DiabetesPhase 1BodiMojoNCT02504658
Mobile Motivation for Health Promotion Among Adolescents
A Phase 1 study testing Lifestyle text messages in people with Diabetes, run by BodiMojo, Inc. at 1 site in United States.
Trial summary
This 4-week pilot study is designed to test the feasibility, adherence, and effectiveness of a cell phone text message program for lifestyle goal setting among adolescents with type 1 or type 2 diabetes. The study entails a small-scale randomized controlled trial with pre-post test of a mobile text message program. Read more about this study
- Who is it for?
- Ages 16 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Lifestyle text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Apr 2012
- Phase
- Phase 1
- 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 16 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 16-21 years
- Diagnosis of type 1 or type 2 diabetes
- Ownership of a cell phone that supports text messaging
- Intention for continued follow-up care at Joslin
- English-speaking
Who cannot join
- Current participation in another intervention study or participation in an intervention study in the past 3 months
- Significant developmental or cognitive disorder in the participant that would prevent full participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
This 4-week pilot study is designed to test the feasibility, adherence, and effectiveness of a cell phone text message program for lifestyle goal setting among adolescents with type 1 or type 2 diabetes. The study entails a small-scale randomized controlled trial with pre-post test of a mobile text message program.
Read the detailed description
Adolescents with diabetes are a complex target group for health prevention initiatives for a number of developmental reasons, such as drive for autonomy, lack of acknowledgement of long term effects of unhealthy behavior, and high frequency of sedentary behaviors and poor diets (Arnett, 2007). Developing interventions that adolescents find appealing and acceptable is a challenge. An emerging health area referred to as "mobile health" has begun to address these issues by developing innovative uses of basic mobile technologies (Vital Wave/United Nations Foundation, 2009). A recent review of 14 studies, most related to diabetes management (n=10) and preventive behaviors, suggests that mobile phone-delivered interventions have positive short-term behavioral outcomes (Fjedshoe et al., 2009). A number of obesity prevention studies with adults have informed the use of mobile features (e.g., tailored messages or visual display of goal progress) and include mobile applications for adult weight loss (Patrick et al., 2009) and physical activity monitoring for women (Consolvo et al., 2008). Studies targeting children are few. However, one randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes, reported some success (Franklin et al., 2006). In a randomized controlled trial, 126 children with type 1 diabetes were allocated to either conventional insulin therapy, conventional therapy and Sweet Talk (the text message program), or intensive insulin therapy and Sweet Talk. Text messages were tailored to patient's age, sex, and insulin regimen. Compared to conventional treatments, automatic daily text messages (info, tips, support) with weekly reminders about personal goals increased self-efficacy and adherence to diabetes management; overall acceptance rates of Sweet Talk were high (82% felt the program improved self-care; 90% wanted to continue receiving messages). Studies such as these prompted the development of BodiMojo, a mobile phone health application to address healthy nutrition, physical activity, and positive body image. BodiMojo will be tested in the current study with up to 90 adolescents with diabetes to determine feasibility and adherence to lifestyle goals, and to examine changes in self-efficacy. It is hypothesized that the experimental participants will report higher self-efficacy for healthy eating and physical activity, and greater adherence to lifestyle goals, compared to control participants. It is also anticipated that the study procedure, design, and intervention will be found to be feasible. In addition, our group at Joslin has previous experience utilizing text message reminders in adolescents and young adults with type 1 diabetes and demonstrated its acceptability and ease of use (Hanauer, 2006).
Ninety adolescents with diabetes will be recruited to participate in an RCT with a pre- and post-test design to assess feasibility, self-efficacy, and adherence to goal setting. Following informed consent, participants will be randomized to the intervention group or control group and followed for 4 weeks.
- Conditions
- Diabetes
- Being tested
- Lifestyle text messages, Attention Control Group
- Keywords
- adolescents text messages eating exercise self-efficacy diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle text messagesBehavioural
Also called Experimental
Throughout the course of the four-week study, the experimental participants will receive one text message each morning related to general nutrition and exercise goals, and an additional "goal status update message" on Monday, Wednesday, and Friday evenings. The goal status update message will ask the participants about the status of attaining their nutrition or physical activity goals. Participants may log their progress toward attaining their goals by using the mobile health dashboard feature on BodiMojo.com from a computer or a web-enabled smartphone to indicate their goal status ("still working on it" or "completed it"). Participants will be encouraged, via the text messages, to look at information on the BodiMojo program found on the Bodimojo.com website.
