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

This study is currently recruiting participants.
Verified October 2011 by University of Michigan
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Susan J Woolford, MD, MPH, University of Michigan
ClinicalTrials.gov Identifier:
NCT01448551
First received: October 5, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: Tailored Mobile Messages to Enhance Weight Loss for Teens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Novel Individually Tailored Mobile Messages to Enhance Weight Loss for Teens

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Session attendance [ Time Frame: Over the course of 6 months ] [ Designated as safety issue: No ]
  • Adherence to MPOWER program homework assignments [ Time Frame: Over the course of 6 months ] [ Designated as safety issue: No ]
  • Satisfaction with the MPOWER program [ Time Frame: At the completion of 3 months and 6 months in the program ] [ Designated as safety issue: No ]
  • Drop out [ Time Frame: Prior to completion of the 6 month program ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in body mass index [ Time Frame: After 3 months and 6 months in the MPOWER program ] [ Designated as safety issue: No ]
  • Objective measurement of daily participation in moderate to vigorous activity [ Time Frame: After 3 months and 6 months in the MPOWER program ] [ Designated as safety issue: No ]
  • Self-efficacy for achieving MPOWER recommendations for the 6 target behaviors [ Time Frame: After 3 months and 6 months in the MPOWER program6 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 3 months and 6 months in the MPOWER program ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 3 months and 6 months in the MPOWER program ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Text Messaging Behavioral: Tailored Mobile Messages to Enhance Weight Loss for Teens
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 Name: MPOWERed Messages
No Intervention: Control
Participation in the MPOWER program without receiving tailored text messages

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448551

Contacts
Contact: Susan J Woolford, MD, MPH 734 615 8214 swoolfor@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Susan J Woolford, MD, MPH University of Michigan
  More Information

No publications provided

Responsible Party: Susan J Woolford, MD, MPH, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01448551     History of Changes
Other Study ID Numbers: F022685-1, 5K23HD058797-02
Study First Received: October 5, 2011
Last Updated: October 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Obesity
Treatment
Adolescents
 Text Messages
Mobile phones
Multidisciplinary

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 23, 2013