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Completed

NCT Number: NCT03691545

Making Healthy Choices: Does Having an Online 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.

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Key information

Conditions

Physical Activity Behavior Dietary Modification Motor Activity

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interactive sessions

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Ottawa

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2018
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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