Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects
NCT ID: NCT02980393
Last Updated: 2016-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2012-05-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Lifestyle intervention
Participants are guided by a fitness specialist who will help the participants to incorporate physical activity into their daily life. Based on the cardiologist assessment, an individual home-based exercise program will be developed. Participants are also guided and advised on nutrition with emphasis on low fat content and increased fiber. The nutrition counseling will focus on sustainable changes and will help participants to make healthy food choices.
Lifestyle intervention
The structured lifestyle intervention involves alternating weekly phone calls with two health coaches: a registered dietitian and a fitness specialist. A total of 50 phone calls (25 nutrition-related and 25 physical activity-related) are delivered over the one-year study. After six months in the program, participants are introduced to supporting program-specific software that they can access online, as an additional way to interact with the program, set goals, and record their progress. Client and family-centred nutrition and physical activity counselling includes an initial and regular behavioural assessment, and subsequent conversations (i.e., phone calls) using motivational interviewing techniques intended to increase knowledge or skills, and improve behaviours.
Interventions
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Lifestyle intervention
The structured lifestyle intervention involves alternating weekly phone calls with two health coaches: a registered dietitian and a fitness specialist. A total of 50 phone calls (25 nutrition-related and 25 physical activity-related) are delivered over the one-year study. After six months in the program, participants are introduced to supporting program-specific software that they can access online, as an additional way to interact with the program, set goals, and record their progress. Client and family-centred nutrition and physical activity counselling includes an initial and regular behavioural assessment, and subsequent conversations (i.e., phone calls) using motivational interviewing techniques intended to increase knowledge or skills, and improve behaviours.
Eligibility Criteria
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Inclusion Criteria
* between 7-17 years of age
* operated or non-operated congenital heart disease
* reside in Southwestern Ontario
Exclusion Criteria
* involvement in any concurrent lifestyle intervention program
7 Years
17 Years
ALL
No
Sponsors
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London Health Sciences Centre
OTHER
Kambiz Norozi
OTHER
Responsible Party
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Kambiz Norozi
Paediatric Cardiologist
Principal Investigators
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Kambiz Norozi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
London Health Science Centre
References
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Rombeek M, De Jesus S, Altamirano-Diaz L, Welisch E, Prapavessis H, Seabrook JA, Norozi K. The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial. Pilot Feasibility Stud. 2017 Nov 15;3:59. doi: 10.1186/s40814-017-0207-y. eCollection 2017.
Other Identifiers
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18843
Identifier Type: OTHER
Identifier Source: secondary_id
102392
Identifier Type: -
Identifier Source: org_study_id