Excessive Weight Gain During PregnancyNCT01782105
Intervention to Promote Changes of Healthy Lifestyle (Physical Activity and Nutrition) During Gestation
A study testing Healthy lifestyle counseling in people with Excessive Weight Gain During Pregnancy and Gestational Diabetes, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The purpose of this study are: Assess the impact of an intervention to the adoption of healthy lifestyles among pregnant women at high risk of gestational diabetes mellitus on: weight gain in pregnancy the levels of maternal and fetal adipokines and glycemic control maternal and fetal. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Excessive Weight Gain During Pregnancy, Gestational Diabetes
- What is being tested?
- Healthy lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Oct 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be aged ≥ 18 years,
- have a pre-pregnancy BMI ≥ 25 kg/m2,
- be at risk of developing a gestational diabetes mellitus (a history of gestational diabetes mellitus or glucose 1 hour post-50g > 7.1 mmol/L.
Who cannot join
- Pre-pregnancy diabetes detected in the first trimester (A1c > 6.5%, fasting glucose > 7.0 mmol/L, random blood glucose> 11.1 mmol/L, glucose > 10.3 mmol/L 1 hour post-50g)
- twin pregnancy
- taking medications that can affect blood sugar or weight,
- practice ≥ 150 minutes of physical activity per week
- against formal-indication for physical activity.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H5N4
About this study
Official title: Intervention en Changement Des Habitudes de Vie Par l'Activité Physique et un Support Nutritionnel Durant la Grossesse en Estrie
The purpose of this study are:
- Assess the impact of an intervention to the adoption of healthy lifestyles among pregnant women at high risk of gestational diabetes mellitus on:
- weight gain in pregnancy
- the levels of maternal and fetal adipokines and
- glycemic control maternal and fetal.
- Determine whether the adoption of healthy lifestyles in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.
- Being tested
- Healthy lifestyle counseling, Control group
- Keywords
- weight gain, healthy lifestyle, gestational diabetes, adipokins, glycemic regulation
- Medical subject headings
- Diabetes, Gestational, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lifestyle counselingBehavioural
Also called Intervention group
Nutritionnal and physical activity counseling and physical activity session group
Control groupBehavioural
Evaluation of nutritional and physcial activity habits
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | In addition to the usual monitoring of pregnancy, this group will receive information about the recommended weight gain during pregnancy and an evaluation about of their nutritional and physical activity habits. Receives: Behavioral: Control group |
| Intervention group | Experimental | This group will receive a regular monitoring by health professionals (nutritionist and kinesiologist) who will ensure nutritional changes and physical activity necessary to secure the adoption of a healthy lifestyle and could participate to a physical activity group session once a week until week 36 of gestation.
The intervention include:
A nutritional counseling every 2 weeks by a nutritionist until week 36 of gestation; a physical activity group session once a week lead by a kinesiologist until week 36 of gestation; 2 sessions of physical activity counseling (weeks 12 and 24). Receives: Behavioral: Healthy lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change during pregnancy
Measured: Weeks 12, 24, 36 of gestation
Secondary outcomes (4)
Levels of maternal and fetal adipokines
Measured: Weeks 12, 24 of gestation and at delivery (in cord blood)
Maternal and fetal glycemic control
Results of glucose tolerance test (50g and 75g)
Measured: Weeks 12, 24 of gestation and at delivery
Determine whether the adoption of healthy lifestyle in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.
Measured: Weeks 12, 24 of gestation and at delivery (cord blood)
Optimize the intervention before measuring its impact on the prevention of gestational diabetes mellitus on a larger scale.
Documentation will be collected about appreciation of the participants and attendance.
