Diabetes MellitusLINDA-BrasilNCT02327286
Randomized Clinical Trial of Lifestyle Interventions to Prevent Diabetes in Women With Previous Gestational Diabetes
A study testing Promote and support healthy behaviors in people with Diabetes Mellitus and Diabetes, Gestational, run by Federal University of Rio Grande do Sul at 3 sites in Brazil.
Trial summary
Randomized trial aiming to investigate the effectiveness of a lifestyle intervention program implemented within the first year after a pregnancy complicated by gestational diabetes (GDM), in delaying or preventing the development of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus, Diabetes, Gestational
- What is being tested?
- Promote and support healthy behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- 3 sitesBrazil
- Study dates
- Jan 2015to 31 Mar 2022
- 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
- Women aged 18 or older having gestational diabetes, regardless of the diagnostic criteria, who used insulin during their pregnancy or were found to have impaired glucose tolerance or impaired fasting glucose (>=100 mg/dL) on a post-partum oral glucose tolerance test (OGTT).
- We amended the protocol to also include women using oral hypoglycemics during pregnancy because their use increased during the trial implementation.
Who cannot join
- Confirmed postpartum diabetes (two abnormal OGTTs) or current use of antidiabetic medication
- Indication that the trial interventions will not be feasible, for example, distance from the trial site
- Poor attendance/response in previous contacts (appointments or phone interviews)
- Health limitations or treatments (assessed by questionnaire) restricting the nutritional intervention or the ability to practice physical activity, affecting glucose tolerance or limiting participation or survival.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Centro de Estudos em Diabetes e Hipertensão
Fortaleza, Ceará, 60135-180
Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96020-220
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Prevenção do Diabetes em Mulheres Com Diabetes Gestacional prévio: Estudo multicêntrico de mudanças Intensivas de Estilo de Vida: LINDA-Brasil
Randomized trial aiming to investigate the effectiveness of a lifestyle intervention program implemented within the first year after a pregnancy complicated by gestational diabetes (GDM), in delaying or preventing the development of type 2 diabetes.
Read the detailed description
LINDA-Brasil is a multicenter randomized clinical trial to test the effectiveness of a lifestyle intervention program tailored to women with a recent diagnosis of GDM to be implemented within two-year after pregnancy with the goal of preventing type 2 diabetes. It is based on a cohort study of women recruited during pregnancy. At first contact, the study protocol is explained, and it is made clear that not all women enrolled in the cohort will be eligible to participate in the post partum clinical trial. During pregnancy and the immediate post-partum period, women are monitored monthly by telephone to maintain contact. From six weeks to two years after delivery, high risk status is determined and women at high risk are contacted to evaluate their eligibility for the trial. Those potentially eligible are then invited to the research center for an examination prior to randomization. Once eligibility is confirmed, women return to the clinical research center at which point key aspects of the clinical trial protocol are reviewed and remaining questions clarified. Those willing to participate provide specific informed consent and are then allocated to one of the two comparison groups. The randomization scheme is 1:1 by trial arm, stratified by center and has random blocks. Based on results of key previous clinical trials on diabetes prevention, LINDA has tailored its intervention to meet the particular needs of women with previous GDM during their post partum. Building from social cognitive theory, interventions are participant-centered, allowing adaptation to each women´s setting, within the limits of a standardized prevention program with defined goals and structure. Communication strategies are based on motivational interviewing and health coaching approaches that can be implemented in the primary care setting. Follow-up is planned to continue until all women have completed at least 18 months of participation and the average length of follow up for the whole sample is at least three years. Outcomes are assessed at baseline, at 6 months and then annually. Women who develop diabetes will be notified and oriented to seek medical treatment.
- Conditions
- Diabetes Mellitus, Diabetes, Gestational
- Being tested
- Promote and support healthy behaviors
- Keywords
- Diabetes Mellitus, Gestational diabetes
- Medical subject headings
- Diabetes Mellitus, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promote and support healthy behaviorsBehavioural
- Exclusive breastfeeding for 6 months and partial breastfeeding for at least 3 additional months.
- Personally monitored weight loss and maintenance with goal: return to pre-pregnancy weight and, if overweight pre-pregnancy, loss of an additional 5% of body weight.
- Healthy eating: avoidance of ultra-processed foods, limited intake of oils, sugars and processed foods, increased intake of foodstuffs in their natural state, regular intake of water, dairy products, unsweetened coffee and tea.
