NCT01448551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

4 years

First QC Date

October 5, 2011

Last Update Submit

December 20, 2016

Conditions

Keywords

ObesityTreatmentAdolescentsText MessagesMobile phonesMultidisciplinary

Outcome Measures

Primary Outcomes (4)

  • Session attendance

    Over the course of 6 months

  • Adherence to MPOWER program homework assignments

    Over the course of 6 months

  • Satisfaction with the MPOWER program

    At the completion of 3 months and 6 months in the program

  • Drop out

    Prior to completion of the 6 month program

Secondary Outcomes (5)

  • Change in body mass index

    After 3 months and 6 months in the MPOWER program

  • Objective measurement of daily participation in moderate to vigorous activity

    After 3 months and 6 months in the MPOWER program

  • Self-efficacy for achieving MPOWER recommendations for the 6 target behaviors

    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

    After 3 months and 6 months in the MPOWER program

  • Change in self-report of the six behaviors targeted in the intervention

    After 3 months and 6 months in the MPOWER program

Study Arms (2)

Text Messaging

EXPERIMENTAL
Behavioral: Tailored Mobile Messages to Enhance Weight Loss for Teens

Control

NO INTERVENTION

Participation in the MPOWER program without receiving tailored text messages

Interventions

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.

Also known as: MPOWERed Messages
Text Messaging

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susan J Woolford, MD, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 7, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 21, 2016

Record last verified: 2016-12

Locations