DiabetesNCT01679210
Study of a Postpartum Diabetes Prevention Program for Hispanic Women
A study testing Lifestyle Intervention in people with Diabetes, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance… 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
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2018
- 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
- Hispanic women with one or more glucose values during the diagnostic test meeting or exceeding the thresholds defined according to the American Diabetes Association
Who cannot join
- history of type 1 or type 2 diabetes, heart disease, or chronic renal disease
- contraindications to postpartum participation in moderate physical activity or a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)
- inability to read English or Spanish at a 6th grade level
- <18 or >45 yrs of age
- women carrying multiples
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Estudio PARTO: Proyecto pAra Reducir Diabetes Tipo dOs / Project Aiming to Reduce Type twO Diabetes
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy.
Read the detailed description
Specific aims are to evaluate the impact of the intervention on 1) postpartum weight loss, 2) biomarkers associated with insulin resistance (i.e., glucose, insulin, HbA1c, leptin, TNF-α, HOMA, AUCgluc, adiponectin), 3) other cardiovascular risk factors (i.e., blood lipids, blood pressure, CRP, fetuin-A, albumin-to-creatinine ratio), and 4) the adoption and maintenance of postpartum behaviors associated with weight loss and prevention of diabetes risk (i.e., physical activity, diet). Eligible Hispanic women will be recruited after routine GDM screening and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) intervention (n=150). The intervention will be based on our efficacious exercise and dietary interventions for Hispanics (R01NR011295; WIC Common Pathways). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention from randomization (29 wks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American College of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific social, cultural, economic, and physical environmental challenges faced by underserved Hispanic women. Measures of adherence will include the Pregnancy Physical Activity Questionnaire (PPAQ), accelerometers, and dietary recalls. The project is a Renewal Application of R01 DK064902, a study of lifestyle risk factors for GDM in Hispanic women. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of lifestyle interventions among Hispanic pregnant women (R01 DK074876; S3948 ASPH/CDC) and controlled trials of lifestyle interventions among low-income Hispanics with type 2 diabetes and pre-diabetes (R18 DK0658850; R18DK067549) and can readily be translated into clinical practice in underserved and minority populations.
- Conditions
- Diabetes
- Being tested
- Lifestyle Intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
Stage-matched physical activity and diet intervention materials and health education.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | Stage-matched physical activity and diet intervention materials and health education. Receives: Behavioral: Lifestyle Intervention |
| Health and Wellness | No intervention | HW served as the comparison group and received the same number of in-person sessions, telephone calls, and mailings at the same time points as LI. Content was limited to general information available to the public from the ACOG and the American Academy of Pediatrics and did not mention exercise behavior change. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum weight change
Postpartum weight change will be measured as the difference between weight at 6 or 12 mos postpartum and weight at delivery. Weight will be measured on a digital scale.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Percent of participants meeting postpartum weight goals
Postpartum weight goals will be defined as weight change to prepregnancy weight if prepregnancy BMI was normal, or a 5% change towards prepregnancy weight if prepregnancy BMI was overweight/obese. Weight will be measured on a digital scale.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Fasting Glucose (FG)
Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL).
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Fasting Insulin (FI)
Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Hemoglobin A1c (HbA1c)
The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Leptin
Leptin will be measured by an ultra-sensitive ELISA assay, an enzymatically amplified "two-step" sandwich-type immunoassay (R\&D Systems, Minneapolis, MN) (pg/mL).
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Total Adiponectin
Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH).
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Lipoprotein Profile
Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL).
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
High Sensitivity C-Reactive Protein
The concentration of High Sensitivity C-Reactive Protein (hsCRP) will be determined using an immunoturbidimetric assay on the Roche P Modular system using reagents and calibrators from DiaSorin (Stillwater, MN) (mg/L).
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
TNF
TNF-receptor II is measured by an ELISA assay from R\&D Systems (pg/mL).
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Albumin-to-creatinine ratio (ACR)
Albumin-to-creatinine ratio (ACR): Albumin will be measured by a colorimetric assay, an automated dye-binding method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (g/dL). Creatinine will be measured by an enzymatic method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (mg/dL).
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Fetuin-A
Fetuin-A will be measured by an enzyme immunoassay (EIA) (BioVendor - Candler, NC) (ng/mL).
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Physical activity
Total activity according to intensity will be measured via the Pregnancy Physical Activity Questionnaire (PPAQ) and hip worn accelerometer. (MET-hrs/week).
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Dietary Intake
Total calories, along with the other nutrients, will be measured via three 24-hr dietary recalls.
Measured: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Northeastern University, Baystate Medical Center, University of Massachusetts, Worcester
- Responsible party
- Principal investigator, Lisa Chasan-Taber, University of Massachusetts, Amherst
- Investigators
- Lisa Chasan-Taber, ScD, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679210
- Sponsor's protocol ID
- NIH 2R01DK064902-06A1
- Status last verified
- Apr 2020
- First submitted
- 7 Aug 2012
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Braun B, Moore Simas TA, Solomon CG, Manson JE, Markenson G. Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol. BMC Pregnancy Childbirth. 2014 Mar 10;14:100. doi: 10.1186/1471-2393-14-100.
