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Physical ActivityNCT03691545

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

A study testing interactive sessions in people with Physical Activity and Dietary Modification, run by University of Ottawa 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
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 39 years
Conditions the study is for
Physical Activity, Dietary Modification
What is being tested?
interactive sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteCanada
Study dates
1 Oct 2018to 30 Sep 2019
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 20 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Ottawa

    Ottawa, Ontario, K1N6N5

Other trials in Canada

About this study

Official title: Helping Rural-living Young Adult Cancer Survivors Make Healthy Lifestyle Choices: Does Having a Telehealth Personal Health Coach Help?

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.

Being tested
interactive sessions
Keywords
physical activity, fruit and vegetable consumption, telehealth, young adult cancer survivors, rural-dwelling
Medical subject headings
Motor Activity

What participants receive

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

  • interactive sessionsBehavioural

    This arm will receive personalized health coaching (behaviour change counseling)

Study groups in NCT03691545
Study groupRoleWhat they receive
Intervention GroupExperimental(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.
Receives: Behavioral: interactive sessions

What is being measured

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

  1. Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000).

    Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.

    Measured: Baseline (week 0) and post-intervention (week 12)

  2. Fruit and vegetable intake behaviour: Behavioural Risk Factor Surveillance System Fruit and Vegetable section (BRFSS-FV; Trowbridge, Wong, Byers, & Serdula, 1990)

    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.

    Measured: Baseline (week 0) and post-intervention (week 12)

Secondary outcomes (9)

  1. Basic psychological needs satisfaction for physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)

    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.

    Measured: Baseline (week 0) and post-intervention (week 12)

  2. Basic psychological need satisfaction for fruit and vegetable consumption: Psychological Need Satisfaction questionnaire (PNS; Deci, Ryan, Gagne, Leone, Usunov, & Kornazheva, 2001)

    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.

    Measured: Baseline (week 0) and post-intervention (week 12)

  3. Motivational regulations for physical activity: Exercise Treatment Self-Regulation Questionnaire (TSRQ-E; Williams, Deci, & Ryan, 1998)

    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.

    Measured: Baseline (week 0) and post-intervention (week 12)

  4. Motivational regulations for fruit and vegetable consumption: Dietary Self-Regulation questionnaire (DSR; Williams, Deci, & Ryan, 1998)

    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.

    Measured: Baseline (week 0) and post-intervention (week 12)

  5. Perceived autonomy support: Health Care Climate Questionnaire (HCCQ; Williams, Grow, Freedman, Ryan, & Deci, 1996)

    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.

    Measured: Post-intervention (week 12)

  6. Recruitment rates

    The number of eligible participants who enrol in the study out of the number assessed for eligibility

    Measured: Duration of recruitment and intervention phase (12 weeks)

  7. Retention rates for intervention

    The number of participants completing the 12-week intervention.

    Measured: Duration of recruitment and intervention phase (12 weeks)

  8. Adherence rates for intervention

    The number of eligible participants completing ≥ 70% of the intervention sessions (i.e., 8/12)

    Measured: Duration of recruitment and intervention phase (12 weeks)

  9. Acceptability of intervention: Semi-structured interviews

    Participants will be asked what they liked, disliked, and experienced during the intervention

    Measured: Post-intervention (12 weeks)

Timeline

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

  1. First posted1 Oct 2018
  2. Study start1 Oct 2018
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03691545
Sponsor's protocol ID
H08-18-882
Status last verified
Mar 2020
First submitted
27 Sep 2018
Last updated
9 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.

    PubMed 10925833

  • 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.

  • Trowbridge FL, Wong FL, Byers TE, Serdula MK. Methodological issues in nutrition surveillance: the CDC experience. J Nutr. 1990 Nov;120 Suppl 11:1512-8. doi: 10.1093/jn/120.suppl_11.1512.

    PubMed 2173743

  • 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.

  • Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.

    PubMed 8558405

  • 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.

  • Price J, Brunet J. Feasibility and acceptability of a telehealth behavior change intervention for promoting physical activity and fruit and vegetable consumption among rural-living young adult cancer survivors. J Psychosoc Oncol. 2021;39(6):715-733. doi: 10.1080/07347332.2021.1896616. Epub 2021 Apr 2.

    PubMed 33798033

Questions about this trial

What is this clinical trial studying?

A study testing interactive sessions in people with Physical Activity and Dietary Modification, run by University of Ottawa 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 8 inclusion and 8 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 9 Mar 2020. 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?

Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000). (time frame: Baseline (week 0) and post-intervention (week 12)). The study lists 2 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 NCT03691545, which also lists 7 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 9 Mar 2020.

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