Overview

This trial is active, not recruiting.

Condition obesity
Treatment tailored mobile messages to enhance weight loss for teens
Sponsor University of Michigan
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date October 2011
End date October 2015
Trial size 60 participants
Trial identifier NCT01448551, 5K23HD058797-02, F022685-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
tailored mobile messages to enhance weight loss for teens MPOWERed Messages
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.
(No Intervention)
Participation in the MPOWER program without receiving tailored text messages

Primary Outcomes

Measure
Session attendance
time frame: Over the course of 6 months
Adherence to MPOWER program homework assignments
time frame: 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
Drop out
time frame: Prior to completion of the 6 month program

Secondary Outcomes

Measure
Change in body mass index
time frame: 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
Self-efficacy for achieving MPOWER recommendations for the 6 target behaviors
time frame: 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
Change in self-report of the six behaviors targeted in the intervention
time frame: After 3 months and 6 months in the MPOWER program

Eligibility Criteria

Male or female participants from 12 years up to 18 years old.

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

Additional Information

Official title Novel Individually Tailored Mobile Messages to Enhance Weight Loss for Teens
Principal investigator Susan J Woolford, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Michigan.