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The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial.

ABSTRACT: Background:Both obesity and congenital heart disease (CHD) are risk factors for the long-term cardiovascular health of children and adolescents. The addition of smart mobile technology to conventional lifestyle counseling for weight management offers great potential to appeal to technologically literate youth and can address a large geographical area with minimal burden to participants. This pilot study seeks to examine the influence of a 1-year lifestyle intervention on nutrition and physical activity-related health outcomes in overweight or obese children and adolescents with CHD. Methods:This is a pilot and feasibility study which utilizes a single-arm, prospective design with a goal to recruit 40 overweight and obese patients. The feasibility metrics will evaluate the integrity of the study protocol, data collection and questionnaires, recruitment and consent, and acceptability of the intervention protocol and primary outcome measures. The primary clinical outcome metrics are anthropometry, body composition, and cardiorespiratory exercise capacity. The secondary clinical metrics include quality of life, nutrition and physical activity behavior, lung and muscle function, and cardio-metabolic risk factors. Outcomes are assessed at baseline, 6 months, and 1 year. To date, a total of 36 children and youth (11 girls), aged 7-17 years (mean = 14.4 years), have commenced the intervention. Recruitment for the study was initiated in June 2012 and is currently ongoing. Discussion:The information provided in this paper is intended to help researchers and health professionals with the development and evaluation of similar lifestyle intervention programs. Since the application of smartphones to pediatric cardiac health and obesity management is a novel approach, and continued research in this area is warranted, this paper may serve as a foundation for further exploration of this health frontier and inform the development of a broader strategy for obesity management in pediatric cardiology. Trial registration:This pilot study was retrospectively registered at the www.ClinicalTrials.gov registry as NCT02980393 in November 2016, with the study commencing in May 2012. Study protocol version 15OCT2014.

SUBMITTER: Rombeek M

PROVIDER: S-EPMC5688613 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial.

Rombeek Meghan M De Jesus Stefanie S Altamirano-Diaz Luis L Welisch Eva E Prapavessis Harry H Seabrook Jamie A JA Norozi Kambiz K

Pilot and feasibility studies 20171115

<h4>Background</h4>Both obesity and congenital heart disease (CHD) are risk factors for the long-term cardiovascular health of children and adolescents. The addition of smart mobile technology to conventional lifestyle counseling for weight management offers great potential to appeal to technologically literate youth and can address a large geographical area with minimal burden to participants. This pilot study seeks to examine the influence of a 1-year lifestyle intervention on nutrition and ph ...[more]

PMID: 29167745

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Project description:BackgroundThe global epidemic of type 2 diabetes (T2D) and obesity has been translated into pregnancy, with approximately 18% of women being diagnosed worldwide with Gestational Diabetes Mellitus (GDM). Whilst preventive strategies have proven effective in the non-pregnant context, attrition rates are high and there is an urgent need to develop a customized, pragmatic lifestyle intervention for women both during and after pregnancy. Diet and exercise modification, behavioral support, and Commercial Weight Management Organizations have been strongly recommended to aid postpartum weight reduction for mothers with previous GDM, subsequently reducing their risk of developing obesity and T2D. This study, informed by a previous pilot study, aims to determine the effectiveness of a pragmatic pregnancy and postpartum lifestyle modification program for overweight women with previous GDM (PAIGE2) to reduce body weight at 12 months postpartum.Methods/designThis paper summarizes the protocol for the PAIGE2 study, which has been developed based on results from a pilot study (PAIGE). A six center, two parallel arm, 12-month, randomized controlled trial will be conducted across Northern Ireland and the Republic of Ireland (3 centers each), involving 340 women with GDM and body mass index ≥25 kg/m2 recruited during pregnancy. The lifestyle intervention involves a one-hour virtual educational program (to take place at 32-36 weeks gestation). Postpartum, the intervention will include monthly phone calls, weekly motivational text messages, weekly step counts, and referral for three months to a Commercial Weight Management Organization (Slimming World). The control arm will receive usual care as offered by the local maternity hospital. The primary outcome is weight loss at 12 months postpartum. Study visits for anthropometric and clinical measurements, fasting blood samples, questionnaires pertaining to health, wellbeing and physical activity will take place at 6 weeks, 6- and 12-months postpartum. Focus groups will be conducted with intervention mothers' post-intervention to determine the acceptability of the study design including utility of a Commercial Weight Management Organization, feasibility of remote patient contact, family involvement and patient satisfaction.DiscussionThe PAIGE2 study will address the gaps in previously conducted research and, if positive, has the potential to have major public health implications for the prevention of future GDM and subsequent T2D.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04579016?term=NCT04579016&draw=2&rank=1, identifier NCT04579016.

