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Body Weight clinical trials

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NCT ID: NCT04777903 Recruiting - Clinical trials for Twin Pregnancy; Body Mass Index; Weight Gain; Pregnancy Outcome

The Relationship Between Pre-pregnancy BMI and Weight Gain and Outcomes in Women With Twin Pregnancy

Start date: January 1, 2016
Phase:
Study type: Observational

Prepregnancy body mass index (BMI) and gestational weight gain (GWG) have Significant effects on the risk of pregnancy outcomes such as gestational hypertension disease and gestational diabetes mellitus in singleton pregnancies. This paper is to investigate the relationship between pre-pregnancy body mass index (BMI) and weight gain during pregnancy and pregnancy outcomes in women with twin pregnancy.

NCT ID: NCT04758559 Recruiting - Weight Loss Clinical Trials

Usability of myfood24 in Clinical Populations

Start date: February 1, 2021
Phase: Early Phase 1
Study type: Interventional

Many patients would benefit from dietary/nutritional support to better manage their conditions but evaluating current intake in relation to personal targets is labour-intensive and often does not feature as part of clinical consultations. Primary objective: test usability and acceptability of 'myfood24 Health' for monitoring dietary intake in a group of patients. Recruit 60 gastroenterology surgery patient (Leeds) and 60 Tier 3 Weight Management patients (30 Leeds/ 30 York). Randomise to 3 groups 1. usual care 2. myfood24Health 3. myfood24Health plus personalised feedback 'diet optimisation engine' which suggests changes to amounts or types of foods During a 2-month follow-up, patients in group 2 or 3 will be asked to record daily diet in myfood24, including weekend and weekdays and use it a minimum of 4 times. HCPs will be able to review diet/nutrients for group 2 and 3 patients and can support dietary change or nutritional goals, as part of patients' ongoing clinical management, during existing scheduled clinic visits (N.B. not all participants will have a scheduled clinic appointment during the study). 2 months after recruitment, all participants will receive a link to an online feedback questionnaire. At end of study, HPCs will be invited to provide feedback during a 30 minute interview.

NCT ID: NCT04744714 Recruiting - Clinical trials for Gestational Weight Gain

Gestational Weight Gain Criteria for Pregnant Women With Gestational Diabetes Mellitus in China

Start date: February 1, 2021
Phase:
Study type: Observational

Appropriate gestational weight gain (GWG) is a key factor in balancing maternal and neonatal needs of nourishment and health, which is especially important in women with gestational diabetes mellitus (GDM). However, there are no specific guidelines for GWG in Chinese pregnant women and even for GDM pregnant women.This project intends to fill in the gaps of this field through multi-center large sample prospective cohort study.

NCT ID: NCT04737681 Recruiting - Clinical trials for BMI/Body Composition

Influence of Body Weight and Composition on Immune Recovery

Start date: September 1, 2020
Phase:
Study type: Observational

Immune dysfunction in individuals with obesity, secondary to chronic inflammation, may have an acute impact on War fighter health and readiness, and subsequent lethality. Indeed, ~51% of military personnel ages 17 or older are overweight, and ~15% have obesity (ranging from 6.4% in the Marine Corps to 18.0% in the Army). In conjunction with in vitro functional tests to assess systemic immune function, the suction blister model is a minimally invasive procedure that allows in vivo assessment of immune function (i.e., skin barrier restoration), and related mechanisms (i.e., pro- and anti-inflammatory cytokine responses at the wound site during the early phases of wound healing), consequent to obesity. We have demonstrated that the blister wound model reliably assesses skin barrier restoration and immune function at the wound site; and that relatively modest sleep disruption degrades immune response at the site of the disrupted skin barrier and delays the initial restoration of the skin barrier. However, our prior work excluded participants with obesity (≥30 kg/m2), since obesity is associated with an altered inflammatory response which may subsequently impact the body's functional response to a skin wound. Prior studies have indicated that immune function and wound healing is perturbed in individuals with obesity versus those without obesity. Existing research mainly relied on blood biomarkers and in vitro tests to assess systemic immune function; however, incorporating the blister wound model permits evaluation of the functional immune response to obesity in addition to local immune response at the wound site. Further, military personnel with obesity may be more physically active than civilians with obesity, which could mitigate the effects of obesity on immune dysfunction. Therefore, the primary aim of this parallel-group study is to utilize a suction blister model and in vitro functional assays to examine differences in immune function between participants without obesity (BMI 18.5-24.9 kg/m2) and with obesity (BMI ≥ 30 kg/m2) and related mechanisms (e.g., local cytokine response at the wound site and circulating markers of inflammation). Research will be conducted in a laboratory environment using males and females with obesity (BMI ≥ 30 kg/m2) compared to normal weight (BMI 18.5-24.9 kg/m2) controls. Participants in the study described herein (n = 50; n = 25 with obesity and n = 25 lean) will undergo baseline testing and a period of dietary surveillance prior to induction of up to eight blisters via suction on participant's forearm, after which time the top layer of blisters will be removed to reveal the dermal layer of skin. The primary outcome measure is initial restoration of the skin barrier (via transepidermal water loss) and additional outcome measures include immune function (e.g., circulating markers of inflammation, cytokines at the blister site, and secretory immunoglobin) and nutrient status. Additionally, to assess the impact of BMI on skeletal muscle inflammation, a subset of volunteers (n = 12 with obesity and n =12 lean) will undergo a single muscle biopsy at the conclusion of skin barrier restoration. Findings from this study will determine if obesity affects the early phases of wound healing and whether further study is warranted, e.g., do stressors exacerbate immune decrements observed in obese individuals, or can nutrition counter-measures mitigate immune decrements given that micronutrient deficiency is common in individuals with obesity.

