ACTIVating and Engaging PAtients Through Clinical Interaction Redesign and Electronically- Integrated Novel Technologies Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 10
- 主要终点
- Recruitment
研究概览
简要总结
Among women with GDM, the investigators will determine if a strategy of (1) a website-based information and motivational resource bank; (2) biosensor/ePlatform-based physical activity and GWG tracking; and/or (3) a health coach will lead to more favourably outcomes; namely, GWG closer to target, higher physical activity levels, better glycemic and blood pressure control, and lower incidence of LGA in offspring.
The current project is designed to assess feasibility and usability to inform the development of a large randomized controlled trial. The investigators will monitor the implementation process and examine patient-oriented outcomes, including perceptions of utility, challenges, and burden. These will be assessed through telephone-based in-depth interview.
Methodology / Study design This is a feasibility randomized controlled trial with a factorial design. The investigators will recruit women with a diagnosis of GDM between 20 and less than 32 weeks' pregnancy. All will receive access to a website resource bank with tips and resources to optimize physical activity and dietary intake a quality during pregnancy. In addition, they will be randomized to one of the four following groups: (1) No additional intervention; (2) ePlatform-based automated support combined with pedometer-based physical activity monitoring and digital scale-based weight monitoring; (3) weekly telephone calls with a health coach to discuss physical activity, eating, gestational weight gain; (4) combination of ePlatform and telephone calls from a health coach.
The investigators will evaluate recruitment rates, drop-out rates, women's perceptions of the strengths and limitations of the strategy, and ease and feasibility of outcome assessment. Assessments will be through in-clinic assessments, on-line questionnaires, clinic-based measures, mailed-in pedometers, and telephone-based interviews. Assessments will be at study entry and two to three weeks before the expected date of delivery or date of scheduled C-section. There will be a telephone-based interview at 12 weeks postpartum.
详细描述
Our overarching aim is to determine, among women with gestational diabetes (GDM), if a strategy of (1) a website-based information and motivational resource bank; (2) biosensor/ePlatform-based physical activity and gestational weight gain (GWG) tracking; and/or (3) a health coach will lead to more favourable outcomes; namely, GWG closer to target, higher physical activity levels, better glycemic and blood pressure control, and lower incidence of large for gestational age (LGA) in offspring.
The current project is designed to assess feasibility and usability to inform the development of a large randomized controlled trial. The specific aims of this feasibility study are:
- To determine the proportion of candidates with GDM who accept to participate in the study at each site (recruitment rates); a minimum overall average recruitment rate of 25/month would favour proceeding to a larger trial.
- To evaluate participant use (log ins) and perceived utility (interviews) of the website resource that the investigators are developing; a minimum average of 5 log-ins overall would favour proceeding to a larger trial
- To determine use (number of planned weekly conversations completed) and perceived utility (interviews) of the health coaching intervention; a minimum completion of 50% of the planned weekly conversations would favour retaining this treatment arm in a larger trial
- To determine use (data upload of step counts and weight data onto ePlatform) and perceived utility (interviews) of the ePlatform intervention ; a minimal upload of 30% of days overall of data would favour retaining this treatment arm in a larger trial
- To assess the proportion of participants in each intervention arm who complete final evaluation procedures (loss to follow-up rates); a minimum retention of 75% of participants enrolled would favour execution of a larger clinical trial
DESIGN Lawson ACTIVE PATIENT has a 2X2 factorial design. All participants will have access to the information and motivational resource bank, housed on a dedicated study website. Each participant will be randomized (1) to an ePlatform yes/no strategy and (2) to a health coach yes/no strategy. Therefore, some participants will have access to the website only, others to the website & ePlatform, others to the website & coach, and some to the website, ePlatform & coach. By interviewing and surveying participants in each of these groups, the investigators will be able to ascertain if there are components that are redundant or synergistic.
RESOURCE BANK The website sections include (1) 'About' with an overview about GDM, its management, and its complications; (2) 'Perspectives' with video and audio clips and interviews with mothers with a GDM history, physicians, dietitians, and kinesiologists, all describing their experiences living with or managing GDM and highlighting the importance of attending to this condition both during pregnancy and thereafter; (3) 'Nutrition' with descriptions and discussion of impact of eating on glucose control, illustration of the 'healthy plate' concepts, grocery shopping tips, links to healthy recipe banks, a photographic repository of health snack ideas, healthy lunches, and healthy breakfasts; (4) 'Activity' with explanations for pedometer use, step count targets, physical activity targets, step and physical activity monitoring, links to exercise video clips, precautions during pregnancy; and (5) 'Postpartum' which will include future diabetes risk facts relevant to mothers, fathers, and children; diabetes prevention approaches; and planning for future pregnancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is a behavioural intervention study. The participant, care provider, and investigator cannot be masked. Outcomes being assessed are objective (weight, steps, etc.) or are participant perspectives that preclude masking. Allocation is concealed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Followed by a ACTIVE patient GDM collaborating doctor
- •Currently diagnosed with gestational diabetes
- •At 20 to <32 weeks during pregnancy
- •Conversant in either English or French
- •Have frequent access to a Smartphone (iPhone iOS 10.0 or Android version 5.0 or higher) with WIFI capabilities
排除标准
- •History or diagnosis of diabetes type 1 or 2
- •Currently pregnant with more than one child
- •Planning to give birth at a place other than the hospital
- •Conditions that are absolute contraindications for exercise during pregnancy (Restrictive lung disease, ruptured membranes, pre-eclampsia, pregnancy-induced hypertension, Premature labour during current pregnancy, persistent bleeding, incomplete cervix, placenta previa, Hemodynamically significant heart disease)
结局指标
主要结局
Recruitment
时间窗: 1 year
Proportion of candidates with GDM who accept to participate in the study
次要结局
- Perceived utility of resource bank(12 weeks)
- Digital weight data(12 weeks)
- Perceived utility of health coaching conversations(12 weeks)
- Perceived utility of step count monitoring with ePlatform support(12 weeks)
- Perceived utility of weight monitoring with ePlatform support(12 weeks)
- Number of planned weekly conversations completed with health coach(12 weeks)
- Use of resource bank(12 weeks)
- Step count data(12 weeks)
- Completion of evaluation procedures(12 weeks)
研究者
Kaberi Dasgupta, MD, MSc, FRCP (C)
Associate Professor of Medicine, McGill University; Physician Scientist and Director, Centre for Outcomes Research and Evaluation (CORE), Research Institute of the McGill University Health Centre (RI-MUHC)
McGill University Health Centre/Research Institute of the McGill University Health Centre