Integrative Health Coaching in Community Settings

NCT02186327 | Completed

• 1 other identifier: Pro00054909
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

This study examines a pilot project to introduce integrative health coaching to two community clinical sites, Healing with CAARE Inc. and the Healthy Lifestyles program at Duke Pediatrics. 10 participants and 10 controls will be referred for enrollment at each site (n=20 per site) by on-site personnel, and 6 coaching sessions will be provided over a 3-month period at no cost by coaching trainees completing their certification hours. Pre and post measurements of BMI, patient activation, and perceived interpersonal support will be collected and analyzed for interaction effects. Qualitative process evaluation will be conducted as a thematic analysis via guided interviews with stakeholders and participants, using the "RE-AIM" framework. Feasibility measures will include recruitment of both coaches and clients, subject/client retention, and number and duration of coaching sessions completed. Finally, a subset of the CAARE Inc. cohort will be consented to participate in a post-intervention focus group that addresses the impact of coaching on perception of health-related resources and needs in the community. Primary Hypotheses: Integrative health coaching will be a feasible intervention in both community and clinical settings, in terms of required resources, patient or client adherence, and satisfaction by community stakeholders, including providers and participants. Additional hypotheses: Individuals who receive integrative health coaching sessions as an adjunct to their standard medical care will see improvements in patient activation and perception of interpersonal supports, when compared to controls. Individuals who receive integrative health coaching (or in the case of the pediatric cohort, children of individuals who receive coaching) will see minor improvements in BMI over the study period when compared to controls.

Conditions

Health Knowledge, Attitudes, Practice

Keywords

Integrative Health Coaching

Outcome Measures

Primary Outcomes (3)

• Subject attrition rate

  As establishing feasibility is a primary purpose of this study, subject attrition will serve as one primary outcome measure.

  3 months from baseline

• Duration (in minutes) of coaching sessions.

  In order to establish subject exposure to the main study intervention and to establish feasibility, number and duration of completed sessions will be measured.

  3 months from baseline

• Subject and site personnel process evaluation (reach, effectiveness, adoption, implementation, and maintenance (RE-AIM)) following intervention completion

  RE-AIM interview guides will tailored to subjects, health coaches, and site personnel will solicit qualitative information for process evaluation, which is the primary purpose of this study.

  up to 6 months (following 3 month timepoint collection for all subjects)

Secondary Outcomes (3)

• Change in patient activation

  Baseline and 3 months

• Change in subject perception of interpersonal support

  Baseline and 3 months

• Change in body mass index

  Baseline and 3 months

Other Outcomes (1)

• Subject perception of community health-related resources and needs following intervention completion

  up to 6 months (following 3 month timepoint for all subjects at the CAARE Inc. site))

Study Arms (2)

Standard care

NO INTERVENTION

The control arm will continue to receive standard care as they did prior to enrollment.

Integrative health coaching

EXPERIMENTAL

Subjects in this arm will receive 6 sessions of integrative health coaching over a 3 month period, in addition to standard care.

Behavioral: Integrative Health Coaching

Interventions

Integrative Health Coaching BEHAVIORAL

Coaching sessions will guide subjects in establishing and maintaining behavior change goals related to their health and overall well-being.

Integrative health coaching

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Site one:
• years or over
• able to speak and understand English
• able and willing to give informed consent
• Site two (pediatric):
• pediatric participant is 5-12
• patient is in care of parent or guardian willing to participate in study intervention and complete baseline and post-intervention surveys and interviews
• both pediatric patient and parent/guardian can speak and understand English
• parent/guardian is able and willing to provide consent (pediatric patients age 12 will also provide assent)

You may not qualify if:

• inability to ambulate or participate in physical activity
• serious chronic disease related complications or conditions that could significantly affect study outcomes (currently treated cancer, renal failure, CVA with residual effects on functioning)
• concurrent participation in a lifestyle-based intervention study for chronic disease or health behaviors

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Healing with CAARE Inc.

Durham, North Carolina, 27701, United States

Location

Duke Healthy Lifestyles Program at Duke Children's Primary Care

Durham, North Carolina, 27704, United States

Location

Related Publications (10)

• Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.

  PMID: 16045394 BACKGROUND

• Wolever RQ, Dreusicke M, Fikkan J, Hawkins TV, Yeung S, Wakefield J, Duda L, Flowers P, Cook C, Skinner E. Integrative health coaching for patients with type 2 diabetes: a randomized clinical trial. Diabetes Educ. 2010 Jul-Aug;36(4):629-39. doi: 10.1177/0145721710371523. Epub 2010 Jun 9.

  PMID: 20534872 BACKGROUND

• Edelman D, Oddone EZ, Liebowitz RS, Yancy WS Jr, Olsen MK, Jeffreys AS, Moon SD, Harris AC, Smith LL, Quillian-Wolever RE, Gaudet TW. A multidimensional integrative medicine intervention to improve cardiovascular risk. J Gen Intern Med. 2006 Jul;21(7):728-34. doi: 10.1111/j.1525-1497.2006.00495.x.

  PMID: 16808774 BACKGROUND

• Vorderstrasse AA, Ginsburg GS, Kraus WE, Maldonado MC, Wolever RQ. Health coaching and genomics-potential avenues to elicit behavior change in those at risk for chronic disease: protocol for personalized medicine effectiveness study in air force primary care. Glob Adv Health Med. 2013 May;2(3):26-38. doi: 10.7453/gahmj.2013.035.

  PMID: 24416670 BACKGROUND

• Taggart J, Williams A, Dennis S, Newall A, Shortus T, Zwar N, Denney-Wilson E, Harris MF. A systematic review of interventions in primary care to improve health literacy for chronic disease behavioral risk factors. BMC Fam Pract. 2012 Jun 1;13:49. doi: 10.1186/1471-2296-13-49.

  PMID: 22656188 BACKGROUND

• Holland SK, Greenberg J, Tidwell L, Malone J, Mullan J, Newcomer R. Community-based health coaching, exercise, and health service utilization. J Aging Health. 2005 Dec;17(6):697-716. doi: 10.1177/0898264305277959.

  PMID: 16377768 BACKGROUND

• Holland SK, Greenberg J, Tidwell L, Newcomer R. Preventing disability through community-based health coaching. J Am Geriatr Soc. 2003 Feb;51(2):265-9. doi: 10.1046/j.1532-5415.2003.51068.x.

  PMID: 12558726 BACKGROUND

• Steventon A, Tunkel S, Blunt I, Bardsley M. Effect of telephone health coaching (Birmingham OwnHealth) on hospital use and associated costs: cohort study with matched controls. BMJ. 2013 Aug 6;347:f4585. doi: 10.1136/bmj.f4585.

  PMID: 23920348 BACKGROUND

• Rubin DL, Freimuth VS, Johnson SD, Kaley T, Parmer J. Training meals on wheels volunteers as health literacy coaches for older adults. Health Promot Pract. 2014 May;15(3):448-54. doi: 10.1177/1524839913494786. Epub 2013 Jul 22.

  PMID: 23877229 BACKGROUND

• Nishita C, Cardazone G, Uehara DL, Tom T. Empowered diabetes management: life coaching and pharmacist counseling for employed adults with diabetes. Health Educ Behav. 2013 Oct;40(5):581-91. doi: 10.1177/1090198112465088. Epub 2012 Nov 21.

  PMID: 23174629 BACKGROUND

MeSH Terms

Conditions

Behavior

Study Officials

• Ruth Wolever, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 10, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 23, 2015

Record last verified: 2015-01

Locations

US (2)