Attention Control GroupBehavioural
Also called Attention Control
Once participants randomized to the control group have completed the baseline assessment, they will be asked to write down two health goals with the RA. The same goals will be suggested for this group as for the Intervention group (see Appendix). They will take home a copy of the goals they have set. The participants will be also given a 16-page pamphlet from NIDDK "A Guide for Teenagers: Take Charge of Your Health!" to take home to read over.
| Study group | Role | What they receive |
|---|---|---|
| Text Message Group | Experimental | Subjects will set 2 lifestyle goals (exercise and nutrition) and receive health tips and goal status check in messages over 1 month. Receives: Behavioral: Lifestyle text messages |
| Control Group | Active comparator | The control subjects will set 2 lifestyle goals and receive a educational booklet to review.They will take home a copy of the goals they have set. The participants will be also given a 16-page pamphlet from NIDDK "A Guide for Teenagers: Take Charge of Your Health!" to take home to read over. The approximate procedure time will be 20-25 minutes. Receives: Behavioral: Attention Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Self-Efficacy Score on the Physical Activity and Healthy Food Efficacy Scale for Children
The Physical Activity and Healthy Food Efficacy Scale for Children (PAHFE, Perry et al., 2008) is an 18-item instrument designed to assess personal goal-setting self-efficacy and decision-making self-efficacy for physical activity and healthy food choices. This questionnaire was previously used in over 200 adolescents by the co-investigators. An example question is "How sure are you that you can set goals for yourself to eat healthy foods (like fruit \& vegetables)?"
Measured: 4 weeks
Secondary outcomes (1)
Number of text message responses to Goal Setting Question, as a measure of Adherence
Adherence will be measured by the frequency of positive or negative responses on status update messages, e.g. "Did you meet your goal today?" [Ans: yes/no]
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startDec 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- BodiMojo, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tara M Cousineau, PHD, Principal investigator, BodiMojo, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504658
- Sponsor's protocol ID
- BodiMojo-R43DK085748
- Other IDs
- 1R43DK085748-01A1
- Acronym
- BodiMojo
- Status last verified
- Jul 2015
- First submitted
- 2 Feb 2012
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Motivation for Health Promotion Among Adolescents
- ClinicalTrials.gov ID
- NCT02504658
- Acronym / sponsor ID
- BodiMojo / BodiMojo-R43DK085748
- Conditions
- Diabetes
- Keywords
- adolescents text messages eating exercise self-efficacy diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- BodiMojo, Inc.University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Jul 2015 (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.
This 4-week pilot study is designed to test the feasibility, adherence, and effectiveness of a cell phone text message program for lifestyle goal setting among adolescents with type 1 or type 2 diabetes. The study entails a small-scale randomized controlled trial with pre-post test of a mobile text message program.
Detailed description
Adolescents with diabetes are a complex target group for health prevention initiatives for a number of developmental reasons, such as drive for autonomy, lack of acknowledgement of long term effects of unhealthy behavior, and high frequency of sedentary behaviors and poor diets (Arnett, 2007). Developing interventions that adolescents find appealing and acceptable is a challenge. An emerging health area referred to as "mobile health" has begun to address these issues by developing innovative uses of basic mobile technologies (Vital Wave/United Nations Foundation, 2009). A recent review of 14 studies, most related to diabetes management (n=10) and preventive behaviors, suggests that mobile phone-delivered interventions have positive short-term behavioral outcomes (Fjedshoe et al., 2009). A number of obesity prevention studies with adults have informed the use of mobile features (e.g., tailored messages or visual display of goal progress) and include mobile applications for adult weight loss (Patrick et al., 2009) and physical activity monitoring for women (Consolvo et al., 2008). Studies targeting children are few. However, one randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes, reported some success (Franklin et al., 2006). In a randomized controlled trial, 126 children with type 1 diabetes were allocated to either conventional insulin therapy, conventional therapy and Sweet Talk (the text message program), or intensive insulin therapy and Sweet Talk. Text messages were tailored to patient's age, sex, and insulin regimen. Compared to conventional treatments, automatic daily text messages (info, tips, support) with weekly reminders about personal goals increased self-efficacy and adherence to diabetes management; overall acceptance rates of Sweet Talk were high (82% felt the program improved self-care; 90% wanted to continue receiving messages). Studies such as these prompted the development of BodiMojo, a mobile phone health application to address healthy nutrition, physical activity, and positive body image. BodiMojo will be tested in the current study with up to 90 adolescents with diabetes to determine feasibility and adherence to lifestyle goals, and to examine changes in self-efficacy. It is hypothesized that the experimental participants will report higher self-efficacy for healthy eating and physical activity, and greater adherence to lifestyle goals, compared to control participants. It is also anticipated that the study procedure, design, and intervention will be found to be feasible. In addition, our group at Joslin has previous experience utilizing text message reminders in adolescents and young adults with type 1 diabetes and demonstrated its acceptability and ease of use (Hanauer, 2006).