- A progressive increase in physical activity of at least 150 minutes of moderate or vigorous physical activity/week (7500 steps/day) and reduction of sedentary behavior with monitoring by personally worn devices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Promote and support healthy behaviors Receives: Behavioral: Promote and support healthy behaviors |
| Control | No intervention | Conventional care for women with prior GDM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident diabetes mellitus
Diabetes mellitus as ascertained by a 75g oral glucose tolerance test.
Measured: Up to 5 years
Secondary outcomes (1)
Weight at one year post randomization
Return to pre-pregnancy weight; if overweight or obese before pregnancy, achieve an additional reduction of at least 5%;
Difference in weight determined between measured weight at 1 year post randomization and self-reported pre-pregnancy weight.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJan 2015
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Eli Lilly and Company, Hospital de Clinicas de Porto Alegre, Fundação Médica do Rio Grande do Sul, Federal University of Pelotas, Centro de Estudos em Diabetes e Hipertensão
- Responsible party
- Principal investigator, MSchmidt, Federal University of Rio Grande do Sul
- Investigators
- Maria I Schmidt, MD, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327286
- Sponsor's protocol ID
- 563942/2010-0
- Other IDs
- U1111-1165-0608, 00914312.0.1001.5327
- Acronym
- LINDA-Brasil
- Status last verified
- Jul 2022
- First submitted
- 23 Dec 2014
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt MI, Duncan BB, Castilhos C, Wendland EM, Hallal PC, Schaan BD, Drehmer M, Costa E Forti A, Facanha C, Nunes MA. Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial. BMC Pregnancy Childbirth. 2016 Mar 30;16:68. doi: 10.1186/s12884-016-0851-x.
PubMed 27029489Schmidt MI, Bracco PA, Nunes MA, Cherubini KA, Castilhos CD, Spagiari JZ, Galliano LM, Ladwig R, Del Vecchio FB, Del Vecchio AHM, Drehmer M, Forti AC, Facanha C, Zajdenverg L, de Almeida-Pititto B, Rea RR, Dualib PM, Duncan BB. Telephone lifestyle intervention to prevent diabetes in women with recent gestational diabetes mellitus attending the national health system: the LINDA-Brasil clinical trial. BMJ Open. 2024 Oct 15;14(10):e082572. doi: 10.1136/bmjopen-2023-082572.
PubMed 39414286Dame P, Cherubini K, Goveia P, Pena G, Galliano L, Facanha C, Nunes MA. Depressive Symptoms in Women with Gestational Diabetes Mellitus: The LINDA-Brazil Study. J Diabetes Res. 2017;2017:7341893. doi: 10.1155/2017/7341893. Epub 2017 Jun 8.
PubMed 28685151
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevenção do Diabetes em Mulheres Com Diabetes Gestacional prévio: Estudo multicêntrico de mudanças Intensivas de Estilo de Vida: LINDA-Brasil
- ClinicalTrials.gov ID
- NCT02327286
- Acronym / sponsor ID
- LINDA-Brasil / 563942/2010-0
- Conditions
- Diabetes Mellitus, Diabetes, Gestational
- Keywords
- Diabetes Mellitus, Gestational diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Eli Lilly and Company, Hospital de Clinicas de Porto Alegre, Fundação Médica do Rio Grande do Sul, Federal University of Pelotas, Centro de Estudos em Diabetes e Hipertensão
- Study start
- Jan 2015 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 30 Dec 2014 (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.
Randomized trial aiming to investigate the effectiveness of a lifestyle intervention program implemented within the first year after a pregnancy complicated by gestational diabetes (GDM), in delaying or preventing the development of type 2 diabetes.
