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

March 6, 2020 updated by: Jennifer Brunet, University of Ottawa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N6N5
        • University of Ottawa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0) and post-intervention (week 12)
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.
Baseline (week 0) and post-intervention (week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0) and post-intervention (week 12)
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.
Baseline (week 0) and post-intervention (week 12)
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.
Baseline (week 0) and post-intervention (week 12)
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.
Baseline (week 0) and post-intervention (week 12)
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.
Post-intervention (week 12)
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
Duration of recruitment and intervention phase (12 weeks)
Retention rates for intervention
Time Frame: Duration of recruitment and intervention phase (12 weeks)
The number of participants completing the 12-week intervention.
Duration of recruitment and intervention phase (12 weeks)
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)
Duration of recruitment and intervention phase (12 weeks)
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
Post-intervention (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ottawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H08-18-882

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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