Ninety adolescents with diabetes will be recruited to participate in an RCT with a pre- and post-test design to assess feasibility, self-efficacy, and adherence to goal setting. Following informed consent, participants will be randomized to the intervention group or control group and followed for 4 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Message Group | Experimental | Behavioral: Lifestyle text messagesSubjects will set 2 lifestyle goals (exercise and nutrition) and receive health tips and goal status check in messages over 1 month. |
| Control Group | Active comparator | Behavioral: Attention Control GroupThe control subjects will set 2 lifestyle goals and receive a educational booklet to review.They will take home a copy of the goals they have set. The participants will be also given a 16-page pamphlet from NIDDK "A Guide for Teenagers: Take Charge of Your Health!" to take home to read over. The approximate procedure time will be 20-25 minutes. |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Ages 16-21 years
- Diagnosis of type 1 or type 2 diabetes
- Ownership of a cell phone that supports text messaging
- Intention for continued follow-up care at Joslin
- English-speaking
Key exclusion criteria (2 listed)
- Current participation in another intervention study or participation in an intervention study in the past 3 months
- Significant developmental or cognitive disorder in the participant that would prevent full participation in the study
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 |
|---|---|---|
| Lifestyle text messagesAlso: ExperimentalThroughout the course of the four-week study, the experimental participants will receive one text message each morning related to general nutrition and exercise goals, and an additional "goal status update message" on Monday, Wednesday, and Friday evenings. The goal status update message will ask the participants about the status of attaining their nutrition or physical activity goals. Participants may log their progress toward attaining their goals by using the mobile health dashboard feature on BodiMojo.com from a computer or a web-enabled smartphone to indicate their goal status ("still working on it" or "completed it"). Participants will be encouraged, via the text messages, to look at information on the BodiMojo program found on the Bodimojo.com website. | Behavioural | Text Message Group |
| Attention Control GroupAlso: Attention ControlOnce participants randomized to the control group have completed the baseline assessment, they will be asked to write down two health goals with the RA. The same goals will be suggested for this group as for the Intervention group (see Appendix). They will take home a copy of the goals they have set. The participants will be also given a 16-page pamphlet from NIDDK "A Guide for Teenagers: Take Charge of Your Health!" to take home to read over. | Behavioural | Control Group |
Primary outcome
Total Self-Efficacy Score on the Physical Activity and Healthy Food Efficacy Scale for Children
Time frame: 4 weeks
The Physical Activity and Healthy Food Efficacy Scale for Children (PAHFE, Perry et al., 2008) is an 18-item instrument designed to assess personal goal-setting self-efficacy and decision-making self-efficacy for physical activity and healthy food choices. This questionnaire was previously used in over 200 adolescents by the co-investigators. An example question is "How sure are you that you can set goals for yourself to eat healthy foods (like fruit \& vegetables)?"
1 secondary outcome
Number of text message responses to Goal Setting Question, as a measure of Adherence
Time frame: 4 weeks
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 22 Jul 2015.
- BodiMojo - Health Promotion portal for teensLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Tara M Cousineau, PHD principal investigator
BodiMojo, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lifestyle text messages in people with Diabetes, run by BodiMojo, Inc. 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 5 inclusion and 2 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 22 Jul 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total Self-Efficacy Score on the Physical Activity and Healthy Food Efficacy Scale for Children (time frame: 4 weeks). 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 22 Jul 2015.