Feasibility and Implementation of a Healthy Lifestyles Program
NCT ID: NCT03258138
Last Updated: 2022-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2018-02-15
2021-09-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A new year-long person-centered healthy lifestyles program is proposed to address the "how to" gap in making lifestyle changes through a combination of individual and group sessions. The feasibility and implementation of this new program will be evaluated through a pilot study looking at the full healthy lifestyles program compared to a less intensive version of the program. The study's hypothesis is that the full program will be feasible, acceptable and more effective for helping participants move across stages of change and for meeting their goals than the less intensive program.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of the Predictors and Moderators of Health Behavior Change
NCT03139656
Healthy Lifestyles for People With Intellectual Disabilities
NCT00597948
Digital Self-help Support for Lifestyle Behavior Changes Among Primary Care Outpatients With Mental Health Problems
NCT03691116
Medical Self-Management for Improving Health Behavior Among Individuals in Community Mental Health Settings
NCT00380536
HEalth Promotion Intervention in MEntal Health Care
NCT01336946
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The qualitative components include semi-structured interviews of participants (exit interviews at 12 months), MIP staff and participants' healthcare providers (at 6 months and 12 months). In addition, focus groups will be conducted with family members of MIP participants at 9 months. These elements will provide perspectives from multiple stakeholders for improving the healthy lifestyles program and on their roles in creating and maintaining healthy lifestyles.
The primary aim of this study is to assess the feasibility and implementation of the healthy lifestyles program. Impact on participant experiences and outcomes will also be measured. Findings from this study will help inform a larger randomized trial to further look at effectiveness of the program and to determine health system implications. A 2-year extension was approved in order to determine sustainability of findings.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
More Intensive Program (MIP)
Participants will receive the more intensive program, which combines usual care with the full version of the healthy lifestyles program. Participants in this arm will meet weekly for group health and wellness learning sessions or brainstorming group sessions. In addition, they will meet monthly for individual sessions with a multidisciplinary health team, including a family physician, physical therapist and dietician to tailor their health goal development and action plans to their particular needs and situations. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
Health and wellness learning sessions
The health and wellness learning sessions provide a platform for concepts from a variety of health behaviour theories and CBT to be combined with evidence- and practice-based recommendations for healthy lifestyles. They provide the basis for participants' development of an individualized action plan. The sessions will last one hour and participants will receive them in a group setting, 18 times throughout the duration of the program. Specifically, the sessions will be delivered during weeks: 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48.
Brainstorming group sessions
The brainstorming group sessions allow for facilitated discussions where individuals explore barriers and facilitators to achieving their goals and provide an interpersonal component to the program through the building of social interactions. Participants will also receive help in finding community programs to support healthy lifestyles. These sessions will last one hour and participants will receive them in a group setting, 30 times throughout the duration of the program. Specifically, these sessions will be delivered during weeks: 9-11, 13-15, 17-19, 21-23, 25-27, 29-31, 33-35, 37-39, 41-43, 45-47.
Individual sessions with a multidisciplinary health team
Monthly individual sessions with a family physician trained in medical CBT, a dietician and a physical therapist help individuals tailor their action plans and recommendations to their particular circumstances and provide supports based on their needs. The initial session will last 3 hours and occur at baseline. The follow-up sessions will last 1 hour.
Health goal development
Participants in both arms will develop health goals. Several components of these goals will be measured throughout the study, including the stage of change, self-efficacy and actual goal achievement. In the more intensive program arm, participants will develop health goals and learn about how to meet those goals through the group and individual sessions. In the less intensive program arm, participants will receive support in developing health goals from a research assistant trained in theories of health behaviour and in goal setting at baseline, 3 months, 6 months, 9 months and 12 months. The initial goal setting session will be provided within a time period of 2 hours, and the follow-up sessions will be provided within one hour time periods.
Physical activity and nutrition journals
Participants in both arm will be asked to maintain a physical activity journal and a nutrition journal for a week each every three months. These journals help participants reflect on current behaviours and areas for change.
Less Intensive Program (LIP)
Participants will receive the less intensive program, which combines usual care along with health goal development. Participants in this arm will meet at baseline to set health goals with the support of a research assistant trained in theories of health behaviour and goal setting. They will also meet every three months to measure progress in achieving their goals. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
Health goal development
Participants in both arms will develop health goals. Several components of these goals will be measured throughout the study, including the stage of change, self-efficacy and actual goal achievement. In the more intensive program arm, participants will develop health goals and learn about how to meet those goals through the group and individual sessions. In the less intensive program arm, participants will receive support in developing health goals from a research assistant trained in theories of health behaviour and in goal setting at baseline, 3 months, 6 months, 9 months and 12 months. The initial goal setting session will be provided within a time period of 2 hours, and the follow-up sessions will be provided within one hour time periods.
Physical activity and nutrition journals
Participants in both arm will be asked to maintain a physical activity journal and a nutrition journal for a week each every three months. These journals help participants reflect on current behaviours and areas for change.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Health and wellness learning sessions
The health and wellness learning sessions provide a platform for concepts from a variety of health behaviour theories and CBT to be combined with evidence- and practice-based recommendations for healthy lifestyles. They provide the basis for participants' development of an individualized action plan. The sessions will last one hour and participants will receive them in a group setting, 18 times throughout the duration of the program. Specifically, the sessions will be delivered during weeks: 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48.