Project description:BackgroundFew studies have examined dietary data or objective measures of physical activity (PA) and sedentary behavior among metabolically healthy overweight/obese (MHO) and metabolically unhealthy overweight/obese (MUO). Thus, the purpose is to determine whether PA, sedentary behavior and/or diet differ between MHO and MUO in a sample of young women.MethodsForty-six overweight/obese (BMI ?25 kg/m2) African American and Caucasian women 19-35 years were classified by cardiometabolic risk factors, including elevated blood pressure, triglyceride, glucose and C-reactive protein, low high density lipoprotein, and insulin resistance (MUO ?2; MHO, <2). Time (mins/day) in light, moderate, vigorous PA, and sedentary behavior were estimated using an accelerometer (?3 days; ?8 hrs wear time). Questionnaires were used to quantify sitting time, TV/computer use and usual daily activity. The Block Food Frequency Questionnaire assessed dietary food intake. Differences between MHO and MUO for lifestyle behaviors were tested with linear regression (continuous data) or logistic regression (categorical data) after adjusting for age, race, BMI, smoking and accelerometer wear and/or total kilocalories, as appropriate.ResultsWomen were 26.7±4.7 years, with a mean BMI of 31.1±3.7 kg/m2, and 61% were African American. Compared to MUO (n = 9), MHO (n = 37; 80%) spent less mins/day in sedentary behavior (difference: -58.1±25.5, p = 0.02), more mins/day in light PA (difference: 38.2±16.1, p = 0.02), and had higher daily METs (difference: 0.21±0.09, p = 0.03). MHO had higher fiber intakes (g/day of total fiber, soluble fiber, fruit/vegetable fiber, bean fiber) and daily servings of vegetables; but lower daily dairy servings, saturated fat, monounsaturated fat and trans fats (g/day) compared to MUO.ConclusionCompared to MUO, MHO young women demonstrate healthier lifestyle habits with less sedentary behavior, more time in light PA, and healthier dietary quality for fat type and fiber. Future studies are needed to replicate findings with larger samples that include men and women of diverse race/ethnic groups.

Project description:The proportion of women entering pregnancy overweight or obese has been rising and, in turn, is associated with adverse maternal and fetal outcomes. Gestational weight gain (GWG) exceeding Institute of Medicine (IOM) guidelines further increases health risks and has been independently associated with postpartum weight retention. Hispanic women are disproportionately affected by overweight and obesity, but have had limited access to interventions that promote healthy lifestyles due to cultural, socioeconomic, and language barriers. Therefore, the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce excess GWG, increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.Overweight/obese Hispanic women are recruited in early pregnancy and randomly assigned to a Lifestyle Intervention (n = 150) or a Comparison Health and Wellness (control) intervention (n = 150). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) are used to deliver the intervention from early pregnancy (12 weeks gestation) to 6 months postpartum, with follow-up to 1 year postpartum. Targets of the intervention are to achieve IOM Guidelines for GWG and postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies to address the specific social, cultural, and economic challenges faced by low-income Hispanic women. Assessments are conducted at baseline (~10 weeks gestation), mid pregnancy (24-28 weeks gestation), late pregnancy (32-34 weeks gestation) and postpartum at 6-weeks, 6-months, and 12-months by bicultural and bilingual personnel blinded to the intervention arm. Efficacy is assessed via GWG, postpartum weight loss, and biomarkers of glycemic control, insulin resistance, and cardiovascular disease risk factors. Changes in physical activity and diet are measured via 7-day accelerometer data and 24-h dietary recalls at each assessment time period.Hispanic women are the fastest growing minority group in the U.S. and are disproportionately affected by overweight and obesity. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.NCT01868230 May 29, 2013.

