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Piloting Conversation Cards for Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821896
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
Providers are not opportunistic enough in addressing lifestyle habits of teens, and can benefit from appropriate tools to support their conversations with families as well as engage all family members in making changes. Since most teens with obesity do not meet minimum lifestyle recommendations, our team developed Conversation Cards for Adolescents (CCAs), a tool to help teens and providers communicate and set lifestyle goals together. In this study, the investigators will (i) observe if and how CCAs fit in a clinical setting for changing teen-provider interactions and teens's lifestyle habits, (ii) ask teens and providers for their thoughts on CCAs and how they are used, and (iii) determine preliminary impact of CCAs on teen behaviors and clinical factors. The investigators will do this with around 50 teens from a primary/secondary care clinic in Edmonton, Alberta. Teens will be randomized to one of two groups - one group will use CCAs in their appointment with their providers to set a goal for change, while the other will also set a goal for change, but without using CCAs. Results from this study will give us insight into how CCAs are best used in a clinical setting and will help us plan a future full-scale study.

Condition or disease Intervention/treatment Phase
Adolescent Obesity Life Style Health Behavior Health Communication Primary Health Care Behavioral: Conversation Cards for Adolescents and Goal-Setting Behavioral: Goal-Setting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: An external party (Women and Children's Health Research Institute, University of Alberta) will run data analysis for the study.
Primary Purpose: Treatment
Official Title: Feasibility, User Experiences, and Preliminary Effectiveness of Conversation Cards for Adolescents, a Patient-centered Communication and Behavior Change Tool: a Pragmatic, Pilot Randomized Controlled Trial
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Conversation Cards for Adolescents and Goal-Setting
Adolescents in the experimental arm will receive the tool 15 minutes prior to their appointment with their primary care provider. They will be instructed to familiarize themselves with the tool and to select the top 3 factors that resonate most with them in their attemps to change their lifestyle habits. They will then proceed to their clinical appointment to set one S.M.A.R.T. goal based on their selections and in collaboration with their primary care provider.
Behavioral: Conversation Cards for Adolescents and Goal-Setting
The intervention includes using an adolescent-tailored tool (a deck of cards) created by researchers at the University of Alberta and adolescents with obesity seeking weight management care. It contains a list of factors that make it easy or hard for teens to make and maintain healthy lifestyle changes. Its use will be paired with a S.M.A.R.T. goal-setting activity using principles of shared decision-making.

Active Comparator: Goal-Setting
Adolescents in the control arm will not complete the tool activity, but will still set a S.M.A.R.T. goal with their primary care provider.
Behavioral: Goal-Setting
Collaborative setting of S.M.A.R.T. goals using principles of shared decision-making.




Primary Outcome Measures :
  1. Feasibility outcomes for resource, management, and scientific assessments per open-ended questions outlined by Tickle-Degnen's (2013) [ Time Frame: Through study completion, an average of 1 year ]
    The study coordinator will monitor and document study procedures and feasibility based on continuous observation at the site.


Secondary Outcome Measures :
  1. Collaborative goal-setting using the Patient Perception of Collaborative Goal-Setting [ Time Frame: Baseline ]
    This questionnaire includes five factors: listen and learn from each other; share ideas; caring relationship; agree on a measurable objective; support for goal achievement. It uses a 5-point scale (worse to better outcome: strongly disagree - disagree - neutral - agree - strongly agree) and has achieved reliability and construct validity. Goal-setting refers to setting one S.M.A.R.T. (specific, measurable, attainable, realistic, timely) goal.

  2. Degree of effort and achievement of treatment goals using researcher-developed questions [ Time Frame: 3 weeks ]
    Questions will use a 0-9 scale (better to worse outcome: 1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9) and will be asked by the study coordinator during the telephone follow-up.

  3. Patient engagement: perspectives on priorities and study design using researcher-developed questions [ Time Frame: 3 weeks ]
    Questions will be open-ended and will be asked by the study coordinator during the telephone follow-up.

  4. Appointment length using a timer on the study-specific iPad [ Time Frame: Baseline ]
    The study coordinator will time the duration of the clinical appointments for both experimental and control groups.

  5. User experience as per the User Experience Questionnaires [ Time Frame: Baseline (pre-appt) ]
    This questionnaire was designed to obtain participants' agreement on contrasting attributes representing gradations between the opposites that may apply to a product. It includes 26 attributes, uses a 7-point scale (better to worse outcome: 1 - 2 - 3 - 4 - 5 - 6 - 7), and has achieved satisfactory reliability and construct validity.

  6. User acceptance as per the Technology Acceptance Model [ Time Frame: At study end point, an average of 1 year ]
    This questionnaire includes 11 items representing perceived usefulness and perceived ease of use of a technology, uses a 7-point scale (better to worse outcome: extremely - quite - slightly - neither - slightly - quite - extremely), and has achieved reliability, internal consistency, and convergent and discriminant validity.

  7. Tool likeability (adolescents) using researcher-developed questions [ Time Frame: Baseline ]
    Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)

  8. Tool usefulness (adolescents) using researcher-developed questions [ Time Frame: Baseline ]
    Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)

  9. Tool feasibility (adolescents) using researcher-developed questions [ Time Frame: Baseline ]
    Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)

  10. Tool usability (adolescents) using researcher-developed questions [ Time Frame: Baseline ]
    Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)

  11. Tool likeability (PCPs) using researcher-developed questions [ Time Frame: At study end point, an average of 1 year ]
    Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)

  12. Tool usefulness (PCPs) using researcher-developed questions [ Time Frame: At study end point, an average of 1 year ]
    Questions will be open-ended and closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)

  13. Tool feasibility (PCPs) using researcher-developed questions [ Time Frame: At study end point, an average of 1 year ]
    Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)

  14. Tool usability (PCPs) using researcher-developed questions [ Time Frame: At study end point, an average of 1 year ]
    Questions will be closed-ended using a 7-point Likert scale (worse to better outcome: strongly disagree - disagree - somewhat disagree - neutral - somewhat agree - agree - strongly agree)



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adolescents are eligible to participate if they are:

  • 13-17 years old
  • At a functioning grade level (English literacy and comprehension)
  • Interested in setting a lifestyle/behavioural goal related to improving diet, physical activity or sedentary activity, and
  • Seeking health services at the Northeast Community Health Centre (NECHC; Edmonton, Alberta, Canada)

All participating providers who deliver care to adolescents at the NECHC are eligible to participate.

Exclusion Criteria:

N/A

Our original eligibility criteria included a BMI ≥85th percentile. After recruiting the first five patients with overweight/obesity from March to August 2019, we decided to remove BMI eligibility criteria given the applicability of our tool's focus on lifestyle and adolescents across the weight spectrum, as well as to enhance recruitment. This decision was made by the research team in conjunction with clinical staff involved in the trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821896


Contacts
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Contact: Geoff DC Ball, PhD, RD (780) 492-8727 gdball@ualberta.ca
Contact: Maryam Kebbe, PhD kebbe@ualberta.ca

Locations
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Canada, Alberta
Northeast Community Health Centre Recruiting
Edmonton, Alberta, Canada, T5A 5E4
Contact: Hasu Rajani, MD         
Sponsors and Collaborators
University of Alberta
Alberta Health Services
Investigators
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Principal Investigator: Geoff DC Ball, PhD, RD University of Alberta
Study Director: Maryam Kebbe, PhD University of Alberta
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03821896    
Other Study ID Numbers: Pro00083903
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Adolescents; Obesity; Lifestyle; Goals; Communication
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight