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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691545
• Other study ID #: H08-18-882
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2020
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Modification
• Physical Activity

Intervention

Behavioral:
• interactive sessions
This arm will receive personalized health coaching (behaviour change counseling)

Locations

Country	Name	City	State
Canada	University of Ottawa	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. — View Citation

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. Review. — View Citation

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. — View Citation

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (week 0) and post-intervention (week 12)
Primary	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.	Baseline (week 0) and post-intervention (week 12)
Secondary	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.	Baseline (week 0) and post-intervention (week 12)
Secondary	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.	Baseline (week 0) and post-intervention (week 12)
Secondary	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.	Baseline (week 0) and post-intervention (week 12)
Secondary	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.	Baseline (week 0) and post-intervention (week 12)
Secondary	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.	Post-intervention (week 12)
Secondary	Recruitment rates	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)
Secondary	Retention rates for intervention	The number of participants completing the 12-week intervention.	Duration of recruitment and intervention phase (12 weeks)
Secondary	Adherence rates for intervention	The number of eligible participants completing = 70% of the intervention sessions (i.e., 8/12)	Duration of recruitment and intervention phase (12 weeks)
Secondary	Acceptability of intervention: Semi-structured interviews	Participants will be asked what they liked, disliked, and experienced during the intervention	Post-intervention (12 weeks)