NCT02504658

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Dec 2011

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

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

February 2, 2012

Last Update Submit

July 20, 2015

Conditions

Keywords

adolescents text messages eating exercise self-efficacy diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Number of text message responses to Goal Setting Question, as a measure of Adherence

    4 weeks

Study Arms (2)

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.

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.

Behavioral: Attention Control Group

Interventions

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.

Also known as: Experimental
Text Message 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.

Also known as: Attention Control
Control Group

Eligibility Criteria

Age16 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tara M Cousineau, PHD

    BodiMojo, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2012

First Posted

July 22, 2015

Study Start

December 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations