Healthy for Two, Healthy for You

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

Detailed Description
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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.

Official Title
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Healthy for Two, Healthy for You: A Pilot Health Coaching Intervention for Pregnant Women

Conditions
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Weight Gain, Pregnancy Related

Intervention / Treatment
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* Behavioral: Healthy for Two, Healthy for You
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy for Two, Healthy for You<br>Remotely delivered behavioral health coaching in pregnancy and postpartum | Behavioral: Healthy for Two, Healthy for You<br>* Remotely delivered health coaching in pregnancy and postpartum to promote healthy weight gain.<br>|
| Active Comparator: Pregnancy Health Education<br>Single health education visit with study staff member | Behavioral: Health Education<br> <br> * Other names: Single health education visit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |