scholarly journals Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Daniela Saes Sartorelli ◽  
Lívia Castro Crivellenti ◽  
Marina Garcia Manochio-Pina ◽  
Naiara Franco Baroni ◽  
Mariana Rinaldi Carvalho ◽  
...  
Keyword(s):  
Weight Gain ◽  
Pregnant Women ◽  
Pregnancy Outcomes ◽  
Controlled Trial ◽  
Nutritional Intervention ◽  
Physical Activities ◽  
Processed Foods ◽  
Minimally Processed ◽  
Randomized Controlled ◽  
Neonatal Adiposity

Abstract Background Evidence from observational studies suggests that a greater intake of ultra-processed foods during pregnancy is associated with a higher chance of obesity, increased gestational weight gain, and neonatal adiposity. The aim of the present study is to evaluate the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women. Additionally, the effect of the intervention on pregnancy outcomes, neonatal adiposity, and the child’s weight and height will be investigated. Methods This is a two-armed parallel randomized controlled trial that will be conducted at primary health units in Ribeirão Preto, SP, Brazil. Adult pregnant women who are overweight and receiving prenatal care in the public health system will be included. The women will be randomly allocated into control (standard care) or intervention groups. Those enrolled in the intervention group will participate in three individualized nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities. The recruitment of the participants will be carried out at seven health facilities over 12 months, with a sample of 300 women expected. Maternal anthropometric, sociodemographic, blood pressure, biochemical, and lifestyle data will be obtained at baseline (up to the 16th week of gestation), and during a second assessment (34th to 36th gestational week). The neonate body composition will be estimated after birth, and data on pregnancy outcomes, weight and height of children at 6, 12 and 24 months of age will be further obtained from medical records. Discussion This will be the first randomized controlled trial to test the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in adult, overweight, pregnant women. Furthermore, the effect of the intervention on pregnancy outcomes, neonatal adiposity and the child’s weight and height will be evaluated. Trial registration Registro Brasileiro de Ensaios Clínicos (Rebec) RBR-2w9bhc July 30th 2018 (http://www.ensaiosclinicos.gov.br/rg/?q=RBR-2w9bhc+), and RBR-7yx36h June 4th 2019 (http://www.ensaiosclinicos.gov.br/rg/?q=RBR-7yx36h+0.

scholarly journals Evaluating Engagement in a Digital and Dietetic Intervention Promoting Healthy Weight Gain in Pregnancy: Mixed Methods Study (Preprint)

2020 ◽  
Author(s):  
Jane C Willcox ◽  
Daniel Chai ◽  
Lawrence J Beilin ◽  
Susan L Prescott ◽  
Desiree Silva ◽  
...  
Keyword(s):  
Weight Gain ◽  
Qualitative Analysis ◽  
Pregnant Women ◽  
Digital Media ◽  
Intervention Program ◽  
Controlled Trial ◽  
Cost Effective ◽  
Lifestyle Interventions ◽  
Healthy Weight ◽  
Randomized Controlled

BACKGROUND Early excess and inadequate gestational weight gain (GWG) have been associated with negative outcomes for mother and child. The use of digital media to deliver pregnancy lifestyle interventions is increasing, but there is little data on participant engagement. The Pregnancy Lifestyle Activity and Nutrition (PLAN) intervention pilot study was an electronic health and dietetic-delivered intervention program promoting healthy GWG in early pregnancy. OBJECTIVE This study aims to explore the interactions of participants with the program and to assess its acceptability. METHODS This study uses both quantitative and qualitative methods using data from parent randomized controlled trial (ACTRN12617000725369). Quantitative data from 22 participants in the intervention arm who completed the study provided measures of the interactions participants had with the digital components of the program and with dietetic consultations. A descriptive qualitative analysis employed semistructured interviews with 9 participants to elicit views on the acceptability of the intervention and its components. RESULTS The electronic delivery of information and recording of weight from 8 to 20 weeks of gestation were universally accepted. Component (face-to-face dietitian, weight tracker, website information delivery, and SMS goal prompting) acceptability and engagement differed between individuals. A total of 4 key themes emerged from the qualitative analysis: supporting lifestyle change, component acceptability and value, delivery platforms, and engagement barriers. CONCLUSIONS The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women. Individuals responded differently to various components, emphasizing the importance of including women in the development of lifestyle interventions and allowing participants to choose and tailor programs. Larger randomized controlled trials using these insights in a broader section of the community are needed to inform the iterative development of practical, time-efficient, and cost-effective ways of supporting optimal GWG with the potential to optimize outcomes for pregnant women and their child.

scholarly journals Individually Tailored, Adaptive Intervention to Manage Gestational Weight Gain: Protocol for a Randomized Controlled Trial in Women With Overweight and Obesity (Preprint)

2017 ◽  
Author(s):  
Danielle Symons Downs ◽  
Jennifer S Savage ◽  
Daniel E Rivera ◽  
Joshua M Smyth ◽  
Barbara J Rolls ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Pregnant Women ◽  
Healthy Eating ◽  
Controlled Trial ◽  
Overweight And Obesity ◽  
Adaptive Intervention ◽  
Gestational Weight ◽  
Randomized Controlled

BACKGROUND High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain. OBJECTIVE The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity. METHODS The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain. RESULTS Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018. CONCLUSIONS This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application. REGISTERED REPORT IDENTIFIER RR1-10.2196/9220

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