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

Sponsor
University of Ottawa (Other)
Overall Status
Completed
CT.gov ID
NCT03691545
Collaborator
(none)
7
1
1
12
0.6

Study Details

Study Description

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
  • Behavioral: interactive sessions
N/A

Study Design

Study Type:
Interventional
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 :
Oct 1, 2018
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000). [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) [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) [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) [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) [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) [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) [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 [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 [Duration of recruitment and intervention phase (12 weeks)]

    The number of participants completing the 12-week intervention.

  8. Adherence rates for intervention [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 [Post-intervention (12 weeks)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Ottawa Ottawa Ontario Canada K1N6N5

Sponsors and Collaborators

  • University of Ottawa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jennifer Brunet, Associate Professor, University of Ottawa
ClinicalTrials.gov Identifier:
NCT03691545
Other Study ID Numbers:
  • H08-18-882
First Posted:
Oct 1, 2018
Last Update Posted:
Mar 9, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jennifer Brunet, Associate Professor, University of Ottawa

Study Results

No Results Posted as of Mar 9, 2020