A Randomized Controlled Trial of an Intensive Nutrition Intervention Versus Standard Nutrition Care to Avoid Excess Weight Gain After Kidney Transplantation: The INTENT Trial

Introduction: Kidney and simultaneous pancreas-kidney (SPK) transplant recipients can have prolonged postoperative hospitalization due to edema. Thrombo-embolic-deterrent (TED) stockings with intermittent pneumatic compression devices (TED+IPC) have been used to improve venous return during the perioperative period. The objective of this trial was to evaluate the effects of TED+IPC vs. muscle pump activator (MPA) devices on factors that could reduce postoperative complications and duration of hospitalization. Methods: In this single-center, prospective, randomized, controlled trial, 221 kidney and SPK transplant recipients were randomized to either wearing TED+IPC or MPA for six days postoperatively. Groups were compared with respect to postoperative urine output, lower limb edema, weight, days in hospital, mobility, serum creatinine, delayed graft function, need for dialysis, and lower extremity blood flow. Results: Patients in the MPA group had significantly higher urine output and less increase in mid-calf leg circumference and weight gain compared to the TED+IPC group (p=0.003, p=0.001, and p=0.003, respectively). The MPA group also experienced shorter hospitalization (p=0.038), higher femoral vein velocity (p=0.001), and took more steps (p=0.009). Incidence of delayed graft function (p=0.72) and number of dialysis runs (p=0.39) was not different between study groups. Subgroup analysis of primary endpoints in donation after cardiac death recipients and SPK recipients did not yield any significance between the study arms. Conclusions: Postoperative use of the MPA device increases urine output, decreases leg edema, minimizes weight gain, and decreases duration of hospitalization after kidney transplantation. A larger and longer-term trial is needed to evaluate the impact on graft function.

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Faculty Opinions recommendation of Effect of lifestyle intervention on dietary habits, physical activity, and gestational weight gain in obese pregnant women: a randomized controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.1280988.746106 ◽

2009 ◽

Author(s):

Marleen van Baak

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Weight Gain ◽

Pregnant Women ◽

Lifestyle Intervention ◽

Gestational Weight Gain ◽

Dietary Habits ◽

Controlled Trial ◽

Gestational Weight ◽

Randomized Controlled

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Rationale, design, and challenges with implementing a clinical intervention to teach appropriate gestational weight gain (TAGG): Protocol of a Randomized controlled trial (Preprint)

10.2196/preprints.17484 ◽

2019 ◽

Author(s):

Awathif Mackeen ◽

Danielle Downs ◽

Vonda Hetherington ◽

Shawnee Lutcher ◽

Jacob Mowery ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Weight Gain ◽

Gestational Diabetes ◽

Usual Care ◽

Gestational Weight Gain ◽

Perceived Stress ◽

Controlled Trial ◽

Household Food Security ◽

Gestational Weight ◽

Randomized Controlled

BACKGROUND Excessive gestational weight gain (GWG) has public health implications including preterm birth, preeclampsia, gestational diabetes, and cesarean delivery. In an effort to mitigate adverse consequences of excessive GWG, this study tests a health intervention that includes enhancements to improve knowledge and awareness of appropriate GWG, and patient-centered nutritional counseling to promote appropriate GWG. OBJECTIVE The primary objective of the study was to increase the proportion of women who are managing their GWG as recommended by the IOM.4,5 METHODS This randomized controlled trial was conducted at Geisinger in Pennsylvania where excessive GWG is common among women with pre-conception obesity. Eligible, consenting participants with pre-pregnancy body mass index >30.0 kg/m2 were randomized (1:1) to: 1) Usual Care: usual written educational materials and counseling by an obstetric care provider or 2) Enhanced Care: Usual Care plus a) a personalized letter from a physician detailing appropriate GWG, b) exposure to individualized GWG chart in the electronic health record via the patient portal, and c) a consult with a Registered Dietitian Nutritionist and follow-up via tele-health counseling (10-20 mins/1-2 weeks) for the duration of the pregnancy. RESULTS The primary outcome was the proportion of women that gain less than 20 pounds over the course of the pregnancy. Secondary outcomes include knowledge, expectations, and attitude about pregnancy weight gain; increased self-efficacy for ability to eat healthy and being physically active to manage weight; and eating behavior. Potential moderators that will be explored include sleep, perceived stress, perceived involvement in care, and household food security. Data collection has been completed as of November 2019. CONCLUSIONS As GWG care was initiated for mothers with pre-pregnancy BMI >30 kg/m2 within the first and second trimesters, the intervention may have the additional benefit of reducing other adverse pregnancy outcomes including the incidence of gestational diabetes due to healthier rates of GWG. In addition to assessing appropriate GWG, this project will assess eating habits, physical activity, GWG attitudes, sleep quality, and psychological measures, all of which are associated with GWG. Exploratory mediators including perceived stress and food insecurity will also be evaluated. CLINICALTRIAL ClinicalTrials.gov NCT02963428

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Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18147510 ◽

2021 ◽

Vol 18 (14) ◽

pp. 7510

Author(s):

Guillermo García Pérez de Sevilla ◽

Olga Barceló Guido ◽

María de la Paz De la Cruz ◽

Ascensión Blanco Fernández ◽

Lidia B. Alejo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Effect Size ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Nutrition Intervention ◽

Sitting Time ◽

Post Intervention ◽

University Employees ◽

Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

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