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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: Dietary and Lifestyle Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary and Lifestyle Counseling<br>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<br>* Dietary and lifestyle education; Peer group support.<br>|
| No Intervention: Standard of Care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain | Weight change from pre-pregnancy to time of delivery | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal fruit intake | 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 | 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 | 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 | 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 | 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 | 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 | Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum | Assessed at 6 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational weight gain