Health Coach Intervention Pilot Study

Satisfaction Clinical Trial

— AHA  

Official title:

Supporting Healthful Lifestyles During Pregnancy: A Health Coach Intervention Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080064
• Other study ID #: PH000523C
• Secondary ID: 14CRP20490354
• Status: Completed
• Phase: N/A
• First received: February 22, 2017
• Last updated: March 14, 2017
• Start date: July 16, 2015
• Est. completion date: June 27, 2016

Study information

• Verified date: March 2017
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this mixed methods study, the investigators assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors among overweight pregnant women. At one northeastern US clinic, the investigators enrolled 30 overweight (pre-pregnancy BMI≥25 kg/m2) pregnant women at a median gestation of 12.5 weeks (IQR: 11-15) into a one arm intervention trial. The investigators connected participants with a health coach to provide behavioral support to help participants adopt or maintain healthy lifestyle goals during pregnancy. Health coaches contacted participants by phone every 2-3 weeks to monitor goals, and sent emails and text messages to check-in between calls. To assess the intervention, participants completed baseline (N=30) and follow-up surveys at the end of the intervention (N=26), as well as follow-up phone interviews (N=18).

Description:

The investigators connected participants at enrollment (median gestation of 12.5 weeks, IQR: 11-15) with a trained health coach who called participants every 2-3 weeks until 36 weeks of gestation. During these phone calls, health coaches helped participants adopt and maintain new healthful lifestyle behaviors that were evidence-based, simple, and easy to track. Goals aimed to promote appropriate gestational weight gain and covered several domains including diet, physical activity, screen time, and sleep.

During the first call, health coaches invited participants to prioritize these goals according to their level of self-efficacy, readiness to change, preferences, and values. Throughout the intervention, health coaches used principles of motivational interviewing that relied on a patient-centered approach to enhance readiness to change by exploring ambivalence and resistance to change. In addition to setting personal goals, health coaches also presented optimal goals for ideal cardiovascular health.

During follow-up calls, health coaches monitored progress and helped adjust goals when necessary (e.g. too many goals, or the goal was too ambitious). Health coaches also addressed barriers and potential solutions with participants, and helped them target higher goal settings or select novel goals when participants attained them. Health coaches sent emails or text messages depending on participant preferences to check-in about progress toward goals or clinical appointments between calls. Research staff (including an MD) met weekly with health coaches to review their conversations with participants, and to address any medical issues to ensure that it would be reported to the primary care provider obstetric team if appropriate.

Participants completed baseline (N=30) and follow-up (N=26) surveys at the end of the intervention as well as follow-up phone interviews (N=18). Surveys collected information on demographics, attitudes related to weight status and pregnancy, opinions about the intervention, and included food frequency questions . Interviews followed a guide of open-ended questions to determine insights on what helped achieve goals, motivation, opinions of the health coach intervention, and areas for improvement. One study staff member, who has experience with qualitative data collection, conducted all of the individual interviews. This study was approved by the Harvard Pilgrim Health Care Human Studies Committee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 27, 2016
• Est. primary completion date: June 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pregnant (less than 16 weeks of gestation),

• overweight or obese (pre-pregnancy BMI=25 kg/m2),

• 18 years of age or older,

• English speaking,

• planned to remain at the same obstetrics clinic for the duration of their pregnancies.

Related Conditions & MeSH terms

• Satisfaction

Intervention

Behavioral:
• Health Coach Intervention
Please see arm description.

Locations

Country	Name	City	State
United States	Harvard Pilgrim Health Care Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Harvard Pilgrim Health Care	American Heart Association, Harvard Vanguard Medical Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction with the health coach intervention as assessed by surveys	The investigators assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors among overweight pregnant women using baseline and follow-up surveys.	From enrollment until the end of the intervention at 36 weeks of gestation.
Primary	Satisfaction with the health coach intervention as assessed by phone interviews	Using an interview guide, the investigators assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors among overweight pregnant women.	From enrollment until the end of the intervention at 36 weeks of gestation.