Expired Study
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Columbia, South Carolina 29208


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

R01HD078407


NCT ID:

NCT02260518


Secondary ID:

R01HD078407


Study Acronym:

HIPP


Brief Title:

Promoting Health in Pregnancy and Postpartum


Official Title:

Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

44 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of South Carolina


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

228


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sara Wilcox, PhD
Principal Investigator
University of South Carolina

Study Dates

Start Date:January 2015
Completion Date:December 2020
Completion Type:Anticipated
Primary Completion Date:October 2020
Primary Completion Type:Anticipated
Verification Date:April 2019
Last Changed Date:April 15, 2019
First Received Date:October 6, 2014

Study Outcomes

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

Study Interventions

Intervention Type:Behavioral
Name:Lifestyle Intervention
Description: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
Arm Name:Lifestyle Intervention
Intervention Type:Behavioral
Name:Standard Care
Description: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
Arm Name:Standard Care

Study Arms

Study Arm Type:Other
Arm Name:Standard Care
Description: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.
Study Arm Type:Experimental
Arm Name:Lifestyle Intervention
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of South Carolina
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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