Health Knowledge, Attitudes, PracticeNCT02186327
Integrative Health Coaching in Community Settings
A study testing Integrative Health Coaching in people with Health Knowledge, Attitudes, Practice, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Integrative Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Site one:
- 18 years or over
- able to speak and understand English
- able and willing to give informed consent
- Site two (pediatric):
- pediatric participant is 5-12
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Healing with CAARE Inc.
Durham, North Carolina, 27701
Duke Healthy Lifestyles Program at Duke Children's Primary Care
Durham, North Carolina, 27704
About this study
Official title: Community Coaching: Integrative Health Coaching Initiative for Behavior Change and Assessment of Perceived Needs in the Community Setting
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:
Read more
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.
Read the detailed description
Integrative health coaching, based on a curriculum designed and implemented by Duke Integrative Medicine, uses a patient-centered approach that features elements of accountability, self-discovery, and patient-driven goals. It strives to empower patients to enact lifestyle changes situated in the context of their lives, and invites them to identify intrinsic values that might help guide those choices This type of approach is rooted in validated theories of health psychology. Preliminary work using IHC has found this new approach to be effective for improving lifestyle behaviors (diet, exercise, medication adherence) with concomitant improvements in glycemic control in type 2 diabetes, and for reducing the risk of cardiovascular disease (CVD) in patients with traditional risk factors. In addition, program outcomes suggest reduced healthcare spending in patients enrolled in IHC. A large trial to evaluate how this approach will perform in the primary care setting is currently ongoing.
Health coaching and health literacy efforts that are "community-based" or take place in community settings have also been evaluated for effectiveness as well as feasibility and acceptability. Approaches utilized include telephonic coaching and peer coaches, often in an effort to provide increased accessibility. These studies highlight diverse coaching interventions with mixed results. There are no studies of Integrative Health Coaching implemented in non-profit community settings.
Study Procedures
Baseline visit - After screening to confirm eligibility, an in-person baseline visit will be organized with the participant, during which full consent will be obtained. Following subject consent, each participant will be asked to fill out a brief survey instrument on paper consisting of the ISEL-12 and PAM (or Parent PAM for the Healthy Lifestyles cohort). Participants (in the case of the Healthy Lifestyles cohort, pediatric participants and not parents or guardians) will then be weighed without shoes or outer garments using a zeroed electronic scale. Weight will be recorded to the nearest tenth of a pound. Height will be recorded to the nearest tenth of a centimeter using a stadiometer. Body mass index (BMI) will be calculated from these measurements using the conversion formula BMI = weight (kg)/ height (m2). Randomization will occur after collecting baseline measures. If randomized to receive health coaching, the participant (or parent) will receive a handout briefly describing what to expect from their health coaching sessions and how to best prepare. They will also be asked to fill out a "Current and Desired States" form, which is part of the IHC coaching model and will be passed along to coaches for use in the first session.
Integrative Health Coaching Sessions - After completing the baseline visit, each participant randomized to coaching will be scheduled for an initial telephone call (~ 60-75 minutes in length) to discuss the role of a health coach, when and how s/he may be contacted by participants, and an initial participant self-assessment of health perceptions and goals. This self-assessment creates the foundation for the personalization of the behavioral intervention. From this point, participants will schedule weekly to biweekly (~ 30-45 minute) calls with their health coach, for a total of 6 coaching calls over a 3-month intervention period. For the Healthy Lifestyles cohort, all telephonic coaching sessions and activities conducted therein will be directed towards the parent or guardian providing consent. While family health goals and the child's weight management may be anticipated areas of focus in these sessions, coaches and clients will not be limited to any particular topics of discussion.
Participants may initiate coaching sessions from their own personal phone, or by using a landline extension on site at CAARE Inc. or Healthy Lifestyles during business hours, depending on which is more convenient for their schedule and budget. This protocol provides no reimbursement for inadvertent phone charges.
