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The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention.

ABSTRACT: BACKGROUND:Gestational diabetes mellitus (GDM) contributes to the epidemic of diabetes and obesity in mothers and their offspring. The primary objective of this pilot study was to: 1) refine the GDM Management System (GooDMomS), a web-based pregnancy and postpartum behavioral intervention and 2) assess the feasibility of the intervention. METHODS:In phase 1, ten semi-structured interviews were conducted with women experiencing current or recent GDM mellitus GDM to garner pilot data on the web based intervention interface, content, and to solicit recommendations from women about refinements to enhance the GooDMomS intervention site. Interviews were audiotaped, transcribed and independently reviewed to identify major themes with Atlas.ti v7.0. In phase 2, a single-arm feasibility study was conducted and 23 participants were enrolled in the GooDMomS program. Participants received web lessons, self-tracking of weight and glucose, automated feedback and access to a message board for peer support. The primary outcome was feasibility, including recruitment and retention and acceptability. Secondary outcomes included the proportion of women whose gestational weight gain (GWG) was within the Institute of Medicine (IOM) guidelines and who were able to return to their pre-pregnancy weight after delivery. RESULTS:Comments from semi-structured interviews focused on: 1) usability of the on-line self-monitoring diary and tracking system, 2) access to a safe, reliable social network for peer support and 3) ability of prenatal clinicians to access the on-line diary for clinical management. Overall, 21 (91 %) completed the pregnancy phase. 15/21 (71 %) of participants were within the Institute of Medicine (IOM) guidelines for GWG. Sixteen (70 %) completed the postpartum phase. 7/16 (43 %) and 9/16 (56 %) of participants returned to their pre-pregnancy weight at 6 and 30 weeks postpartum, respectively. CONCLUSIONS:This study documents the feasibility of the GooDMomS program. The results can have implications for web technology in perinatal care and inform the current care paradigm for women with GDM. Findings are supportive of further research with recruitment of a larger sample of participants and comparison of the outcomes with the intervention and standard care. TRIAL REGISTRATION:The study was registered at ClinicalTrials.gov on May 15, 2012 under protocol no. NCT01600534 .

SUBMITTER: Nicholson WK

PROVIDER: S-EPMC5031324 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention.

Nicholson Wanda K WK Beckham A Jenna AJ Hatley Karen K Diamond Molly M Johnson La-Shell LS Green Sherri L SL Tate Deborah D

BMC pregnancy and childbirth 20160921 1

<h4>Background</h4>Gestational diabetes mellitus (GDM) contributes to the epidemic of diabetes and obesity in mothers and their offspring. The primary objective of this pilot study was to: 1) refine the GDM Management System (GooDMomS), a web-based pregnancy and postpartum behavioral intervention and 2) assess the feasibility of the intervention.<h4>Methods</h4>In phase 1, ten semi-structured interviews were conducted with women experiencing current or recent GDM mellitus GDM to garner pilot dat ...[more]

PMID: 27654119

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Project description:BackgroundDuring the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit.ObjectivesThe primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention.MethodsWe used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception.ResultsThe median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users' experience and further improved the program. A total of 34 postpartum women with Medicaid insurance were approached for the pilot trial, and 30 (88%) were consented and randomized. All women randomized to Healthy Beyond Pregnancy completed the Web-based program, had text-enabled cell phones, and were willing to receive text messages from the study team. Women in the Healthy Beyond Pregnancy arm were more likely to return for a postpartum visit compared with women in the control arm with 85% of women in Healthy Beyond Pregnancy returning versus 53% in the control arm (odds ratio in the Healthy Beyond Pregnancy group: 5.3; 95% CI 0.9-32.0; P=.06).ConclusionsWe have developed a highly usable and acceptable Web-based program designed to increase attendance at the postpartum visit. Our pilot trial demonstrates that women are willing and able to participate in a randomized trial of a Web-based program and text messaging system.Trial registrationClinicaltrials.gov NCT03296774; https://clinicaltrials.gov/ct2/show/NCT03296774 (Archived by WebCite at http://www.webcitation.org/6tpgXFzyk).

Project description:Purpose: Dysfunctional breathing behaviors are prevalent in chronic obstructive pulmonary disease (COPD). Although these behaviors contribute to dyspnea, abnormal carbon dioxide (CO2) levels, and COPD exacerbations, they are modifiable. Current dyspnea treatments for COPD are suboptimal, because they do not adequately address dysfunctional breathing behaviors and anxiety together. We developed a complementary mind-body breathlessness therapy, called capnography-assisted respiratory therapy (CART), that uses real-time CO2 biofeedback at the end of exhalation (end-tidal CO2 or ETCO2), to target dysfunctional breathing habits and improve dyspnea treatment and pulmonary rehabilitation (PR) adherence in COPD. The study aim was to test the feasibility of integrating CART with a traditional, clinic-based PR program in an urban setting. Methods: We used a feasibility pre- and post-test design, with 2:1 randomization to CART+PR or control (PR-alone) groups, to test and refine CART. Multi-component CART consisted of six, 1-h weekly sessions of slow breathing and mindfulness exercises, ETCO2 biofeedback, motivational counseling, and a home program. All participants were offered twice weekly, 1-h sessions of PR over 10 weeks (up to 20 sessions). Results: Thirty-one participants with COPD were enrolled in the study. Approximately a third of participants had symptoms of psychological distress. Results showed that CART was feasible and acceptable based on 74% session completion and 91.7% homework exercise completion (n = 22). Within-group effect sizes for CART+PR were moderate to large (Cohen's d = 0.51-1.22) for reduction in resting Borg dyspnea (anticipatory anxiety) and respiratory rate, St. George's Respiratory Questionnaire (SGRQ) respiratory symptoms; and increase in Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and physical activity; all p < 0.05. Conclusions: CART is a new mind-body breathing therapy that targets eucapnic breathing, interoceptive function, and self-regulated breathing to relieve dyspnea and anxiety symptoms in COPD. Study findings supported the feasibility of CART and showed preliminary signals that CART may improve exercise tolerance, reduce dyspnea, and enhance PR completion by targeting reduced dysfunctional breathing patterns (CTR No. NCT03457103).

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Dataset Information

The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention.

Publications

The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention.

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