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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03551054
Other study ID # IRB00084709
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 22, 2016
Est. completion date March 27, 2018

Study information

Verified date May 2018
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators conducted a pilot feasibility and acceptability randomized controlled trial of a remotely delivered behavioral health coaching program in pregnancy and postpartum.


Description:

Half of pregnant women are overweight or obese. Obesity disproportionately impacts low-income women and women of racial and ethnic minorities. Maternal obesity is linked with adverse perinatal outcomes, including gestational diabetes and preeclampsia, as well as longer-term health problems such as obesity in offspring and maternal cardiovascular disease. Pregnancy provides a unique opportunity to engage women in improving their health behaviors because women are motivated to protect the health of their babies and have frequent interactions with the healthcare system. Advances in behavioral weight management and obesity prevention have not yet been translated into real-world prenatal care settings. Our team was recently supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-funded Nutrition and Obesity Research Center Pilot and Feasibility program to adapt an evidence-based telephonic health coaching program for pregnant women. Investigators conducted 20 in-depth interviews with patients and providers to gain valuable feedback to inform the intervention design and delivery, and have put together a multi-disciplinary team to adapt the intervention. Investiagtors developed the intervention specific for pregnancy and postpartum based on this feedback and are testing the intervention, Healthy for Two / Healthy for You, to assess feasibility and acceptability.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 27, 2018
Est. primary completion date June 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Mothers:

- BMI >= 18.5 kg/m2 at time of eligibility screening

- Age >=18

- Able to provide informed consent

- 12 weeks gestation or earlier

- English speaking

- Insurance type

- Willing to provide address and >=2 contact people

- Consistent use of a personal smartphone and willingness to use for health behavior tracking as part of the study

- Patient at a participating prenatal clinical site

- Access to internet (including public library and smartphone)

- Demonstrated ability to track caloric intake for 4 days

- Singleton pregnancy

Infants:

• Born during Mother's enrollment in study

Exclusion Criteria:

- • Type 1 or type 2 diabetes, pre-pregnancy or gestational diabetes, diagnosed prior to start of intervention (14 weeks gestation)

- Multiple fetuses

- Prior history of severe preeclampsia, pre-term birth (before 32 weeks gestation)

- Prior history of or current diagnosis of incompetent cervix

- Poorly controlled blood pressure (>160/100)

- Unable to walk 1 block without pain, shortness of breath

- Serious medication condition hindering use of recommendations for pregnancy weight gain

- Not cleared by study's maternal-fetal medicine or treating obstetrician

- Planning to relocate from areas in next 2 years

- Psychiatric or substance use related hospitalization in past 1 year

- (There is no exclusion criteria for the infants)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthy for Two, Healthy for You
Remotely delivered health coaching in pregnancy and postpartum to promote healthy weight gain.
Health Education


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Mid-Atlantic Nutrition Obesity Research Center

Outcome

Type Measure Description Time frame Safety issue
Primary Gestational weight gain Gestational weight gain is calculated as weight, in pounds recorded at 37 weeks gestation minus the baseline weight recorded by 14 weeks gestation. At 37 weeks gestation
Secondary Postpartum weight retention Postpartum weight retention is calculated as weight, in pounds, recorded at 3 months after delivery minus the weight recorded at baseline (by 14 weeks gestation). At 3 months after delivery
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