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The Feasibility and Preliminary Efficacy of an eHealth Lifestyle Program in Women with Recent Gestational Diabetes Mellitus: A Pilot Study.

ABSTRACT: Self-administered eHealth interventions provide a potential low-cost solution for reducing diabetes risk. The aim of this pilot randomised controlled trial (RCT) was to evaluate the feasibility, including recruitment, retention, preliminary efficacy (primary outcome) and acceptability (secondary outcome) of the "Body Balance Beyond" eHealth intervention in women with previous gestational diabetes mellitus (GDM). Women with overweight/obesity who had recent GDM (previous 24 months) were randomised into one of three groups: 1) high personalisation (access to "Body Balance Beyond" website, individual telehealth coaching via video call by a dietitian and exercise physiologist, and text message support); 2) low personalisation (website only); or 3) waitlist control. To evaluate preliminary efficacy, weight (kg), glycosylated hemoglobin, type A1C (HbA1c), cholesterol (total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL)), diet quality and moderate-vigorous physical activity were analysed at baseline and at 3 and 6 months using generalised linear mixed models. To investigate acceptability, process evaluation was conducted at 3 and 6 months. Of the 327 potential participants screened, 42 women (mean age 33.5 ± 4.0 years and BMI 32.4 ± 4.3 kg/m2) were randomised, with 30 (71%) completing the study. Retention at 6 months was 80%, 54% and 79% for high personalisation, low personalisation and waitlist control, respectively (reasons: personal/work commitments, n = 4; started weight-loss diet, n = 1; pregnant, n = 1; resources not useful, n = 1; and not contactable, n = 5). No significant group-by-time interactions were observed for preliminary efficacy outcomes, with the exception of HDL cholesterol, where a difference favoured the low personalisation group relative to the control (p = 0.028). The majority (91%) of women accessed the website in the first 3 months and 57% from 4-6 months. The website provided useful information for 95% and 92% of women at 3 and 6 months, respectively, although only a third of women found it motivating (30% and 25% at 3 and 6 months, respectively). Most women agreed that the telehealth coaching increased their confidence for improving diet (85%) and physical activity (92%) behaviours, although fewer women regarded the text messages as positive (22% and 31% for improving diet and physical activity, respectively). The majority of women (82% at 3 months and 87% at 6 months) in the high personalisation group would recommend the program to other women with GDM. Recruiting and retaining women with a recent diagnosis of GDM is challenging. The "Body Balance Beyond" website combined with telehealth coaching via video call is largely acceptable and useful for women with recent GDM. Further analysis of the effect on diabetes risk reduction in a larger study is needed.

SUBMITTER: Rollo ME

PROVIDER: S-EPMC7579575 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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The Feasibility and Preliminary Efficacy of an eHealth Lifestyle Program in Women with Recent Gestational Diabetes Mellitus: A Pilot Study.

Rollo Megan E ME Baldwin Jennifer N JN Hutchesson Melinda M Aguiar Elroy J EJ Wynne Katie K Young Ashley A Callister Robin R Haslam Rebecca R Collins Clare E CE

International journal of environmental research and public health 20200928 19

Self-administered eHealth interventions provide a potential low-cost solution for reducing diabetes risk. The aim of this pilot randomised controlled trial (RCT) was to evaluate the feasibility, including recruitment, retention, preliminary efficacy (primary outcome) and acceptability (secondary outcome) of the "Body Balance Beyond" eHealth intervention in women with previous gestational diabetes mellitus (GDM). Women with overweight/obesity who had recent GDM (previous 24 months) were randomise ...[more]

