Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects

NCT02980393 | Completed DMC

• 2 other identifiers: 10239218843
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to assess whether a lifestyle intervention with diet, exercise and counselling in young patients will have a positive influence on their weight and overall well-being. This study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart disease, and have been identified being overweight or obese. A total of 40 individuals will participate in this study. The study duration will last for 1 year.

Conditions

Congenital Heart Disease; Pediatric Obesity

Keywords

congenital heart disease; smart mobile technology; children; adolescents; lifestyle counselling; nutrition; physical activity

Outcome Measures

Primary Outcomes (8)

• Change in Baseline Body Mass Index (BMI) at 1 year

  BMI is derived from body mass divided by the square of the body height

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Fat Mass at 1 year

  Dual energy x-ray absorptiometry (DEXA) will measure fat mass.

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Lean Mass at 1 year

  Dual energy x-ray absorptiometry (DEXA) will measure lean mass.

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Percent Fat at 1 year

  Dual energy x-ray absorptiometry (DEXA) will measure percent fat.

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Percent Android Fat at 1 year

  Dual energy x-ray absorptiometry (DEXA) will measure percent android fat.

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Visceral Adipose Tissue at 1 year

  Dual energy x-ray absorptiometry (DEXA) will measure visceral adipose tissue.

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Bone Mineral Content at 1 year

  Dual energy x-ray absorptiometry (DEXA) will measure bone mineral content.

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Maximum Oxygen Consumption at 1 year

  Maximal exercise graded treadmill test will determine maximal oxygen consumption.

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

Secondary Outcomes (15)

• Change in Baseline Average Caloric Intake at 1 year

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Self-Report Physical Activity Levels at 1 year

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Physical Activity Levels at 1 year

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Quality of Life at 1 year

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

• Change in Baseline Muscle function at 1 year

  This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

Study Arms (1)

Lifestyle intervention

EXPERIMENTAL

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.

Behavioral: Lifestyle intervention

Interventions

Lifestyle intervention BEHAVIORAL

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.

Lifestyle intervention

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• overweight or obese (BMI\> 85%) patients
• between 7-17 years of age
• operated or non-operated congenital heart disease
• reside in Southwestern Ontario

You may not qualify if:

• inability to comply with research testing or intervention components due to mental and/or physical disabilities, medications or comorbidities affecting weight or metabolic condition
• involvement in any concurrent lifestyle intervention program

Sponsors & Collaborators

• Kambiz Norozi: lead
• London Health Sciences Centre: collaborator

Related Publications (1)

• 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.

  PMID: 29167745 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Kambiz Norozi, MD, PhD

  London Health Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Paediatric Cardiologist

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 2, 2016
• Study Start: May 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 22, 2016

Record last verified: 2016-12