Post-intervention follow-up meeting - Three months following baseline (+ or - one week) and after 6 coaching sessions for the IHC group, participants will meet with a member of the research team to complete the same survey instruments from the baseline visit, and to reassess height and weight, using identical methods to those at baseline. At this time, participants randomized to the IHC group will also have the opportunity to offer recorded feedback regarding their experience in a coaching intervention. This feedback will be solicited via an interview guide of pre-drafted questions, after which the participant will have the opportunity to add additional comments. At this point, unless the participant is part of the subset allocated to the focus group (see below), his/her role in the study is completed. After the post-intervention survey has been completed, coaches and clients may agree to continue sessions on an individual basis, although coaches-in-training must clearly communicate that further sessions are not part of the study.
Focus Group regarding impact of coaching on community needs assessment - This portion of the study will recruit a subset of those participants enrolled from the Healing with CAARE Inc. site. All participants previously enrolled, consented and randomized to receive health coaching will be asked to participate in a focus group session of about 1.5 hours regarding community needs assessment; the target participatory goal is 6-8 participants. The session will take place following post-intervention data collection for all participants who received coaching. It will be guided around a series of questions detailed in a separate document, and centered around data from the 2013 State of the County Health Report and 2013 Community Health Assessment Survey Results conducted and reported by the Durham County Health Department (DCHD) and Partnership for a Healthy Durham. 32 Participants will be invited to comment on the results of these assessments relative to their personal experiences, and to offer their perspectives on community needs, current resources or areas for improvement regarding health and wellness. They will also be asked about their experiences in using community resources or identifying community or environmental barriers through their behavior change efforts while receiving coaching. Participants will be asked whether and how their perspectives on community needs or available resources may have changed following coaching, and if and how they intend to utilize or advocate for community resources in the future.
Post-Intervention Qualitative Evaluation In order to learn as much as possible from this community engagement project, after completion of the study intervention, interviews will be conducted with the coaches that delivered the interventions as well as clinical and administrative staff of the respective community sites. These interviews will take place in small groups or individually and may include briefer, follow-up conversations with the same individuals by phone or in person, to clarify responses as needed. The interviews will be recorded for the purposes of subsequent review and analysis. Participants in the interviews will be identified only by their role in the study in any written analysis of interview content.
The interviews will be structured around a series of interview guides, each of which is composed of a series of questions directed at the health coaches, and community staff or providers who referred patients. Participants will also have an opportunity to draft their own questions regarding the study, and common themes of these questions will be explored further in the group conversation.
Interviews will also be conducted with study participants individually, as outlined above, at the time of their post-intervention follow-up visit. As in the provider and staff interviews, the participant interviews will also be structured around interview guide questions, with an opportunity for participants to draft additional questions or share feedback beyond the question prompts.
The interviews will provide feedback regarding feasibility, delivery, resources utilized, and interprofessional communication throughout the study. Specifically, the areas addressed will include reach, effectiveness, adoption, implementation and maintenance, as have been outlined in previous studies and briefs.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Integrative Health Coaching
- Keywords
- Integrative Health Coaching
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Health CoachingBehavioural
Coaching sessions will guide subjects in establishing and maintaining behavior change goals related to their health and overall well-being.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Integrative Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject attrition rate
As establishing feasibility is a primary purpose of this study, subject attrition will serve as one primary outcome measure.
Measured: 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.
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.
Measured: up to 6 months (following 3 month timepoint collection for all subjects)
Secondary outcomes (3)
Change in patient activation
The Patient Activation Measure is a 13-item scale designed for this purpose.
Measured: Baseline and 3 months
Change in subject perception of interpersonal support
The Interpersonal Support Evaluation List (ISEL-12) will be used for this purpose.
Measured: Baseline and 3 months
Change in body mass index
BMI will be calculated using height measurement from baseline, and weight measurements at baseline and then again at 3 months.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Wolever, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186327
- Sponsor's protocol ID
- Pro00054909
- Status last verified
- Jan 2015
- First submitted
- 2 Jul 2014
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16045394Wolever 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.
PubMed 20534872Edelman 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.
PubMed 16808774Vorderstrasse 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.
PubMed 24416670Taggart 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.
PubMed 22656188Holland 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.
PubMed 16377768Holland 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.
PubMed 12558726Steventon 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.
PubMed 23920348Rubin 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.
PubMed 23877229Nishita 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.
