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Text2bHealthy: Using Innovative Methods in Childhood Obesity Treatment

Primary Purpose

Overweight and Obesity

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Text2bHealthy
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The British Columbia Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Text2bHealthy

Control group

Arm Description

The intervention arm receives the Text2bHealthy program on a PDA

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

Outcomes

Primary Outcome Measures

BMI-z scores

Secondary Outcome Measures

Physical activity (physical activity recall, questions and pedometer steps)
Nutrition
Sitting behaviour (recall)

Full Information

First Posted
February 18, 2013
Last Updated
May 8, 2015
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01800331
Brief Title
Text2bHealthy: Using Innovative Methods in Childhood Obesity Treatment
Official Title
Text2bHealthy: Enhancing Adherence to Childhood Obesity Treatment Through the Use of Innovative Methods
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
My post-doctoral fellow did not return from her mat leave and I have no other students to take on this project.
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Around the world, the amount of people who are overweight is increasing. This has become a public health crisis. Obesity, especially in children, is a problem because it is associated with risk for health problems and psychological issues. These problems include heart disease and poor quality of life and can happen both in childhood and later life. Programs that help people change their lifestyle and behaviour are effective to help people lose weight and improve their mental health. In children, the main issue for treating obesity is to help the child keep weight off and to prevent a return to unhealthy behaviours. This means that long-term support is needed. But the health care system is not set up to do this because of a limited amount of resources. The aim of this study is to see if there are better long-term results if we use a technology tool along with a lifestyle program. The aim of this study is to examine a personal digital assistant (PDA) program (Text2bHealthy) supplemented to an existing family-based group treatment for overweight and obese children. This treatment is called the British Columbia Centre for Healthy Weights (BCCHW) Shapedown BC program. The aim of this study is to see if Text2bHealthy supplemented to the Shapedown BC program helps children to keep the weight of and improves physical activity as well as fruit, vegetable, and fat intake. We know from studies that reporting one's own behaviour, goal setting, and tailored feedback are key elements in changing health behaviours. Text2bHealthy includes these key elements. PDAs will be given to 30 10-16 year old children and adolescents after completing the Shapedown BC program. They will be explained how to use the PDA. Children who participate in the Text2bHealthy program will set weekly goals related to their physical activity, eating or sitting behaviours. Also, they will report on their lifestyle behaviours twice a week. They will receive personalized feedback on their progress. The feedback is designed to be supportive and to reinforce their behaviour in a positive way. The control group (N=30) will use a paper dairy to keep track of their lifestyle behaviours. At 0 and 3 months after completing the Shapedown BC program, measurements such as height and weight will be taken. Also, exercise and nutrition behaviour will be measured. Physical activity will be measured with pedometers and a recall and nutrition intake with questionnaires. Because it is hard to maintain weight loss, we need to provide programs that offer the long-term support of behaviour change. Tools such as PDAs seem to be ideal to offer long-term support. For the purpose of this study, PDAs will be used as a proof of concept; the programming can be incorporated into smart phones in the future. From previous studies we know that reporting one's own behaviour seems to improve weight loss in children. Also, behaviours are more likely to be reported when using mobile phones compared to paper & pencil diaries. I am one of the first to study the effect of innovative technologies by using self-reporting, goal setting, and personalized feedback in childhood obesity treatment. We hope that the results from this study will increase our knowledge on the use and feasibility of digital devices in childhood obesity treatment. The outcomes of this research will be used to better understand how to improve weight loss maintenance among obese children. Obesity places children at higher risk for heart disease and poor quality of life when they are adults. Thus time and cost-effective long-term support programs need to be developed to improve weight loss maintenance. This new program has the potential to improve maintenance of weight loss and healthy lifestyle in overweight and obese children and adolescents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text2bHealthy
Arm Type
Experimental
Arm Description
The intervention arm receives the Text2bHealthy program on a PDA
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will complete a paper dairy to keep track of their lifestyle behaviours
Intervention Type
Behavioral
Intervention Name(s)
Text2bHealthy
Intervention Description
The intervention group uses handheld computers to keep track of their lifestyle behaviours and they will receive feedback on thier progress and tips (Text2bHealthy)
Primary Outcome Measure Information:
Title
BMI-z scores
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Physical activity (physical activity recall, questions and pedometer steps)
Time Frame
3 months
Title
Nutrition
Time Frame
3 months
Title
Sitting behaviour (recall)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Masse, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 0B3
Country
Canada

12. IPD Sharing Statement

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Text2bHealthy: Using Innovative Methods in Childhood Obesity Treatment

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