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startDec 2011
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Weight Gain During PregnancyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Québec, Fonds de la Recherche en Santé du Québec
- Responsible party
- Principal investigator, Marie-France Hivert, Université de Sherbrooke
- Investigators
- Marie-France Hivert, MD, MSc, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782105
- Sponsor's protocol ID
- I-CHANGE
- Status last verified
- Dec 2013
- First submitted
- 18 Jun 2012
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention en Changement Des Habitudes de Vie Par l'Activité Physique et un Support Nutritionnel Durant la Grossesse en Estrie
- ClinicalTrials.gov ID
- NCT01782105
- Acronym / sponsor ID
- I-CHANGE
- Keywords
- weight gain, healthy lifestyle, gestational diabetes, adipokins, glycemic regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Diabetes Québec, Fonds de la Recherche en Santé du Québec
- Study start
- Dec 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Feb 2013 (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.
The purpose of this study are:
- Assess the impact of an intervention to the adoption of healthy lifestyles among pregnant women at high risk of gestational diabetes mellitus on:
- weight gain in pregnancy
- the levels of maternal and fetal adipokines and
- glycemic control maternal and fetal.
- Determine whether the adoption of healthy lifestyles in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Control groupIn addition to the usual monitoring of pregnancy, this group will receive information about the recommended weight gain during pregnancy and an evaluation about of their nutritional and physical activity habits. |
| Intervention group | Experimental | Behavioral: Healthy lifestyle counselingThis group will receive a regular monitoring by health professionals (nutritionist and kinesiologist) who will ensure nutritional changes and physical activity necessary to secure the adoption of a healthy lifestyle and could participate to a physical activity group session once a week until week 36 of gestation. The intervention include: A nutritional counseling every 2 weeks by a nutritionist until week 36 of gestation; a physical activity group session once a week lead by a kinesiologist until week 36 of gestation; 2 sessions of physical activity counseling (weeks 12 and 24). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be aged ≥ 18 years,
- have a pre-pregnancy BMI ≥ 25 kg/m2,
- be at risk of developing a gestational diabetes mellitus (a history of gestational diabetes mellitus or glucose 1 hour post-50g > 7.1 mmol/L.
Key exclusion criteria (5 listed)
- Pre-pregnancy diabetes detected in the first trimester (A1c > 6.5%, fasting glucose > 7.0 mmol/L, random blood glucose> 11.1 mmol/L, glucose > 10.3 mmol/L 1 hour post-50g)
- twin pregnancy
- taking medications that can affect blood sugar or weight,
- practice ≥ 150 minutes of physical activity per week
- against formal-indication for physical activity.
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 lifestyle counselingAlso: Intervention groupNutritionnal and physical activity counseling and physical activity session group | Behavioural | Intervention group |
| Control groupEvaluation of nutritional and physcial activity habits | Behavioural | Control group |
Primary outcome
Weight change during pregnancy
Time frame: Weeks 12, 24, 36 of gestation
4 secondary outcomes
Levels of maternal and fetal adipokines
Time frame: Weeks 12, 24 of gestation and at delivery (in cord blood)
Maternal and fetal glycemic control
Time frame: Weeks 12, 24 of gestation and at delivery
Determine whether the adoption of healthy lifestyle in pregnancy is associated with epigenetic changes that influence the levels of adipokines and glucose regulation during pregnancy and in newborns.
Time frame: Weeks 12, 24 of gestation and at delivery (cord blood)
Optimize the intervention before measuring its impact on the prevention of gestational diabetes mellitus on a larger scale.
Time frame: throughout the study
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 11 Dec 2013.
Related trials for Excessive Weight Gain During Pregnancy
Active, not recruiting
An Optimized Programming of Healthy Children (APPROACH)
Pregnancy, Obesity
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.
Marie-France Hivert, MD, MSc principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy lifestyle counseling in people with Excessive Weight Gain During Pregnancy and Gestational Diabetes, run by Université de Sherbrooke 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 3 inclusion and 5 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 11 Dec 2013. 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?
Weight change during pregnancy (time frame: Weeks 12, 24, 36 of gestation). 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 11 Dec 2013.