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Making Healthy Choices: Does Having an Online Health Coach Help?

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ClinicalTrials.gov Identifier: NCT03691545
Recruitment Status : Completed
First Posted : October 1, 2018
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Jennifer Brunet, University of Ottawa

Brief Summary:
Participating in regular physical activity and consuming a diet high in fruits and vegetables can aid in the management of various acute and chronic side effects of cancer treatment; however, few rural-dwelling young adult cancer survivors are active enough and consume enough fruits and vegetables to accrue benefits. Telehealth interventions show promise for helping these young adults increase their motivation to participate in these behaviours by addressing barriers associated with accessing face-to-face behaviour counselling services (e.g., time commitment, travel distance). Yet, few researchers have examined the feasibility and acceptability of a telehealth intervention that provides motivational support grounded in self-determination theory for these health behaviours in rural-dwelling young adult cancer survivors. Based on previous research, the researchers reasoned that rural-dwelling young adult cancer survivors' physical activity and fruit and vegetable consumption would be more likely to increase if they participated in a telehealth intervention therefore, the researchers aim to test the feasibility, acceptability, and preliminary efficacy of the intervention. The researchers also aim to assess if changes in perceived basic psychological need satisfaction, behaviour regulation, and perceived autonomy support are associated with changes in physical activity and fruit and vegetable consumption.

Condition or disease Intervention/treatment Phase
Physical Activity Dietary Modification Behavioral: interactive sessions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Helping Rural-living Young Adult Cancer Survivors Make Healthy Lifestyle Choices: Does Having a Telehealth Personal Health Coach Help?
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
(1) 12 weekly interactive sessions with a health coach to help them set goals and make changes toward becoming physically active and consuming the recommended number of fruits and vegetables.
Behavioral: interactive sessions
This arm will receive personalized health coaching (behaviour change counseling)




Primary Outcome Measures :
  1. Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000). [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.

  2. Fruit and vegetable intake behaviour: Behavioural Risk Factor Surveillance System Fruit and Vegetable section (BRFSS-FV; Trowbridge, Wong, Byers, & Serdula, 1990) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in self-reported fruit and vegetable intake (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.


Secondary Outcome Measures :
  1. Basic psychological needs satisfaction for physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in basic psychological need satisfaction for physical activity from baseline to post-intervention, using a 1 (false) to 6 (true) scale with higher scores representing a better outcome.

  2. Basic psychological need satisfaction for fruit and vegetable consumption: Psychological Need Satisfaction questionnaire (PNS; Deci, Ryan, Gagne, Leone, Usunov, & Kornazheva, 2001) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in basic psychological need satisfaction for fruit and vegetable consumption from baseline to post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.

  3. Motivational regulations for physical activity: Exercise Treatment Self-Regulation Questionnaire (TSRQ-E; Williams, Deci, & Ryan, 1998) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in motivational regulations for physical activity from baseline to post-intervention, using a 1 (not at all true) to 7 (very true) scale with higher scores representing a better outcome.

  4. Motivational regulations for fruit and vegetable consumption: Dietary Self-Regulation questionnaire (DSR; Williams, Deci, & Ryan, 1998) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in motivational regulations for fruit and vegetable consumption from baseline to post-intervention, using a 1 (not at all true) to 7 (very true) scale with higher scores representing a better outcome.

  5. Perceived autonomy support: Health Care Climate Questionnaire (HCCQ; Williams, Grow, Freedman, Ryan, & Deci, 1996) [ Time Frame: Post-intervention (week 12) ]
    Level of perceived autonomy support for health behaviours post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.

  6. Recruitment rates [ Time Frame: Duration of recruitment and intervention phase (12 weeks) ]
    The number of eligible participants who enrol in the study out of the number assessed for eligibility

  7. Retention rates for intervention [ Time Frame: Duration of recruitment and intervention phase (12 weeks) ]
    The number of participants completing the 12-week intervention.

  8. Adherence rates for intervention [ Time Frame: Duration of recruitment and intervention phase (12 weeks) ]
    The number of eligible participants completing ≥ 70% of the intervention sessions (i.e., 8/12)

  9. Acceptability of intervention: Semi-structured interviews [ Time Frame: Post-intervention (12 weeks) ]
    Participants will be asked what they liked, disliked, and experienced during the intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are between the ages of 20-39 years
  • Live in a rural area (i.e., areas with <35,000 inhabitants)
  • Have completed primary treatment for non-metastatic cancer
  • Are not currently meeting the American Cancer Society guidelines for physical activity and fruit and vegetable consumption
  • Have access to the Internet and to audio-visual devices
  • Are willing to provide informed consent to participate in this study and willing to follow study protocol
  • Able to read and understand English
  • Are ambulatory

Exclusion Criteria:

  • Have a serious condition that precludes safe participation in physical activity
  • Have symptomatic heart or vascular diseases (angina, peripheral vascular disease, congestive heart failure)
  • Have severe hypertension
  • Have had a recent stroke
  • Have a chronic obstructive pulmonary disease
  • Have severe insulin-dependent diabetes mellitus
  • Have renal disease
  • Have liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691545


Locations
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Canada, Ontario
University of Ottawa
Ottawa, Ontario, Canada, K1N6N5
Sponsors and Collaborators
University of Ottawa
Publications:
Deci, E. L., Ryan, R.M., Gagne, M., Leone, D.R., Usunov, J., & Kornazheva, B.P. (2001). Need satisfaction, motivation, and well-being in the work organizations of a former eastern bloc country: A cross-sectional study of self-determination. Journal of Personality and Social Psychology, 27(8), 930-942.
Williams, G. C., Deci, E. L., & Ryan, R. M. (1998). Building health-care partnerships by supporting autonomy: Promoting maintained behavior change and positive health outcomes. In A. L. Suchman, P. Hinton-Walker, & R. Botelho (Ed.), Partnerships in healthcare: Transforming relational process (pp. 67-87). Rochester, NY: University of Rochester Press.
Wilson, P. M., Rogers, W. T., Rodgers, W. M., & Wild, T. C. (2006). Psychological need satisfaction in exercise scale. Journal of Sport & Exercise Psychology, 28, 231-251.

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Responsible Party: Jennifer Brunet, Associate Professor, University of Ottawa
ClinicalTrials.gov Identifier: NCT03691545    
Other Study ID Numbers: H08-18-882
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Brunet, University of Ottawa:
physical activity
fruit and vegetable consumption
telehealth
young adult cancer survivors
rural-dwelling