Clinical trial NCT02504658: Mobile Motivation for Health Promotion Among Adolescents
Official title: Mobile Motivation for Health Promotion Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: adolescents text messages eating exercise self-efficacy diabetes
Lead sponsor: BodiMojo, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-07-22
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Self-Efficacy Score on the Physical Activity and Healthy Food Efficacy Scale for Children
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of text message responses to Goal Setting Question, as a measure of Adherence
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: BodiMojo, Inc.
name: Tara M Cousineau, PHD
role: PRINCIPAL_INVESTIGATOR
References: