Active Patient GDM

NCT03802877 | Completed

• 1 other identifier: GRT 2017-16
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 6

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.

Conditions

Gestational Diabetes

Keywords

gestational weight gain; large for gestational age status; step counts; physical activity; health coaching; ePlatform; pedometer

Outcome Measures

Primary Outcomes (1)

• Recruitment

  Proportion of candidates with GDM who accept to participate in the study

  1 year

Secondary Outcomes (9)

• Use of resource bank

  12 weeks

• Perceived utility of resource bank

  12 weeks

• Step count data

  12 weeks

• Digital weight data

  12 weeks

• Perceived utility of step count monitoring with ePlatform support

  12 weeks

Other Outcomes (11)

• Change in physical activity

  12 weeks

• Gestational weight gain (GWG)

  12 weeks

• Blood pressure

  12 weeks

Study Arms (4)

Resource bank

ACTIVE COMPARATOR

The web-based resource bank includes information and perspectives about GDM, nutrition, and physical activity. The information is presented through video capsules, on-line text, printable pdfs, and podcasts. It is presented by health care professionals and patients.

Behavioral: Resource bank

Resource bank and ePlatform

EXPERIMENTAL

In addition to resource bank access, 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. Data will be uploaded onto a secure cloud-based platform controlled by the pedometer and digital scale companies.

Behavioral: Resource bank; Behavioral: ePlatform

Resource bank and health coach

EXPERIMENTAL

In addition to resource bank access, the coach will contact the participant weekly (telephone, text, email) to discuss progress and challenges in terms of achieving physical activity goals, rate of GWG, and maintaining health eating patterns, as well as any concerns.Participants not randomized to a coaching strategy will be advised to consult with their treating healthcare team directly if they develop symptoms of concern. The coach will encourage participants to track their weight gain and physical activity (e.g., walks, classes, activity lists, etc.) and to share this information. However, they will not have access to the study ePlatform and will not be provided with pedometers or digital scales.

Behavioral: Resource bank; Behavioral: Health coach

Resource bank with ePlatform and coach

EXPERIMENTAL

Participants will have resource bank access as well as ePlatform and coaching interventions.The health coach will have access to the data on the ePlatform. They 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.

Behavioral: Resource bank; Behavioral: ePlatform; Behavioral: Health coach

Interventions

Resource bank BEHAVIORAL

See intervention arm descriptions

Resource bank; Resource bank and ePlatform; Resource bank and health coach; Resource bank with ePlatform and coach

ePlatform BEHAVIORAL

See intervention arm descriptions

Resource bank and ePlatform; Resource bank with ePlatform and coach

Health coach BEHAVIORAL

See intervention arm descriptions

Resource bank and health coach; Resource bank with ePlatform and coach

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is looking at the effects of interventions on pregnant women with gestational diabetes
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• The Lawson Foundation: collaborator

Study Sites (6)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

Location

IWK Helath Centre

Halifax, Nova Scotia, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Related Publications (1)

• Dasgupta K, Chan D, Bond R, Wang SJ, Garfield N, Coolen J, Halperin IJ, Peters TM, Shen GX, Yamamoto J, Butalia S, Dowling J, Rendon L, Haichin K, Sharafi M, Shields C, Godbout A, Costa DD, Kaouache M, Shah BR, Rahme E, Brazeau AS, Meltzer S; ACTIVE PATIENT GDM team. Step and weight tracking with targets and coaching interventions in gestational diabetes: A randomized factorial feasibility trial. Diabetes Res Clin Pract. 2025 Jun;224:112241. doi: 10.1016/j.diabres.2025.112241. Epub 2025 May 9.

  PMID: 40349846 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Gestational Weight Gain; Motor Activity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Kaberi Dasgupta, MD, MSC

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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)

Model Details: This is a feasibility (pilot) interventional study with a factorial design

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: August 29, 2019
• Primary Completion: June 26, 2023
• Study Completion: October 5, 2023
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

CA (6)