Dataset Information

Efficacy of an Internet-Based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: Study Protocol for a Randomised Controlled Trial.

ABSTRACT: Background: Infertility is estimated to affect 15% of couples of reproductive age. Weight management problems (being obese or overweight) are among the problems that produce infertility, both in women seeking spontaneous pregnancy and in those undergoing assisted reproduction techniques. Over the last few decades, the prevalence of obesity has increased alarmingly in our society and is now considered one of the most important public health problems. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women. In other population groups, it has been shown that Internet-based interventions are just as effective as traditional ones, and these cover a larger population with a good cost-benefit ratio. However, to the best of our knowledge, no studies so far have analysed any specific online interventions for this group of infertile women. Thus, the objective of this project will be to evaluate the effectiveness of an online program to promote a healthy lifestyle among women who are overweight or obese who also have a diagnosis of infertility and are on the waiting list for in vitro fertilisation treatment. Methods: This will be a randomised controlled clinical trial conducted in 94 women which will compare a self-administered Internet-based intervention promoting a healthy lifestyle in terms of diet and exercise (n = 47) to a control group that will receive standard medical care. The online program will comprise nine modules, will last for 3 months, and will be monitored every 3 months after the intervention until the final follow-up at 12 months. The main outcome will be the spontaneous pregnancy rate. Secondary outcomes will include changes in body composition, dietary and physical exercise habits, glycaemic profiles, lipid profiles, hormonal profiles, and patient quality of life related to their fertility problems. The data analysis will be done on an intention-to-treat basis. Discussion: The aim of this study is to increase our knowledge of the effectiveness of online interventions specifically adapted to infertile women who are overweight or obese in the promotion of healthy lifestyles.

SUBMITTER: Bivia-Roig G

PROVIDER: S-EPMC7696477 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Efficacy of an Internet-Based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: Study Protocol for a Randomised Controlled Trial.

Biviá-Roig Gemma G Blasco-Sanz Ruth R Boldó-Roda Ana A Vara M Dolores MD Escrivá-Martínez Tamara T Herrero Rocío R La Rosa Valentina Lucia VL Baños Rosa M RM Lisón Juan Francisco JF

International journal of environmental research and public health 20201110 22

<i>Background:</i> Infertility is estimated to affect 15% of couples of reproductive age. Weight management problems (being obese or overweight) are among the problems that produce infertility, both in women seeking spontaneous pregnancy and in those undergoing assisted reproduction techniques. Over the last few decades, the prevalence of obesity has increased alarmingly in our society and is now considered one of the most important public health problems. The combination of diet and exercise to ...[more]

PMID: 33561055

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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:BACKGROUND: There is a need to develop sustainable and clinically effective weight management interventions that are suitable for delivery in community settings where the vast majority of overweight and obese adolescents should be treated. This study aims to evaluate the effect of additional therapeutic contact as an adjunct to the Loozit group program -- a community-based, lifestyle intervention for overweight and lower grade obesity in adolescents. The additional therapeutic contact is provided via telephone coaching and either mobile phone Short Message Service or electronic mail, or both. METHODS AND DESIGN: The study design is a two-arm randomised controlled trial that aims to recruit 168 overweight and obese 13-16 year olds (Body Mass Index z-score 1.0 to 2.5) in Sydney, Australia. Adolescents with secondary causes of obesity or significant medical illness are excluded. Participants are recruited via schools, media coverage, health professionals and several community organisations. Study arm one receives the Loozit group weight management program (G). Study arm two receives the same Loozit group weight management program plus additional therapeutic contact (G+ATC). The 'G' intervention consists of two phases. Phase 1 involves seven weekly group sessions held separately for adolescents and their parents. This is followed by phase 2 that involves a further seven group sessions held regularly, for adolescents only, until two years follow-up. Additional therapeutic contact is provided to adolescents in the 'G+ATC' study arm approximately once per fortnight during phase 2 only. Outcome measurements are assessed at 2, 12 and 24 months post-baseline and include: BMI z-score, waist z-score, metabolic profile indicators, physical activity, sedentary behaviour, eating patterns, and psychosocial well-being. DISCUSSION: The Loozit study is the first randomised controlled trial of a community-based adolescent weight management intervention to incorporate additional therapeutic contact via a combination of telephone coaching, mobile phone Short Message Service, and electronic mail. If shown to be successful, the Loozit group weight management program with additional therapeutic contact has the potential to be readily translatable to a range of health care settings. TRIAL REGISTRATION: The protocol for this study is registered with the Australian Clinical Trials Registry (ACTRNO12606000175572).

