AzTrials
AzTrials

Health BehaviorNCT03258138

Feasibility and Implementation of a Healthy Lifestyles Program

A study testing Health and wellness learning sessions, Brainstorming group sessions and Individual sessions with a multidisciplinary health team in people with Health Behavior and Quality of Life, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Chronic conditions, such as obesity and diabetes, are increasing worldwide. Lifestyle changes (e.g., physical activity, healthy diet, sufficient sleep, managing stress, smoking cessation) are often recommended to prevent or manage these conditions, but changing habits is difficult. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Health Behavior, Quality of Life, Chronic Disease
What is being tested?
Health and wellness learning sessions, Brainstorming group sessions and Individual sessions with a multidisciplinary health team
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
15 Feb 2018to 22 Sep 2021
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • English-speaking
  • 18 years of age or older
  • Inclusion criteria for qualitative components (family focus groups):
  • English-speaking
  • 16 years of age or older
  • related to participants in randomized controlled trial
Show all 10Show fewer
  • Inclusion criteria for qualitative components (program staff):
  • Provide services within the more intensive program
  • Inclusion criteria for qualitative components (healthcare providers):
  • Provide health care outside of the healthy lifestyles program for participants in randomized controlled trial

Who cannot join

  • NA

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8S 4K1

Other trials in Canada

About this study

Official title: Feasibility and Implementation of a Healthy Lifestyles Program: A Pilot Study

Chronic conditions, such as obesity and diabetes, are increasing worldwide. Lifestyle changes (e.g., physical activity, healthy diet, sufficient sleep, managing stress, smoking cessation) are often recommended to prevent or manage these conditions, but changing habits is difficult. Mental health can play a role in the ability to seek out and follow through on the changes necessary to achieve or maintain a healthy lifestyle, yet this aspect is rarely addressed, and access to mental health services is often limited. Furthermore, individuals are influenced by factors at the individual, interpersonal, community and policy levels (e.g., lack of socialization, unsafe neighborhoods). These factors can act as barriers and need to be addressed in order for individuals to make sustainable lifestyle changes.

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.

Read the detailed description

A pragmatic mixed methods design including a randomized controlled trial and qualitative components will be used for this pilot study. The randomized controlled trial will include a 1:1 allocation comparing a more intensive program (MIP - usual care plus healthy lifestyles program) with a less intensive program (LIP - usual care plus development of health goals).

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.

Being tested
Health and wellness learning sessions, Brainstorming group sessions, Individual sessions with a multidisciplinary health team, Health goal development, Physical activity and nutrition journals
Keywords
Pragmatic, Pilot study, Mixed methods, Randomized controlled trial, Implementation research, Person-centered care, Multidisciplinary, Ecological approach
Medical subject headings
Health Behavior, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health and wellness learning sessionsBehavioural

    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 sessionsBehavioural

    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 teamBehavioural

    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 developmentBehavioural

    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 journalsBehavioural

    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.

Study groups in NCT03258138
Study groupRoleWhat they receive
More Intensive Program (MIP)ExperimentalParticipants 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.
Receives: Behavioral: Health and wellness learning sessions; Behavioral: Brainstorming group sessions; Behavioral: Individual sessions with a multidisciplinary health team; Behavioral: Health goal development; Behavioral: Physical activity and nutrition journals
Less Intensive Program (LIP)ExperimentalParticipants 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.
Receives: Behavioral: Health goal development; Behavioral: Physical activity and nutrition journals

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention rates

    Number of participants recruited and number of participants completing the program

    Measured: Baseline to 12 months

Secondary outcomes (14)

  1. Changes in health goals - Stage of change over time

    For each health goal, stage of change will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months

  2. Changes in health goals - Self-efficacy over time

    For each health goal, self-efficacy will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months

  3. Changes in health goals - Goal achievement over time

    For each health goal, goal achievement will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months

  4. Changes in health-related quality of life on the SF-36

    Using a validated scale, health-related quality of life will be measured over time. Comparisons will be made with baseline but also with other time points.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months

  5. Changes in health-related quality of life on the Health Utilities Index (HUI) 2/3

    Using a validated scale, health-related quality of life will be measured over time. Comparisons will be made with baseline but also with other time points.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months

  6. Changes in the Patient Health Questionnaire (PHQ)

    Using a validated scale, five common mental health conditions (depression, anxiety, alcohol misuse, somatoform disorder and bulimia) will be measured over time. Comparisons will be made with baseline but also with other time points.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months

  7. Changes in the Insomnia Severity Index (ISI)

    Using a validated scale, signs and symptoms of insomnia will be measured over time. Comparisons will be made with baseline but also with other time points.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months

  8. Changes in the Perceived Stress Scale

    Using a validated scale, signs and symptoms of perceived stress will be measured over time. Comparisons will be made with baseline but also with other time points.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months

  9. Changes in the DeJong Gierveld 6-item Loneliness Scale

    Using a validated scale, emotional and social loneliness will be measured over time. Comparisons will be made with baseline but also with other time points.

    Measured: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months

  10. Changes in blood pressure

    Both systolic and diastolic blood pressure will be measured

    Measured: Baseline and 12 months, 24 months, 36 months

  11. Changes in weight

    Weight will be measured in kilograms

    Measured: Baseline and 12 months, 24 months, 36 months

  12. Changes in body mass index (BMI)

    Weight and height will be combined to report BMI in kg/m^2

    Measured: Baseline and 12 months, 24 months, 36 months

  13. Changes in waist circumference

    Measured around waist with a tape measure in inches

    Measured: Baseline and 12 months, 24 months, 36 months

  14. Changes in waist:hip ratio

    Measured around waist and hips with a tape measure in inches

    Measured: Baseline and 12 months, 24 months, 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2017
  2. Study start15 Feb 2018
  3. Primary completion30 Oct 2019
  4. Study completion22 Sep 2021

Resources

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
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Enrolled participants will be allocated to one of the two intervention groups for the duration of the study. One group will be assigned to the more intensive program (MIP= usual care plus healthy lifestyles program) and the other group will be assigned to the less intensive program (LIP= usual care plus health goal development).
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03258138
Sponsor's protocol ID
Healthy lifestyles pilot
Status last verified
Oct 2022
First submitted
17 Aug 2017
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9404886

  • 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.

    PubMed 16134568

  • 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.

    PubMed 24486933

  • 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.

    PubMed 25817907

  • 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.

    PubMed 20080305

  • 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.

    PubMed 19622682

  • 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.

    PubMed 10617175

  • 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.

    PubMed 12211511

  • 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.

    PubMed 28291312

  • Dubord G. Part 1. Goalification. Can Fam Physician. 2010 Dec;56(12):1312. No abstract available.

    PubMed 21375060

  • Dubord G. Part 2. Scalification. Can Fam Physician. 2011 Jan;57(1):54. No abstract available.

    PubMed 21322287

  • 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.

    PubMed 6863699

  • Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues Clin Neurosci. 2011;13(2):217-24. doi: 10.31887/DCNS.2011.13.2/npatsopoulos.

    PubMed 21842619

  • 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.

    PubMed 26329614

  • 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.

    PubMed 24279835

Questions about this trial

What is this clinical trial studying?

A study testing Health and wellness learning sessions, Brainstorming group sessions and Individual sessions with a multidisciplinary health team in people with Health Behavior and Quality of Life, run by McMaster University at 1 site in Canada.

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 10 inclusion and 1 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 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Retention rates (time frame: Baseline to 12 months). 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 NCT03258138, which also lists 29 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 14 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in