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NCT ID: NCT03500835 Active, not recruiting - Pediatric Obesity Clinical Trials

An Addiction-Based Mobile Health Weight Loss Intervention With Coaching

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

New and creative approaches are needed to address childhood obesity. Current strategies result in suboptimal outcomes and are intensive and costly. It has been theorized that overeating, may have addictive qualities, although few weight management interventions have tested therapeutic techniques founded on addiction medicine principles, such as, withdrawal, tolerance and craving control1, 2. A pilot study utilizing an addiction model based mobile health (mHealth) weight-loss intervention in adolescents showed that the app intervention reduced BMI Z-score (zBMI) to a greater extent than youth participating in an in-clinic multidisciplinary weight management intervention, and appeared to be a cost-effective, labor efficient method for adolescent weight management. The proposed multi-site randomized control trial (RCT) will test the effectiveness of an addiction-based weight loss intervention, embodied first as a smartphone app with telephone coaching and second as an identical approach phone-coaching alone intervention compared to age matched controls participating in an in-clinic weight management interventions in a larger sample of economically, racially and ethnically diverse adolescents (ages 14-18). One hundred and eighty adolescents will be recruited from pediatric interdisciplinary weight management clinics operating out of five different hospital systems in Southern California and through targeted mailing to 40 ethnically, racially and economically diverse neighborhoods in Los Angeles County. The adolescents will be randomized 1:1 via stratified block randomization to either receive 1) interactive addiction model based mobile health (mHealth) weight-loss intervention with personalized phone-coaching (AppCoach), 2) interactive addiction model based mHealth weight-loss intervention alone (App) or 3) Multidisciplinary in-clinic weight management program (Clinic). Assessment of the intervention's effect on zBMI and percent over the 95th percentile (%BMIp95), fasting metabolic parameters, addictive eating habits, executive function, and motivation for change will be obtained at enrollment, 3, 6, 12 and 18 months (1 year post intervention follow up). In addition, a real-life economic analysis (cost, cost-saving and non-monetary benefits) analysis will be completed comparing AppCoach to 1) App and 2) Clinic. We will further explore whether primary and secondary outcomes differ by race and whether race moderates the relationship between initial intervention efficacy and prolonged weight maintenance.

NCT ID: NCT03435445 Active, not recruiting - Obesity Clinical Trials

Online Platform for Healthy Weight Loss (POEmaS)

POEmaS
Start date: September 24, 2017
Phase: N/A
Study type: Interventional

Clinical trial to test the efficacy of an online platform based on behavior change principles in promoting weight loss among overweight and obese students and employees of the Federal University of Minas Gerais. The hypothesis is that participants of the group which use the platform with or without a dietitian coaching will lose more weight than those allocated to the group who receives dietary and physical activity orientations by educational videos only.

NCT ID: NCT03271034 Active, not recruiting - Metabolism Clinical Trials

Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema

Lipedema
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Lipedema is a disorder characterized by massive, bilateral accumulation of fat below the waist and in the legs. Enlargement of the lower extremities is often accompanied by leg pain and accumulation of fluid. Little is known about the functional changes that lead to fat accumulation and pain in women with lipedema. The goals of this project are to conduct a comprehensive characterization of abdominal and femoral fat tissues in lean and obese women with lipedema and to evaluate the potential effect of diet-induced weight loss as a therapy. Once enrolled in the study, the following tests will be conducted on lean women with lipedema: characterization of body composition (fat tissue distribution), insulin sensitivity (response to insulin) and adipose tissue biology. The following tests will be conducted on obese women with lipedema: characterization of body composition (fat tissue distribution), insulin sensitivity (response to insulin), adipose tissue biology, and immune system function/inflammation. As control, we will have BMI-matched women that are metabolically normal lean (MNL), metabolically normal obese (MNO) and metabolically abnormal obese (MAO) already analyzed in different studies at Washington University (IRB# 201512086). MNL, MAO and MNO subjects underwent the same testing described above for the lipedema. Therefore, we will use the data generated from IRB# 201512086 as comparison groups in the statistical analysis to understand differences and similarities between lipedema and obesity. A second aim of the study is to determine the effect of diet-induced weight loss on body composition, insulin sensitivity, and adipose tissue biology in women with lipedema. The results from this second aim of the study will hopefully provide important insights on the efficacy of diet therapy in managing lipedema.

