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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Jennifer Brunet，University of Ottawa

Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 1, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

September 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.
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.
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.
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.
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 in intervention group participants at post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.
Recruitment rates[ Time Frame: Duration of recruitment and intervention phases (12 weeks) ]
The number of eligible participants who enrol in the study out of the number assessed for eligibility
Retention rates for intervention[ Time Frame: Duration of recruitment and intervention phases (12 weeks) ]
The number of participants completing the twelve-week intervention.
Adherence rates for intervention[ Time Frame: Duration of recruitment and intervention phases (12 weeks) ]
The number of eligible participants completing ≥ 70% of the intervention sessions (i.e., 8/12)
Acceptability of intervention: Semi-structured interviews[ Time Frame: Duration of recruitment and intervention phases (12 weeks) ]
For participants randomized to the intervention group, what participants liked, disliked, and experienced during the intervention

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 in comparison to if they received only digital copies of the American Cancer Society guidelines for physical activity and nutrition. The researchers therefore developed a pilot, two-armed randomized controlled trial to test this hypothesis, and aim to test its feasibility, acceptability, and preliminary efficacy. The study also aims 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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Supportive Care

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: interactive sessions
This arm will receive personalized health coaching (behaviour change counseling)
Behavioral: American Cancer Society guidelines
This arm will receive the American Cancer Society guidelines

Study Arms

Experimental: Intervention Group
a copy of the American Cancer Society guidelines for physical activity and nutrition by email. twelve weekly interactive sessions with a health coach to help them set goals and make changes towards becoming physically active and consuming fruits and vegetables.
Active Comparator: Comparison Group
1. a copy of the American Cancer Society guidelines for physical activity and nutrition by email.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 2019

Estimated Primary Completion Date

September 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Are between the ages of 20-39 years - Live in a rural area (i.e., locations >100km from large urban centres with <1000 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Canada

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Jennifer Brunet，University of Ottawa

Study Sponsor ^ICMJE

University of Ottawa

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

University of Ottawa

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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