ObesityNCT01448551
MPOWERed Messages: Tailored Mobile Messages to Enhance Weight Loss for Teens
A study testing Tailored Mobile Messages to Enhance Weight Loss for Teens in people with Obesity, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- Tailored Mobile Messages to Enhance Weight Loss for Teens
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Tailored Mobile Messages to Enhance Weight Loss for Teens
- Keywords
- Obesity, Treatment, Adolescents, Text Messages, Mobile phones, Multidisciplinary
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Mobile Messages to Enhance Weight Loss for TeensBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Text Messaging | Experimental | Not described Receives: Behavioral: Tailored Mobile Messages to Enhance Weight Loss for Teens |
| Control | No intervention | Participation in the MPOWER program without receiving tailored text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session attendance
Measured: Over the course of 6 months
Adherence to MPOWER program homework assignments
Measured: Over the course of 6 months
Satisfaction with the MPOWER program
Measured: At the completion of 3 months and 6 months in the program
Drop out
Measured: Prior to completion of the 6 month program
Secondary outcomes (5)
Change in body mass index
Measured: After 3 months and 6 months in the MPOWER program
Objective measurement of daily participation in moderate to vigorous activity
Measured: After 3 months and 6 months in the MPOWER program
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.
Measured: 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
Intrinsic motivation will be measured using the Treatment Self-Regulation Questionnaire for Nutrition and the Treatment Self-Regulation Questionnaire for Physical Activity
Measured: After 3 months and 6 months in the MPOWER program
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)
Measured: After 3 months and 6 months in the MPOWER program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Susan J Woolford, MD, MPH, University of Michigan
- Investigators
- Susan J Woolford, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448551
- Sponsor's protocol ID
- F022685-1
- Other IDs
- 5K23HD058797-02
- Status last verified
- Dec 2016
- First submitted
- 5 Oct 2011
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Individually Tailored Mobile Messages to Enhance Weight Loss for Teens
- ClinicalTrials.gov ID
- NCT01448551
- Acronym / sponsor ID
- F022685-1
- Conditions
- Obesity
- Keywords
- Obesity, Treatment, Adolescents, Text Messages, Mobile phones, Multidisciplinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Mobile Messages to Enhance Weight Loss for TeensAlso: MPOWERed MessagesFor 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. | Behavioural | Text Messaging |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Woolford, MD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Mobile Messages to Enhance Weight Loss for Teens in people with Obesity, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session attendance (time frame: Over the course of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.