Healthy for Two, Healthy for You (H42/H4U)
Primary Purpose
Weight Gain, Pregnancy Related
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healthy for Two, Healthy for You
Health Education
Sponsored by
About this trial
This is an interventional prevention trial for Weight Gain
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
- (There is no exclusion criteria for the infants)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Healthy for Two, Healthy for You
Pregnancy Health Education
Arm Description
Remotely delivered behavioral health coaching in pregnancy and postpartum
Single health education visit with study staff member
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03551054
First Posted
May 29, 2018
Last Updated
May 29, 2018
Sponsor
Johns Hopkins University
Collaborators
Mid-Atlantic Nutrition Obesity Research Center
1. Study Identification
Unique Protocol Identification Number
NCT03551054
Brief Title
Healthy for Two, Healthy for You
Acronym
H42/H4U
Official Title
Healthy for Two, Healthy for You: A Pilot Health Coaching Intervention for Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 22, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
March 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Mid-Atlantic Nutrition Obesity Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain, Pregnancy Related
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy for Two, Healthy for You
Arm Type
Experimental
Arm Description
Remotely delivered behavioral health coaching in pregnancy and postpartum
Arm Title
Pregnancy Health Education
Arm Type
Active Comparator
Arm Description
Single health education visit with study staff member
Intervention Type
Behavioral
Intervention Name(s)
Healthy for Two, Healthy for You
Intervention Description
Remotely delivered health coaching in pregnancy and postpartum to promote healthy weight gain.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Other Intervention Name(s)
Single health education visit
Primary Outcome Measure Information:
Title
Gestational weight gain
Description
Gestational weight gain is calculated as weight, in pounds recorded at 37 weeks gestation minus the baseline weight recorded by 14 weeks gestation.
Time Frame
At 37 weeks gestation
Secondary Outcome Measure Information:
Title
Postpartum weight retention
Description
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).
Time Frame
At 3 months after delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnancy condition
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
(There is no exclusion criteria for the infants)
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Healthy for Two, Healthy for You
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