Brainstorming group sessions
The brainstorming group sessions allow for facilitated discussions where individuals explore barriers and facilitators to achieving their goals and provide an interpersonal component to the program through the building of social interactions. Participants will also receive help in finding community programs to support healthy lifestyles. These sessions will last one hour and participants will receive them in a group setting, 30 times throughout the duration of the program. Specifically, these sessions will be delivered during weeks: 9-11, 13-15, 17-19, 21-23, 25-27, 29-31, 33-35, 37-39, 41-43, 45-47.
Individual sessions with a multidisciplinary health team
Monthly individual sessions with a family physician trained in medical CBT, a dietician and a physical therapist help individuals tailor their action plans and recommendations to their particular circumstances and provide supports based on their needs. The initial session will last 3 hours and occur at baseline. The follow-up sessions will last 1 hour.
Health goal development
Participants in both arms will develop health goals. Several components of these goals will be measured throughout the study, including the stage of change, self-efficacy and actual goal achievement. In the more intensive program arm, participants will develop health goals and learn about how to meet those goals through the group and individual sessions. In the less intensive program arm, participants will receive support in developing health goals from a research assistant trained in theories of health behaviour and in goal setting at baseline, 3 months, 6 months, 9 months and 12 months. The initial goal setting session will be provided within a time period of 2 hours, and the follow-up sessions will be provided within one hour time periods.
Physical activity and nutrition journals
Participants in both arm will be asked to maintain a physical activity journal and a nutrition journal for a week each every three months. These journals help participants reflect on current behaviours and areas for change.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 years of age or older
* English-speaking
* 16 years of age or older
* related to participants in randomized controlled trial
* Provide services within the more intensive program
* Provide health care outside of the healthy lifestyles program for participants in randomized controlled trial
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
McMaster University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elizabeth Alvarez
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth Alvarez, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
McMaster University
Hamilton, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Choban PS, Flancbaum L. The impact of obesity on surgical outcomes: a review. J Am Coll Surg. 1997 Dec;185(6):593-603. doi: 10.1016/s1072-7515(97)00109-9. No abstract available.
Mehrotra C, Remington PL, Naimi TS, Washington W, Miller R. Trends in total knee replacement surgeries and implications for public health, 1990-2000. Public Health Rep. 2005 May-Jun;120(3):278-82. doi: 10.1177/003335490512000310.
El Nakeeb A, Hamed H, Shehta A, Askr W, El Dosoky M, Said R, Abdallah T. Impact of obesity on surgical outcomes post-pancreaticoduodenectomy: a case-control study. Int J Surg. 2014;12(5):488-93. doi: 10.1016/j.ijsu.2014.01.017. Epub 2014 Jan 30.
Liu W, Wahafu T, Cheng M, Cheng T, Zhang Y, Zhang X. The influence of obesity on primary total hip arthroplasty outcomes: A meta-analysis of prospective cohort studies. Orthop Traumatol Surg Res. 2015 May;101(3):289-96. doi: 10.1016/j.otsr.2015.01.011. Epub 2015 Mar 25.
Gibbons CJ, Fournier JC, Stirman SW, DeRubeis RJ, Crits-Christoph P, Beck AT. The clinical effectiveness of cognitive therapy for depression in an outpatient clinic. J Affect Disord. 2010 Sep;125(1-3):169-76. doi: 10.1016/j.jad.2009.12.030. Epub 2010 Jan 18.
Porto PR, Oliveira L, Mari J, Volchan E, Figueira I, Ventura P. Does cognitive behavioral therapy change the brain? A systematic review of neuroimaging in anxiety disorders. J Neuropsychiatry Clin Neurosci. 2009 Spring;21(2):114-25. doi: 10.1176/jnp.2009.21.2.114.
Chesson AL Jr, Anderson WM, Littner M, Davila D, Hartse K, Johnson S, Wise M, Rafecas J. Practice parameters for the nonpharmacologic treatment of chronic insomnia. An American Academy of Sleep Medicine report. Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep. 1999 Dec 15;22(8):1128-33. doi: 10.1093/sleep/22.8.1128.
Resnicow K, DiIorio C, Soet JE, Ernst D, Borrelli B, Hecht J. Motivational interviewing in health promotion: it sounds like something is changing. Health Psychol. 2002 Sep;21(5):444-51.
Sherman MD, Miller LW, Keuler M, Trump L, Mandrich M. Managing Behavioral Health Issues in Primary Care: Six Five-Minute Tools. Fam Pract Manag. 2017 Mar/Apr;24(2):30-35. No abstract available.
Dubord G. Part 1. Goalification. Can Fam Physician. 2010 Dec;56(12):1312. No abstract available.
Dubord G. Part 2. Scalification. Can Fam Physician. 2011 Jan;57(1):54. No abstract available.
