Health Coach Intervention Pilot Study

NCT03080064 | Completed

• 2 other identifiers: PH000523C14CRP20490354
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (1)

Health Coach Intervention

EXPERIMENTAL

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.

Behavioral: Health Coach Intervention

Interventions

Health Coach Intervention BEHAVIORAL

Please see arm description.

Health Coach Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant (less than 16 weeks of gestation),
• overweight or obese (pre-pregnancy BMI≥25 kg/m2),
• years of age or older,
• English speaking,
• planned to remain at the same obstetrics clinic for the duration of their pregnancies.

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• American Heart Association: collaborator
• Harvard Vanguard Medical Associates: collaborator

Study Sites (1)

Harvard Pilgrim Health Care Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 30223779 DERIVED

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Marie-France Hivert, MD, MMSc

  Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: One-arm intervention trial.

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 15, 2017
• Study Start: July 16, 2015
• Primary Completion: June 27, 2016
• Study Completion: June 27, 2016
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)