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

December 20, 2016 updated by: Susan J Woolford, MD, MPH, University of Michigan

Novel Individually Tailored Mobile Messages to Enhance Weight Loss for Teens

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Text Messaging
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.
Other Names:
  • MPOWERed Messages
No Intervention: Control
Participation in the MPOWER program without receiving tailored text messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Session attendance
Time Frame: Over the course of 6 months
Over the course of 6 months
Adherence to MPOWER program homework assignments
Time Frame: Over the course of 6 months
Over the course of 6 months
Satisfaction with the MPOWER program
Time Frame: At the completion of 3 months and 6 months in the program
At the completion of 3 months and 6 months in the program
Drop out
Time Frame: Prior to completion of the 6 month program
Prior to completion of the 6 month program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body mass index
Time Frame: After 3 months and 6 months in the MPOWER program
After 3 months and 6 months in the MPOWER program
Objective measurement of daily participation in moderate to vigorous activity
Time Frame: After 3 months and 6 months in the MPOWER program
After 3 months and 6 months in the MPOWER program
Self-efficacy for achieving MPOWER recommendations for the 6 target behaviors
Time Frame: After 3 months and 6 months in the MPOWER program6 month
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.
After 3 months and 6 months in the MPOWER program6 month
Intrinsic motivation to increase intake of fruits and vegetables and to increase physical activity
Time Frame: After 3 months and 6 months in the MPOWER program
Intrinsic motivation will be measured using the Treatment Self-Regulation Questionnaire for Nutrition and the Treatment Self-Regulation Questionnaire for Physical Activity
After 3 months and 6 months in the MPOWER program
Change in self-report of the six behaviors targeted in the intervention
Time Frame: After 3 months and 6 months in the MPOWER program
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)
After 3 months and 6 months in the MPOWER program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susan J Woolford, MD, MPH, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 5, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F022685-1
  • 5K23HD058797-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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