HperglycemiaNCT01585454
Healthy Lifestyle in Pregnancy
An observational study of Hperglycemia and Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial summary
Background: Women can gain too much weight or develop diabetes during pregnancy. If the mother is overweight or has diabetes during pregnancy, her baby may also be at risk of being overweight or developing diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hperglycemia, Diabetes Mellitus, Weight Gain
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Mar 2012to 20 Jan 2016
- Phase
- Observational
- 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
- At least 18 years of age.
- Receive prenatal care at the nurse midwifery/obstetrics service of PIMC and plan to continue receiving such care throughout the pregnancy.
- Are able to have an OGTT prior to 16 weeks gestation (if diabetes was not previously diagnosed). Hyperemesis can preclude some pregnant women from successfully completing the OGTT; these women will not be excluded if the fasting blood samples can be obtained. Pregnant women with previously diagnosed diabetes are eligible if measures of glycemia (FPG, HbA1c, glycated albumin) are completed prior to 16 weeks gestation.
- Estimated prenatal BMI >25 kg/m2.
- Able to commit the time required for the interventions and follow-up.
- Able and willing to provide informed consent.
Who cannot join
- Contraindication to aerobic or resistance exercise (ACOG, 2002).
- Twin or multiple gestation.
- Severe anemia, uncontrolled asthma, uncontrolled hypertension, cardiac disease, or any condition that requires follow-up at specialty care clinics outside of PIMC (e.g., pregnancies at high risk for maternal or fetal demise).
- Any condition that in the opinion of the investigators would interfere with consent, treatment, or follow-up.
About this study
Background:
- Women can gain too much weight or develop diabetes during pregnancy. If the mother is overweight or has diabetes during pregnancy, her baby may also be at risk of being overweight or developing diabetes. A woman s chance of getting diabetes increases if her parents or family members are overweight or have diabetes. Poor diet and exercise habits can also lead to weight gain and diabetes. Researchers want to study how best to improve the health of pregnant women and their children. They will do so by providing healthy lifestyle counseling for women receiving prenatal care at the Phoenix Indian Medical Center.
Read more
Objectives:
- To study the effectiveness of healthy lifestyle counseling for overweight and/or diabetic pregnant women.
Eligibility:
- Women at least 18 years of age who will receive pregnancy care at the Phoenix Indian Medical Center.
- Participants must be overweight or obese. They may or may not have diabetes.
Design:
- Participants will receive standard prenatal care from the midwives, doctors, and dietitians at the Phoenix Indian Medical Center.
- Participants will work with National Institutes of Health staff for about 2 hours every week. These sessions may include phone calls, home visits, or group meetings.
- Participants will have a total of nine measurement visits. The first visit will be at or before 16 weeks of pregnancy. The next three visits will be within a week of the first visit. Another four visits will take place between 23 and 28 weeks of pregnancy.
- Participants will have different tests through their pregnancy. They will wear heart monitors and wrist monitors to measure heart rate and movement. They will provide information on their eating habits, physical activity, and mood and feelings during pregnancy. Blood samples will be collected to measure blood glucose (sugar) levels.
- Participants will receive counseling on healthy eating and physical activity habits. They will be encouraged to invite friends or family members to learn more about healthy lifestyle choices.
- The study will end with the final visit about 6 to 8 weeks after giving birth. A final blood sample will be collected. Participants will be asked questions about mood and feelings.
