Clinical trial NCT03802877: Active Patient GDM
Official title: ACTIVating and Engaging PAtients Through Clinical Interaction Redesign and Electronically- Integrated Novel Technologies Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Keywords: gestational weight gain
large for gestational age status
step counts
physical activity
health coaching
ePlatform
pedometer
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: The Lawson Foundation
First posted: 2019-01-14
Enrollment: 227
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a feasibility (pilot) interventional study with a factorial design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. 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.
2. 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
3. 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
4. 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
5. 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.

ePLATFORM WITH SENSORS Participants randomized to the ePlatform strategy (i.e., 50% of participants) will receive a digital scale, physical activity monitor (pedometer), and ePlatform log-in information. They will track daily weights and step counts. They will receive prompts to access educational and motivational tools based on the data that they enter and whether or not they enter data. The investigators will use the ePlatform developed by StepsCount, a Canadian pedometer company with a well-developed ePlatform for pedometer data upload, tracking, and automated messaging. The company is permitting us further customization for study purposes. Participants randomized to the use of an ePlatform in combination with a pedometer and digital scale will have data uploaded onto a secure cloud-based platform controlled by the pedometer and digital scale companies.

HEALTH PROFESSIONAL COACH Participants randomized to the health coach strategy (i.e., 50% of participants) will work by telephone and email with a health coach. The coach will be a health professional hired through the study (dietitian/kinesiologist/nurse). On a weekly basis, She/he will contact the participant to discuss progress and challenges in terms of achieving physical activity goals, rate of GWG, and maintaining health eating patterns. She/he will respond to specific questions on strategies and interplay between health behaviours and parameters such as blood glucose and blood pressure levels. She/he may enquire about any problems associated with higher physical activity levels such as contractions or lower blood sugar levels, and will advise participants accordingly and consult with the treating physician. Participants not randomized to a coaching strategy will be advised to consult with their treating healthcare team directly if they develop symptoms of concern.

Fifty percent of participants will be randomized to a health coach. In turn, half of these participants will also be randomized to the ePlatform with sensors strategy. The health coaching approach will slightly differ between those randomized to the health coach \& ePlatform with biosensors strategy vs. those randomized to the health coach without ePlatform strategy.

For those randomized to the health coach \& ePlatform with biosensors strategy, the health coach will have access to the data on the ePlatform. This data transfer is termed facilitated relay, the exchange of patient collected health data between patients and providers outside of traditional clinic visits (i.e., electronic and web-based sharing).

Participants randomized to both the ePlatform and the health coach will receive telephone calls from the research assistant/health coach if they are off target despite the platform tools and support. They will be encouraged to consult the resource bank and will brainstorm with the health coach to decide how to achieve their GWG and step count targets.

Participants randomized to the health coach without the ePlatform will receive weekly calls from the health coach, encouraging them to engage in healthy eating practices and aim to achieve the GWG targets recommended by the Institute of Medicine (IOM). They will be encouraged to track their weight gain and physical activity (e.g., walks, gym sessions, classes, activity lists, etc.) and to share this information with the health coach for discussion. However, they will not have access to the study ePlatform and will not be provided with pedometers or digital scales.

At least one coach will be trained for each of the recruitment sites (5). The training will consist of completion of 5 30-minute on-line modules supplemented by teleconferences with our team of experts in health behaviour change (J Fowles, C Shields, C Chan, A-S Brazeau, D Da Costa, K Dasgupta). The on-line training modules for health coaches address motivational communication, key content areas (GDM, health behaviours, stress management), review the bank of resources, discusses the decision trees/algorithms that will create triggers and alerts, and demonstrates navigation of the ePlatform.

SETTING GDM clinics in Montreal (McGill University Health Centre/MUHC with Dr Sara Meltzer, Dr Natasha Garfield, and Dr Rachel Bond; and Centre hospitalier de l'Université de Montréal/CHUM with Dr Ariane Godbout and colleagues), Toronto (Sunnybrook Health Sciences Centre with Dr Illana Halparin, Dr Baiju Shah, and colleagues), Calgary (Rockyview General Hospital with Dr Sonia Butalia and colleagues), Winnipeg (Health Sciences Centre Winnipeg with Dr P Katz and colleagues), and Halifax (Queen Elizabeth II Health Sciences Centre with Dr Tom Ransom and colleagues).

RECRUITMENT GDM clinic staff will invite potentially eligible patients to consider participation. With their permission, contact information will be forwarded to the local ACTIVE PATIENT GDM research assistant. She/he will communicate with the participant to review study procedures and obtain informed consent through an on-line form and telephone conversation. The investigators aim to recruit and enroll at least 5 participants per month per site.

ELIGIBILITY CRITERIA See relevant section

RUN-IN PHASE AND RANDOMIZATION Participants will receive instructions to log onto an electronic platform. This will allow them to view a brief video on GDM-related complications. If the participant logs onto the system within a week of baseline assessment, web-based randomization will be performed. The participant will be encouraged to call or email the research assistant if there is difficulty logging on.

DATA COLLECTION See outcomes for baseline and final data collected

SAMPLE SIZE The investigators will recruit 225 participants across 5 cities, resulting in up to 45 participants per city over 9 months (to allow for 3 month intervention periods) or 5 participants per city per month. The present study is not designed to assess for between-arm differences in GWG or LGA status of the offspring. The intent is to gather experience with logistical procedures, participant perspectives, and estimates of indicators of feasibility.

INCENTIVES On three occasions (completion of the questionnaire at the beginning of the study, completion of the questionnaire and interview before delivery, and completion of the questionnaire and interview 12 weeks after delivery), participants will receive a $20 gift card.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Smokers
* 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)

Primary outcomes:
measure: Recruitment
timeFrame: 1 year
Secondary outcomes:
measure: Use of resource bank
timeFrame: 12 weeks
measure: Perceived utility of resource bank
timeFrame: 12 weeks
measure: Step count data
timeFrame: 12 weeks
measure: Digital weight data
timeFrame: 12 weeks
measure: Perceived utility of step count monitoring with ePlatform support
timeFrame: 12 weeks
measure: Perceived utility of weight monitoring with ePlatform support
timeFrame: 12 weeks
measure: Number of planned weekly conversations completed with health coach
timeFrame: 12 weeks
measure: Perceived utility of health coaching conversations
timeFrame: 12 weeks
measure: Completion of evaluation procedures
timeFrame: 12 weeks
Other outcomes:
measure: Change in physical activity
timeFrame: 12 weeks
measure: Gestational weight gain (GWG)
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Glucose levels
timeFrame: 12 weeks
measure: Content of conversations with health coach
timeFrame: 12 weeks
measure: Offspring birthweight percentile
timeFrame: at birth
measure: Gestational age at birth
timeFrame: at birth
measure: Delivery method
timeFrame: at birth
measure: Apgar score
timeFrame: at birth
measure: Completion of postpartum screen for diabetes
timeFrame: 12 weeks' postpartum
measure: Breastfeeding
timeFrame: 12 weeks' postpartum
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: IWK Helath Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Kaberi Dasgupta, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References: