Diabetes Mellitus Gestational Previous PregnancyHEALD-GDMNCT02483949
Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus
A study testing Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus in people with Diabetes Mellitus Gestational Previous Pregnancy, run by Athabasca University at 2 sites in Canada.
Trial summary
To examine the effectiveness of a group-based lifestyle modification program followed by peer-led telephone counselling for type 2 diabetes (T2D) and cardiovascular disease risk reduction. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Gestational Previous Pregnancy
- What is being tested?
- Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- laboratory confirmed previous and recent (within last 12 months) gestational diabetes mellitus • informed consent
Who cannot join
- unable to provide informed consent or unwilling to participate in the study
- unable to read, understand and converse in English
- contraindications based on the Canadian Society for Exercise Physiology Physical Activity Readiness Questionnaire Plus (PAR-Q+)
- currently enrolled in other diabetes-related research studies
- pregnant or planning another pregnancy in the next 12 months (any participants becoming pregnant at any point during the study will only contribute data prior to their pregnancy date)
- hemoglobin A1c >6.5% or clinical suspicion of type 1 or type 2 diabetes
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Athabasca University
Athabasca, Alberta, T9S 3A3
Alliance for Canadian Health Outcomes Research in Diabetes
Edmonton, Alberta
About this study
To examine the effectiveness of a group-based lifestyle modification program followed by peer-led telephone counselling for type 2 diabetes (T2D) and cardiovascular disease risk reduction. The lifestyle modification program will support daily ambulatory activity and low glycemic index food intake among women with previous gestational diabetes mellitus (GDM).
Read the detailed description
Study Objective:
To examine the effectiveness of a group-based lifestyle modification program followed by peer-led telephone counselling for type 2 diabetes (T2D) and cardiovascular disease risk reduction. The lifestyle modification program will support daily ambulatory activity and low glycemic index food intake among women with previous GDM.
Methods:
To achieve the study objective, the HEALD-GDM lifestyle modification program already proven effective for adults with T2D among women with previous GDM within 12 months postpartum will be evaluated. Women will take part in either the HEALD-GDM program (intervention) or in usual care (control). To evaluate the effectiveness of HEALD-GDM, a randomized, two-arm, before and after study design is proposed. Potentially eligible participants will be recruited from Diabetes in Pregnancy Clinics in Calgary and Edmonton, Alberta. Following identification of eligible participants, the investigators will randomize 100 participants to either the HEALD-GDM program or to usual care control (i.e., 50 per group). A Canadian Society of Exercise Physiology certified instructor (Exercise Specialist) trained in HEALD-GDM delivery will lead the program. Group-based classes will be held at community recreational centres in Calgary and Edmonton (one site each) in months one and four of the 24-week HEALD-GDM program. Theory-guided peer-led telephone counselling will supplement the program. HEALD-GDM focuses broadly on T2D prevention through lifestyle modification and will be based on a proven effective pedometer-based active living behaviour.
The primary outcome will be change in objectively measured moderate and vigorous physical activity at assessment appointments (baseline and 24 weeks). Secondary outcomes include: 1) body mass, 2) glycemic control (hemoglobin A1c), 3) musculoskeletal and cardiorespiratory fitness, 4) dietary intake, 5) metabolic biomarkers, 6) health-related quality of life (HRQL), social-cognitive mediators and 7) mental health.
Significance:
Evidence for appropriate lifestyle modification programs for this high-risk population is lacking. This study will serve to inform best practices for diabetes and cardiovascular disease risk reduction through known modifiable risk reduction targets such as healthy eating and active living.
- Being tested
- Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating and Active Living for Diabetes - Gestational Diabetes MellitusBehavioural
Also called HEALD-GDM
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Lifestyle intervention with peer-counseling follow-up Receives: Behavioral: Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 6 months of moderate and vigorous physical activity (walking).
Accelerometer derived MVPA
Measured: 6 months
Secondary outcomes (1)
Change from baseline to 6 months in Low Glycemic Index foods.
Low glycemic index food intake will be assessed using three-day food records.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Gestational Previous PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athabasca University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven T. Johnson, Athabasca University
- Investigators
- Steven T. Johnson, PhD, Principal investigator, Athabasca University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483949
- Sponsor's protocol ID
- HEALD-GDM
- Acronym
- HEALD-GDM
- Status last verified
- Jul 2016
- First submitted
- 28 May 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson ST, Mladenovic AB, Mathe N, Davenport MH, Butalia S, Qiu W, Johnson JA. Healthy eating and active living after gestational diabetes mellitus (HEALD-GDM): Rationale, design, and proposed evaluation of a randomized controlled trial. Contemp Clin Trials. 2017 Oct;61:23-28. doi: 10.1016/j.cct.2017.07.008. Epub 2017 Jul 9.
