Healthy for Two, Healthy for You (H42/H4U)

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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Weight Gain
• Intervention / Treatment: Behavioral: Health Education; Behavioral: Healthy for Two, Healthy for You

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Mid-Atlantic Nutrition Obesity Research Center

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): March 27, 2018

Study Registration Dates

• First Submitted: May 29, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: IRB00084709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No