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

NCT02520167 | Completed

• 1 other identifier: 15-0760
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Gestational weight gain

Outcome Measures

Primary Outcomes (1)

• Gestational weight gain

  Weight change from pre-pregnancy to time of delivery

  40 weeks

Secondary Outcomes (7)

• Maternal fruit intake

  Assessed from 12 weeks gestation through 6 weeks postpartum

• Maternal vegetable intake

  Assessed from 12 weeks gestation through 6 weeks postpartum

• Maternal whole grains intake

  Assessed from 12 weeks gestation through 6 weeks postpartum

• Maternal solid fats intake

  Assessed from 12 weeks gestation through 6 weeks postpartum

• Maternal added sugars intake

  Assessed from 12 weeks gestation through 6 weeks postpartum

Study Arms (2)

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.

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.

Interventions

Dietary and Lifestyle Counseling BEHAVIORAL

Dietary and lifestyle education; Peer group support.

Dietary and Lifestyle Counseling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Denver Health and Hospital Authority: collaborator

Study Sites (1)

Denver Health Eastside Family Health Center

Denver, Colorado, 80205, United States

Location

MeSH Terms

Conditions

Gestational Weight Gain

Interventions

Diet

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Katherine A Sauder, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 11, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)