PMID: 32998401

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Project description:BACKGROUND:A history of gestational diabetes mellitus (GDM) has been related to an elevated risk of type 2 diabetes. The melanocortin-4 receptor (MC4R) genotype has been related to glycemic changes in women with prior GDM. OBJECTIVE:The objective of this study was to analyze whether lifestyle intervention modified the association between the MC4R genotype and changes in insulin sensitivity among women with prior GDM. METHODS:We genotyped MC4R rs6567160 and measured glucose and insulin in fasting plasma samples at baseline and during the first 2 follow-up visits in 1128 women with prior GDM. They were randomly assigned to either a 4-y lifestyle intervention involving both diet and physical activity or a control group from a randomized clinical trial, the Tianjin Gestational Diabetes Mellitus Prevention Program. We analyzed the interaction between the MC4R genotype and lifestyle intervention on changes in insulin resistance. RESULTS:From baseline to 1.28 y, the MC4R genotype was related to changes in fasting insulin, HOMA-IR, and homeostasis model assessment of β cell function (HOMA-B) in the intervention group. Each risk allele (C) of rs6567160 was associated with a 0.08-unit greater decrease in log(insulin), log(HOMA-IR), and log(HOMA-B) (P = 0.02, 0.04, and 0.04, respectively), whereas in the control group, each C allele tended to be associated with a greater increase in HOMA-IR (P = 0.09). We found significant interactions between the MC4R genotype and lifestyle intervention on 1.28-y changes in fasting insulin and HOMA-IR (P = 0.006 and 0.008, respectively), and such interaction remained significant when we analyzed the trajectory of changes in insulin and HOMA-IR from baseline to 2.55 y (both P = 0.03). CONCLUSIONS:The exploratory results from the first 2 follow-up visits indicate that women with prior GDM carrying a diabetes-increasing MC4R genotype (CC or TC) may obtain better improvement than the TT genotype in insulin resistance through lifestyle intervention. This trial was registered at clinicaltrials.gov as NCT01554358.

Project description:ObjectiveThe postpartum period is a window of opportunity for diabetes prevention in women with recent gestational diabetes (GDM), but recruitment for clinical trials during this period of life is a major challenge.MethodsWe adapted a social-ecologic model to develop a multi-level recruitment strategy at the macro (high or institutional level), meso (mid or provider level), and micro (individual) levels. Our goal was to recruit 100 women with recent GDM into the Balance after Baby randomized controlled trial over a 17-month period. Participants were asked to attend three in-person study visits at 6 weeks, 6, and 12 months postpartum. They were randomized into a control arm or a web-based intervention arm at the end of the baseline visit at six weeks postpartum. At the end of the recruitment period, we compared population characteristics of our enrolled subjects to the entire population of women with GDM delivering at Brigham and Women's Hospital (BWH).ResultsWe successfully recruited 107 of 156 (69 %) women assessed for eligibility, with the majority (92) recruited during pregnancy at a mean 30 (SD ± 5) weeks of gestation, and 15 recruited postpartum, at a mean 2 (SD ± 3) weeks postpartum. 78 subjects attended the initial baseline visit, and 75 subjects were randomized into the trial at a mean 7 (SD ± 2) weeks postpartum. The recruited subjects were similar in age and race/ethnicity to the total population of 538 GDM deliveries at BWH over the 17-month recruitment period.ConclusionsOur multilevel approach allowed us to successfully meet our recruitment goal and recruit a representative sample of women with recent GDM. We believe that our most successful strategies included using a dedicated in-person recruiter, integrating recruitment into clinical flow, allowing for flexibility in recruitment, minimizing barriers to participation, and using an opt-out strategy with providers. Although the majority of women were recruited while pregnant, women recruited in the early postpartum period were more likely to present for the first study visit. Given the increased challenges of recruiting postpartum women with GDM into research studies, we believe our findings will be useful to other investigators seeking to study this population.

