Healthy for Two, Healthy for You

NCT03551054 | Completed

• 1 other identifier: IRB00084709
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Weight Gain; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postpartum weight retention

  At 3 months after delivery

Study Arms (2)

Healthy for Two, Healthy for You

EXPERIMENTAL

Remotely delivered behavioral health coaching in pregnancy and postpartum

Behavioral: Healthy for Two, Healthy for You

Pregnancy Health Education

ACTIVE COMPARATOR

Single health education visit with study staff member

Behavioral: Health Education

Interventions

Healthy for Two, Healthy for You BEHAVIORAL

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

Healthy for Two, Healthy for You

Health Education BEHAVIORAL

Also known as: Single health education visit

Pregnancy Health Education

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnancy condition
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers:
• BMI \>= 18.5 kg/m2 at time of eligibility screening
• Age \>=18
• Able to provide informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Mid-Atlantic Nutrition Obesity Research Center: collaborator

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel randomized controlled trial

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 11, 2018
• Study Start: July 22, 2016
• Primary Completion: June 30, 2017
• Study Completion: March 27, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share