Active clinical trials for "Weight Gain"

Objective: The objective of the present research is to compare the nutritional status, weight gain, length of hospital stay, and development of some complications in very low birth-weight (VLBW) infants who received and did not receive olive oil supplementation enterally.

The primary purpose of this study is to assess the responses of pregnant women and their social network to six videos about health in pregnancy. Our goal is to assess a) acceptability and b) understanding of core messages about healthy eating, exercise and weight gain during pregnancy. We will also assess c) non-clinical sources of health information during pregnancy.

To assess the association of the number of medical nutrition therapy (MNT) consultations and eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with GWG in women with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM).

Switching patients with HIV infection from tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF) based drug regimen can provide many safety benefits including preserving bone mineral density and kidney function. This study will examine metabolic changes that patients may encounter due to the switch in medication regimens and the maintenance of viral suppression.

Background: Burden: Hypertensive disorders of pregnancy, including preeclampsia, complicate up to 10% of pregnancies worldwide, constituting one of the greatest causes of fetal growth restriction, preterm birth, low birth weight, perinatal mortality, and maternal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive causes. Conventional antenatal care practice often delays in or misses diagnosing hypertension in pregnancy, which makes the women vulnerable to its adverse consequences. Knowledge gap: Although there are randomised controlled trials (RCT) of efforts directed at preventing development of hypertension in pregnancy or reducing its complications, there have been no published RCTs of the intervention focusing on regular monitoring of weight gain and blood pressure among pregnant women who are at risk of developing hypertension in pregnancy or its complications to ensure early diagnosis, and thereby optimizing the perinatal outcomes through prompt referral and management. Relevance: To undertake an RCT of intervention to optimize adverse consequences in hypertension in pregnancy raises important practical concerns including: commitment of the enrolled women, the need to make a decision regarding participation due to longer duration of intervention and adherence to protocol. Investigators aim to perform this study to address whether an RCT of the intervention in individual patients is an appropriate trial design, and is feasible. Objectives: To evaluate the accuracy of Salu Health Gauge device in measuring blood pressure. To test the design, feasibility, acceptability and fidelity of a future definitive randomized controlled trial focusing on regular monitoring of weight gain and continuous self-monitoring of blood pressure among pregnant women who are at risk of developing hypertension in pregnancy. Methods: The study will be completed in two steps: 1) the validation of Salu Health Gauge and 2) the pilot trial. The study will be conducted in Matlab, Bangladesh. Salu Health Gauge device will be validated according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010) in general adult population (including men and non-pregnant women) as well as in specific groups such as adolescents and pregnant women. The pilot trial is designed as a prospective, two-arm, parallel, and open-label randomized controlled external pilot trial. Eligible participants (pregnant women at risk of developing hypertension in pregnancy) will be individually randomized 1:1 to the intervention arm who will use a wearable device (Salu Health Gauge) from 20 weeks of gestation up to termination of pregnancy alongside conventional antenatal and postnatal care or the control arm who will receive conventional antenatal and postnatal care only. In Matlab, a woman is diagnosed as pregnant by HDSS field staff by 12-16 weeks of gestation and is enlisted. The investigators will obtain this list from HDSS and conduct baseline interviews to identify pregnant women at risk of developing hypertension in pregnancy. Outcome measures/variables: Feasibility outcomes: Recruitment rate, Retention rate, compliance, Acceptability etc. Clinical outcomes: gestational weight gain, birth weight, adverse consequence of hypertension in pregnancy (episodes or occurrence and when), blood pressure profile of high-risk pregnancies, prevalence of specific risk factors for hypertension in pregnancy Serious adverse events

Apart from obesity, craniofacial factors are well recognized in the pathogenesis of obstructive sleep apnea (OSA) and are likely to play an important role in influencing the response to weight loss. The prevalence of OSA syndrome is as common among the middle-aged Hong Kong Chinese populations as the Caucasians, despite our Chinese patients having much lower body mass index (BMI). From previous work on ethnic comparison, for the same degree of OSA severity, Caucasians were more overweight, whereas Chinese exhibited more craniofacial bony restriction. Cephalometric measurements based on lateral radiograph of the upper airway have shown that a shorter distance between maxillary projection from the cranial base, a smaller posterior airway space, less mandibular protrusion, a narrower space between the hard palate and cranial base, and a more caudally placed hyoid bone predispose to a higher apnea-hypopnea index (AHI). A recent study shown that a shorter mandibular length as measured by lateral cephalometry was associated with a greater fall in AHI after weight loss. Another study using craniofacial computed tomography (CT) scans to evaluate the maxillomandibular bony volume found that craniofacial restriction influenced the relationship between weight loss and OSA improvement. Collectively, these studies suggest that the effect on AHI with weight loss is likely to be more pronounced in those with a smaller craniofacial skeleton. However, the effect of the craniofacial restriction on the degree of rebound in OSA following weight gain after the weight loss intervention is unknown. The study aims to investigate the change in weight and OSA severity following cessation of a lifestyle modification program (LMP) and examine the relationship between craniofacial restriction and the degree of OSA reoccurrence.

