AzTrials
AzTrials

ObesityHIPPNCT02260518

Promoting Health in Pregnancy and Postpartum

A study testing Lifestyle Intervention in people with Obesity and Pregnancy, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 44 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Pregnancy, Overweight
What is being tested?
Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
1 siteUnited States
Study dates
Jan 2015to 1 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of South Carolina Prevention Research Center

    Columbia, South Carolina, 29208

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Lifestyle Intervention, Standard Care
Keywords
Gestational weight gain, Lifestyle intervention, Pregnancy, Postpartum, Physical activity, Nutrition
Medical subject headings
Obesity, Overweight, Gestational Weight Gain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle InterventionBehavioural

    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 CareBehavioural

    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).

Study groups in NCT02260518
Study groupRoleWhat they receive
Lifestyle InterventionExperimentalThe intervention will focus on women gaining the recommended amount of weight, increasing physical activity to 150 minutes per week, and meeting healthy eating guidelines.
Receives: Behavioral: Lifestyle Intervention
Standard CareOtherWomen 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.
Receives: Behavioral: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gestational weight gain in pounds

    Defined as delivery room weight minus pre-pregnancy weight

    Measured: Delivery

Secondary outcomes (17)

  1. Gestational weight gain category

    Based on delivery room weight minus pre-pregnancy weight and categorized as Inadequate, adequate, excessive

    Measured: Delivery

  2. Postpartum weight retention

    Defined as weight during 6 month postpartum visit minus pre-pregnancy weight

    Measured: Weight retained at the 6 month postpartum visit

  3. Postpartum weight retention

    Defined as weight during 12 month postpartum visit minus pre-pregnancy weight

    Measured: Weight retained at the 12 month postpartum visit

  4. Physical Activity

    Sense Wear Armband and self-report measure will assess physical activity

    Measured: 32 weeks gestation

  5. Physical Activity

    Sense Wear Armband and self-report measure will assess physical activity

    Measured: 6 months postpartum

  6. Physical Activity

    Sense Wear Armband and self-report measure will assess physical activity

    Measured: 12 months postpartum

  7. 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.

    Measured: 32 weeks gestation

  8. 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.

    Measured: 6 months postpartum

  9. 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.

    Measured: 12 months postpartum

  10. Depressive Symptoms

    Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.

    Measured: 32 weeks gestation

  11. Depressive Symptoms

    Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.

    Measured: 6 months postpartum

  12. Depressive Symptoms

    Depressive symptoms will be assessed with the Edinburgh Prenatal/Postnatal Depression Scale.

    Measured: 12 months postpartum

  13. Health-Related Quality of Life

    The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.

    Measured: 32 weeks gestation

  14. Health-Related Quality of Life

    The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.

    Measured: 6 months postpartum

  15. Health-Related Quality of Life

    The Short Form-12 (SF-12) questionnaire will be used to assess quality of life.

    Measured: 12 months postpartum

  16. Child Adiposity

    Z-scores and skinfolds will be used to measure child adiposity.

    Measured: 6 months postpartum

  17. Child Adiposity

    Z-scores and skinfolds will be used to measure child adiposity.

    Measured: 12 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2014 (estimated)
  2. Study startJan 2015
  3. Primary completion1 Nov 2020
  4. Study completion1 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02260518
Sponsor's protocol ID
R01HD078407
Other IDs
R01HD078407
Acronym
HIPP
Status last verified
Apr 2021
First submitted
6 Oct 2014
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No

Publications

  • Wilcox S, Liu J, Sevoyan M, Parker-Brown J, Turner-McGrievy GM. Effects of a behavioral intervention on physical activity, diet, and health-related quality of life in postpartum women with elevated weight: results of the HIPP randomized controlled trial. BMC Pregnancy Childbirth. 2024 Dec 3;24(1):808. doi: 10.1186/s12884-024-07007-8.

    PubMed 39627794

  • Wilcox S, Liu J, Turner-McGrievy GM, Boutte AK, Wingard E. Effects of a behavioral intervention on physical activity, diet, and health-related quality of life in pregnant women with elevated weight: results of the HIPP randomized controlled trial. Int J Behav Nutr Phys Act. 2022 Dec 9;19(1):145. doi: 10.1186/s12966-022-01387-w.

    PubMed 36494702

  • Wilcox S, Dahl AA, Boutte AK, Liu J, Day K, Turner-McGrievy G, Wingard E. Process evaluation methods and results from the Health in Pregnancy and Postpartum (HIPP) randomized controlled trial. BMC Pregnancy Childbirth. 2022 Oct 26;22(1):794. doi: 10.1186/s12884-022-05107-x.

    PubMed 36289464

  • Wirth MD, Liu J, Wallace MK, McLain AC, Turner-McGrievy GM, Davis JE, Ryan N, Hebert JR. Dietary Inflammatory Index and sleep quality and duration among pregnant women with overweight or obesity. Sleep. 2022 Dec 12;45(12):zsac241. doi: 10.1093/sleep/zsac241.

    PubMed 36173829

  • Liu J, Wilcox S, Hutto B, Turner-McGrievy G, Wingard E. Effects of a lifestyle intervention on postpartum weight retention among women with elevated weight. Obesity (Silver Spring). 2022 Jul;30(7):1370-1379. doi: 10.1002/oby.23449. Epub 2022 Jun 20.

    PubMed 35722816

  • Liu J, Wilcox S, Wingard E, Burgis J, Schneider L, Dahl A. Strategies and Challenges in Recruiting Pregnant Women with Elevated Body Mass Index for a Behavioral Lifestyle Intervention. Womens Health Rep (New Rochelle). 2020 Dec 7;1(1):556-565. doi: 10.1089/whr.2020.0089. eCollection 2020.

    PubMed 33786522

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Intervention in people with Obesity and Pregnancy, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational weight gain in pounds (time frame: Delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02260518, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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