Bariatric Times

MAY 2017

A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional

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24 Research Bites Bariatric Times • May 2017 EFFECT OF A TECHNOLOGY-BASED INTERVENTION ON WEIGHT CHANGE POST-BARIATRIC SURGERY Status: This study is currently recruiting participants. P urpose: The primary aim of this study is to examine the effect of applying a minimal contact technology- based intervention (TECH) at 1-year post-bariatric surgery on weight change compared to Standard Care. Forty participants at 1-year post bariatric surgery will be randomized to TECH or Standard Care for a period of 6 months (12 to 18 months post-surgery). Analyses will be conducted to compare these interventions for differences in body weight, body composition, fitness, physical activity, engagement, psychosocial measures, and intervention cost and cost-effectiveness of each approach. TECH will consist of a wearable monitor that provides feedback on energy expenditure and physical activity, electronic tracking of dietary intake, and integration of an electronic scale to provide comprehensive feedback to the participant on all components of weight management. TECH participants will receive a monthly telephone call from the intervention staff to provide guidance on their weight management efforts. Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Eligibility: • Ages Eligible for Study: 18 Years to 60 Years (Adult) • Sexes Eligible for Study: All • Accepts Healthy Volunteers: Yes Criteria: Inclusion Criteria: -Between the ages of 18-60 years. -1-year post-bariatric surgery. -Able to walk at 3 miles per hour during a cardiorespiratory fitness test. Exclusion Criteria: -Reports not having access to a computer, access to the Internet, email, or the availability to download s oftware onto a computer. -Reports not having a smart phone device that is compatible with the Jawbone UP3 System that will be examined in this study. - Has a physical limitation that would prevent engaging in physical activity. -Reports being treated for a current medical condition that could affect body weigh (diabetes mellitus, cancer, chronic renal insufficiency, hyperthyroidism, hypothyroidism, chronic liver disease). -Reports current congestive failure, angina, uncontrolled arrhythmia, symptoms indicative of increased risk of an acute cardiovascular event, coronary artery bypass grafting or angioplasty, prior myocardial infarction, and conditions requiring anticoagulation therapy (deep vein thrombosis). -Has a resting systolic blood pressure ≥ 150 mmHg or resting diastolic blood pressure of ≥100 mmHg or taking medication to control blood pressure that affects heart rate. -Reports being treated for a psychological issue (i.e., depression, bipolar disorder, etc). -Taking prescription or over-the- counter medications that affect body weight and metabolism. -Currently participating in an exercise or weight control study or a current participant in a commercial weight reduction program. -Currently being treated for an eating disorder. -Currently pregnant, pregnant in the last 6 months, breast feeding in the last 3 months, lactating, to planning on becoming pregnant in the next 6 months. -Planning on relocating outside of the greater Pittsburgh area within the next 6 months. Primary Outcome Measures: • To examine the effect of applying a minimal contact technology-based intervention (TECH) at 1-year post- bariatric surgery on weight change compared to Standard Care over the subsequent 6 months. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ] • Body Weight (5 minutes; 0, 3, 6 months): Body weight will be measured to the nearest 0.1 kg on a Tanita WB-110A digital scale (Tanita Corporation; Arlington Heights, IL). M easures will be taken in a light- weight hospital gown with shoes and accessories removed. Secondary Outcome Measures: • See clinical trials website Sponsors and Collaborators: • University of Pittsburgh, Pittsburgh, Pennsylvania ClinicalTrials.gov identifier: NCT02867696 THE IMPACT OF BARIATRIC SURGERY INDUCED WEIGHT LOSS ON LUNG FUNCTION IN ADOLESCENTS Status: This study is currently recruiting participants. Purpose: In this prospective study we will evaluate the changes in respiratory physiology occurring in morbidly obese adolescents following bariatric surgery at Schneider Children's Medical Center of Israel (SCMCI). Study Type: Observational Study Design: Observational Model: Cohort Time Perspective: Prospective Eligibility: • Ages Eligible for Study: 11 Years to 18 Years (Child, Adult) • Sexes Eligible for Study: All • Accepts Healthy Volunteers: No • Sampling Method: Probability Sample • Study Population: Adolescents with morbid obesity who will undergo bariatric surgery Criteria: Inclusion Criteria: -Adolescents with morbid obesity who will undergo bariatric surgery at the paediatric surgery ward of Schneider Children's Medical Center during 2016-2018 Exclusion Criteria: -Adolescents with background diseases which might influence their ability to conduct pulmonary function tests (for example, patients with neurological disorders) Primary Outcome Measures: • Change from Baseline Lung Clearance Index [Time Frame: 3 m onths post op] Secondary Outcome Measures: • Change from Baseline High sensitivity C reactive protein [Time Frame: 3 months post op] S ponsors and Collaborators: Rabin Medical Center, Petach Tikva, Israel ClinicalTrials.gov identifier: NCT02644174 SLEEP AND IMMUNE RESPONSE IN SEVERE OBESE PATIENTS UNDERGOING BARIATRIC SURGERY Status: This study is not yet open for participant recruitment. Purpose: Obesity is a major public health problem in developed and developing countries, causing a range of respiratory and metabolic changes. There is a strong correlation between obesity and cardiorespiratory sleep disorders. The weight loss reduces the comorbidities and improves the quality of life, but clinical treatment it is not effective for a long period. In this context, currently bariatric surgery is an option for the real weight loss in the long term. Obstructive sleep apnea (OSA) is a common clinical condition observed in patients with obesity. The primary aim of this protocol are to assess the inflammatory profile of severe obese patients undergone to bariatric surgery, through systemic and adipose markers of inflammation. A secondary objective is study the impact of this surgery on sleep variables and quality of life. Investigators hypothesized that weight loss induced by bariatric surgery reduces systemic inflammatory profile, improve sleep quality and quality of life of subjects with severe obesity. Will participate in this study, patients with severe obesity (BMI > 40 or 35 to 39.9 kg/m2 associated comorbidities), with indication of bariatric surgery, screened Bariatric Surgery Service of Santa Casa de São Paulo in São Paulo. Inclusion criteria are severely obese, bariatric surgery indication and agreement to participate in the study. Are excluded patients with BMI > 55 kg/m2, clinical instability, mental instability or significant and unrealistic expectations of surgery. Patients will be assessed before and after bariatric surgery, 90, Clinical Trials in Bariatric and Metabolic Medicine Information provided from clinicaltrials.gov Research Bites

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