Healthy Lifestyle in Pregnancy

December 13, 2019 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

  • INCLUSION CRITERIA:

    1. At least 18 years of age.
    2. Receive prenatal care at the nurse midwifery/obstetrics service of PIMC and plan to continue receiving such care throughout the pregnancy.
    3. 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.
    4. Estimated prenatal BMI >25 kg/m2.
    5. Able to commit the time required for the interventions and follow-up.
    6. Able and willing to provide informed consent.

EXCLUSION CRITERIA:

  1. Contraindication to aerobic or resistance exercise (ACOG, 2002).
  2. Twin or multiple gestation.
  3. 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).
  4. Any condition that in the opinion of the investigators would interfere with consent, treatment, or follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Gestational Weight Gain

Secondary Outcome Measures

Outcome Measure
Gestational Diabetes
Complications of Pregnancy and Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: William C Knowler, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 27, 2012

Study Completion

January 20, 2016

Study Registration Dates

First Submitted

April 24, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

January 20, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999912108
  • 12-DK-N108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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