A Randomized Controlled Trial to Evaluate the Effects of a Smartphone Application-Based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, Maternal, and Neonatal Outcomes in Women With Gestational Diabetes Mellitus: The SMART-GDM Study

OBJECTIVE SMART-GDM examined whether Habits-GDM, a smartphone app coaching program, can prevent excessive gestational weight gain (EGWG) and improve glycemic control, maternal and neonatal outcomes in gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS In this randomized controlled trial, women diagnosed with GDM between 12-30 weeks were randomly assigned usual care (Control) or additional support from Habits-GDM that integrated dietary, physical activity, weight and glucose monitoring (Intervention). The primary outcome was the proportion of participants with EGWG. Secondary outcomes included absolute gestational weight gain (GWG), glycemic control, and maternal, delivery and neonatal outcomes. RESULTS In total, 340 women were randomized (170 Intervention, 170 Control; mean age 32.0 years [SD 4.2]; mean BMI 25.6kg/m2 [SD 5.6]). There were no statistically significant differences in the proportions of women with EGWG, absolute GWG, or maternal and delivery outcomes between experimental groups. Average glucose readings were lower in Intervention (mean difference -0.15mmol/L [95% CI -0.26; -0.03]; P=0.011), so were the proportions of glucose above targets (pre-meal 17.9% vs. 23.3%, OR=0.68 [95% CI 0.53; 0.87]; P=0.003; 2-hours post-meal 19.9% vs. 50%, OR=0.54 [95% CI 0.42; 0.70]; P<0.001). When regarded as a composite (although not prespecified), the overall neonatal complications (including birth trauma, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress, neonatal intensive care unit admission, perinatal death) were significantly lower in Intervention (38.1% vs. 53.7%, OR=0.53 [95% CI 0.34; 0.84]; P=0.006). CONCLUSIONS When added to usual care, Habits-GDM resulted in better maternal glycemic control and composite neonatal outcomes (non-prespecified), but did not reduce EGWG among women with GDM.

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A Randomized Controlled Trial to Evaluate the Effects of a Smartphone App-based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, Maternal and Neonatal Outcomes in Women with Gestational Diabetes: The SMART-GDM Study

10.2337/figshare.13073030.v1 ◽

2020 ◽

Author(s):

Tong Wei Yew ◽

Claudia Chi ◽

Shiao-Yng Chan ◽

Rob M. van Dam ◽

Clare Whitton ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Weight Gain ◽

Glycemic Control ◽

Gestational Weight Gain ◽

Controlled Trial ◽

Neonatal Outcomes ◽

Smartphone App ◽

Gestational Weight ◽

Randomized Controlled ◽

Maternal And Neonatal Outcomes

OBJECTIVE SMART-GDM examined whether Habits-GDM, a smartphone app coaching program, can prevent excessive gestational weight gain (EGWG) and improve glycemic control, maternal and neonatal outcomes in gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS In this randomized controlled trial, women diagnosed with GDM between 12-30 weeks were randomly assigned usual care (Control) or additional support from Habits-GDM that integrated dietary, physical activity, weight and glucose monitoring (Intervention). The primary outcome was the proportion of participants with EGWG. Secondary outcomes included absolute gestational weight gain (GWG), glycemic control, and maternal, delivery and neonatal outcomes. RESULTS In total, 340 women were randomized (170 Intervention, 170 Control; mean age 32.0 years [SD 4.2]; mean BMI 25.6kg/m2 [SD 5.6]). There were no statistically significant differences in the proportions of women with EGWG, absolute GWG, or maternal and delivery outcomes between experimental groups. Average glucose readings were lower in Intervention (mean difference -0.15mmol/L [95% CI -0.26; -0.03]; P=0.011), so were the proportions of glucose above targets (pre-meal 17.9% vs. 23.3%, OR=0.68 [95% CI 0.53; 0.87]; P=0.003; 2-hours post-meal 19.9% vs. 50%, OR=0.54 [95% CI 0.42; 0.70]; P<0.001). When regarded as a composite (although not prespecified), the overall neonatal complications (including birth trauma, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress, neonatal intensive care unit admission, perinatal death) were significantly lower in Intervention (38.1% vs. 53.7%, OR=0.53 [95% CI 0.34; 0.84]; P=0.006). CONCLUSIONS When added to usual care, Habits-GDM resulted in better maternal glycemic control and composite neonatal outcomes (non-prespecified), but did not reduce EGWG among women with GDM.

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Rationale, design, and challenges with implementing a clinical intervention to teach appropriate gestational weight gain (TAGG): Protocol of a Randomized controlled trial (Preprint)

10.2196/preprints.17484 ◽

2019 ◽

Author(s):

Awathif Mackeen ◽

Danielle Downs ◽

Vonda Hetherington ◽

Shawnee Lutcher ◽

Jacob Mowery ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Weight Gain ◽

Gestational Diabetes ◽

Usual Care ◽

Gestational Weight Gain ◽

Perceived Stress ◽

Controlled Trial ◽

Household Food Security ◽

Gestational Weight ◽

Randomized Controlled

BACKGROUND Excessive gestational weight gain (GWG) has public health implications including preterm birth, preeclampsia, gestational diabetes, and cesarean delivery. In an effort to mitigate adverse consequences of excessive GWG, this study tests a health intervention that includes enhancements to improve knowledge and awareness of appropriate GWG, and patient-centered nutritional counseling to promote appropriate GWG. OBJECTIVE The primary objective of the study was to increase the proportion of women who are managing their GWG as recommended by the IOM.4,5 METHODS This randomized controlled trial was conducted at Geisinger in Pennsylvania where excessive GWG is common among women with pre-conception obesity. Eligible, consenting participants with pre-pregnancy body mass index >30.0 kg/m2 were randomized (1:1) to: 1) Usual Care: usual written educational materials and counseling by an obstetric care provider or 2) Enhanced Care: Usual Care plus a) a personalized letter from a physician detailing appropriate GWG, b) exposure to individualized GWG chart in the electronic health record via the patient portal, and c) a consult with a Registered Dietitian Nutritionist and follow-up via tele-health counseling (10-20 mins/1-2 weeks) for the duration of the pregnancy. RESULTS The primary outcome was the proportion of women that gain less than 20 pounds over the course of the pregnancy. Secondary outcomes include knowledge, expectations, and attitude about pregnancy weight gain; increased self-efficacy for ability to eat healthy and being physically active to manage weight; and eating behavior. Potential moderators that will be explored include sleep, perceived stress, perceived involvement in care, and household food security. Data collection has been completed as of November 2019. CONCLUSIONS As GWG care was initiated for mothers with pre-pregnancy BMI >30 kg/m2 within the first and second trimesters, the intervention may have the additional benefit of reducing other adverse pregnancy outcomes including the incidence of gestational diabetes due to healthier rates of GWG. In addition to assessing appropriate GWG, this project will assess eating habits, physical activity, GWG attitudes, sleep quality, and psychological measures, all of which are associated with GWG. Exploratory mediators including perceived stress and food insecurity will also be evaluated. CLINICALTRIAL ClinicalTrials.gov NCT02963428

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