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A web-based lifestyle intervention for women with recent gestational diabetes mellitus: a randomized controlled trial.

ABSTRACT: To test the feasibility and effectiveness of a Web-based lifestyle intervention based on the Diabetes Prevention Program modified for women with recent gestational diabetes mellitus to reduce postpartum weight retention.We randomly allocated 75 women with recent gestational diabetes mellitus to either a Web-based lifestyle program (Balance after Baby) delivered over the first postpartum year or to a control group. Primary outcomes were change in body weight at 12 months from 1) first postpartum measured weight; and 2) self-reported prepregnancy weight.There were no significant differences in baseline characteristics between groups including age, body mass index, race, and income status. Women assigned to the Balance after Baby program (n=36, three lost to follow-up) lost a mean of 2.8 kg (95% confidence interval -4.8 to -0.7) from 6 weeks to 12 months postpartum, whereas the control group (n=39, one lost to follow-up) gained a mean of 0.5 kg (-1.4 to +2.4) (P=.022). Women in the intervention were closer to prepregnancy weight at 12 months postpartum (mean change -0.7 kg; -3.5 to +2.2) compared with women in the control arm (+4.0 kg; +1.3 to +6.8) (P=.035).A Web-based lifestyle modification program for women with recent gestational diabetes mellitus decreased postpartum weight retention.ClinicalTrials.gov, www.clinicaltrials.gov, NCT01158131.I.

SUBMITTER: Nicklas JM

PROVIDER: S-EPMC4401073 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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A web-based lifestyle intervention for women with recent gestational diabetes mellitus: a randomized controlled trial.

Nicklas Jacinda M JM Zera Chloe A CA England Lucinda J LJ Rosner Bernard A BA Horton Edward E Levkoff Sue E SE Seely Ellen W EW

Obstetrics and gynecology 20140901 3

<h4>Objective</h4>To test the feasibility and effectiveness of a Web-based lifestyle intervention based on the Diabetes Prevention Program modified for women with recent gestational diabetes mellitus to reduce postpartum weight retention.<h4>Methods</h4>We randomly allocated 75 women with recent gestational diabetes mellitus to either a Web-based lifestyle program (Balance after Baby) delivered over the first postpartum year or to a control group. Primary outcomes were change in body weight at 1 ...[more]

PMID: 25162257

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Project description: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.

Project description:BackgroundWomen with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited.ObjectiveThis trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes.MethodsIn this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI≤23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI>23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group.ResultsIn total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (P=.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (P<.001) and higher health-directed behavior scores (P=.045). The intervention group also reported increased emotional distress scores (P=.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%).ConclusionsAlthough a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management.Trial registrationClinicalTrials.gov NCT03324737; https://clinicaltrials.gov/ct2/show/NCT03324737.International registered report identifier (irrid)RR2-10.1186/s12889-019-7691-3.

Project description:BackgroundOur objective was to examine whether gestational diabetes mellitus (GDM) or newborns' high birthweight can be prevented by lifestyle counseling in pregnant women at high risk of GDM.Method and findingsWe conducted a cluster-randomized trial, the NELLI study, in 14 municipalities in Finland, where 2,271 women were screened by oral glucose tolerance test (OGTT) at 8-12 wk gestation. Euglycemic (n = 399) women with at least one GDM risk factor (body mass index [BMI] ? 25 kg/m(2), glucose intolerance or newborn's macrosomia (? 4,500 g) in any earlier pregnancy, family history of diabetes, age ? 40 y) were included. The intervention included individual intensified counseling on physical activity and diet and weight gain at five antenatal visits. Primary outcomes were incidence of GDM as assessed by OGTT (maternal outcome) and newborns' birthweight adjusted for gestational age (neonatal outcome). Secondary outcomes were maternal weight gain and the need for insulin treatment during pregnancy. Adherence to the intervention was evaluated on the basis of changes in physical activity (weekly metabolic equivalent task (MET) minutes) and diet (intake of total fat, saturated and polyunsaturated fatty acids, saccharose, and fiber). Multilevel analyses took into account cluster, maternity clinic, and nurse level influences in addition to age, education, parity, and prepregnancy BMI. 15.8% (34/216) of women in the intervention group and 12.4% (22/179) in the usual care group developed GDM (absolute effect size 1.36, 95% confidence interval [CI] 0.71-2.62, p = 0.36). Neonatal birthweight was lower in the intervention than in the usual care group (absolute effect size -133 g, 95% CI -231 to -35, p = 0.008) as was proportion of large-for-gestational-age (LGA) newborns (26/216, 12.1% versus 34/179, 19.7%, p = 0.042). Women in the intervention group increased their intake of dietary fiber (adjusted coefficient 1.83, 95% CI 0.30-3.25, p = 0.023) and polyunsaturated fatty acids (adjusted coefficient 0.37, 95% CI 0.16-0.57, p < 0.001), decreased their intake of saturated fatty acids (adjusted coefficient -0.63, 95% CI -1.12 to -0.15, p = 0.01) and intake of saccharose (adjusted coefficient -0.83, 95% CI -1.55 to -0.11, p ?=? 0.023), and had a tendency to a smaller decrease in MET minutes/week for at least moderate intensity activity (adjusted coefficient 91, 95% CI -37 to 219, p = 0.17) than women in the usual care group. In subgroup analysis, adherent women in the intervention group (n = 55/229) had decreased risk of GDM (27.3% versus 33.0%, p = 0.43) and LGA newborns (7.3% versus 19.5%, p = 0.03) compared to women in the usual care group.ConclusionsThe intervention was effective in controlling birthweight of the newborns, but failed to have an effect on maternal GDM.Trial registrationCurrent Controlled Trials ISRCTN33885819. Please see later in the article for the Editors' Summary.

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.

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A web-based lifestyle intervention for women with recent gestational diabetes mellitus: a randomized controlled trial.

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A web-based lifestyle intervention for women with recent gestational diabetes mellitus: a randomized controlled trial.

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