Read the detailed description
American Indians are at high risk for developing type 2 diabetes mellitus (T2DM) and its complications. Major factors responsible for this finding include obesity and intrauterine exposure to diabetes; the latter increases the risk of diabetes in the offspring particularly during childhood and adolescence. This study is designed to evaluate the feasibility of conducting an intensive lifestyle intervention (ILI) in adult (age greater than or equal to 18 years) pregnant women of any race or ethnicity who are eligible for prenatal care at Phoenix Indian Medical Center (PIMC). Most of these women or their fetuses will be of American Indian heritage. Interventions will be provided to overweight and obese pregnant women who may have diabetes, develop gestational diabetes (GDM), or be at high risk of developing diabetes. We will evaluate our ability to maintain engagement and motivate adoption of a healthy diet and increased physical activity. The lifestyle intervention will be patterned after the Diabetes Prevention Program (DPP) that prevented or delayed the onset of diabetes in non pregnant adults; the interventions will be modified to be appropriate in pregnancy. A major modification will be to encourage managed weight gain instead of weight loss. For women who have or develop diabetes, interventions will include coaching to optimize glycemic control. In this protocol, we will seek to identify strategies that can successfully accomplish these goals. Results from this study will permit us to formulate appropriate intervention strategies for a large randomized clinical study to evaluate the impact of an intensive lifestyle intervention on pregnant women and their offspring.
The project will be conducted in collaboration between the nurse midwifery and obstetrics services at Phoenix Indian Medical Center (PIMC) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Important feasibility measures include evaluating our ability to enroll and retain pregnant women in a lifestyle intervention program and collect serial measures of gestational weight and glucose, objective measures of physical activity, and nutritional questionnaires.
- Conditions
- Hperglycemia, Diabetes Mellitus, Weight Gain
- Keywords
- Pregnancy, Diabetes Mellitus, Weight Gain, Diabetes
- Medical subject headings
- Diabetes Mellitus, Weight Gain
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Weight Gain
Secondary outcomes (2)
Gestational Diabetes
Complications of Pregnancy and Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study start27 Mar 2012
- Study completion20 Jan 2016
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 HperglycemiaStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William C Knowler, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585454
- Sponsor's protocol ID
- 999912108
- Other IDs
- 12-DK-N108
- Status last verified
- 20 Jan 2016
- First submitted
- 24 Apr 2012
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Cedergren MI. Optimal gestational weight gain for body mass index categories. Obstet Gynecol. 2007 Oct;110(4):759-64. doi: 10.1097/01.AOG.0000279450.85198.b2.
PubMed 17906006Dabelea D, Hanson RL, Lindsay RS, Pettitt DJ, Imperatore G, Gabir MM, Roumain J, Bennett PH, Knowler WC. Intrauterine exposure to diabetes conveys risks for type 2 diabetes and obesity: a study of discordant sibships. Diabetes. 2000 Dec;49(12):2208-11. doi: 10.2337/diabetes.49.12.2208.
PubMed 11118027International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.
PubMed 20190296
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Lifestyle in Pregnancy
- ClinicalTrials.gov ID
- NCT01585454
- Acronym / sponsor ID
- 999912108
- Conditions
- Hperglycemia, Diabetes Mellitus, Weight Gain
- Keywords
- Pregnancy, Diabetes Mellitus, Weight Gain, Diabetes
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 27 Mar 2012
- Study completion
- 20 Jan 2016
- First posted
- 25 Apr 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.
Background:
- Women can gain too much weight or develop diabetes during pregnancy. If the mother is overweight or has diabetes during pregnancy, her baby may also be at risk of being overweight or developing diabetes. A woman s chance of getting diabetes increases if her parents or family members are overweight or have diabetes. Poor diet and exercise habits can also lead to weight gain and diabetes. Researchers want to study how best to improve the health of pregnant women and their children. They will do so by providing healthy lifestyle counseling for women receiving prenatal care at the Phoenix Indian Medical Center.
Objectives:
- To study the effectiveness of healthy lifestyle counseling for overweight and/or diabetic pregnant women.
Eligibility:
- Women at least 18 years of age who will receive pregnancy care at the Phoenix Indian Medical Center.
- Participants must be overweight or obese. They may or may not have diabetes.
Design:
- Participants will receive standard prenatal care from the midwives, doctors, and dietitians at the Phoenix Indian Medical Center.
- Participants will work with National Institutes of Health staff for about 2 hours every week. These sessions may include phone calls, home visits, or group meetings.
