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Dietary ModificationDEPARTNCT02872402

Feasibility of a Postpartum Lifestyle Intervention on the Cardiometabolic Risk Profile of GDM Women

A study testing Lifestyle intervention in people with Dietary Modification and Weight Loss, run by Laval University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of the study is to investigate the effect of a lifestyle intervention program (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on minimizing postpartum weight retention among women with recent GDM. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
Dec 2016to Dec 2025
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Pregnant women diagnosed with GDM
  • Fluent in French
  • Had a singleton pregnancy
  • At least 18 yrs old
  • With a reported pre-pregnancy BMI ≥18.5 kg/m2

Who cannot join

  • Women who had bariatric surgery
  • Women who plan another pregnancy in the following year
  • Women with a history of type 1 or type 2 diabetes
  • Women with a multiple pregnancy

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institut sur la nutrition et les aliments fonctionnels

    Québec, Quebec, G1V0A6

Other trials in Canada

About this study

Official title: Feasibility of a Lifestyle Intervention Early After Delivery on the Cardiometabolic Risk Profile of Women With Recent Gestational Diabetes

The goal of the study is to investigate the effect of a lifestyle intervention program (adoption of exclusive breastfeeding, healthy diet and regular physical activity) on minimizing postpartum weight retention among women with recent GDM.

Read the detailed description

Women with a history of gestational diabetes (GDM) are characterized by increased risk for subsequent type 2 diabetes (T2D) and cardiovascular disease (CVD). These women are also characterized by higher body mass index (BMI) and waist circumference compared to women without prior GDM. Failure to lose the weight gained during pregnancy can lead to increased BMI for subsequent pregnancies. As such, the childbearing-age period has been described as a potential period of weight gain and represents a critical window for the development of obesity, T2D and CVD. Therefore, strategies aiming at preventing postpartum weight retention (WR) and early cardiometabolic alterations in women with a history of GDM are of paramount importance. Principal investigator have shown that a low diet quality score was associated with greater adiposity and lower insulin sensitivity in women with prior GDM. Furthermore, less than 10% of women with prior GDM met the recommendations for breastfeeding, nutrition, and physical activity. Investigators have shown that attitude and perceived behavioral control were significant predictors of the intention to adopt healthy eating. For those who did engage in healthy behaviors, lower prevalence of cardiometabolic alterations was observed, providing supportive evidence that the adoption of healthy behaviors may be key to prevent the progression to an altered cardiometabolic profile.

Being tested
Lifestyle intervention, Active control lifestyle intervention
Keywords
gestational diabetes, dietary modification, weight loss, physical activity, breastfeeding
Medical subject headings
Weight Loss, Motor Activity, Breast Feeding, Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionBehavioural

    Women who are still breastfeeding at the first postpartum visit will be encouraged to pursue. References to local breastfeeding supporting groups will be done, if needed. The intervention will be conducted in order to reach recommendations for food servings and nutrient needs. Particular attention will be paid to increase fruits, vegetables, fish and whole grains intake, and decrease added sugars and high fat meat/dairy products. Women will be strongly encouraged to be active at least 150 min/week. They will be provided with targeted strategies for exercising, types of exercises and tips for including physical activity into the daily routine as well as fun exercises for the whole family.

  • Active control lifestyle interventionBehavioural

    Participants in the control group will receive standard lifestyle recommendations in the form of written information at each visit.

Study groups in NCT02872402
Study groupRoleWhat they receive
Intervention groupExperimentalAt 2-mo postpartum, women will start the 1-yr lifestyle intervention that will consist of 7 face-to-face individual sessions of 1-hr (at 2, 3, 4, 5, 6, 9, 12 mo postpartum and a follow-up at 18 mo). Metabolic and anthropometric measurements will be assessed at 2,6,12 and 18 mo postpartum. In addition, 7 individual sessions of 30 min between face-to-face sessions will be carried out on the phone. Benefits of exclusive breastfeeding, healthy eating and physical activity will be portrayed at each visit .
Receives: Behavioral: Lifestyle intervention
Active control lifestyle interventionActive comparatorWomen in the control group will come to the testing unit at 2, 6, 12 and 18 mo postpartum for metabolic and anthropometric measurements and at 3, 4, 5, 9 mo for weight measurements only. They will receive standard lifestyle recommendations in the form of written information at each visit.
Receives: Behavioral: Active control lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight retention

    Measured: 12 months postpartum

Secondary outcomes (11)

  1. Waist circumference

    Measured: 12 months postpartum

  2. Body composition

    Measured: 12 months postpartum

  3. Glucose

    Measured: 12 months

  4. Insuline

    Measured: 12 months

  5. Oral glucose tolerance test (75g)

    Measured: 12 months

  6. Glycated hemoglobin

    Measured: 12 months

  7. Lipid profile

    Measured: 12 months

  8. Resting blood pressure

    Measured: 12 months

  9. Breastfeeding duration

    , time physically active

    Measured: 12 months

  10. Healthy eating index

    Measured: 12 months

  11. Time physically active

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionOct 2020
  4. Study completionDec 2025 (estimated)

Resources

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
Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02872402
Sponsor's protocol ID
DEPART
Acronym
DEPART
Status last verified
Apr 2022
First submitted
4 Aug 2016
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Petitclerc I, Perron J, Dugas C, Mayer T, Raymond F, Di Marzo V, Veilleux A, Robitaille J. Association between gestational diabetes mellitus, maternal health and diet, and gut microbiota in mother-infant dyads. BMC Pregnancy Childbirth. 2025 Apr 24;25(1):486. doi: 10.1186/s12884-025-07584-2.

    PubMed 40275186

  • Fradet A, Castonguay-Paradis S, Dugas C, Perron J, St-Arnaud G, Marc I, Doyen A, Flamand N, Dahhani F, Di Marzo V, Veilleux A, Robitaille J. The human milk endocannabinoidome and neonatal growth in gestational diabetes. Front Endocrinol (Lausanne). 2024 Jun 13;15:1415630. doi: 10.3389/fendo.2024.1415630. eCollection 2024.

    PubMed 38938519

  • Dugas C, Laberee L, Perron J, St-Arnaud G, Richard V, Perreault V, Leblanc N, Marc I, Di Marzo V, Doyen A, Veilleux A, Robitaille J. Gestational Diabetes Mellitus, Human Milk Composition, and Infant Growth. Breastfeed Med. 2023 Jan;18(1):14-22. doi: 10.1089/bfm.2022.0085. Epub 2022 Nov 21.

    PubMed 36409543

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Dietary Modification and Weight Loss, run by Laval University 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Apr 2022. 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?

Results are not available in the source record.

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?

Weight retention (time frame: 12 months postpartum). 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 NCT02872402, which also lists 3 linked publications.

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 8 Apr 2022.

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