NCT01800331

Brief Summary

In Canada, the number of obese children and adolescents has increased tremendously. Interventions addressing diet and physical activity have been successful in the short-term. However, a great number of individuals have difficulties maintaining achieved weight loss and returning to treatment sessions. New technology interventions, through the web or delivered trough Personal Digital Assistants (PDAs) (e.g. iPhone or Blackberry), are increasingly being used in health interventions. PDAs have emerged as appealing in health interventions as they are easily accessible and their interactivity makes them well suited to promote long-term engagement in behaviour change interventions. This study will look at the utility of supplementing a family-based lifestyle program for overweight and obese adolescents (Shapedown BC) with a PDA intervention (Text2bHealthy) focussing mainly on physical activity, sedentary behaviours, and dietary intake to maintain treatment success by improving self-management skills. Adolescents and will receive Text2bHealthy for 3-months after 3 months participation in the Shapedown BC program. Results from this study will provide needed information on how to improve treatment adherence and maintenance outcomes through the use of innovative methods and will ultimately contribute to the improvement of long-term outcomes in obesity treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

February 18, 2013

Last Update Submit

May 8, 2015

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • BMI-z scores

    3 months

Secondary Outcomes (3)

  • Physical activity (physical activity recall, questions and pedometer steps)

    3 months

  • Nutrition

    3 months

  • Sitting behaviour (recall)

    3 months

Study Arms (2)

Text2bHealthy

EXPERIMENTAL

The intervention arm receives the Text2bHealthy program on a PDA

Behavioral: Text2bHealthy

Control group

NO INTERVENTION

The control group will complete a paper dairy to keep track of their lifestyle behaviours

Interventions

Text2bHealthyBEHAVIORAL

The intervention group uses handheld computers to keep track of their lifestyle behaviours and they will receive feedback on thier progress and tips (Text2bHealthy)

Text2bHealthy

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Overweight/obese teens
  • Aged 10 to 16 years
  • Completion of the Shapedown BC program
  • Being a resident of the greater metropolitan area of Vancouver
  • Not expected to move within the study time period
  • Ability to read and speak in English at a 6th grade level

You may not qualify if:

  • Participating in other physical activity or nutrition studies or programs such as the Weight Watchers or Jenny Craig
  • Pregnancy
  • Any co-morbidities which require immediate medical attention
  • Any musculoskeletal, cardiovascular, pulmonary, or orthopedic problems or disabilities precluding from being physically active
  • Use of a prescription medication which could interfere with the child's weight
  • Failure to complete the Shapedown BC program
  • Diagnosis of Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The British Columbia Children's Hospital

Vancouver, British Columbia, V6H 0B3, Canada

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Louise Masse, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 27, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

CA(1)