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Overweight clinical trials

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NCT ID: NCT05473767 Recruiting - Diabetes Clinical Trials

Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children

Start date: November 18, 2022
Phase: N/A
Study type: Interventional

This randomized-controlled pilot study will examine the implementation of a cardiovascular health intervention on postpartum mothers and infants. The investigators will adapt a cardiovascular health intervention into an evidence-based home visiting program, Family Check-Up to create Family Check-Up Heart. Through a Type 1 hybrid effectiveness implementation design, the pilot study will test the feasibility and effectiveness of Family Check-Up Heart (Family Check-Up Heart, n=100; Family Check-Up, n=50). The investigators hypothesize that Family Check-Up Heart will show comparable levels of engagement and acceptability as Family Check-Up alone, and mothers receiving Family Check-Up Heart will have greater improvements in cardiovascular health at 6 months postpartum compared to Family Check-Up alone.

NCT ID: NCT05471414 Recruiting - Prostate Cancer Clinical Trials

Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer

WFPBD
Start date: September 22, 2022
Phase: N/A
Study type: Interventional

The study is comparing the effect on weight of providing home-delivered whole-food, plant-based meals versus standard, general nutritional counseling to men with prostate cancer on androgen-deprivation therapy (ADT).

NCT ID: NCT05461495 Recruiting - Diabetes Clinical Trials

NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This study will conduct a two-arm randomized controlled trial to test the efficacy of a culturally tailored version of the NYU Caregiver Intervention (NYUCI) plus enhanced support (ES) through online chat groups (the NYUCI plus WeChat/Kakaotalk [population social media app for Chinese/Korean] peer support which we call the NYUCI-ES in reducing health risks for cardiometabolic disease among older Chinese and Korean American adults caring for relatives with ADRD. In collaboration with community organizations across the New York and northern New Jersey metropolitan area, we will enroll 300 caregivers of people with ADRD (150 Chinese and 150 Korean) in this study. Aim 1: Develop culturally adapted informational and educational materials about dementia and caregiving issues for social service providers of the intervention and for family caregivers. Aim 2: Test the hypothesis, H1: A counseling and support intervention (the NYUCI-ES) will significantly improve psychosocial factors such as depression, stress self-rated health and chronic disease management among Chinese and Korean-American ADRD caregivers and these changes will be mediated by improvement in social support. H1a: By the first (6- month) follow-up, the mediators (increases in social support, stress reaction) will improve significantly in the intervention group compared to baseline values and the control group. H1b: These improvements will be maintained, and lead to reduction in depressive symptoms, and improvement in self-reported health and chronic disease self-management by the 12-month follow-up compared to the control group. Aim 3: Test the hypothesis, H2: the NYUCI-ES will reduce biologic risk factors, including metabolic health (glycosylated hemoglobin) and inflammation (Oxidative stress, lipid metabolism, etc.) within 6 months of enrollment compared to baseline and a control group; these changes will be mediated through increases in social support and decreases in depressive symptoms and will be maintained at the 12-month follow-up. The public health significance of these findings will likely have an impact on health care policy for CGs from diverse underserved ethnic and cultural backgrounds, potentially reducing morbidity, and improving their quality of life.

NCT ID: NCT05442450 Recruiting - Obesity Clinical Trials

Efficacy of Oral Semaglutide in Overweight or Obesity

OSO
Start date: July 10, 2022
Phase: Phase 4
Study type: Interventional

All the eligible participants after screening will be randomized into two groups (Group 1 and 2) by block randomization (block size of 4 and 6) using computer generated random number. Randomization is performed by the individual not involved in the study. Participants in both groups will receive individual counselling sessions to help them adhere to a reduced-calorie diet (500-kcal deficit per day relative to the energy expenditure estimated at the time) and increased physical activity (with 150 minutes per week of physical activity, such as walking). Both diet and activity will be recorded daily in a diary or by use of a smartphone application or other tools and were reviewed during counselling sessions. Participants in group 1 also receive oral Semaglutide along with diet and exercise. Treatment will be initiated with the 3 mg once-daily dose. The dose will be increased to 7 mg and then maximum of 14mg per day in 2-4weeks interval based on patient tolerance. Dose escalation schedule will be used to decrease the gastrointestinal side effects. Participants will be assessed for gastrointestinal complaints (nausea, vomiting) during escalation and follow-up. Once the desired dose is achieved, patient will remain at the maximum 14mg daily dose unless a reduction was warranted owing to problems with side effects. In such cases, investigators will reescalate the dose once symptoms are resolved or diminished.The absorption of oral Semaglutide is affected by food and fluid in the stomach, hence patients receiving oral Semaglutide will be instructed to take each tablet with up to 120 mL of water in the morning, in a fasting state, and a minimum of 30 min before the first meal of the day. Counselling will be done by a dietician or a similar qualified healthcare professional every 4th week via visits/phone contacts till the completion of the study. Participants have to physically visit the hospital at the end of 28 weeks for assessment.

NCT ID: NCT05428137 Recruiting - Obesity Clinical Trials

Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals

KOBI
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.

NCT ID: NCT05426525 Recruiting - Clinical trials for Overweight and Obesity

Use of Empagliflozin to Treat Prediabetes

Start date: October 13, 2022
Phase: Phase 4
Study type: Interventional

The overall purpose of this study is to identify how empagliflozin (a drug commonly used to treat type 2 diabetes) impacts skeletal muscle metabolic health among adults with prediabetes. Our aims are to: 1) Test the ability of empagliflozin to improve regulation of glucose metabolism (i.e., blood sugar) among overweight and obese individuals at risk for diabetes, and 2) Identify mechanisms to explain how empagliflozin may improve skeletal muscle glucose metabolism. We hypothesize empagliflozin will improve regulation of glucose metabolism due to changes in whole-body and skeletal muscle metabolism (e.g., increased rates of whole-body fat oxidation, evidence of impaired skeletal muscle mitochondrial respiratory function and increased energetic stress, lower accumulation of skeletal muscle lipids and improved skeletal muscle insulin signaling compared with placebo treatment).

