Diabetes PreventionFDDNCT01425645
Families Defeating Diabetes
A study testing FDD program in people with Diabetes Prevention, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
No evidence-based, evaluated, population-appropriate resources exist to translate Type 2 diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such large-scale interventions include: the need to identify, then target specific at-risk populations significant time-delays before any program… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention
- What is being tested?
- FDD program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to 1 Mar 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- women aged 18-50 with recent GDM
- able to speak and write English
- overweight (BMI >25 before pregnancy)
- significant other family members
Who cannot join
- women with Types 1 or 2 diabetes
- women with BMI under 25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Families Defeating Diabetes: Canadian Intervention for Family-Centered Diabetes Prevention Following Gestational Diabetes (GDM)
No evidence-based, evaluated, population-appropriate resources exist to translate Type 2 diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such large-scale interventions include:
- the need to identify, then target specific at-risk populations
- significant time-delays before any program effects on T2DM incidence may manifest.
Read more
However, women with gestational diabetes (GDM) are a readily identifiable study cohort at significant risk for recurrent GDM and T2DM-hence GDM women provide important opportunities for rigorous, timely diabetes prevention intervention studies. The investigators propose FDD (Families Defeating Diabetes), a Canadian diabetes prevention intervention uniquely targeting women with recent GDM in the context of their families.
FDD is a 12 month, randomized, controlled T2DM prevention intervention targeting women with recent GDM, within their family context. Five Canadian sites and 177 women will participate. Multifaceted information and behavioural change support will be provided for diet, weight loss, and activity through: seminar, walking groups, electronic updates, password-protected social networking site.
Subjects and controls will be compared for: DM prevention knowledge; diet/activity choices; HbA1C; body habitus at study onset/during study/12 months/24 months.
Consenting immediate family members will have protective knowledge/diet/exercise choices/body habitus measures documented at study onset/12 and 24 months.
- Conditions
- Diabetes Prevention
- Being tested
- FDD program
- Keywords
- gestational diabetes, GDM, prevention
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDD programOther
FDD is a 12 month lifestyle intervention and behavioural support program delivered in the context of the surrounding family
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle and behavioural change support | Active comparator | Interventional arm will be offered a 12 month lifestyle program translating DM prevention issues to the family milieu Receives: Other: FDD program |
| control | No intervention | Control arm will receive standard diabetes prevention care as outlined in the current Canadian diabetes association Clinical Practice Guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of study subjects achieving a 7% weight loss
Weight loss in intervnetional vs control women will be documented by one year post-partum
Measured: one year post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startJan 2012
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes PreventionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth McManus, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425645
- Sponsor's protocol ID
- RXX
- Acronym
- FDD
- Status last verified
- Sep 2017
- First submitted
- 27 Aug 2011
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families Defeating Diabetes: Canadian Intervention for Family-Centered Diabetes Prevention Following Gestational Diabetes (GDM)
- ClinicalTrials.gov ID
- NCT01425645
- Acronym / sponsor ID
- FDD / RXX
- Conditions
- Diabetes Prevention
- Keywords
- gestational diabetes, GDM, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 30 Aug 2011 (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.
No evidence-based, evaluated, population-appropriate resources exist to translate Type 2 diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such large-scale interventions include:
- the need to identify, then target specific at-risk populations
- significant time-delays before any program effects on T2DM incidence may manifest.
However, women with gestational diabetes (GDM) are a readily identifiable study cohort at significant risk for recurrent GDM and T2DM-hence GDM women provide important opportunities for rigorous, timely diabetes prevention intervention studies. The investigators propose FDD (Families Defeating Diabetes), a Canadian diabetes prevention intervention uniquely targeting women with recent GDM in the context of their families.
FDD is a 12 month, randomized, controlled T2DM prevention intervention targeting women with recent GDM, within their family context. Five Canadian sites and 177 women will participate. Multifaceted information and behavioural change support will be provided for diet, weight loss, and activity through: seminar, walking groups, electronic updates, password-protected social networking site.
Subjects and controls will be compared for: DM prevention knowledge; diet/activity choices; HbA1C; body habitus at study onset/during study/12 months/24 months.
Consenting immediate family members will have protective knowledge/diet/exercise choices/body habitus measures documented at study onset/12 and 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle and behavioural change support | Active comparator | Other: FDD programInterventional arm will be offered a 12 month lifestyle program translating DM prevention issues to the family milieu |
| control | No intervention | –Control arm will receive standard diabetes prevention care as outlined in the current Canadian diabetes association Clinical Practice Guidelines. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women aged 18-50 with recent GDM
- able to speak and write English
- overweight (BMI >25 before pregnancy)
- significant other family members
Key exclusion criteria (2 listed)
- women with Types 1 or 2 diabetes
- women with BMI under 25
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 |
|---|---|---|
| FDD programFDD is a 12 month lifestyle intervention and behavioural support program delivered in the context of the surrounding family | Other | Lifestyle and behavioural change support |
Primary outcome
Proportion of study subjects achieving a 7% weight loss
Time frame: one year post-partum
Weight loss in intervnetional vs control women will be documented by one year post-partum
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 12 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDD program in people with Diabetes Prevention, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site 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 4 inclusion and 2 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 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Proportion of study subjects achieving a 7% weight loss (time frame: one year post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2017.