Detailed description
LINDA-Brasil is a multicenter randomized clinical trial to test the effectiveness of a lifestyle intervention program tailored to women with a recent diagnosis of GDM to be implemented within two-year after pregnancy with the goal of preventing type 2 diabetes. It is based on a cohort study of women recruited during pregnancy. At first contact, the study protocol is explained, and it is made clear that not all women enrolled in the cohort will be eligible to participate in the post partum clinical trial. During pregnancy and the immediate post-partum period, women are monitored monthly by telephone to maintain contact. From six weeks to two years after delivery, high risk status is determined and women at high risk are contacted to evaluate their eligibility for the trial. Those potentially eligible are then invited to the research center for an examination prior to randomization. Once eligibility is confirmed, women return to the clinical research center at which point key aspects of the clinical trial protocol are reviewed and remaining questions clarified. Those willing to participate provide specific informed consent and are then allocated to one of the two comparison groups. The randomization scheme is 1:1 by trial arm, stratified by center and has random blocks. Based on results of key previous clinical trials on diabetes prevention, LINDA has tailored its intervention to meet the particular needs of women with previous GDM during their post partum. Building from social cognitive theory, interventions are participant-centered, allowing adaptation to each women´s setting, within the limits of a standardized prevention program with defined goals and structure. Communication strategies are based on motivational interviewing and health coaching approaches that can be implemented in the primary care setting. Follow-up is planned to continue until all women have completed at least 18 months of participation and the average length of follow up for the whole sample is at least three years. Outcomes are assessed at baseline, at 6 months and then annually. Women who develop diabetes will be notified and oriented to seek medical treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Promote and support healthy behaviorsPromote and support healthy behaviors |
| Control | No intervention | –Conventional care for women with prior GDM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 18 or older having gestational diabetes, regardless of the diagnostic criteria, who used insulin during their pregnancy or were found to have impaired glucose tolerance or impaired fasting glucose (>=100 mg/dL) on a post-partum oral glucose tolerance test (OGTT).
- We amended the protocol to also include women using oral hypoglycemics during pregnancy because their use increased during the trial implementation.
Key exclusion criteria (4 listed)
- Confirmed postpartum diabetes (two abnormal OGTTs) or current use of antidiabetic medication
- Indication that the trial interventions will not be feasible, for example, distance from the trial site
- Poor attendance/response in previous contacts (appointments or phone interviews)
- Health limitations or treatments (assessed by questionnaire) restricting the nutritional intervention or the ability to practice physical activity, affecting glucose tolerance or limiting participation or survival.
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 |
|---|---|---|
| Promote and support healthy behaviors* Exclusive breastfeeding for 6 months and partial breastfeeding for at least 3 additional months. * Personally monitored weight loss and maintenance with goal: return to pre-pregnancy weight and, if overweight pre-pregnancy, loss of an additional 5% of body weight. * Healthy eating: avoidance of ultra-processed foods, limited intake of oils, sugars and processed foods, increased intake of foodstuffs in their natural state, regular intake of water, dairy products, unsweetened coffee and tea. * A progressive increase in physical activity of at least 150 minutes of moderate or vigorous physical activity/week (7500 steps/day) and reduction of sedentary behavior with monitoring by personally worn devices. | Behavioural | Intervention |
Primary outcome
Incident diabetes mellitus
Time frame: Up to 5 years
Diabetes mellitus as ascertained by a 75g oral glucose tolerance test.
1 secondary outcome
Weight at one year post randomization
Time frame: 1 year
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 27 Jul 2022.
- Background: PubMed 27029489Schmidt MI, Duncan BB, Castilhos C, Wendland EM, Hallal PC, Schaan BD, Drehmer M, Costa E Forti A, Facanha C, Nunes MA. Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial. BMC Pregnancy Childbirth. 2016 Mar 30;16:68. doi: 10.1186/s12884-016-0851-x.
- Derived from this study: PubMed 39414286Schmidt MI, Bracco PA, Nunes MA, Cherubini KA, Castilhos CD, Spagiari JZ, Galliano LM, Ladwig R, Del Vecchio FB, Del Vecchio AHM, Drehmer M, Forti AC, Facanha C, Zajdenverg L, de Almeida-Pititto B, Rea RR, Dualib PM, Duncan BB. Telephone lifestyle intervention to prevent diabetes in women with recent gestational diabetes mellitus attending the national health system: the LINDA-Brasil clinical trial. BMJ Open. 2024 Oct 15;14(10):e082572. doi: 10.1136/bmjopen-2023-082572.
- Derived from this study: PubMed 28685151Dame P, Cherubini K, Goveia P, Pena G, Galliano L, Facanha C, Nunes MA. Depressive Symptoms in Women with Gestational Diabetes Mellitus: The LINDA-Brazil Study. J Diabetes Res. 2017;2017:7341893. doi: 10.1155/2017/7341893. Epub 2017 Jun 8.
- Study protocolLink 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.
Maria I Schmidt, MD, PhD principal investigator
Federal University of Rio Grande do Sul
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promote and support healthy behaviors in people with Diabetes Mellitus and Diabetes, Gestational, run by Federal University of Rio Grande do Sul at 3 sites in Brazil.
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 2 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: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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?
Incident diabetes mellitus (time frame: Up to 5 years). 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 NCT02327286, 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 27 Jul 2022.