NCT ID: NCT05410353 Recruiting - Clinical trials for Overweight and Obesity

Choosing Healthy Activities and Lifestyle Management Through Portal Support

CHAMPS
Start date: February 24, 2023
Phase: N/A
Study type: Interventional

The study aims to randomize 250 participants to 1 of 2 arms: a.) an Active Intervention Group (based on the Look AHEAD* ILI) or b.) a Comparison Group (based on the Look AHEAD DSE Comparison group) to test the hypothesis that a multicomponent, multilevel behavioral weight loss intervention (Active Intervention Group) adapted for underserved groups and delivered through Health Information Technology (Health IT) tools via the Electronic Health Record (EHR) patient portal, will result in significantly greater weight loss 12 months after enrollment compared to the Comparison Group. *The Look AHEAD study was a multi-center, randomized clinical trial involving overweight and obese persons with type 2 diabetes, aimed to determine the effects on the cardiovascular outcomes of an intensive lifestyle intervention (ILI) for weight loss, in comparison to the diabetes support and education intervention (DSE).

NCT ID: NCT05399407 Recruiting - Clinical trials for Overweight and Obesity

PRALIMAP-CINeCO: Comparison of Health E-coaching Versus Referral to the Usual Care System

PRALIMAPCINeCO
Start date: January 9, 2023
Phase: N/A
Study type: Interventional

This study involves young adults from the PRALIMAP-INES trial and student volunteers from the University of Lorraine, who are overweight or obese. For young adults from the PRALIMAP-INES trial, the proposed research is a continuation of the PRALIMAP-CINeCO research (part 1). For students at the University of Lorraine, the proposed research is aimed at volunteer students who are overweight or obese, via the University of Lorraine's Student Health Service (SSE). Young adults and overweight or obese students not receiving medical care at the time of the inclusion visit (4th measurement time for PRALIMAP-INES participants and 1st time for others) will be offered the chance to take part in a randomized trial comparing the acceptability of health e-coaching versus referral to standard care. Experimental group: health e-coaching Control group: usual care system Primary objective : To determine the effectiveness of an e-health coaching intervention using new technologies that promotes changes in eating and physical activity behavior in overweight and obese young adults aged 20, an intervention targeting the development of autonomous self-regulation. Secondary objectives : 1. Determine the acceptability of health e-coaching: acceptability of new technologies (container), acceptability of personalized health e-coaching (content). 2. Determine the effectiveness of health e-coaching on the criteria of corpulence (BMI; body composition), changes in eating behaviors (TCA), emotion management skills and social interaction skills. 3. Evaluate the benefit of health e-coaching alone or combined with the previous intervention received in the PRALIMAP-INÈS trial on primary and secondary endpoints. 4. Evaluate and compare participation in a health promotion program over two life periods (adolescence and young adulthood) for young adults from the PRALIMAP-INÈS trial. 5. Evaluate the effectiveness of health e-coaching (reinforcement of autonomous self-regulation and changes in eating behaviors and physical activity practices/time spent sitting) according to the dose of intervention received by young adults (received-treatment analysis). 6. Determine the cost-efficiency and cost-utility ratios by means of a medico-economic evaluation based on the incremental cost of the e-coaching intervention in relation to the usual care offered by the health care system (ICER: Incremental Cost-Effectiveness Ratio).

NCT ID: NCT05392920 Recruiting - Obese Clinical Trials

Determination of the Validity of One-Minute Sit-to-Stand Test in Obese and Overweight Children and Adolescents

Start date: July 8, 2022
Phase:
Study type: Observational

Obese individuals need to be evaluated comprehensively before exercise programs are determined. Determination of exercise intolerance is important for the detection of functional limitations. One minute sit to stand test (1MSTST) can be used as an alternative to cardiopulmonary exercise tests (CPET) or field tests. It is easy to use, quick to apply, valid and reliable, and applicable even in small areas. In addition, it is a simple assessment adequate for children's needs and behaviors and can be easily applied both in the clinic and at home, making it easier to use in children. Studies have shown that 1MSTST is a valid test in chronic obstructive pulmonary disease (COPD), cystic fibrosis, interstitial lung disease, and, healthy children and adolescents. However, no study has been found regarding the validity of its use in obese children and adolescents.The aim of our study is to investigate the validity and reliability of 1MSTST in overweight-obese children and adolescents.

NCT ID: NCT05386017 Recruiting - Clinical trials for Overweight and Obesity

Post-interventional Future for Adolescents From the PRALIMAP-INÉS Trial

PRALIMAPCINeCO
Start date: December 13, 2022
Phase:
Study type: Observational

The research focuses on a follow-up measure of participants in the PRALIMAP-INÈS cohort (NCT01688453 - Legrand et al. 2017). PRALIMAP-INÈS was conducted between 2012 and 2015 with the objective of showing that adapted overweight support for less advantaged adolescents has an effect equivalent to standard support for advantaged adolescents in the short term. This trial included 3 measurement times: T0 (before intervention), T1 (after intervention, at the end of the school year), T2 (after intervention) and of the school year), T2 (one year later). The proposed research is a continuation of PRALIMAP-INÈS with the addition of a 4th measurement time (T3) to study the trajectories of the intervention. (T3) to study the long-term social, economic, educational and health trajectories (in particular weight) of weight) of adolescents who have become young adults.