Pediatric Obesity Clinical Trial
— RMI-FamilyOfficial title:
The Readiness and Motivation Interview for Families (RMI-Family) Managing Pediatric Obesity
NCT number | NCT03527394 |
Other study ID # | Pro00051447 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 6, 2017 |
Est. completion date | March 31, 2022 |
Verified date | May 2022 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Approximately one-third of Canadian children have excess weight, putting them at increased risk of type 2 diabetes, cardiovascular disease, bone and joint problems, and some forms of cancer. Because current therapies for managing obesity have modest success, there is a need to develop and test innovative strategies to enhance pediatric weight management. Using a novel interview designed to measure motivation to change lifestyle habits, interviewers will conduct separate and structured 1-on-1 interviews with youth with obesity and parents. By applying principles of motivational interviewing, trained interviewers will ask youth and their parents about their motivation to change lifestyle habits related to diet and physical activity. Subsequently, interview data will be used to examine predictors of clinically-meaningful outcomes over time, including changes in weight status, lifestyle habits, health care utilization, and attrition. The investigators will also measure a number of variables related to weight management, including dietary intake, physical activity, anthropometry, and psychosocial health.
Status | Completed |
Enrollment | 54 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | Inclusion Criteria: - 13-17 years old - Youth with an age- and sex-specific BMI =97th percentile. - Parents or guardians who self-identify as the primary caregiver of the youth and are able to provide in-depth perspective on youth lifestyle habits. - Youth and parents who are proficient in English (reading and communicating). Exclusion Criteria: - <13 or >18 years old - Youth with an age- and sex-specific BMI <97th percentile. - Parents or guardians who do not self-identify as the youth primary caregiver or are not able to provide in-depth perspective on youth lifestyle habits. - Families who are not proficient in English (reading and communicating). |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital (Pediatric Centre for Weight and Health) | Calgary | Alberta |
Canada | Stollery Children's Hospital (Pediatric Centre for Weight and Health) | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Canadian Institutes of Health Research (CIHR) |
Canada,
Ball GD, Spence ND, Browne NE, O'Connor K, Srikameswaran S, Zelichowska J, Ho J, Gokiert R, Mâsse LC, Carson V, Morrison KM, Kuk JL, Holt NL, Kebbe M, Gehring ND, Cesar M, Virtanen H, Geller J. The readiness and motivation interview for families (RMI-Family) managing pediatric obesity: study protocol. BMC Health Serv Res. 2017 Apr 11;17(1):261. doi: 10.1186/s12913-017-2201-8. — View Citation
Geller J, Avis J, Srikameswaran S, Zelichowska J, Dartnell K, Scheuerman B, Perez A, Rasquinha A, Brown KE, Chanoine JP, Ball G. Developing and Pilot Testing the Readiness and Motivation Interview for Families in Pediatric Weight Management. Can J Diet Pract Res. 2015 Dec;76(4):190-3. doi: 10.3148/cjdpr-2015-024. Epub 2015 Aug 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline psychometric properties at 6- and 12-months | A number of psychometric properties of the Readiness and Motivation Interview for Families (RMI-Family) will be examined, including internal consistency, test-retest reliability, convergent validity, and concurrent validity. Based on data derived from the RMI-Family, we will generate youth, parent, and family (youth-parent) total motivation and motivation sub-scores (5-point Likert scale). | Baseline, 6- and 12-months post-baseline | |
Secondary | Predictive value of the Readiness and Motivation Interview (RMI-Family) | Predictive validity of the RMI-Family will be examined by relating youth, parent, and family (youth-parent) scores (5-point Likert scale) from the interview to clinically-meaningful outcomes at baseline, 6- and 12-month follow-up, including anthropometry, lifestyle habits, psychosocial health, health care use, and program attrition. | Baseline, 6- and 12-months post-baseline |
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