Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Promoting Health in Pregnancy and Postpartum (HIPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02260518
Recruitment Status : Active, not recruiting
First Posted : October 9, 2014
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sara Wilcox, University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Obesity Pregnancy Overweight Behavioral: Lifestyle Intervention Behavioral: Standard Care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women
Study Start Date : January 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lifestyle Intervention
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
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 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
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).




Primary Outcome Measures :
  1. Gestational weight gain in pounds [ Time Frame: Delivery ]
    Defined as delivery room weight minus pre-pregnancy weight


Secondary Outcome Measures :
  1. Gestational weight gain category [ Time Frame: Delivery ]
    Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive

  2. Postpartum weight retention [ Time Frame: Weight retained at the 6 month postpartum visit ]
    Defined as weight during 6 month postpartum visit minus pre-pregnancy weight

  3. Postpartum weight retention [ Time Frame: Weight retained at the 12 month postpartum visit ]
    Defined as weight during 12 month postpartum visit minus pre-pregnancy weight

  4. Physical Activity [ Time Frame: 32 weeks gestation ]
    Sense Wear Armband and self-report measure will assess physical activity

  5. Physical Activity [ Time Frame: 6 months postpartum ]
    Sense Wear Armband and self-report measure will assess physical activity

  6. Physical Activity [ Time Frame: 12 months postpartum ]
    Sense Wear Armband and self-report measure will assess physical activity

  7. Dietary intake [ Time Frame: 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.

  8. Dietary intake [ Time Frame: 6 months postpartum ]
    Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.

  9. Dietary intake [ Time Frame: 12 months postpartum ]
    Two 24-hour dietary recalls using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA-24) will assess dietary intake.

  10. Depressive Symptoms [ Time Frame: 32 weeks gestation ]
    Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.

  11. Depressive Symptoms [ Time Frame: 6 months postpartum ]
    Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.

  12. Depressive Symptoms [ Time Frame: 12 months postpartum ]
    Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.

  13. Quality of Life [ Time Frame: 32 weeks gestation ]
    The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.

  14. Quality of Life [ Time Frame: 6 months postpartum ]
    The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.

  15. Quality of Life [ Time Frame: 12 months postpartum ]
    The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.

  16. Child Adiposity [ Time Frame: 6 months postpartum ]
    Z-scores and skinfolds will be used to measure child adiposity.

  17. Child Adiposity [ Time Frame: 12 months postpartum ]
    Z-scores and skinfolds will be used to measure child adiposity.


Other Outcome Measures:
  1. Self-efficacy for diet and physical activity [ Time Frame: 32 weeks gestation ]
    Self-report measure

  2. Self-efficacy for diet and physical activity [ Time Frame: 6 months postpartum ]
    Self-report measure

  3. Self-efficacy for diet and physical activity [ Time Frame: 12 months postpartum ]
    Self-report measure

  4. Social support for diet and physical activity [ Time Frame: 32 weeks gestation ]
    Self-report measure

  5. Social support for diet and physical activity [ Time Frame: 6 months postpartum ]
    Self-report measure

  6. Social support for diet and physical activity [ Time Frame: 12 months postpartum ]
    Self-report measure

  7. Decisional balance for diet and physical activity [ Time Frame: 32 weeks gestation ]
    Self-report measure

  8. Decisional balance for diet and physical activity [ Time Frame: 6 months postpartum ]
    Self-report measure

  9. Decisional balance for diet and physical activity [ Time Frame: 12 months postpartum ]
    Self-report measure

  10. Self-regulation for diet and physical activity [ Time Frame: 32 weeks gestation ]
    Self-report measure

  11. Self-regulation for diet and physical activity [ Time Frame: 6 months postpartum ]
    Self-report measure

  12. Self-regulation for diet and physical activity [ Time Frame: 12 months postpartum ]
    Self-report measure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260518


Locations
Layout table for location information
United States, South Carolina
University of South Carolina Prevention Research Center
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Sara Wilcox, PhD University of South Carolina
Principal Investigator: Jihong Liu, Sc.D University of South Carolina
Layout table for additonal information
Responsible Party: Sara Wilcox, Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT02260518    
Other Study ID Numbers: R01HD078407 ( U.S. NIH Grant/Contract )
R01HD078407 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Sara Wilcox, University of South Carolina:
Gestational weight gain
Lifestyle intervention
Pregnancy
Postpartum
Physical activity
Nutrition
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight