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MPOWERed Messages: Tailored Mobile Messages to Enhance Weight Loss for Teens

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Mobile Messages to Enhance Weight Loss for Teens
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Treatment, Adolescents, Text Messages, Mobile phones, Multidisciplinary

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI ≥ 95th percentile for sex and age according to CDC growth charts
  • Enrollment in the MPOWER program
  • At least one parent willing and able to participate in the MPOWER program with the adolescent
  • Absence of any major medical illness, disability, or moderate/severe mental disorder (e.g., liver disease, renal failure, cancer, bipolar disorder)

Exclusion Criteria:

  • Presence of any major medical illness, disability, or moderate/severe mental disorder (e.g., renal failure, cancer, bipolar disorder)
  • Physical, mental, or cognitive handicaps that prevent participation
  • Chronic use of medications that may affect study outcomes (e.g., Diuretics, oral steroids)
  • Girls who are pregnant, planning to become pregnant in the next 6 months, lactating, or within 6 months postpartum

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Text Messaging

Control

Arm Description

Participation in the MPOWER program without receiving tailored text messages

Outcomes

Primary Outcome Measures

Session attendance
Adherence to MPOWER program homework assignments
Satisfaction with the MPOWER program
Drop out

Secondary Outcome Measures

Change in body mass index
Objective measurement of daily participation in moderate to vigorous activity
Self-efficacy for achieving MPOWER recommendations for the 6 target behaviors
Using a self-efficacy scale developed by Resnicow we will measure self-efficacy for consuming breakfast daily, achieving recommended amounts of fruits and vegetables, obtaining 60 to 90 minutes of moderate to vigorous physical activity on most days, limiting fast food consumption to no more than once per week, consuming no more than three 8 oz servings of sugar-sweetened beverages per week, and engaging in no more than 2 hours of screen time per day.
Intrinsic motivation to increase intake of fruits and vegetables and to increase physical activity
Intrinsic motivation will be measured using the Treatment Self-Regulation Questionnaire for Nutrition and the Treatment Self-Regulation Questionnaire for Physical Activity
Change in self-report of the six behaviors targeted in the intervention
The behaviors addressed are: Breakfast (self-report, in response to the question, During the last 7days, how many days did you eat breakfast?) Fruits and vegetables (24 hour food recall) Fast food (self-report in response to the question, During the last 7 days, how often did you eat food purchased at a fast food restaurant?) Sugar-sweetened beverages (24 hour food recall) Screen time (self-report in response to questions regarding number of hours of screen time per day on school days and non-school days) Physical activity (self-report using the Fitnessgram Activity log)

Full Information

First Posted
October 5, 2011
Last Updated
December 20, 2016
Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01448551
Brief Title
MPOWERed Messages: Tailored Mobile Messages to Enhance Weight Loss for Teens
Official Title
Novel Individually Tailored Mobile Messages to Enhance Weight Loss for Teens
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Obesity affects millions of American children and increases their risk of adult obesity, a myriad of serious illnesses, increased healthcare costs, and premature death. It is vital to find ways to reverse this epidemic. Multidisciplinary behavioral weight management programs offer the promise of effectively treating childhood obesity. However, participants in such programs often find it challenging to follow recommended treatment plans and frequently drop out from programs without completing them. The proposed project aims to address these problems through frequent contact with patients between office visits. This interim contact will be achieved by automatically sending tailored messages to the mobile phones of adolescents enrolled in a multidisciplinary weight management program (the MPOWER program), as an adjunct to clinic visits. The investigators hypothesize that program participants who receive the tailored text messages will experience lower attrition rates, increased treatment adherence, and greater weight loss compared to those program participants who do not receive the messages.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Treatment, Adolescents, Text Messages, Mobile phones, Multidisciplinary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text Messaging
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participation in the MPOWER program without receiving tailored text messages
Intervention Type
Behavioral
Intervention Name(s)
Tailored Mobile Messages to Enhance Weight Loss for Teens
Other Intervention Name(s)
MPOWERed Messages
Intervention Description
For this trial adolescents will be allowed to use their own phone (with reimbursement for any study-related costs), or will be provided with a mobile phone, if requested. Participants will receive messages delivered daily over the course of 20 weeks. The content of the messages will be tailored on participants' responses to the MPOWER enrollment survey and the initial tailoring questionnaire. On school days, all messages will be sent after 3 pm (which is after school hours for most Michigan middle and high schools). Therefore, patients will not need to carry cell phones to school. The tailored messages will utilize various degrees of personalization, adaptation and feedback - including momentary assessments with feedback requiring a text reply from the adolescents.
Primary Outcome Measure Information:
Title
Session attendance
Time Frame
Over the course of 6 months
Title
Adherence to MPOWER program homework assignments
Time Frame
Over the course of 6 months
Title
Satisfaction with the MPOWER program
Time Frame
At the completion of 3 months and 6 months in the program
Title
Drop out
Time Frame
Prior to completion of the 6 month program
Secondary Outcome Measure Information:
Title
Change in body mass index
Time Frame
After 3 months and 6 months in the MPOWER program
Title
Objective measurement of daily participation in moderate to vigorous activity
Time Frame
After 3 months and 6 months in the MPOWER program
Title
Self-efficacy for achieving MPOWER recommendations for the 6 target behaviors
Description
Using a self-efficacy scale developed by Resnicow we will measure self-efficacy for consuming breakfast daily, achieving recommended amounts of fruits and vegetables, obtaining 60 to 90 minutes of moderate to vigorous physical activity on most days, limiting fast food consumption to no more than once per week, consuming no more than three 8 oz servings of sugar-sweetened beverages per week, and engaging in no more than 2 hours of screen time per day.
Time Frame
After 3 months and 6 months in the MPOWER program6 month
Title
Intrinsic motivation to increase intake of fruits and vegetables and to increase physical activity
Description
Intrinsic motivation will be measured using the Treatment Self-Regulation Questionnaire for Nutrition and the Treatment Self-Regulation Questionnaire for Physical Activity
Time Frame
After 3 months and 6 months in the MPOWER program
Title
Change in self-report of the six behaviors targeted in the intervention
Description
The behaviors addressed are: Breakfast (self-report, in response to the question, During the last 7days, how many days did you eat breakfast?) Fruits and vegetables (24 hour food recall) Fast food (self-report in response to the question, During the last 7 days, how often did you eat food purchased at a fast food restaurant?) Sugar-sweetened beverages (24 hour food recall) Screen time (self-report in response to questions regarding number of hours of screen time per day on school days and non-school days) Physical activity (self-report using the Fitnessgram Activity log)
Time Frame
After 3 months and 6 months in the MPOWER program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI ≥ 95th percentile for sex and age according to CDC growth charts Enrollment in the MPOWER program At least one parent willing and able to participate in the MPOWER program with the adolescent Absence of any major medical illness, disability, or moderate/severe mental disorder (e.g., liver disease, renal failure, cancer, bipolar disorder) Exclusion Criteria: Presence of any major medical illness, disability, or moderate/severe mental disorder (e.g., renal failure, cancer, bipolar disorder) Physical, mental, or cognitive handicaps that prevent participation Chronic use of medications that may affect study outcomes (e.g., Diuretics, oral steroids) Girls who are pregnant, planning to become pregnant in the next 6 months, lactating, or within 6 months postpartum
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J Woolford, MD, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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MPOWERed Messages: Tailored Mobile Messages to Enhance Weight Loss for Teens

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