- Participants will have a total of nine measurement visits. The first visit will be at or before 16 weeks of pregnancy. The next three visits will be within a week of the first visit. Another four visits will take place between 23 and 28 weeks of pregnancy.
- Participants will have different tests through their pregnancy. They will wear heart monitors and wrist monitors to measure heart rate and movement. They will provide information on their eating habits, physical activity, and mood and feelings during pregnancy. Blood samples will be collected to measure blood glucose (sugar) levels.
- Participants will receive counseling on healthy eating and physical activity habits. They will be encouraged to invite friends or family members to learn more about healthy lifestyle choices.
- The study will end with the final visit about 6 to 8 weeks after giving birth. A final blood sample will be collected. Participants will be asked questions about mood and feelings.
Detailed description
American Indians are at high risk for developing type 2 diabetes mellitus (T2DM) and its complications. Major factors responsible for this finding include obesity and intrauterine exposure to diabetes; the latter increases the risk of diabetes in the offspring particularly during childhood and adolescence. This study is designed to evaluate the feasibility of conducting an intensive lifestyle intervention (ILI) in adult (age greater than or equal to 18 years) pregnant women of any race or ethnicity who are eligible for prenatal care at Phoenix Indian Medical Center (PIMC). Most of these women or their fetuses will be of American Indian heritage. Interventions will be provided to overweight and obese pregnant women who may have diabetes, develop gestational diabetes (GDM), or be at high risk of developing diabetes. We will evaluate our ability to maintain engagement and motivate adoption of a healthy diet and increased physical activity. The lifestyle intervention will be patterned after the Diabetes Prevention Program (DPP) that prevented or delayed the onset of diabetes in non pregnant adults; the interventions will be modified to be appropriate in pregnancy. A major modification will be to encourage managed weight gain instead of weight loss. For women who have or develop diabetes, interventions will include coaching to optimize glycemic control. In this protocol, we will seek to identify strategies that can successfully accomplish these goals. Results from this study will permit us to formulate appropriate intervention strategies for a large randomized clinical study to evaluate the impact of an intensive lifestyle intervention on pregnant women and their offspring.
The project will be conducted in collaboration between the nurse midwifery and obstetrics services at Phoenix Indian Medical Center (PIMC) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Important feasibility measures include evaluating our ability to enroll and retain pregnant women in a lifestyle intervention program and collect serial measures of gestational weight and glucose, objective measures of physical activity, and nutritional questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (4 listed)
- Contraindication to aerobic or resistance exercise (ACOG, 2002).
- Twin or multiple gestation.
- Severe anemia, uncontrolled asthma, uncontrolled hypertension, cardiac disease, or any condition that requires follow-up at specialty care clinics outside of PIMC (e.g., pregnancies at high risk for maternal or fetal demise).
- Any condition that in the opinion of the investigators would interfere with consent, treatment, or follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gestational Weight Gain
2 secondary outcomes
Gestational Diabetes
Complications of Pregnancy and Delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 17906006Cedergren MI. Optimal gestational weight gain for body mass index categories. Obstet Gynecol. 2007 Oct;110(4):759-64. doi: 10.1097/01.AOG.0000279450.85198.b2.
- Background: PubMed 11118027Dabelea D, Hanson RL, Lindsay RS, Pettitt DJ, Imperatore G, Gabir MM, Roumain J, Bennett PH, Knowler WC. Intrauterine exposure to diabetes conveys risks for type 2 diabetes and obesity: a study of discordant sibships. Diabetes. 2000 Dec;49(12):2208-11. doi: 10.2337/diabetes.49.12.2208.
- Background: PubMed 20190296International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.
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.
William C Knowler, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Questions about this trial
What is this clinical trial studying?
An observational study of Hperglycemia and Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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 6 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: withdrawn, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Gestational Weight Gain. 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 NCT01585454, 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 16 Dec 2019.