PubMed 23174629
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Coaching: Integrative Health Coaching Initiative for Behavior Change and Assessment of Perceived Needs in the Community Setting
- ClinicalTrials.gov ID
- NCT02186327
- Acronym / sponsor ID
- Pro00054909
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- Integrative Health Coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Integrative health coaching, based on a curriculum designed and implemented by Duke Integrative Medicine, uses a patient-centered approach that features elements of accountability, self-discovery, and patient-driven goals. It strives to empower patients to enact lifestyle changes situated in the context of their lives, and invites them to identify intrinsic values that might help guide those choices This type of approach is rooted in validated theories of health psychology. Preliminary work using IHC has found this new approach to be effective for improving lifestyle behaviors (diet, exercise, medication adherence) with concomitant improvements in glycemic control in type 2 diabetes, and for reducing the risk of cardiovascular disease (CVD) in patients with traditional risk factors. In addition, program outcomes suggest reduced healthcare spending in patients enrolled in IHC. A large trial to evaluate how this approach will perform in the primary care setting is currently ongoing.
Health coaching and health literacy efforts that are "community-based" or take place in community settings have also been evaluated for effectiveness as well as feasibility and acceptability. Approaches utilized include telephonic coaching and peer coaches, often in an effort to provide increased accessibility. These studies highlight diverse coaching interventions with mixed results. There are no studies of Integrative Health Coaching implemented in non-profit community settings.
Study Procedures
Baseline visit - After screening to confirm eligibility, an in-person baseline visit will be organized with the participant, during which full consent will be obtained. Following subject consent, each participant will be asked to fill out a brief survey instrument on paper consisting of the ISEL-12 and PAM (or Parent PAM for the Healthy Lifestyles cohort). Participants (in the case of the Healthy Lifestyles cohort, pediatric participants and not parents or guardians) will then be weighed without shoes or outer garments using a zeroed electronic scale. Weight will be recorded to the nearest tenth of a pound. Height will be recorded to the nearest tenth of a centimeter using a stadiometer. Body mass index (BMI) will be calculated from these measurements using the conversion formula BMI = weight (kg)/ height (m2). Randomization will occur after collecting baseline measures. If randomized to receive health coaching, the participant (or parent) will receive a handout briefly describing what to expect from their health coaching sessions and how to best prepare. They will also be asked to fill out a "Current and Desired States" form, which is part of the IHC coaching model and will be passed along to coaches for use in the first session.
Integrative Health Coaching Sessions - After completing the baseline visit, each participant randomized to coaching will be scheduled for an initial telephone call (~ 60-75 minutes in length) to discuss the role of a health coach, when and how s/he may be contacted by participants, and an initial participant self-assessment of health perceptions and goals. This self-assessment creates the foundation for the personalization of the behavioral intervention. From this point, participants will schedule weekly to biweekly (~ 30-45 minute) calls with their health coach, for a total of 6 coaching calls over a 3-month intervention period. For the Healthy Lifestyles cohort, all telephonic coaching sessions and activities conducted therein will be directed towards the parent or guardian providing consent. While family health goals and the child's weight management may be anticipated areas of focus in these sessions, coaches and clients will not be limited to any particular topics of discussion.
Participants may initiate coaching sessions from their own personal phone, or by using a landline extension on site at CAARE Inc. or Healthy Lifestyles during business hours, depending on which is more convenient for their schedule and budget. This protocol provides no reimbursement for inadvertent phone charges.
Post-intervention follow-up meeting - Three months following baseline (+ or - one week) and after 6 coaching sessions for the IHC group, participants will meet with a member of the research team to complete the same survey instruments from the baseline visit, and to reassess height and weight, using identical methods to those at baseline. At this time, participants randomized to the IHC group will also have the opportunity to offer recorded feedback regarding their experience in a coaching intervention. This feedback will be solicited via an interview guide of pre-drafted questions, after which the participant will have the opportunity to add additional comments. At this point, unless the participant is part of the subset allocated to the focus group (see below), his/her role in the study is completed. After the post-intervention survey has been completed, coaches and clients may agree to continue sessions on an individual basis, although coaches-in-training must clearly communicate that further sessions are not part of the study.
