Randomized Controlled Trial of an Online Diabetes Prevention Program
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Abstract
Background: Worldwide, 300 million adults are estimated to have pre-diabetes. One-third of U.S. adults, 79 million, have pre-diabetes, many of whom will progress to diabetes. The annual U.S. cost of diagnosed diabetes is estimated to be $245 billion. Cost-effective strategies are needed to reach millions with assistance in changing their health behaviors.
Objective: To test the effectiveness of Alive-PreventDiabetes (Alive-PD), a multichannel email-web-smartphone program to help pre-diabetics reduce their risk of progressing to diabetes by improving their physical activity, eating habits and weight.
Methods: Alive-PD was developed with the same basic behavioral principles as those used in a previously-tested behavior-change program, Alive!, shown in a randomized trial to improve diet and activity. These include tailoring, small-step goal-setting, targeted health information and social support. However, to be optimally effective, technology-based behavior-change programs need to move beyond the usual health behavior-change principles, to overcome the common problem of low engagement and dropout. In creating Alive-PD, we focused on features to increase and sustain engagement. Different learning styles are engaged through infographics, quizzes, automated phone-based coaching (IVR) and printed newsletters. Sharing with social media is enabled, and a team system promotes competition between and support within teams. A points system may be used for monetary rewards or contributions to charity. These engagement features support a program of long- and short-term goal-setting, a user-defined activity plan, diabetes-focused health information, and motivational messaging. All aspects of the program are completely automated, with low to no administrative burden.
A randomized controlled trial is being conducted by NutritionQuest in collaboration with the Palo Alto Medical Foundation Research Institute, in Palo Alto, California. The development and trial of the program are funded by the National Institute for Nursing Research. The trial began in February, 2014, with a goal of enrolling approximately 350 persons with confirmed pre-diabetes into the six-month program. Participants are randomized to Alive-PD or delayed Control. The hypothesis being tested is that persons in the Alive-PD group will significantly reduce their hemoglobin A1c and glucose compared with changes in the control group. Secondary endpoints are change in weight, lipids and blood pressure, along with change in self-reported diet and exercise. Clinic visits occur at baseline, three and six months after enrollment, with online follow-up at one year.
Results: Enrollment is still ongoing. Of the 102 enrolled so far, mean BMI is 31.5, mean fasting glucose and HbA1c are 107 mg/dL and 5.7% respectively, both in the pre-diabetic range. Data will be presented on problems, participation rates and usage of different aspects of the program. Endpoint results from the three-month visit will be reported.
Conclusions: Effective evidence-based programs capable of reaching the millions of pre-diabetics could help reduce the personal and economic costs of the diabetes epidemic. Preliminary evidence suggests that Alive-PD, and the principles it embodies, can be a major tool in this effort.
Objective: To test the effectiveness of Alive-PreventDiabetes (Alive-PD), a multichannel email-web-smartphone program to help pre-diabetics reduce their risk of progressing to diabetes by improving their physical activity, eating habits and weight.
Methods: Alive-PD was developed with the same basic behavioral principles as those used in a previously-tested behavior-change program, Alive!, shown in a randomized trial to improve diet and activity. These include tailoring, small-step goal-setting, targeted health information and social support. However, to be optimally effective, technology-based behavior-change programs need to move beyond the usual health behavior-change principles, to overcome the common problem of low engagement and dropout. In creating Alive-PD, we focused on features to increase and sustain engagement. Different learning styles are engaged through infographics, quizzes, automated phone-based coaching (IVR) and printed newsletters. Sharing with social media is enabled, and a team system promotes competition between and support within teams. A points system may be used for monetary rewards or contributions to charity. These engagement features support a program of long- and short-term goal-setting, a user-defined activity plan, diabetes-focused health information, and motivational messaging. All aspects of the program are completely automated, with low to no administrative burden.
A randomized controlled trial is being conducted by NutritionQuest in collaboration with the Palo Alto Medical Foundation Research Institute, in Palo Alto, California. The development and trial of the program are funded by the National Institute for Nursing Research. The trial began in February, 2014, with a goal of enrolling approximately 350 persons with confirmed pre-diabetes into the six-month program. Participants are randomized to Alive-PD or delayed Control. The hypothesis being tested is that persons in the Alive-PD group will significantly reduce their hemoglobin A1c and glucose compared with changes in the control group. Secondary endpoints are change in weight, lipids and blood pressure, along with change in self-reported diet and exercise. Clinic visits occur at baseline, three and six months after enrollment, with online follow-up at one year.
Results: Enrollment is still ongoing. Of the 102 enrolled so far, mean BMI is 31.5, mean fasting glucose and HbA1c are 107 mg/dL and 5.7% respectively, both in the pre-diabetic range. Data will be presented on problems, participation rates and usage of different aspects of the program. Endpoint results from the three-month visit will be reported.
Conclusions: Effective evidence-based programs capable of reaching the millions of pre-diabetics could help reduce the personal and economic costs of the diabetes epidemic. Preliminary evidence suggests that Alive-PD, and the principles it embodies, can be a major tool in this effort.
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