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

NCT ID: NCT02520167

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-07-31

Brief 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 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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary and Lifestyle Counseling

Intervention Type: BEHAVIORAL

Dietary and lifestyle education; Peer group support.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary and Lifestyle Counseling

Dietary and lifestyle education; Peer group support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Denver Health and Hospital Authority

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine A Sauder, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Denver Health Eastside Family Health Center

Denver, Colorado, United States

Countries

United States

Other Identifiers

15-0760

Identifier Type: -

Identifier Source: org_study_id