Obesity, Overweight, Pregnancy
Conditions
Keywords
Gestational weight gain, Lifestyle intervention, Pregnancy, Postpartum, Physical activity, Nutrition
Brief summary
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
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.
Interventions
BEHAVIORALLifestyle Intervention
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.
BEHAVIORALStandard Care
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).
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational weight gain in pounds | Delivery | Defined as delivery room weight minus pre-pregnancy weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 32 weeks gestation | Sense Wear Armband and self-report measure will assess physical activity |
| Dietary intake | 32 weeks gestation | Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake. |
| Depressive Symptoms | 32 weeks gestation | Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale. |
| Health-Related Quality of Life | 32 weeks gestation | The Short Form-12 (SF-12) questionnaire will be used to assess quality of life. |
| Child Adiposity | 6 months postpartum | Z-scores and skinfolds will be used to measure child adiposity. |
| Gestational weight gain category | Delivery | Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive |
| Postpartum weight retention | Weight retained at the 6 month postpartum visit | Defined as weight during 6 month postpartum visit minus pre-pregnancy weight |
Other
| Measure | Time frame | Description |
|---|---|---|
| Decisional balance for diet and physical activity | 32 weeks gestation | Self-report measure |
| Self-regulation for diet and physical activity | 32 weeks gestation | Self-report measure |
| Self-efficacy for diet and physical activity | 32 weeks gestation | Self-report measure |
| Social support for diet and physical activity | 32 weeks gestation | Self-report measure |
Countries
United States
Outcome results
None listed