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Employing a Multi-level Approach to Recruit a Representative Sample of Women with Recent Gestational Diabetes Mellitus into a Randomized Lifestyle Intervention Trial.

ABSTRACT: OBJECTIVE:The 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. METHODS:We 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). RESULTS:We 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. CONCLUSIONS:Our 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.

SUBMITTER: Nicklas JM

PROVIDER: S-EPMC4888039 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Employing a Multi-level Approach to Recruit a Representative Sample of Women with Recent Gestational Diabetes Mellitus into a Randomized Lifestyle Intervention Trial.

Nicklas Jacinda M JM Skurnik Geraldine G Zera Chloe A CA Reforma Liberty G LG Levkoff Sue E SE Seely Ellen W EW

Maternal and child health journal 20160201 2

<h4>Objective</h4>The 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.<h4>Methods</h4>We 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 B ...[more]

PMID: 26520160

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Project description: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.

Project description:Background:Obesity (BMI ?30) during pregnancy is becoming an increasing public health issue and is associated with adverse maternal and perinatal outcomes. Excessive gestational weight gain (GWG) further increases the risks of adverse outcomes. However, lifestyle intervention can help pregnant women with obesity to limit their GWG. This study evaluated whether an antenatal lifestyle intervention programme for pregnant women with obesity, with emphasis on nutrition and physical activity, could influence GWG and maternal and perinatal outcomes. Methods:The intervention was performed in a city in Sweden 2011-2013. The study population was women with BMI ?30 in early pregnancy who received standard antenatal care and were followed until postpartum check-up. The intervention group (n?=?459) was provided with additional support for a healthier lifestyle, including motivational talks with the midwife, food advice, prescriptions of physical activity, walking poles, pedometers, and dietician consultation. The control group was recruited from the same (n?=?105) and from a nearby antenatal organisation (n?=?790). Results:In the per-protocol population, the intervention group had significantly lower GWG compared with the control group (8.9?±?6.0 kg vs 11.2?±?6.9 kg; p?=?0.031). The women managed to achieve GWG <?7 kg to a greater extent (37.1% vs. 23.0%; p?=?0.036) and also had a significantly lower weight retention at the postpartum check-up (-?0.3?±?6.0 kg vs. 1.6?±?6.5 kg; p?=?0.019) compared to the first visit. The most commonly used components of the intervention, apart from the extra midwife time, were support from the dietician and retrieval of pedometers. Overall compliance with study procedures, actual numbers of visits with logbook activity, and dietician contact correlated significantly with GWG. There was no statistically significant difference in GWG (10.3?±?6.1 kg vs. 11.2?±?6.9 kg) between the intervention and control groups in the intention-to-treat population. Conclusion:Pregnant women with obesity who follow a lifestyle intervention programme in primary health care can limit their weight gain during pregnancy and show less weight retention after pregnancy. This modest intervention can easily be implemented in a primary care setting. Trial registration:The study has been registered at ClinicalTrials.gov, Identifier: NCT03147079. May 10 2017, retrospectively registered.

Project description:BackgroundResearchers are increasingly acknowledging the importance of understanding patterns of engagement in multiple, as opposed to isolated, health behaviours. Accordingly, several studies, targeting various geographical regions, have begun to identify and characterize unique classes of individuals in terms of their engagement in health behaviours, towards gaining insights that might guide tailored health interventions. Our study extends this stream of research to the Israeli context, as well as examines whether certain sociodemographic characteristics tend to be associated with affiliation to a specific group of individuals, i.e., class membership.MethodsTwo large representative samples were obtained from the 2010 and 2017 National Social Surveys of the Israel Central Bureau of Statistics. Latent Class Analysis was used to identify different classes, based on levels of engagement in five health behaviours: fruit-and-vegetable consumption, physical activity, smoking avoidance, sleep, and influenza vaccination. Multinomial logistic regression was applied to test the associations between sociodemographic characteristics (age, gender, religion, education level) and class membership.ResultsWe identified three distinct classes (denoted "healthy", "unhealthy", and "mixed"). Overall, the "healthy" class was characterized by healthy levels of fruit-and-vegetable consumption and physical activity, a low rate of currently-smoking individuals, and a high proportion of influenza vaccination. The "mixed" class was characterized by healthy levels of fruit-and-vegetable consumption and sleep duration, moderate levels of physical exercise, a high proportion of currently light smokers, and a low rate of vaccination. The "unhealthy" class was marked by relatively low levels of engagement in health behaviours. Generally, older, Jewish, and more-educated individuals were more likely to belong to the "healthy" class, while young, non-Jewish, and less-educated individuals were more likely to belong to the "unhealthy" class. We further identified differences between the 2010 and 2017 samples (e.g., differences in men's likelihood of being in the "unhealthy" class), suggesting that some behavioural patterns might have changed over time.ConclusionThis research identified three classes of engagement in health behaviours across two large and representative samples. Moreover, the classes were associated with unique sociodemographic characteristics. Consequently, our findings can highlight health-behavioural patterns relevant to different sub-populations that should be considered in public health interventions.

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.

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Employing a Multi-level Approach to Recruit a Representative Sample of Women with Recent Gestational Diabetes Mellitus into a Randomized Lifestyle Intervention Trial.

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Employing a Multi-level Approach to Recruit a Representative Sample of Women with Recent Gestational Diabetes Mellitus into a Randomized Lifestyle Intervention Trial.

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