Romaina Iqbal, Sabahat Naz, Sana Sheikh, Rahat Qureshi, Shereen Bhutta, Haleema Yasmeen, Iqbal Azam, Paramjit Gill
{"title":"Conducting a diabetes mellitus prevention trial in women with GDM in Pakistan: a feasibility study.","authors":"Romaina Iqbal, Sabahat Naz, Sana Sheikh, Rahat Qureshi, Shereen Bhutta, Haleema Yasmeen, Iqbal Azam, Paramjit Gill","doi":"10.1186/s40814-024-01514-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Women with gestational diabetes mellitus (GDM) are at a greater risk of developing type 2 diabetes mellitus (T2DM) than women without GDM. Despite this elevated risk, few trials on the prevention of T2DM among South Asian women with GDM have been reported. Therefore, this study aimed to assess the feasibility of conducting a diabetes prevention program on women with a history of GDM to inform the development of a contextually relevant definitive trial.</p><p><strong>Methods: </strong>Using a randomized controlled trial, women with GDM (n = 180) who delivered at the study hospitals (one public and one private teaching hospital, Karachi) with fasting blood glucose levels < 120 mg/dl at 6 weeks postpartum were randomized to the intervention (n = 88) or control arms (n = 92). Women in the intervention group received individualized home-based educational sessions from trained community health workers at 0, 1, 3, 6, and 9 months. In addition, they received short text messages, prerecorded messages, and printed educational material (calendars and pamphlets) for reinforcement. The intervention was centered on equipping women with knowledge, skills, and confidence to eat a healthy diet rich in fruits, vegetables, and low-fat dairy products and perform regular physical activity based on walking and household chores to reduce weight (up to 5% of their initial body weight). Women in the control arm received standard care. The feasibility outcomes of the study included screening, recruitment, and retention rates and in-depth interviews at 6 months post-intervention to explore women's experiences with the intervention. Descriptive analysis and thematic analysis were performed.</p><p><strong>Results: </strong>Of the 324 women screened during the antenatal care visits and after delivery, 255 (78.7%) were contactable 6 weeks postpartum, and 180 (70.6%) were eligible and randomized to intervention (n = 88) and control (n = 92) groups. Loss to follow-up in the intervention and control arms was 22.7% (n = 20/88) and 18.5% (n = 17/92), respectively. Women expressed satisfaction with home-based counseling and follow-up visits, text message reminders, and printed material in the form of a calendar through our qualitative interviews.</p><p><strong>Conclusions: </strong>Home-based lifestyle modification intervention augmented with text messages and printed material is feasible. However, to evaluate the intervention's effectiveness, a larger trial is warranted to assess its long-term impact on diabetes prevention.</p><p><strong>Trial registration: </strong>ISRCTN, ISRCTN11387113 . Registered 5 December 2017-retrospectively registered.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"10 1","pages":"92"},"PeriodicalIF":1.5000,"publicationDate":"2024-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179295/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pilot and Feasibility Studies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40814-024-01514-3","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Women with gestational diabetes mellitus (GDM) are at a greater risk of developing type 2 diabetes mellitus (T2DM) than women without GDM. Despite this elevated risk, few trials on the prevention of T2DM among South Asian women with GDM have been reported. Therefore, this study aimed to assess the feasibility of conducting a diabetes prevention program on women with a history of GDM to inform the development of a contextually relevant definitive trial.
Methods: Using a randomized controlled trial, women with GDM (n = 180) who delivered at the study hospitals (one public and one private teaching hospital, Karachi) with fasting blood glucose levels < 120 mg/dl at 6 weeks postpartum were randomized to the intervention (n = 88) or control arms (n = 92). Women in the intervention group received individualized home-based educational sessions from trained community health workers at 0, 1, 3, 6, and 9 months. In addition, they received short text messages, prerecorded messages, and printed educational material (calendars and pamphlets) for reinforcement. The intervention was centered on equipping women with knowledge, skills, and confidence to eat a healthy diet rich in fruits, vegetables, and low-fat dairy products and perform regular physical activity based on walking and household chores to reduce weight (up to 5% of their initial body weight). Women in the control arm received standard care. The feasibility outcomes of the study included screening, recruitment, and retention rates and in-depth interviews at 6 months post-intervention to explore women's experiences with the intervention. Descriptive analysis and thematic analysis were performed.
Results: Of the 324 women screened during the antenatal care visits and after delivery, 255 (78.7%) were contactable 6 weeks postpartum, and 180 (70.6%) were eligible and randomized to intervention (n = 88) and control (n = 92) groups. Loss to follow-up in the intervention and control arms was 22.7% (n = 20/88) and 18.5% (n = 17/92), respectively. Women expressed satisfaction with home-based counseling and follow-up visits, text message reminders, and printed material in the form of a calendar through our qualitative interviews.
Conclusions: Home-based lifestyle modification intervention augmented with text messages and printed material is feasible. However, to evaluate the intervention's effectiveness, a larger trial is warranted to assess its long-term impact on diabetes prevention.
Trial registration: ISRCTN, ISRCTN11387113 . Registered 5 December 2017-retrospectively registered.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
