scholarly journals Baby’s first bites: a randomized controlled trial to assess the effects of vegetable-exposure and sensitive feeding on vegetable acceptance, eating behavior and weight gain in infants and toddlers

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
S. M. C. van der Veek ◽  
C. de Graaf ◽  
J. H. M. de Vries ◽  
G. Jager ◽  
C. M. J. L. Vereijken ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Eating Behavior ◽  
Controlled Trial ◽  
Infants And Toddlers ◽  
Randomized Controlled

scholarly journals The INTER-ACT E-Health Supported Lifestyle Intervention Improves Postpartum Food Intake and Eating Behavior, but Not Physical Activity and Sedentary Behavior—A Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1287
Author(s):  
Margriet Bijlholt ◽  
Lieveke Ameye ◽  
Hanne Van Uytsel ◽  
Roland Devlieger ◽  
Annick Bogaerts
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Food Intake ◽  
Eating Behavior ◽  
Controlled Trial ◽  
Gestational Weight ◽  
Randomized Controlled ◽  
Excessive Gestational Weight Gain

Unhealthy postpartum lifestyle is related to long-term adverse psychological, metabolic and cardiovascular health outcomes as well as to complications in the next pregnancy. Especially women with preceding excessive gestational weight gain are at risk. This paper aims to evaluate the effect of the postpartum phase of the INTER-ACT randomized controlled trial (RCT) on food intake, eating behavior, physical activity and sedentary time at the end of the intervention (six months postpartum) and at six-months follow-up (12 months postpartum). The study population comprised women with excessive gestational weight gain in the preceding pregnancy. The lifestyle intervention combined a smartphone application with four face-to-face coaching sessions between six weeks and six months postpartum. After the intervention, restrained eating score was 1 point higher (95% CI 0.5, 1.5; p < 0.001), uncontrolled eating score was 1 point lower (95% CI −1.9, −0.2; p = 0.02) and energy intake was 69 kcal lower (95% CI −123, −15; p = 0.01) in the intervention group compared to the control group. The differences were no longer statistically significant at follow-up. No significant effects on emotional eating, physical activity and sedentary behavior were found. In conclusion, the postpartum phase of the INTER-ACT RCT was effective in improving nutrition-related outcomes, however, these improvements could not be sustained at follow-up. ClinicalTrials.gov identifier: NCT02989142.

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

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

scholarly journals Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial

2020 ◽  
Vol 7 ◽  
pp. 205435812094043
Author(s):  
A. Dave Nagpal ◽  
Andrea Cowan ◽  
Linna Li ◽  
Graeme Nusca ◽  
Linrui Guo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Weight Gain ◽  
Controlled Trial ◽  
Coronary Revascularization ◽  
Small Sample ◽  
Resource Limitations ◽  
Randomized Controlled ◽  
Surgery Patient ◽  
Double Blinded

Background: Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a “real-world” trial in cardiac surgery. Objective: We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient. Design: A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy. Setting: A large tertiary academic center in London Ontario between September 2009 and February 2011. Participants: Patients undergoing planned, isolated coronary revascularization. Measurements: Serum creatinine and patient weight were measured daily postoperatively. Methods: Patients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization. Results: The study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, “risk” occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9; P = 1.00), whereas “injury” occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups. Limitations: The study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes. Conclusions: This pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.

Limiting Excess Weight Gain in High-Risk Pregnancies: A Randomized Controlled Trial

2011 ◽  
pp. P1-466-P1-466
Author(s):  
Cheryce L Harrison ◽  
Catherine B Lombard ◽  
Melanie Gibson-Helm ◽  
Amanda Deeks ◽  
Helena J Teede
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
High Risk ◽  
Controlled Trial ◽  
Excess Weight ◽  
Randomized Controlled ◽  
Excess Weight Gain

scholarly journals Targeted prevention of excess weight gain and eating disorders in high-risk adolescent girls: a randomized controlled trial

2014 ◽  
Vol 100 (4) ◽  
pp. 1010-1018 ◽  
Author(s):  
Marian Tanofsky-Kraff ◽  
Lauren B Shomaker ◽  
Denise E Wilfley ◽  
Jami F Young ◽  
Tracy Sbrocco ◽  
...  
Keyword(s):  
Eating Disorders ◽  
Randomized Controlled Trial ◽  
Weight Gain ◽  
High Risk ◽  
Adolescent Girls ◽  
Controlled Trial ◽  
Excess Weight ◽  
Targeted Prevention ◽  
Randomized Controlled ◽  
Excess Weight Gain

Use and effect of web-based embodied conversational agents for improving eating behavior and decreasing loneliness among community-dwelling older adults: A randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Lean L. Kramer ◽  
Lex van Velsen ◽  
Jenna L. Clark ◽  
Bob C. Mulder ◽  
Emely de Vet
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Eating Behavior ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Embodied Conversational Agents ◽  
Conversational Agents ◽  
Web Based ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

BACKGROUND Embodied conversational agents (ECAs) have been proposed as a promising interaction modality for the delivery of programs focused on promoting lifestyle changes. However, it is not understood which factors influence use of an ECA and their health effects. OBJECTIVE We aim to (1) identify whether ECAs can persuade community-dwelling older adults to change their dietary behavior and whether ECAs use can decrease loneliness, (2) test these pathways to effects, and (3) understand the use of an ECA. METHODS The web-based eHealth app PACO is a fully automated 8-week intervention in which 2 ECAs engage older adults in dialogue to motivate them to change their dietary behavior and decrease their loneliness. PACO was developed via a human-centered and stakeholder-inclusive design approach and incorporates Self-determination Theory and various behavior change techniques For this study, an unblinded web-based randomized controlled trial was conducted. Participants were recruited via social media, an online panel, flyers and advertorials. The intervention group received access to the PACO service for eight weeks. The waitlist group received PACO after waiting for four weeks. The primary outcomes, eating behavior and loneliness, were assessed via self-assesed online questionnaires at intake, waitlist, after 4 weeks, and after eight weeks. In addition, the primary outcome—use—was assessed via data logs. Secondary outcomes were measured at the same times, via questionnaires or an optional interview. RESULTS In total, 32 participants completed the intervention. We found a significant correlation between use in minutes on the one hand, and perceived usefulness (r = .39, P =.030) and enjoyment on the other (r = .38, P = .032). However, these did not predict use in the full regression model (F(2,29) = 1.98, P = .16, R2 = .12). Additionally, PACO use did not lead to improvements in eating behavior (χ2(2) = .34, = .85) or a decrease in loneliness (χ2(2) = .02, = .99). CONCLUSIONS Our study did not provide any concluding evidence about factors that are linked to the use or health effects of ECAs. Future service design could benefit from either creating a functional design catered towards the predominant stage of the targeted population, or by personalizing the service based on an intake in which the end-user’s stage is determined. CLINICALTRIAL ClinicalTrials.gov NCT04510883; https://clinicaltrials.gov/ct2/show/NCT04510883 INTERNATIONAL REGISTERED REPORT RR2-10.2196/22186

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