Project description:BackgroundTo tackle the problem of obesity and related diseases in Switzerland, cost-efficient, effective, and innovative primary health care interventions for weight management are required. In this context, Oviva has developed a scalable technology for registered dietitians to counsel overweight and obese patients via a mobile phone app.ObjectiveThe aim of this study was to evaluate the effectiveness and feasibility of weight loss counseling by dietitians using a mobile phone app for patients with overweight and obesity.MethodsIn this pre- and posttest pilot study, overweight and obese adults participated in a 1-year behavioral intervention to lose weight through remote counseling by dietitians in the German-speaking part of Switzerland. The study started in April 2016 and finished in May 2018. Participants received individual counseling through the app and the exchange with the dietitian focused on regular feedback on photo-based food log, motivation, and education. The contents were tailored to the individual lifestyle goal set. The predefined intensity of remote counseling decreased during the year. Group chat could be used. The outcomes examined were changes in weight (primary outcome), hemoglobin A1c, fasting glucose, fasting insulin, triglyceride, high-density lipoprotein cholesterol, blood pressure (BP), body mass index (BMI), waist circumference, body fat, and responses to a self-administered questionnaire with questions regarding participants' physical activity, dietary assessment, and health-related quality of life. Changes were tested at baseline, after 3 months, and after 12 months, as well as between the third and the 12th month.ResultsIn total, 36 women and 7 men, with a mean age of 40.6 years, participated and 36 participants completed the study. Median weight change after the first 12 weeks was -3.8 kg (range: -15 to 2.4 and P<.001), between week 12 and week 52 it was -1.1 kg (range: -9.7 to 7 and P=.08), and the median change during the entire period of intervention was -4.9 kg (range: -21.9 to 7.5 and P<.001). Furthermore, changes in BMI, waist circumference, body fat, and BP between baseline and 12 weeks and between baseline and 52 weeks were also significant. Significant changes in certain eating habits were also demonstrated (higher frequency of vegetable, fruit, and breakfast consumption and lower frequency of alcohol, sweet, and fat consumption).ConclusionsIn addition to the professional skills of a dietitian, a profession-specific app such as Oviva can provide effective support that meets the needs of dietitians and clients on the long path of behavioral change and sustainable weight reduction.Trial registrationClinicalTrials.gov NCT02694614; https://clinicaltrials.gov/ct2/show/NCT02694614 (Archived by WebCite at http://www.webcitation.org/76gYkGOIc).

Project description:IntroductionChanges in social and lifestyle factors have led to increasing rates of metabolic and mental health problems. We hypothesise that a transformation of the current maternal and child health system is required to deliver interventions that effectively promote a good start to life in populations at risk of metabolic and mental health problems. We describe a single-arm implementation study 'Healthy Early Life Moments in Singapore', which aims to examine whether an integrated lifestyle intervention initiated at preconception and continuing throughout pregnancy and postpartum periods can improve the metabolic and mental health of overweight and obese women, and improve early child growth.Methods and analysisThis single-centre implementation trial is conducted at KK Women's and Children's Hospital, Singapore. The trial aims to recruit 500 women, aged 21-40 years with a body mass index of 25-40 kg/m2 who plan to get pregnant, with interventions delivered before conception, until 18 months postdelivery. Primary outcomes comprise pregnancy rate, maternal metabolic and mental health status. Secondary outcomes include maternal reproductive health, pregnancy outcomes and offspring growth. The intervention will be delivered using a mobile health application, to provide anticipatory guidance, raise awareness and guide goal-setting on lifestyle behaviours that include diet, physical activity, mental wellness and sleep hygiene from preconception to postpartum. Women who conceive within 1 year of recruitment will be followed through pregnancy and studied with their infants at six-time points during the first 18 months of life. Questionnaires, anthropometric measurements and multiple biosamples will be collected at each visit.Ethics and disseminationThe study has been approved by the Centralised Institutional Review Board of SingHealth (2021/2247). Written informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and disseminated to national and international policy makers.Trial registration numberNCT05207059.

Dataset Information

The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial.

Publications

The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial.

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