 45.7% of adolescents and 80.0% of adults were overweight or obese. Moderate levels of self-efficacy and social support were reported for physical activity and nutrition. DISCUSSION Processes and products from this program are relevant to other communities aiming to reduce cardiovascular risk and negative health behaviors among immigrants and refugees. TRIAL REGISTRATION This trial was registered at Clinicaltrials.gov (NCT01952808).
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Gastric antral injections of botulinum toxin delay gastric emptying but do not reduce body weight.
Topazian, M, Camilleri, M, Enders, FT, Clain, JE, Gleeson, FC, Levy, MJ, Rajan, E, Nehra, V, Dierkhising, RA, Collazo-Clavell, ML, et al
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2013;(2):145-50.e1
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BACKGROUND & AIMS Gastric injections of botulinum toxin A (BTA) have been reported to delay gastric emptying, increase satiation, and reduce body weight, but there are few data from randomized, placebo-controlled studies. METHODS We enrolled 60 obese participants in a 24-week, double-blind, randomized, placebo-controlled, concealed allocation trial to compare the effects of gastric antral injections of BTA (100, 300, or 500 U) and saline placebo. The study was conducted at an outpatient clinical research unit. Participants were given one set of injections of BTA or placebo into the gastric antral muscularis propria by using endoscopic ultrasound guidance. Gastric emptying of solids was measured by scintigraphy; we also measured body weight, satiation (maximum tolerated volume in a caloric liquid drink test), calorie intake (by food frequency questionnaire), gastrointestinal symptoms, and psychological aspects of eating behavior (by rating scale). RESULTS Compared with baseline values, 2 weeks after injections, the mean half-time for gastric emptying of solids increased by 0.8, 14, 24, and 14 minutes among subjects given placebo, 100, 300, or 500 U BTA, respectively (P = .24 overall, P = .04 for the group given 300 U vs placebo); 16 weeks after the injections, mean body weights were reduced by 2.2, 0.2, 2.3, and 3.0 kg in these groups, respectively. There were no statistically significant differences in mean body weight change, satiation volume, caloric intake, gastrointestinal symptoms, or psychological aspects of eating behavior among groups. CONCLUSIONS Gastric antral injections of BTA may delay gastric emptying at a dose of 300 U but do not cause early satiety, altered eating behaviors, or loss of body weight. Clinicaltrials.gov identifier: NCT00976443.
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Effect of alginate on satiation, appetite, gastric function, and selected gut satiety hormones in overweight and obesity.
Odunsi, ST, Vázquez-Roque, MI, Camilleri, M, Papathanasopoulos, A, Clark, MM, Wodrich, L, Lempke, M, McKinzie, S, Ryks, M, Burton, D, et al
Obesity (Silver Spring, Md.). 2010;(8):1579-84
Abstract
Lack of control of food intake, excess size, and frequency of meals are critical to the development of obesity. The stomach signals satiation postprandially and may play an important role in control of calorie intake. Sodium alginate (based on brown seaweed Laminaria digitata) is currently marketed as a weight loss supplement, but its effects on gastric motor functions and satiation are unknown. We evaluated effects of 10 days treatment with alginate or placebo on gastric functions, satiation, appetite, and gut hormones associated with satiety in overweight or obese adults. We conducted a randomized, 1:1, placebo-controlled, allocation-concealed study in 48 overweight or obese participants with excluded psychiatric comorbidity and binge eating disorder. All underwent measurements of gastric emptying (GE), fasting, and postprandial gastric volumes (GVs), postprandial satiation, calorie intake at a free choice meal and selected gut hormones after 1 week of alginate (three capsules vs. matching placebo per day, ingested 30 min before the main meal). Six capsules were ingested with water 30 min before the GE, GV, and satiation tests on days 8-10. There were no treatment group effects on GE or volumes, gut hormones (ghrelin, cholecystokinin (CCK), glucagon-like peptide-1 (GLP-1), peptide YY (PYY)), satiation, total and macronutrient calorie intake at a free choice meal. There was no difference detected in results between obese and overweight patients. Alginate treatment for a period of 10 days showed no effect on gastric motor functions, satiation, appetite, or gut hormones. These results question the use of short-term alginate treatment for weight loss.