PubMed 24606590Wagner KA, St Laurent CW, Pekow P, Marcus B, Rosal MC, Braun B, Manson JE, Whitcomb BW, Sievert LL, Chasan-Taber L. The Impact of a Lifestyle Intervention on Postpartum Cardiometabolic Risk Factors Among Hispanic Women With Abnormal Glucose Tolerance During Pregnancy: Secondary Analysis of a Randomized Trial. J Phys Act Health. 2023 Oct 27;21(1):40-50. doi: 10.1123/jpah.2023-0145. Print 2024 Jan 1.
PubMed 37890839Wilkie G, Leung K, Moore Simas TA, Tucker KL, Chasan-Taber L. The Association Between Acculturation and Diet and Physical Activity Among Pregnant Hispanic Women with Abnormal Glucose Tolerance. J Womens Health (Larchmt). 2022 Dec;31(12):1791-1799. doi: 10.1089/jwh.2022.0017. Epub 2022 Aug 30.
PubMed 36040352Moore Simas TA, Leung K, Nuss E, Marieni M, Marcus B, Rosal MC, Chasan-Taber L. Factors Associated with Risk of Perinatal Depressive Symptoms Among Puerto Rican Women with Hyperglycemia. Matern Child Health J. 2022 Aug;26(8):1741-1751. doi: 10.1007/s10995-022-03429-y. Epub 2022 Apr 6.
PubMed 35386031Hawkins M, Marcus B, Pekow P, Rosal MC, Tucker KL, Spencer RMC, Chasan-Taber L. The Impact of a Randomized Controlled Trial of a Lifestyle Intervention on Sleep Among Latina Postpartum Women. Ann Behav Med. 2021 Aug 23;55(9):892-903. doi: 10.1093/abm/kaaa118.
PubMed 33580651Gubrium A, Leckenby D, Harvey MW, Marcus BH, Rosal MC, Chasan-Taber L. Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. BMC Health Serv Res. 2019 Jun 6;19(1):357. doi: 10.1186/s12913-019-4207-x.
PubMed 31170973
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio PARTO: Proyecto pAra Reducir Diabetes Tipo dOs / Project Aiming to Reduce Type twO Diabetes
- ClinicalTrials.gov ID
- NCT01679210
- Acronym / sponsor ID
- NIH 2R01DK064902-06A1
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- University of California, San Diego, Northeastern University, Baystate Medical Center, University of Massachusetts, Worcester
- Study start
- Jan 2013
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 5 Sep 2012 (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 overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy.
Detailed description
Specific aims are to evaluate the impact of the intervention on 1) postpartum weight loss, 2) biomarkers associated with insulin resistance (i.e., glucose, insulin, HbA1c, leptin, TNF-α, HOMA, AUCgluc, adiponectin), 3) other cardiovascular risk factors (i.e., blood lipids, blood pressure, CRP, fetuin-A, albumin-to-creatinine ratio), and 4) the adoption and maintenance of postpartum behaviors associated with weight loss and prevention of diabetes risk (i.e., physical activity, diet). Eligible Hispanic women will be recruited after routine GDM screening and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) intervention (n=150). The intervention will be based on our efficacious exercise and dietary interventions for Hispanics (R01NR011295; WIC Common Pathways). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention from randomization (29 wks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American College of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific social, cultural, economic, and physical environmental challenges faced by underserved Hispanic women. Measures of adherence will include the Pregnancy Physical Activity Questionnaire (PPAQ), accelerometers, and dietary recalls. The project is a Renewal Application of R01 DK064902, a study of lifestyle risk factors for GDM in Hispanic women. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of lifestyle interventions among Hispanic pregnant women (R01 DK074876; S3948 ASPH/CDC) and controlled trials of lifestyle interventions among low-income Hispanics with type 2 diabetes and pre-diabetes (R18 DK0658850; R18DK067549) and can readily be translated into clinical practice in underserved and minority populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionStage-matched physical activity and diet intervention materials and health education. |
| Health and Wellness | No intervention | –HW served as the comparison group and received the same number of in-person sessions, telephone calls, and mailings at the same time points as LI. Content was limited to general information available to the public from the ACOG and the American Academy of Pediatrics and did not mention exercise behavior change. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Hispanic women with one or more glucose values during the diagnostic test meeting or exceeding the thresholds defined according to the American Diabetes Association
Key exclusion criteria (5 listed)
- history of type 1 or type 2 diabetes, heart disease, or chronic renal disease
- contraindications to postpartum participation in moderate physical activity or a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)
- inability to read English or Spanish at a 6th grade level
- <18 or >45 yrs of age
- women carrying multiples
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 |
|---|---|---|
| Lifestyle InterventionStage-matched physical activity and diet intervention materials and health education. | Behavioural | Lifestyle Intervention |
Primary outcome
Postpartum weight change
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Postpartum weight change will be measured as the difference between weight at 6 or 12 mos postpartum and weight at delivery. Weight will be measured on a digital scale.
