Promoting Health in Pregnancy and Postpartum

Study Overview
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Brief Summary
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The purpose of this study is to examine the impact of a lifestyle intervention on gestational weight gain, postpartum weight loss, and other secondary outcomes relative to a usual care control group.

Detailed Description
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Our study will address the following specific aims: (1) examine the impact of a lifestyle intervention on gestational weight gain and postpartum weight loss in overweight and obese women, (2) examine the impact of the intervention on physical activity (PA), dietary intake, and quality of life (QOL), (3) examine race differences in total gestational weight gain, PA, dietary intake, and QOL; and (4) examine the impact of the intervention on offspring adiposity.

Official Title
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Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women

Conditions
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Obesity, Pregnancy, Overweight

Intervention / Treatment
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* Behavioral: Lifestyle Intervention
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: White or African American woman Overweight or obese (prepregnancy BMI: 25-45 kg/m2) ≤ 16 wks gestation at screening Age 18-44 years No plan to move out of the greater Columbia area in next 18 months Regular and consistent telephone access Availability for telephone calls Willing to accept random assignment Exclusion Criteria: Uncontrolled hypertension Fetal anomaly Taking insulin for diabetes Uncontrolled or untreated thyroid disease Mental health or substance-abuse hospitalization in last 6 months Multiple gestation Persistent bleeding in the first trimester History of more than 3 miscarriages History of an eating disorder or current eating disorder History of an incompetent cervix Physical disability that prevents exercise Told by health care provider not to exercise Any other medical conditions that might be a contraindication to exercise or dietary change

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 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: Lifestyle Intervention<br>The intervention will focus on women gaining the recommended amount of weight, increasing physical activity to 150 minutes per week, and meeting healthy eating guidelines. | Behavioral: Lifestyle Intervention<br>* During pregnancy, participants complete one face-to-face counseling session, receive 10 behavioral podcasts, and receive weekly phone calls until delivery. Participants will be asked to attend one group session on breastfeeding. Participants will have the opportunity to participate in a private Facebook group during pregnancy and postpartum. During postpartum, participants complete one face-to-face counseling session, receive 16 behavioral podcasts, receive brief weekly check-in telephone calls for six weeks, and receive up to 8 telephone counseling calls through 6 months after delivery.<br>|
| Other: Standard Care<br>Women in the standard care group will attend their regularly scheduled obstetric (OB) visits with their prenatal care providers and will receive monthly mailings and matched number of podcasts. | Behavioral: Standard Care<br>* Women will receive standard nutrition counseling provided by physicians, nurses, nutritionists, and counselors from the Women, Infants, and Children (WIC) program (if applicable). They will receive a monthly study mailing that is educational in nature as well as podcasts related to a healthy pregnancy. During pregnancy, the mailings will focus on tips for a healthy pregnancy and on fetal development. During postpartum the mailings will focus on infant development and parenting. We will select a matched number of podcasts from Pea in the Podcast, commercially available podcasts. All mailings and podcasts will avoid discussion of weight, PA, or diet (except for foods to avoid in pregnancy for safety reasons).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain in pounds | Defined as delivery room weight minus pre-pregnancy weight | Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain category | Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive | Delivery | 
| Postpartum weight retention | Defined as weight during 6 month postpartum visit minus pre-pregnancy weight | Weight retained at the 6 month postpartum visit | 
| Postpartum weight retention | Defined as weight during 12 month postpartum visit minus pre-pregnancy weight | Weight retained at the 12 month postpartum visit | 
| Physical Activity | Sense Wear Armband and self-report measure will assess physical activity | 32 weeks gestation | 
| Physical Activity | Sense Wear Armband and self-report measure will assess physical activity | 6 months postpartum | 
| Physical Activity | Sense Wear Armband and self-report measure will assess physical activity | 12 months postpartum | 
| Dietary intake | Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake. | 32 weeks gestation | 
| Dietary intake | Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake. | 6 months postpartum | 
| Dietary intake | Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake. | 12 months postpartum | 
| Depressive Symptoms | Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale. | 32 weeks gestation | 
| Depressive Symptoms | Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale. | 6 months postpartum | 
| Depressive Symptoms | Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale. | 12 months postpartum | 
| Health-Related Quality of Life | The Short Form-12 (SF-12) questionnaire will be used to assess quality of life. | 32 weeks gestation | 
| Health-Related Quality of Life | The Short Form-12 (SF-12) questionnaire will be used to assess quality of life. | 6 months postpartum | 
| Health-Related Quality of Life | The Short Form-12 (SF-12) questionnaire will be used to assess quality of life. | 12 months postpartum | 
| Child Adiposity | Z-scores and skinfolds will be used to measure child adiposity. | 6 months postpartum | 
| Child Adiposity | Z-scores and skinfolds will be used to measure child adiposity. | 12 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational weight gain, Lifestyle intervention, Pregnancy, Postpartum, Physical activity, Nutrition