Clinical trial NCT03080064: Health Coach Intervention Pilot Study
Official title: Supporting Healthful Lifestyles During Pregnancy: A Health Coach Intervention Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Harvard Vanguard Medical Associates
First posted: 2017-03-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One-arm intervention trial.
Primary purpose: PREVENTION

Brief 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).

Detailed description: \<Health Coach Intervention \> 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.

\<Study Design and Sample\> 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Satisfaction with the health coach intervention as assessed by surveys
timeFrame: From enrollment until the end of the intervention at 36 weeks of gestation.
measure: Satisfaction with the health coach intervention as assessed by phone interviews
timeFrame: From enrollment until the end of the intervention at 36 weeks of gestation.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Pilgrim Health Care Institute
state: Massachusetts
Study officials:
affiliation: Harvard Pilgrim Health Care Institute
name: Marie-France Hivert, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seward MW, Simon D, Richardson M, Oken E, Gillman MW, Hivert MF. Supporting healthful lifestyles during pregnancy: a health coach intervention pilot study. BMC Pregnancy Childbirth. 2018 Sep 17;18(1):375. doi: 10.1186/s12884-018-2010-z.