Percent of participants meeting postpartum weight goals
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Postpartum weight goals will be defined as weight change to prepregnancy weight if prepregnancy BMI was normal, or a 5% change towards prepregnancy weight if prepregnancy BMI was overweight/obese. Weight will be measured on a digital scale.
Fasting Glucose (FG)
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL).
Fasting Insulin (FI)
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL.
Hemoglobin A1c (HbA1c)
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells.
Leptin
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Leptin will be measured by an ultra-sensitive ELISA assay, an enzymatically amplified "two-step" sandwich-type immunoassay (R\&D Systems, Minneapolis, MN) (pg/mL).
Total Adiponectin
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH).
Lipoprotein Profile
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL).
High Sensitivity C-Reactive Protein
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
The concentration of High Sensitivity C-Reactive Protein (hsCRP) will be determined using an immunoturbidimetric assay on the Roche P Modular system using reagents and calibrators from DiaSorin (Stillwater, MN) (mg/L).
TNF
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
TNF-receptor II is measured by an ELISA assay from R\&D Systems (pg/mL).
Albumin-to-creatinine ratio (ACR)
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Albumin-to-creatinine ratio (ACR): Albumin will be measured by a colorimetric assay, an automated dye-binding method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (g/dL). Creatinine will be measured by an enzymatic method using the Roche P Modular system and Roche Diagnostics reagents (Indianapolis, IN) (mg/dL).
Fetuin-A
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Fetuin-A will be measured by an enzyme immunoassay (EIA) (BioVendor - Candler, NC) (ng/mL).
Physical activity
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Total activity according to intensity will be measured via the Pregnancy Physical Activity Questionnaire (PPAQ) and hip worn accelerometer. (MET-hrs/week).
Dietary Intake
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Total calories, along with the other nutrients, will be measured via three 24-hr dietary recalls.
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 29 Apr 2020.
- Background: PubMed 24606590Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Braun B, Moore Simas TA, Solomon CG, Manson JE, Markenson G. Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial - study protocol. BMC Pregnancy Childbirth. 2014 Mar 10;14:100. doi: 10.1186/1471-2393-14-100.
- Derived from this study: PubMed 37890839Wagner KA, St Laurent CW, Pekow P, Marcus B, Rosal MC, Braun B, Manson JE, Whitcomb BW, Sievert LL, Chasan-Taber L. The Impact of a Lifestyle Intervention on Postpartum Cardiometabolic Risk Factors Among Hispanic Women With Abnormal Glucose Tolerance During Pregnancy: Secondary Analysis of a Randomized Trial. J Phys Act Health. 2023 Oct 27;21(1):40-50. doi: 10.1123/jpah.2023-0145. Print 2024 Jan 1.
- Derived from this study: PubMed 36040352Wilkie G, Leung K, Moore Simas TA, Tucker KL, Chasan-Taber L. The Association Between Acculturation and Diet and Physical Activity Among Pregnant Hispanic Women with Abnormal Glucose Tolerance. J Womens Health (Larchmt). 2022 Dec;31(12):1791-1799. doi: 10.1089/jwh.2022.0017. Epub 2022 Aug 30.
- Derived from this study: PubMed 35386031Moore Simas TA, Leung K, Nuss E, Marieni M, Marcus B, Rosal MC, Chasan-Taber L. Factors Associated with Risk of Perinatal Depressive Symptoms Among Puerto Rican Women with Hyperglycemia. Matern Child Health J. 2022 Aug;26(8):1741-1751. doi: 10.1007/s10995-022-03429-y. Epub 2022 Apr 6.
- Derived from this study: PubMed 33580651Hawkins M, Marcus B, Pekow P, Rosal MC, Tucker KL, Spencer RMC, Chasan-Taber L. The Impact of a Randomized Controlled Trial of a Lifestyle Intervention on Sleep Among Latina Postpartum Women. Ann Behav Med. 2021 Aug 23;55(9):892-903. doi: 10.1093/abm/kaaa118.
- Derived from this study: PubMed 31170973Gubrium A, Leckenby D, Harvey MW, Marcus BH, Rosal MC, Chasan-Taber L. Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. BMC Health Serv Res. 2019 Jun 6;19(1):357. doi: 10.1186/s12913-019-4207-x.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Lisa Chasan-Taber, ScD principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Diabetes, run by University of Massachusetts, Amherst at 1 site in United States.
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 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 29 Apr 2020. 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 United States. 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?
Postpartum weight change (time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum). The study lists 14 primary outcomes in all. 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 NCT01679210, which also lists 6 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 29 Apr 2020.