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Comparison of a Behavioral Versus an Educational Weight Management Intervention After Renal Transplantation: A Randomized Controlled Trial.

ABSTRACT: Background:In the first year following renal transplantation, preventing weight gain to minimize overweight or obesity is particularly important. The aim of this study is to test the effect of an 8-month behavioral intervention BMI and physical activity. Methods:This randomized controlled study included 123 adult kidney or kidney-pancreas recipients. Patients were randomized to usual (1 educational session, then weight self-monitoring) and intervention care (usual care plus 7-8 counseling sessions). Alongside weight, body composition, and physical activity, satisfaction and perceptions regarding care were measured at weeks 2-6 (baseline), then at months 8 and 12. Results:Both groups reported comparably high satisfaction. The intervention group (IG) reported more chronic care-related activities. In patients with BMIs ? 18.5, mean weight gain (from baseline) was unexpectedly low in both groups: at month 8, +0.04?kg/m2 in IG patients and +0.14?kg/m2 in the control group (P = 0.590), and respectively, +0.03?kg/m2 and +0.19?kg/m2 at month 12 (P = 0.454). Both groups were physically active, walking averages of 10 807 (IG) and 11 093 (control group) steps per day at month 8 (P = 0.823), and respectively 9773 and 11 217 at month 12 (P = 0.195). Conclusions:The behavioral intervention had high patient acceptance and supported patients in maintaining their weight, but had no superior effect on a single educational session. Further research is needed to assess patient weight gain risk profiles to stratify the intervention.

SUBMITTER: Schmid-Mohler G

PROVIDER: S-EPMC7004588 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Comparison of a Behavioral Versus an Educational Weight Management Intervention After Renal Transplantation: A Randomized Controlled Trial.

Schmid-Mohler Gabriela G Zala Patrizia P Graf Nicole N Witschi Patrick P Mueller Thomas F TF Peter Wüthrich Rudolf R Huber Laura L Fehr Thomas T Spirig Rebecca R

Transplantation direct 20191115 12

<h4>Background</h4>In the first year following renal transplantation, preventing weight gain to minimize overweight or obesity is particularly important. The aim of this study is to test the effect of an 8-month behavioral intervention BMI and physical activity.<h4>Methods</h4>This randomized controlled study included 123 adult kidney or kidney-pancreas recipients. Patients were randomized to usual (1 educational session, then weight self-monitoring) and intervention care (usual care plus 7-8 co ...[more]

PMID: 32095502

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Project description:Heart failure (HF) is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level.In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months. Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success.The primary outcome is the combined incidence of all cause hospitalization and death. Secondary outcomes include HF-related quality of life, HF-related hospitalizations, knowledge regarding HF, self-care behavior, and self-efficacy. The effects of each intervention will be stratified by patient literacy, in order to identify any differential effects.Enrollment of the proposed 660 subjects will continue through the end of 2009. Outcome assessments are projected to be completed by early 2011.ClinicalTrials.gov (http://www.clinicaltrials.gov/) NCT00378950.

Project description:BackgroundLow physical activity and reduced physical functioning are common after renal transplantation, resulting in a reduced quality of life. Another common post-transplantation complication is poor cardio-metabolic health, which plays a main role in long-term outcomes in renal transplant recipients (RTR). It is increasingly recognized that weight gain in the first year after transplantation, especially an increase in fat mass, is a highly common contributor to cardio-metabolic risk. The aim of this study is to compare the outcomes of usual care to the effects of exercise alone, and exercise combined with dietary counseling, on physical functioning, quality of life and post-transplantation weight gain in RTR.MethodsThe Active Care after Transplantation study is a multicenter randomized controlled trial with three arms in which RTR from 3 Dutch hospitals are randomized within the first year after transplantation to usual care, to exercise intervention (3 months supervised exercise 2 times per week followed by 12 months active follow-up), or to an exercise + diet intervention, consisting of the exercise training with additional dietary counseling (12 sessions over 15 months by a renal dietician). In total, 219 participants (73 per group) will be recruited. The primary outcome is the subdomain physical functioning of quality of life, (SF-36 PF). Secondary outcomes include other evaluations of quality of life (SF-36, KDQOL-SF, EQ-5D), objective measures of physical functioning (aerobic capacity and muscle strength), level of physical activity, gain in adiposity (body fat percentage by bio-electrical impedance assessment, BMI, waist circumference), and cardiometabolic risk factors (blood pressure, lipids, glucose metabolism). Furthermore, data on renal function, medical history, medication, psychological factors (motivation, kinesiophobia, coping style), nutrition knowledge, nutrition intake, nutrition status, fatigue, work participation, process evaluation and cost-effectiveness are collected.DiscussionEvidence on the effectiveness of an exercise intervention, or an exercise + diet intervention on physical functioning, weight gain and cardiometabolic health in RTR is currently lacking. The outcomes of the present study may help to guide future evidence-based lifestyle care after renal transplantation.Trial registrationNumber: NCT01047410 .

Project description:BackgroundExcessive gestational weight gain (GWG) is common and can result in maternal and child health complications. Pragmatic behavioral interventions that can be incorporated into standard obstetric care are needed, and financial incentives are a promising approach.ObjectiveThe aim of this study is to evaluate the feasibility of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction, in a behavioral program. The program provided small incentives for meeting behavioral goals of self-weighing and physical activity as well as larger outcome incentives for meeting GWG goals.MethodsWe recruited 40 adult women in their first trimester of pregnancy from February 2019 to September 2019 at an obstetric clinic. Participants were randomized to 3 intervention components using a 2×2×2 factorial design: daily incentives for self-weighing (lottery vs certain loss), incentives for adhering to the Institute of Medicine's GWG guidelines based on BMI category (monthly vs overall), and incentives for reaching physical activity goals (yes vs no). Participants were asked to complete daily weigh-ins using the Withings Body wireless scale provided by the study, as well as wear a physical activity tracker (Fitbit Flex 2). Feasibility outcomes of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction, were assessed. Weight assessments were conducted at baseline, 32-week gestation, and 36-week gestation.ResultsParticipants were enrolled at, on average, 9.6 (SD 1.8) weeks' gestation. Of the 39 participants who were oriented to their condition and received the intervention, 24 (62%) were Black or African American, 30 (77%) were not married, and 29 (74%) had an annual household income of less than US $50,000. Of the 39 participants, 35 (90%) completed the follow-up data collection visit. Participants were generally quite positive about the intervention components, with a particular emphasis on the helpfulness of, and the enjoyment of using, the e-scale in both the quantitative and qualitative feedback. Participants who received the loss incentive, on average, had 2.86 times as many days of self-weighing as those who received the lottery incentive. Participants had a relatively low level of activity, with no difference between those who received a physical activity incentive and those who did not.ConclusionsA financial incentive-based pragmatic intervention was feasible and acceptable for pregnant women for promoting self-weighing, physical activity, and healthy GWG. Participants were successfully recruited early in their first trimester of pregnancy and retained for follow-up data collection in the third trimester. Participants demonstrated promising engagement in self-weighing, particularly with loss-based incentives, and reported finding the self-weighing especially helpful. This study supports further investigation of pragmatic, clinic-based financial incentive-based interventions for healthy GWG behaviors.Trial registrationClinicalTrials.gov NCT03834194; https://clinicaltrials.gov/ct2/show/NCT03834194.

Dataset Information

Comparison of a Behavioral Versus an Educational Weight Management Intervention After Renal Transplantation: A Randomized Controlled Trial.

Publications

Comparison of a Behavioral Versus an Educational Weight Management Intervention After Renal Transplantation: A Randomized Controlled Trial.

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