The objective of this study is to assess the impact of emollient therapy on gain in weight and length among preterm and low birth weight babies.

Weight gain following antiretroviral therapy (ART) initiation occurs with all modern regimens. Recent real-world reports suggest that integrase strand transfer inhibitor (INSTI)-based ART may be associated with excess weight gain compared to other regimens. Weight gain appears to occur regardless of baseline weight, and is most pronounced among women and minorities, often those at highest risk of obesity-associated comorbidities. INSTI- and TAF-based regimens are now preferred regimens for most persons according to the Department of Health and Human Services ART-Treatment Guidelines. As a result, there is an urgent need to understand the underlying mechanisms for this weight gain. This study aims to understand the changes in energy balance that occur with changes in ART. Participants with HIV who have experienced >10% weight gain on INSTI (bictegravir or dolutegravir-based therapy) will be switched to doravirine for 12 weeks, and then back to their prior INSTI regimen, allowing for assessment of changes in metabolic parameters with drug withdrawal and reintroduction (with no change to NRTI-backbone). Twenty-four hour energy balance will be measured on both regimens during a 24-hour stay using a whole room indirect calorimetry, with a standardized diet. Ultimately, the investigator's goal is to understand the mechanisms of weight gain so that future interventions can most effectively mitigate ART-associated weight changes.

Schizophrenia and bipolar disorders are major public health problems. The second generation anti-psychotic drugs have efficacy for both positive and negative symptoms and a favorable risk profile as far as movement disorders. However, these drugs are associated with clinically significant weight gain and metabolic effects. The underlying mechanisms of these side effects are unclear, however in our preliminary studies with schizophrenic patients on atypical anti-psychotic drugs, we found that weight gain and vitamin D deficiency was present in about 50% of this population. Given the considerable heterogeneity among the patients on atypical anti-psychotics and potential for weight gain in vitamin D-deficient states, we propose that patients with schizophrenia who gain weight on atypical antipsychotic medications are vitamin D-deficient. This hypothesis will be tested in patients with schizophrenia receiving second-generation anti-psychotic drugs for a minimum duration of 4 months. Specific Aim: We predict that the patients with schizophrenia, who gain weight with antipsychotic treatment, are vitamin D-deficient compared to the patients who do not gain weight. We will examine circulating levels of serum 25(OH)D, mRNA transcripts and protein expression of vitamin D receptor (VDR) and the enzymes, CYP24A and CYP27B, in the white blood cells of the subjects and correlate with BMI and the blood levels of leptin and adiponectin.

NCDs are observed mostly in adults, however there is strong evidence that suggests NCDs origin early in life, thus the first 1000 days of life (conception to age 2yrs). Studies show that maternal BMI before conception and during pregnancy predict future risk of obesity and associated metabolic conditions in both mother and offspring. Weight gain during the first two years of life is also critical in defining the infant's predisposition to obesity during adulthood. Objective: to assess the effectiveness of delivering a primary health care intervention to enhance compliance with updated nutrition and health care (diet, physical activity and breastfeeding) standards from early pregnancy through the first year of life. Methods: cluster randomized controlled trial (CRCT), designed as a public health intervention "program effectiveness" study (i.e. intervention will be available through the established national health system under standard operating conditions). A cluster unit will be a primary health care centers (PHCC) in South-East Santiago 12 PHCC will be randomly allocated to: enhanced nutrition and health care (intervention group) or routine nutrition and health care (control group).We will recruit 200 women in each of 12 PHCC; assuming a 20% loss to f-up we will complete 960 women per arm. After randomization, pregnant women in the intervention PHCCs starting at their first pre-natal visit (< 15 wks.) will receive, diet and physical activity (PA) counseling-support based on updated recommendations and monitoring goals for weight gain & glycemic control and breastfeeding (BF) promotion till 12 m postpartum. Pregnant women who attend control PHCCs will receive routine antenatal care according to national guidelines. Expected results: participants in the intervention PHCCs will benefit by achieving adequate nutritional status & metabolic control, during and early after, pregnancy as well as adequate infant growth & development as a result of improved nutrition and health care practices. The results will likely be generalizable through the primary health care system; considering this is a "program effectiveness" trial conducted under "real life" conditions . Additionally, we will include specific ancillary mechanistic projects to better characterize the intervention and its impact.