NCT ID: NCT04731688 Recruiting - Obesity Clinical Trials

A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity

Healthy Mamas
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

The aims of this randomized controlled trial are to determine the effects of a lifestyle program that supports weight maintenance and fat mass loss during pregnancy in women with obesity on changes in 1) maternal weight, fat mass, and cardiometabolic risk factors; 2) safety measures, including fetal and neonatal growth; 3) the mediators and moderators of the fat mass loss intervention and 4) the effects gestational fat mass loss has on reducing incidence of adverse obstetrical outcomes, including non-elective cesarean delivery, gestational diabetes, hypertension, and pre-eclampsia.

NCT ID: NCT04724330 Recruiting - Clinical trials for Overweight and Obesity

Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity

H42/H4U
Start date: March 15, 2021
Phase: N/A
Study type: Interventional

Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.

NCT ID: NCT04697719 Recruiting - Body Weight Clinical Trials

Body Weight, Aspirin Dose and Pro-resolving Mediators

Start date: November 4, 2021
Phase: Phase 4
Study type: Interventional

This study employs a placebo-controlled randomized cross-over design to investigate the impact of body weight and aspirin dose on levels of specialized pro-resolving lipid mediators in blood and neutrophils.

NCT ID: NCT04694235 Recruiting - Child Development Clinical Trials

Egg Intervention During Pregnancy in Indonesia

PRECODE
Start date: February 12, 2021
Phase: N/A
Study type: Interventional

The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old

NCT ID: NCT04690738 Recruiting - Weight Gain Clinical Trials

Role of Pancreatic Exocrine Secretion in Weight Gain After Pancreas Transplantation

Start date: August 17, 2020
Phase:
Study type: Observational

Pancreas transplantation is currently the most reliable method for glycemic control in insulin dependent diabetic patients. Outcomes of pancreas transplantation have improved significantly over the years due to improved surgical techniques, medical management and immunosuppression. However, weight gain after pancreas transplantation remains a common problem with associated consequences such as development of type 2 diabetes, coronary artery disease, graft loss, metabolic syndrome and increased risk of cardiovascular death. Excessive weight gain is well known after liver and kidney transplantation; however there are very few studies that have looked at weight gain after pancreas transplantation. In a recent study by Knight et al, 26% of the pancreas transplant recipients had excessive weight gain, defined as more than 30% of their baseline weight by 1-year post transplant. The study focused mainly on the endocrine function of the pancreas, explaining that excessive peripheral insulin circulation post-transplant may explain the weight gain. Other factors like immunosuppression, increased oral intake and potentially reduced activity may also have played a role. However no study has looked at the possible role of exocrine secretion from the new pancreatic allograft, combined with exocrine secretion of the old pancreas, leading to excessive availability of digestive juices like trypsin, chymotrypsin, lipase, amylase, gelatinase, elastase etc. Our hypothesis is that the excessive weight gain after pancreas transplant, which is more than in other solid organ transplants, is driven by the excessive digestive juice leading to improved conversion of available food and nutrient into storable energy and subsequently leading to weight gain. The patient will therefore need to either increase physical activity to avoid weight gain post-transplant or significantly reduce caloric intake. Fecal elastase test (FE-1)-elastase is a proteolytic enzyme produced by pancreatic acinar cells. They bind to bile salt and pass through the gut without degradation. These levels correlate well with the other pancreatic enzyme levels. Fecal elastase concentration (FEC) has been used routinely to screen for pancreatic exocrine insufficiency (PEI). Exocrine pancreatic juice has been a target for the management of obesity lately, with the use of drugs like Orlistat (Xenical) that inhibits pancreatic lipase and therefore interfere with the absorption of fat. If our theory of excessive pancreatic juice availability after pancreas transplant can be proven, it can help guide the targeted use and appropriate dosing of such drugs based on the level of the pancreatic juice as measured by the FEC.

NCT ID: NCT04639778 Recruiting - Bariatric Surgery Clinical Trials

Monitoring the Weight Evolution Using a Connected Scale

TELEBARIA
Start date: March 25, 2021
Phase: N/A
Study type: Interventional

Current guideline recommend yearly multidisciplinary postoperative follow-up after bariatric surgery. However, practices remain very heterogeneous, and only a fraction of patients are still follow-up beyond two years after the operation. This study will assess a new care pathway in which the patients are follow-up according to the weight evolution measured by the patient using a connected scale.