Project description:BackgroundThere is growing attention to the use of mHealth technologies to promote glycemic control for women with GDM around the world, but research on promoting a change in health behaviors is lacking. This study aimed to document the process of designing, developing, and testing the feasibility and acceptability of the SEESPA.MethodsThis single-arm pilot clinical trial study included 15 pregnant women with GDM. Following SEESPA development (e.g., goal setting and action plan, role modeling, motivational messages, mastery of experiences, and tracking healthy behaviors), all participants were provided access to use the SEESPA for 4 weeks. Feasibility outcomes assessed were rates of recruitment, retention rate, success rate of transmitting motivational text messages, rate of participants acknowledging receipt of text messages, and success rate of recording healthy behaviors. Acceptability outcomes were determined by asking open-ended questions through telephone interview at 4-week post-intervention.ResultsFifteen randomly selected women consented to participate in the study, with a 60.0% (n = 9) retention rate at post-trial intervention and 40.0% (n = 6) trial dropout. Two motivational text messages per week were sent to all participants. Of these, 68.1% were acknowledged by the participants. Study participants reported that SEESPA is useful, effective, and they felt satisfied about it. In addition, they brought few suggestions that will be integrated on the final version of the app.Conclusionsand Clinical Relevance. The developed innovative SEESPA is a feasible and acceptable intervention for behavioral modifications among women with GDM, and is ready to be tested in a larger RCT study which is expected to inform the health policymakers to integrate SEESPA with the antenatal health care practice of women with GDM, specifically in developing countries where there is a greater risk of developing GDM complications among mothers and their infants.Trial registrationThe study is registered on September 16, 2019 (ACTRN12619001278123p) by the Australian New Zealand Clinical Trials Registry.

Project description:BackgroundGestational diabetes mellitus (GDM) is one of the most common medical complications during pregnancy. eHealth technologies are proving to be successful in supporting the self-management of medical conditions. Digital technologies have the potential to improve GDM self-management.ObjectiveThe primary objective of this systematic literature review was to identify the views of health professionals (HPs) and women with GDM regarding the use of eHealth for GDM self-management. The secondary objective was to investigate the usability and user satisfaction levels when using these technologies.MethodsFollowing the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) approach, the search included primary papers in English on the evaluation of technology to support self-management of GDM from January 2008 to September 2021 using MEDLINE, CINAHL, Embase, ACM, and IEEE databases. The lists of references from previous systematic literature reviews, which were related to technology and GDM, were also examined for primary studies. Papers with qualitative, quantitative, and mixed methodologies were included and evaluated. The selected papers were assessed for quality using the Cochrane Collaboration tool, National Institute for Health and Care Excellence clinical guidelines, Critical Appraisal Skills Programme Qualitative Checklist, and McGill University Mixed Methods Appraisal Tool. NVivo (QSR International) was used to extract qualitative data, which were subjected to thematic analysis. Narrative synthesis was used to analyze the quantitative data.ResultsA total of 26 papers were included in the review. Of these, 19% (5/26) of studies used quantitative research methodologies, 19% (5/26) used qualitative methods, and 62% (16/26) used mixed methods. In all, 4 themes were identified from the qualitative data: the benefits of using technology, engagement with people via technology, the usability of technology, and discouragement factors for the use of technology. The thematic analysis revealed a vast scope of challenges and facilitators in the use of GDM self-management systems. The challenges included usability aspects of the system, technical problems, data privacy, lack of emotional support, the accuracy of reported data, and adoption of the system by HPs. Convenience, improved GDM self-management, peer support, increased motivation, increased independence, and consistent monitoring were facilitators to use these technologies. Quantitative data showed that there is potential for improving the usability of the GDM self-management systems. It also showed that convenience, usefulness, increasing motivation for GDM self-management, helping with GDM self-management, and being monitored by HPs were facilitators to use the GDM self-management systems.ConclusionsThis novel systematic literature review shows that HPs and women with GDM encountered some challenges in using GDM self-management systems. The usability of GDM systems was the primary challenge derived from qualitative and quantitative results, with convenience, consistent monitoring, and optimization of GDM self-management emerging as important facilitators.