Prochaska JO, DiClemente CC. Stages and processes of self-change of smoking: toward an integrative model of change. J Consult Clin Psychol. 1983 Jun;51(3):390-5. doi: 10.1037//0022-006x.51.3.390. No abstract available.
Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13(2):217-24. doi: 10.31887/DCNS.2011.13.2/npatsopoulos.
Thabane L, Kaczorowski J, Dolovich L, Chambers LW, Mbuagbaw L; CHAP Investigators. Reducing the confusion and controversies around pragmatic trials: using the Cardiovascular Health Awareness Program (CHAP) trial as an illustrative example. Trials. 2015 Sep 2;16:387. doi: 10.1186/s13063-015-0919-3.
Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. 2013 Dec;48(6 Pt 2):2134-56. doi: 10.1111/1475-6773.12117. Epub 2013 Oct 23.
Anderson TJ, Gregoire J, Pearson GJ, Barry AR, Couture P, Dawes M, Francis GA, Genest J Jr, Grover S, Gupta M, Hegele RA, Lau DC, Leiter LA, Lonn E, Mancini GB, McPherson R, Ngui D, Poirier P, Sievenpiper JL, Stone JA, Thanassoulis G, Ward R. 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult. Can J Cardiol. 2016 Nov;32(11):1263-1282. doi: 10.1016/j.cjca.2016.07.510. Epub 2016 Jul 25.
Padwal RS, Pajewski NM, Allison DB, Sharma AM. Using the Edmonton obesity staging system to predict mortality in a population-representative cohort of people with overweight and obesity. CMAJ. 2011 Oct 4;183(14):E1059-66. doi: 10.1503/cmaj.110387. Epub 2011 Aug 15.
Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
Marshall D, Pericak D, Grootendorst P, Gooch K, Faris P, Frank C, Bellamy N, Torrance G, Feeny D. Validation of a prediction model to estimate health utilities index Mark 3 utility scores from WOMAC index scores in patients with osteoarthritis of the hip. Value Health. 2008 May-Jun;11(3):470-7. doi: 10.1111/j.1524-4733.2007.00258.x.
Kohrt BA, Luitel NP, Acharya P, Jordans MJ. Detection of depression in low resource settings: validation of the Patient Health Questionnaire (PHQ-9) and cultural concepts of distress in Nepal. BMC Psychiatry. 2016 Mar 8;16:58. doi: 10.1186/s12888-016-0768-y.
Seo JG, Park SP. Validation of the Generalized Anxiety Disorder-7 (GAD-7) and GAD-2 in patients with migraine. J Headache Pain. 2015;16:97. doi: 10.1186/s10194-015-0583-8. Epub 2015 Nov 23.
Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.
Lynch DJ, McGrady A, Alvarez E, Forman J. Recent life changes and medical utilization in an academic family practice. J Nerv Ment Dis. 2005 Sep;193(9):633-5. doi: 10.1097/01.nmd.0000177778.27069.77.
Reis RS, Hino AA, Anez CR. Perceived stress scale: reliability and validity study in Brazil. J Health Psychol. 2010 Jan;15(1):107-14. doi: 10.1177/1359105309346343.
Leung DY, Lam TH, Chan SS. Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010 Aug 25;10:513. doi: 10.1186/1471-2458-10-513.
Grygiel P, Humenny G, Rebisz S. Using the De Jong Gierveld Loneliness Scale With Early Adolescents: Factor Structure, Reliability, Stability, and External Validity. Assessment. 2019 Mar;26(2):151-165. doi: 10.1177/1073191116682298. Epub 2016 Dec 8.
Horowitz CR, Robinson M, Seifer S. Community-based participatory research from the margin to the mainstream: are researchers prepared? Circulation. 2009 May 19;119(19):2633-42. doi: 10.1161/CIRCULATIONAHA.107.729863.
Anderson JB. Unraveling health disparities: examining the dimensions of hypertension and diabetes through community engagement. J Health Care Poor Underserved. 2005 Nov;16(4 Suppl A):91-117. doi: 10.1353/hpu.2005.0121.
Alvarez E, Qutob M, Mbuagbaw L, Lavis J, Lokker C, Walli-Attaei M, Samaan Z, Sutton A, Singh J, Feeny D, Fortuna J. Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study. BMJ Open. 2019 Oct 16;9(10):e031298. doi: 10.1136/bmjopen-2019-031298.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Participants
Document Type: Informed Consent Form: Healthcare providers
Document Type: Informed Consent Form: Program staff
Document Type: Informed Consent Form: Family members
Related Links
Access external resources that provide additional context or updates about the study.
Obesity and overweight
Obesity in Canada
Obesity Puts Young Kids at Risk of Social Isolation
Socializing key to "successful aging"
Ontario youth wait a year or more for mental health care: report
Taking patient-centred health care from rhetoric to reality
Maslow's Hierarchy of Needs
Prochaska and diclemente's stages of change model - Google Search
Mixed methods embedded design in medical education, mental health and health services research: A methodological analysis
Chapter 4: Screening for Type 1 and Type 2 Diabetes
Measuring and Valuing Health
Patient Healthcare Questionnaire
Validation of the Insomnia Severity Index as an outcome measure for insomnia research
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Healthy lifestyles pilot
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.