PubMed 28700892
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02483949
- Acronym / sponsor ID
- HEALD-GDM / HEALD-GDM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Athabasca UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the effectiveness of a group-based lifestyle modification program followed by peer-led telephone counselling for type 2 diabetes (T2D) and cardiovascular disease risk reduction. The lifestyle modification program will support daily ambulatory activity and low glycemic index food intake among women with previous gestational diabetes mellitus (GDM).
Detailed description
Study Objective:
To examine the effectiveness of a group-based lifestyle modification program followed by peer-led telephone counselling for type 2 diabetes (T2D) and cardiovascular disease risk reduction. The lifestyle modification program will support daily ambulatory activity and low glycemic index food intake among women with previous GDM.
Methods:
To achieve the study objective, the HEALD-GDM lifestyle modification program already proven effective for adults with T2D among women with previous GDM within 12 months postpartum will be evaluated. Women will take part in either the HEALD-GDM program (intervention) or in usual care (control). To evaluate the effectiveness of HEALD-GDM, a randomized, two-arm, before and after study design is proposed. Potentially eligible participants will be recruited from Diabetes in Pregnancy Clinics in Calgary and Edmonton, Alberta. Following identification of eligible participants, the investigators will randomize 100 participants to either the HEALD-GDM program or to usual care control (i.e., 50 per group). A Canadian Society of Exercise Physiology certified instructor (Exercise Specialist) trained in HEALD-GDM delivery will lead the program. Group-based classes will be held at community recreational centres in Calgary and Edmonton (one site each) in months one and four of the 24-week HEALD-GDM program. Theory-guided peer-led telephone counselling will supplement the program. HEALD-GDM focuses broadly on T2D prevention through lifestyle modification and will be based on a proven effective pedometer-based active living behaviour.
The primary outcome will be change in objectively measured moderate and vigorous physical activity at assessment appointments (baseline and 24 weeks). Secondary outcomes include: 1) body mass, 2) glycemic control (hemoglobin A1c), 3) musculoskeletal and cardiorespiratory fitness, 4) dietary intake, 5) metabolic biomarkers, 6) health-related quality of life (HRQL), social-cognitive mediators and 7) mental health.
Significance:
Evidence for appropriate lifestyle modification programs for this high-risk population is lacking. This study will serve to inform best practices for diabetes and cardiovascular disease risk reduction through known modifiable risk reduction targets such as healthy eating and active living.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Behavioral: Healthy Eating and Active Living for Diabetes - Gestational Diabetes MellitusLifestyle intervention with peer-counseling follow-up |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- laboratory confirmed previous and recent (within last 12 months) gestational diabetes mellitus • informed consent
Key exclusion criteria (6 listed)
- unable to provide informed consent or unwilling to participate in the study
- unable to read, understand and converse in English
- contraindications based on the Canadian Society for Exercise Physiology Physical Activity Readiness Questionnaire Plus (PAR-Q+)
- currently enrolled in other diabetes-related research studies
- pregnant or planning another pregnancy in the next 12 months (any participants becoming pregnant at any point during the study will only contribute data prior to their pregnancy date)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Eating and Active Living for Diabetes - Gestational Diabetes MellitusAlso: HEALD-GDM | Behavioural | Intervention |
Primary outcome
Change from baseline to 6 months of moderate and vigorous physical activity (walking).
Time frame: 6 months
Accelerometer derived MVPA
1 secondary outcome
Change from baseline to 6 months in Low Glycemic Index foods.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Derived from this study: PubMed 28700892Johnson ST, Mladenovic AB, Mathe N, Davenport MH, Butalia S, Qiu W, Johnson JA. Healthy eating and active living after gestational diabetes mellitus (HEALD-GDM): Rationale, design, and proposed evaluation of a randomized controlled trial. Contemp Clin Trials. 2017 Oct;61:23-28. doi: 10.1016/j.cct.2017.07.008. Epub 2017 Jul 9.
- Funding agencyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven T. Johnson, PhD principal investigator
Athabasca University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus in people with Diabetes Mellitus Gestational Previous Pregnancy, run by Athabasca University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 6 months of moderate and vigorous physical activity (walking). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.