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:ObjectivesTo assess, in terms of self-efficacy in weight management, the effectiveness of the SLIM lifestyle intervention among overweight or obese women during pregnancy and after delivery, and further to exploit machine learning and event mining approaches to build personalized models. Additionally, the aim is to evaluate the implementation of the SLIM intervention.MethodsThis prospective trial, which is a non-randomized, quasi-experimental, pre-post intervention, includes an embedded mixed-method process evaluation. The SLIM Intervention is delivered by public health nurses (n = 9) working in maternity clinics. The public health nurses recruited overweight women (n = 54) at their first antenatal visit using convenience sampling. The core components of the intervention i.e. health technology, motivational interviewing, feedback, and goal setting, are utilized in antenatal visits in maternity clinics starting from gestational week 15 or less and continuing to 12 weeks after delivery. Mixed effect models are used to evaluate change over time in self-efficacy, weight management and weight change. Simple mediation models are used to assess calories consumed and moderate to vigorous physical activity (MVPA) as mediators between self-efficacy and weight change. Signal processing and machine learning techniques are exploited to extract events from the data collected via the Oura ring and smartphone-based questionnaires.DiscussionThe SLIM intervention was developed in collaboration with overweight women and public health nurses working in maternity clinics. This study evaluates the effectiveness of the intervention among overweight women in increasing self-efficacy and achieving a healthy weight; thus, impacting the healthy lifestyle and long-term health of the whole family. The long-term objective is to contribute to women's health by supporting weight-management through behavior change via interventions conducted in maternity clinics.Trial registrationThe trial was registered at the Clinicaltrials.gov register platform (ID NCT04826861) on 17 March 2021.

Project description:BackgroundThe prevalence of overweight and obesity is on the rise worldwide with severe physical and psychosocial consequences. One of the most dangerous is hypertension. Lifestyle changes related to eating behaviour and physical activity are the critical components in the prevention and treatment of hypertension and obesity. Data indicates that the usual procedures to promote these healthy habits in health services are either insufficient or not efficient enough. Internet has been shown to be an effective tool for the implementation of lifestyle interventions based on this type of problem. This study aims to assess the efficacy of a totally self-administered online intervention programme versus the usual medical care for obese and overweight participants with hypertension (from the Spanish public health care system) to promote healthy lifestyles (eating behaviour and physical activity).MethodA randomized controlled trial will be conducted with 100 patients recruited from the hypertension unit of a public hospital. Participants will be randomly assigned to one of two conditions: a) SII: a self-administered Internet-based intervention protocol; and b) MUC-medical usual care. The online intervention is an Internet-delivered, multimedia, interactive, self-administered programme, composed of nine modules designed to promote healthy eating habits and increase physical activity. The first five modules will be activated at a rate of one per week, and access for modules 5 to 9 will open every two weeks. Patients will be assessed at four points: before the intervention, after the intervention (3 months), and at 6 and 12 months (follow-up). The outcome variables will include blood pressure, and Body Mass Index, as primary outcome measures, and quality of life and other lifestyle and anthropometrical variables as secondary outcome measures.DiscussionThe literature highlights the need for more studies on the benefits of using the Internet to promote lifestyle interventions. This study aims to investigate the efficiency of a totally self-administered Internet - +based programme for promoting healthy habits and improving the medical indicators of a hypertensive and overweight population.Trial registrationNCT02445833.

Dataset Information

Efficacy of an Internet-Based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: Study Protocol for a Randomised Controlled Trial.

Publications

Efficacy of an Internet-Based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: Study Protocol for a Randomised Controlled Trial.

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