Focus Group regarding impact of coaching on community needs assessment - This portion of the study will recruit a subset of those participants enrolled from the Healing with CAARE Inc. site. All participants previously enrolled, consented and randomized to receive health coaching will be asked to participate in a focus group session of about 1.5 hours regarding community needs assessment; the target participatory goal is 6-8 participants. The session will take place following post-intervention data collection for all participants who received coaching. It will be guided around a series of questions detailed in a separate document, and centered around data from the 2013 State of the County Health Report and 2013 Community Health Assessment Survey Results conducted and reported by the Durham County Health Department (DCHD) and Partnership for a Healthy Durham. 32 Participants will be invited to comment on the results of these assessments relative to their personal experiences, and to offer their perspectives on community needs, current resources or areas for improvement regarding health and wellness. They will also be asked about their experiences in using community resources or identifying community or environmental barriers through their behavior change efforts while receiving coaching. Participants will be asked whether and how their perspectives on community needs or available resources may have changed following coaching, and if and how they intend to utilize or advocate for community resources in the future.
Post-Intervention Qualitative Evaluation In order to learn as much as possible from this community engagement project, after completion of the study intervention, interviews will be conducted with the coaches that delivered the interventions as well as clinical and administrative staff of the respective community sites. These interviews will take place in small groups or individually and may include briefer, follow-up conversations with the same individuals by phone or in person, to clarify responses as needed. The interviews will be recorded for the purposes of subsequent review and analysis. Participants in the interviews will be identified only by their role in the study in any written analysis of interview content.
The interviews will be structured around a series of interview guides, each of which is composed of a series of questions directed at the health coaches, and community staff or providers who referred patients. Participants will also have an opportunity to draft their own questions regarding the study, and common themes of these questions will be explored further in the group conversation.
Interviews will also be conducted with study participants individually, as outlined above, at the time of their post-intervention follow-up visit. As in the provider and staff interviews, the participant interviews will also be structured around interview guide questions, with an opportunity for participants to draft additional questions or share feedback beyond the question prompts.
The interviews will provide feedback regarding feasibility, delivery, resources utilized, and interprofessional communication throughout the study. Specifically, the areas addressed will include reach, effectiveness, adoption, implementation and maintenance, as have been outlined in previous studies and briefs.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –The control arm will continue to receive standard care as they did prior to enrollment. |
| Integrative health coaching | Experimental | Behavioral: Integrative Health CoachingSubjects in this arm will receive 6 sessions of integrative health coaching over a 3 month period, in addition to standard care. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or over
- able to speak and understand English
- able and willing to give informed consent
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Health CoachingCoaching sessions will guide subjects in establishing and maintaining behavior change goals related to their health and overall well-being. | Behavioural | Integrative health coaching |
Primary outcome
Subject attrition rate
Time frame: 3 months from baseline
As establishing feasibility is a primary purpose of this study, subject attrition will serve as one primary outcome measure.
Duration (in minutes) of coaching sessions.
Time frame: 3 months from baseline
In order to establish subject exposure to the main study intervention and to establish feasibility, number and duration of completed sessions will be measured.
Subject and site personnel process evaluation (reach, effectiveness, adoption, implementation, and maintenance (RE-AIM)) following intervention completion
Time frame: up to 6 months (following 3 month timepoint collection for all subjects)
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.
3 secondary outcomes
Change in patient activation
Time frame: Baseline and 3 months
Change in subject perception of interpersonal support
Time frame: Baseline and 3 months
Change in body mass index
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Background: PubMed 16045394Seligman 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.
- Background: PubMed 20534872Wolever 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.
- Background: PubMed 16808774Edelman 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.
- Background: PubMed 24416670Vorderstrasse 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.
- Background: PubMed 22656188Taggart 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.
- Background: PubMed 16377768Holland 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.
- Background: PubMed 12558726Holland 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.
- Background: PubMed 23920348Steventon 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.
- Background: PubMed 23877229Rubin 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.
- Background: PubMed 23174629Nishita 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.
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Mental Health, Stigma of Mental Illness
Not yet recruiting
Effects of Immersive VR, Non-Immersive VR, and 3D-Printed Models on Anatomy Learning and Cognitive Load
Healthy, Health Knowledge, Attitudes, Practice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Wolever, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Health Coaching in people with Health Knowledge, Attitudes, Practice, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject attrition rate (time frame: 3 months from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02186327, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.