Promoting Health in Pregnancy and Postpartum

Obesity Clinical Trial

— HIPP  

Official title:

Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260518
• Other study ID #: R01HD078407
• Secondary ID: R01HD078407
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: November 1, 2020

Study information

• Verified date: April 2021
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pregnancy

Intervention

Behavioral:
• Lifestyle 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.
• Standard 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).

Locations

Country	Name	City	State
United States	University of South Carolina Prevention Research Center	Columbia	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-efficacy for diet and physical activity	Self-report measure	32 weeks gestation
Other	Self-efficacy for diet and physical activity	Self-report measure	6 months postpartum
Other	Self-efficacy for diet and physical activity	Self-report measure	12 months postpartum
Other	Social support for diet and physical activity	Self-report measure	32 weeks gestation
Other	Social support for diet and physical activity	Self-report measure	6 months postpartum
Other	Social support for diet and physical activity	Self-report measure	12 months postpartum
Other	Decisional balance for diet and physical activity	Self-report measure	32 weeks gestation
Other	Decisional balance for diet and physical activity	Self-report measure	6 months postpartum
Other	Decisional balance for diet and physical activity	Self-report measure	12 months postpartum
Other	Self-regulation for diet and physical activity	Self-report measure	32 weeks gestation
Other	Self-regulation for diet and physical activity	Self-report measure	6 months postpartum
Other	Self-regulation for diet and physical activity	Self-report measure	12 months postpartum
Primary	Gestational weight gain in pounds	Defined as delivery room weight minus pre-pregnancy weight	Delivery
Secondary	Gestational weight gain category	Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive	Delivery
Secondary	Postpartum weight retention	Defined as weight during 6 month postpartum visit minus pre-pregnancy weight	Weight retained at the 6 month postpartum visit
Secondary	Postpartum weight retention	Defined as weight during 12 month postpartum visit minus pre-pregnancy weight	Weight retained at the 12 month postpartum visit
Secondary	Physical Activity	Sense Wear Armband and self-report measure will assess physical activity	32 weeks gestation
Secondary	Physical Activity	Sense Wear Armband and self-report measure will assess physical activity	6 months postpartum
Secondary	Physical Activity	Sense Wear Armband and self-report measure will assess physical activity	12 months postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	Depressive Symptoms	Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.	32 weeks gestation
Secondary	Depressive Symptoms	Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.	6 months postpartum
Secondary	Depressive Symptoms	Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.	12 months postpartum
Secondary	Health-Related Quality of Life	The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.	32 weeks gestation
Secondary	Health-Related Quality of Life	The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.	6 months postpartum
Secondary	Health-Related Quality of Life	The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.	12 months postpartum
Secondary	Child Adiposity	Z-scores and skinfolds will be used to measure child adiposity.	6 months postpartum
Secondary	Child Adiposity	Z-scores and skinfolds will be used to measure child adiposity.	12 months postpartum