Mobile Motivation for Health Promotion Among Adolescents

Diabetes Clinical Trial

— BodiMojo  

Official title:

Mobile Motivation for Health Promotion Among Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504658
• Other study ID #: BodiMojo-R43DK085748
• Secondary ID: 1R43DK085748-01A
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2012
• Last updated: July 20, 2015
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2015
• Source: BodiMojo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 22 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Lifestyle text messages
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 Group
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.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
BodiMojo, Inc.	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)?"	4 weeks	No
Secondary	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]	4 weeks	No

External Links

•   BodiMojo - Health Promotion portal for teens
•   Joslin Diabetes Center