Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study

July 10, 2017 updated by: University of Colorado, Denver
This study will pilot and assess feasibility of a prenatal intervention for obese pregnant women based on the Diabetes Prevention Program (DPP). Intervention group participants will meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a DPP-based curriculum and receive breastfeeding education. Control group participants will receive usual prenatal care. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will pilot and test feasibility of a prenatal lifestyle intervention designed to limit gestational weight gain and prevent gestational diabetes. The intervention is based on the Diabetes Prevention Program lifestyle intervention, will include prenatal breastfeeding education and online peer group support, and will be integrated into the participants' regular prenatal appointments. Women (n=24) will be enrolled in early pregnancy. After baseline assessments (demographics, maternal diet, physical activity, mental health), women randomized equally to the intervention or usual care conditions. Further data collection will occur at approximately 24 weeks gestation, 36 weeks gestation, and 6 weeks postpartum, and clinical data (weight, pregnancy and obstetric complications) will be abstracted from medical records at the end of the study. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum. The investigators hypothesize that the intervention will reduce gestational weight gain, improve maternal dietary intake, increase total energy expenditure, and increase breastfeeding exclusivity in the first 6 weeks postpartum.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80205
        • Denver Health Eastside Family Health Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnancies of <12 weeks gestation
  • Pre-pregnant body mass index >=30
  • Speak and understand English
  • Plan to continue care at the clinic through pregnancy and postpartum

Exclusion Criteria:

  • Pre-existing diabetes
  • History of serious chronic illnesses
  • History of prior gestational diabetes
  • Prior delivery at <37 weeks gestation
  • Prior delivery of infant weighing <2500g

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dietary and Lifestyle Counseling
Women randomized to the intervention group will meet with a dietary counselor for 15 minutes at every prenatal appointment. They will receive a dietary and lifestyle curriculum based on the Diabetes Prevention Program curriculum (11 lessons) with one additional lesson providing prenatal breastfeeding education. They will also have access to a private online Facebook page for additional education and peer group support.
Behavioral: Dietary and Lifestyle Counseling
Dietary and lifestyle education; Peer group support.
No Intervention: Standard of Care
Usual prenatal care consists of regular clinical appointments, pregnancy ultrasounds, and recommendations to use prenatal multivitamins, eat a balanced diet, and remain physically active. Women with a pre-pregnant body mass index > 30 complete early glucose screening (as early as possible after presentation at the clinic) to detect pre-existing diabetes, and all women undergo routine gestational diabetes screening at 24-28 weeks. Women who test positive for pre-existing diabetes or gestational diabetes are referred to a registered dietitian.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gestational weight gain
Time Frame: 40 weeks
Weight change from pre-pregnancy to time of delivery
40 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal fruit intake
Time Frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in daily servings of fruit from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal vegetable intake
Time Frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in daily servings of vegetables from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal whole grains intake
Time Frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in daily servings of whole grains from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal solid fats intake
Time Frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in daily servings of solid fats from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal added sugars intake
Time Frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in daily servings of added sugars from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal physical activity
Time Frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in total estimated energy expenditure from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Assessed from 12 weeks gestation through 6 weeks postpartum
Exclusive breastfeeding
Time Frame: Assessed at 6 weeks postpartum
Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum
Assessed at 6 weeks postpartum

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Denver Health and Hospital Authority

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine A Sauder, PhD, University of Colorado, Denver

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-0760

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available for this small pilot and feasibility study

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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