Healthy for Two, Healthy for You

NCT ID: NCT03551054

Last Updated: 2018-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-22
• Study Completion Date: 2018-03-27

Brief Summary

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

Detailed 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.

Conditions

Weight Gain; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy for Two, Healthy for You

Remotely delivered behavioral health coaching in pregnancy and postpartum

Group Type: EXPERIMENTAL

Healthy for Two, Healthy for You

Intervention Type: BEHAVIORAL

Remotely delivered health coaching in pregnancy and postpartum to promote healthy weight gain.

Pregnancy Health Education

Single health education visit with study staff member

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: BEHAVIORAL

Interventions

Healthy for Two, Healthy for You

Remotely delivered health coaching in pregnancy and postpartum to promote healthy weight gain.

Intervention Type: BEHAVIORAL

Health Education

Intervention Type: BEHAVIORAL

Other Intervention Names

Single health education visit

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mid-Atlantic Nutrition Obesity Research Center

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRB00084709

Identifier Type: -

Identifier Source: org_study_id