Project description:The study addressed a significant gap in the profiling and understanding of the gut microbiota's influence on Malaysian Malay women with gestational diabetes mellitus (GDM). This prospective cohort study aimed to explore the intricate relationship between gut microbiota, dietary choices, and lifestyle factors among Malay women, both with and without GDM. The research specifically focused on participants during the second (T0) and third (T1) trimesters of pregnancy in Johor Bahru, Malaysia. In Part 1 of the study, a diverse pool of pregnant women at T0 was categorized into two groups: those diagnosed with GDM and those without GDM, with a total sample size of 105 individuals. The assessments encompassed demographic, clinical, lifestyle, and dietary factors at the T0 and T1 trimesters. Part 2 of the study delved into microbiome analysis, targeting a better understanding of the gut microbiota among the participants. Stool samples were randomly collected from 50% of the individuals in each group (GDM and non-GDM) at T0 and T1. The collected samples underwent processing, and 16s rRNA metagenomic analysis was employed to study the microbial composition. The results suggested an association between elevated body weight and glucose levels, poor sleep quality, lack of physical activity, greater intake of iron and meat, and reduced fruit consumption among women with GDM compared to non-GDM groups. The microbiome analysis revealed changes in microbial composition over time, with reduced diversity observed in the GDM group during the third trimester. The genera Lactiplantibacillus, Parvibacter, Prevotellaceae UCG001, and Vagococcus positively correlated with physical activity levels in GDM women in the second trimester. Similarly, the genus Victivallis exhibited a strong positive correlation with gravida and parity. On the contrary, the genus Bacteroides and Roseburia showed a negative correlation with omega-3 polyunsaturated fatty acids (PUFAs) in women without GDM in the third trimester. The study highlighted the multifaceted nature of GDM, involving a combination of lifestyle factors, dietary choices, and changes in gut microbiota composition. The findings emphasized the importance of considering these interconnected elements in understanding and managing gestational diabetes among Malaysian Malay women. Further exploration is essential to comprehend the mechanisms underlying this relationship and develop targeted interventions for effective GDM management.

Project description:Women with gestational diabetes mellitus (GDM) have a substantial risk of subsequently developing type 2 diabetes. This risk may be mitigated by engaging in healthy eating, physical activity, and weight loss when indicated. Since postpartum depressive symptoms may impair a woman's ability to engage in lifestyle changes, we sought to identify factors associated with depressive symptoms in the early postpartum period among women with recent GDM. The participants are part of the baseline cohort of the TEAM GDM (Taking Early Action for Mothers with Gestational Diabetes Mellitus) study, a one-year randomized trial of a lifestyle intervention program for women with a recent history of GDM, conducted in Boston, Massachusetts between June 2010 and September 2012. We administered the Edinburgh Postnatal Depression Scale (EPDS) at 4-15 weeks postpartum to women whose most recent pregnancy was complicated by GDM (confirmed by laboratory data or medical record review). An EPDS score ?9 indicated depressive symptoms. We measured height and thyroid stimulating hormone, and administered a questionnaire to collect demographic data and information about breastfeeding and sleep. We calculated body mass index (BMI) using self-reported pre-pregnancy weight and measured height. We reviewed medical records to obtain data about medical history, including history of depression, mode of delivery, and insulin use during pregnancy. We conducted bivariable analyses to identify correlates of postpartum depressive symptoms, and then modeled the odds of postpartum depressive symptoms using multivariable logistic regression. Our study included 71 women (mean age 33 years ± 5; 59 % White, 28 % African-American, 13 % Asian, with 21 % identifying as Hispanic; mean pre-pregnancy BMI 30 kg/m(2) ± 6). Thirty-four percent of the women scored ?9 on the EPDS at the postpartum visit. In the best fit model, factors associated with depressive symptoms at 6 weeks postpartum included cesarean delivery (aOR 4.32, 95 % CI 1.46, 13.99) and gestational weight gain (aOR 1.21 [1.02, 1.46], for each additional 5 lbs gained). Use of insulin during pregnancy, breastfeeding, personal history of depression, and lack of a partner were not retained in the model. Identifying factors associated with postpartum depression in women with GDM is important since depression may interfere with lifestyle change efforts in the postpartum period. In this study, cesarean delivery and greater gestational weight gain were correlated with postpartum depressive symptoms among women with recent GDM (Clinicaltrials.gov NCT01158131).

Dataset Information

The Feasibility and Preliminary Efficacy of an eHealth Lifestyle Program in Women with Recent Gestational Diabetes Mellitus: A Pilot Study.

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The Feasibility and Preliminary Efficacy of an eHealth Lifestyle Program in Women with Recent Gestational Diabetes Mellitus: A Pilot Study.

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