NCT ID: NCT03238794 Active, not recruiting - Obesity Clinical Trials

Bariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss

Start date: May 17, 2019
Phase: N/A
Study type: Interventional

It is unknown whether the bile acid pathway reacts differently to weight loss resulting from Roux-En-Y Gastric Bypass (RYGB) surgery than weight loss resulting from caloric restriction alone.

NCT ID: NCT03188094 Active, not recruiting - Weight Loss Clinical Trials

Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes

Start date: December 17, 2018
Phase:
Study type: Observational

The proposed study will inform efforts to prevent diabetes and promote weight loss in a high-risk population and generate a reproducible, scalable, and sustainable model for use with other insurer groups and clinical settings that work in immigrant populations with a high burden of chronic disease.

NCT ID: NCT03186885 Active, not recruiting - Obesity Clinical Trials

Healthy Frio: A Rural Community Partnership to Advance Latino Obesity Research

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Much has been learned about the efficacy and effectiveness of comprehensive healthy lifestyle interventions to reduce obesity. Few studies have been translated into rural settings or among Latinos. Y Living is an evidence-based family-focused intervention (FI) designed for urban Latino families. The FI is a 12-week behavioral modification program grounded in social cognitive theory, designed to engage the whole family in lifestyle changes by developing knowledge and skills in physical activity and healthy eating, building skills in goal-setting and self-monitoring, and creating a supportive home environment. Researchers will engage community partners in formative research to adapt the current FI for rural Latino families. Two parallel delivery methods of the FI will be developed and tested: 1) in-person group setting at a community center (FI-IP) and 2) home-based delivered remotely with technology (FI-RT). Both will be designed to address the unique social, cultural and environmental factors facing rural Latino families. The FI-RT will take advantage of innovative modern technology and e-Learning to increase program availability, accessibility and participation in rural settings. Researchers will conduct a 3-arm randomized controlled trial (RCT) to compare effectiveness of the two delivery approaches on weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese Latino parent-child pairs versus control. The researchers will recruit 270 obese Latino adults (ages 21-65) with a child (ages 8-17) from three primary care practices in rural South Texas. These parent-child pairs will be randomized to one of three arms stratified by clinic: 1) FI-IP (n=90); 2) FI-RT (n=90); or 3) control group (n=90). Primary specific aims are to: 1) Conduct community-engaged formative studies to transform the existing FI into two unique delivery methods (FI-IP and FI-RT) for use in a subsequent RCT in a rural Latino community; and 2) Conduct a RCT to evaluate the comparative effectiveness of FI-IP and FI-RT to address weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese rural Latino adults compared with adult participants in control group at immediate post intervention (3 months), after a 3-month maintenance program (6 months post randomization) and a 6-month follow-up (12 months post randomization). A secondary aim is to examine the impact of FI-IP and FI-RT children's weight and energy balance behaviors.

NCT ID: NCT03036800 Active, not recruiting - Obesity Clinical Trials

Saxenda in Obesity Services (STRIVE Study)

STRIVE
Start date: November 28, 2017
Phase: Phase 4
Study type: Interventional

A two year, parallel, two group, open-label, real-world randomised controlled trial (RCT) design for subjects with severe and complex obesity who are referred to a Tier 3 or equivalent specialist weight management/obesity service. Participants will be randomised to receive 1) standard care (obesity-specialist care), or 2) targeted prescribing pathway (obesity-specialist care plus targeted use of Liraglutide 3.0mg [LIRA 3mg] with pre-specified stopping rules for the medication). The aim of the study is to compare the effectiveness, budget impact, and cost-effectiveness between the two groups in a real-world setting among otherwise largely unselected patients.

NCT ID: NCT03035409 Active, not recruiting - Weight Loss Clinical Trials

Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors

Start date: February 8, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.

NCT ID: NCT02931344 Active, not recruiting - Obesity Clinical Trials

Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

BIO-LOSEIT-I
Start date: November 2016
Phase: N/A
Study type: Interventional

This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention

NCT ID: NCT02905422 Active, not recruiting - Overweight Clinical Trials

Healthy Eating, Activity, & Lifestyle Training Headquarters: II Pilot Project

Start date: January 2016
Phase: N/A
Study type: Interventional

The proposed study aims to combine evidenced based tools and guidance (H.E.A.L.T.H.: Healthy Eating Activity Lifestyle Training Headquarters) previously tested that has been developed specifically for use by Army Soldiers and a remote clinical intervention model that includes mobile tracking technology/devices for physical activity, weight and nutrition. This program is called the H.E.A.L.T.H. Intensive.