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

Obesity Clinical Trial

Official title:

Novel Individually Tailored Mobile Messages to Enhance Weight Loss for Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448551
• Other study ID #: F022685-1
• Secondary ID: 5K23HD058797-02
• Status: Completed
• Phase: N/A
• First received: October 5, 2011
• Last updated: December 20, 2016
• Start date: October 2011
• Est. completion date: October 2015

Study information

• Verified date: December 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Session attendance		Over the course of 6 months	No
Primary	Adherence to MPOWER program homework assignments		Over the course of 6 months	No
Primary	Satisfaction with the MPOWER program		At the completion of 3 months and 6 months in the program	No
Primary	Drop out		Prior to completion of the 6 month program	No
Secondary	Change in body mass index		After 3 months and 6 months in the MPOWER program	No
Secondary	Objective measurement of daily participation in moderate to vigorous activity		After 3 months and 6 months in the MPOWER program	No
Secondary	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.	After 3 months and 6 months in the MPOWER program6 month	No
Secondary	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	After 3 months and 6 months in the MPOWER program	No
Secondary	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)	After 3 months and 6 months in the MPOWER program	No