PregnancyNCT02520167
Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study
A study testing Dietary and Lifestyle Counseling in people with Pregnancy, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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… 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
- Pregnancy
- What is being tested?
- Dietary and Lifestyle Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jul 2017
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Eastside Family Health Center
Denver, Colorado, 80205
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Dietary and Lifestyle Counseling
- Keywords
- Gestational weight gain
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and Lifestyle CounselingBehavioural
Dietary and lifestyle education; Peer group support.
| Study group | Role | What they receive |
|---|---|---|
| Dietary and Lifestyle Counseling | Experimental | 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. Receives: Behavioral: Dietary and Lifestyle Counseling |
| Standard of Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Weight change from pre-pregnancy to time of delivery
Measured: 40 weeks
Secondary outcomes (7)
Maternal fruit intake
Change in daily servings of fruit from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Measured: Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal vegetable intake
Change in daily servings of vegetables from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Measured: Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal whole grains intake
Change in daily servings of whole grains from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Measured: Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal solid fats intake
Change in daily servings of solid fats from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Measured: Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal added sugars intake
Change in daily servings of added sugars from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Measured: Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal physical activity
Change in total estimated energy expenditure from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Measured: Assessed from 12 weeks gestation through 6 weeks postpartum
Exclusive breastfeeding
Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum
Measured: Assessed at 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health and Hospital Authority
- Responsible party
- Sponsor
- Investigators
- Katherine A Sauder, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520167
- Sponsor's protocol ID
- 15-0760
- Status last verified
- Jul 2017
- First submitted
- 5 Aug 2015
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be made available for this small pilot and feasibility study
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT02520167
- Acronym / sponsor ID
- 15-0760
- Conditions
- Pregnancy
- Keywords
- Gestational weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Denver Health and Hospital Authority
- Study start
- Oct 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 Aug 2015 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary and Lifestyle Counseling | Experimental | Behavioral: Dietary and Lifestyle CounselingWomen 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. |
| Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Dietary and Lifestyle CounselingDietary and lifestyle education; Peer group support. | Behavioural | Dietary and Lifestyle Counseling |
Primary outcome
Gestational weight gain
Time frame: 40 weeks
Weight change from pre-pregnancy to time of delivery
7 secondary outcomes
Maternal fruit intake
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal vegetable intake
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal whole grains intake
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal solid fats intake
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal added sugars intake
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Maternal physical activity
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Exclusive breastfeeding
Time frame: Assessed at 6 weeks postpartum
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 13 Jul 2017.
- Individual participant dataSharing planned: No. Individual participant data will not be made available for this small pilot and feasibility study
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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.
Katherine A Sauder, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary and Lifestyle Counseling in people with Pregnancy, run by University of Colorado, Denver 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 4 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 13 Jul 2017. 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?
Gestational weight gain (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2017.