SBIR-STTR Award

Significance: Almost 30% of U.S. adults have pre-diabetes. Without weight loss and changes in physical activity and diet, more than 50% of them will eventually develop type 2 diabetes (T2DM), with its increased risk of cardiovascular disease and many other complications. The Diabetes Prevention Program (DPP) proved that lifestyle changes involving weight loss, increased physical activity and dietary changes can delay or prevent the onset of T2DM in pre-diabetics. However, intensive interventions like DPP are expensive (DPP: $1,399/person) and demanding of both patient and professional time. As a result, despite the critical need to prevent progression to T2DM, prevention programs have not been embodied in effective, low-cost, real-world interventions that can assist millions of pre-diabetics. Objectives: The overall goal of this fast-track proposal is to produce a commercializable product aimed at changing physical activity, diet and weight loss behaviors of pre-diabetics. The specific aims are to 1) Adapt an existing successful email/Internet wellness program to focus on prediabetics;2) Conduct a randomized trial of effectiveness in changing weight, glucose and physical activity in pre-diabetics;3) Provide data on cost and participation, for commercialization and future phase 3 trials. Methods: ""Alive"" is an email-delivered intervention to improve physical activity and diet, developed through an R01 to Kaiser Permanente. In a randomized controlled trial, Alive significantly improved all of its target behaviors. The latest version, through an SBIR grant, has added automated tailored print and phone counseling, social networking and a substantial emphasis on weight control. Alive will now be modified to focus on pre-diabetes and the behaviors required for its effective control. The modified program will be delivered over I year through 3 channels (email/internet, phone, print), and will use computerized algorithms to deliver highly individualized weekly goal-setting and motivational support. In the clinical trial, pre-diabetics will be identified through the Kaiser Permanente member database. At clinic visits at baseline, 3 and 12 months, weight and measures of glycemic control will be obtained. Subjects will be randomly assigned to the modified program, Alive-PD, or a control condition representing usual care of pre-diabetics. There is statistical power to detect a clinically meaningful difference between the two groups in weight loss and glycemic control (A1c). Effectiveness, proportion reached, participation and cost will be reported. Impact: A low-cost program such as this could reach thousands or millions of prediabetics with a behavior- change intervention, at a fraction of the cost of in-person or group approaches. If proven effective at improving weight loss and glycemic control in a randomized trial, it could become an important component of the standard of care for prediabetics as a stand-alone service, as a complement to pre-diabetes education classes, and as an important reinforcer of physician and nurse practitioner recommendations.

Public Health Relevance:
Pre-diabetes affects almost 30% of U.S. adults, many of whom will progress to type 2 diabetes unless they lose weight and increase their physical activity. Currently, effective interventions are expensive and burdensome. This project will modify and test an effective program that could be widely used to help pre-diabetics lose weight and be more active and prevent the progression to diabetes.

Thesaurus Terms:
21+ Years Old;Adult;Adult Human;Adult-Onset Diabetes Mellitus;Advisory Committees;Affect;Algorithms;Behavior;Behavioral;Body Weight Changes;Body Weight Decreased;Cdc;Centers For Disease Control;Centers For Disease Control And Prevention;Centers For Disease Control And Prevention (U.S.);Client;Clinic Visits;Complement;Complement Proteins;Control Groups;Counseling;D-Glucose;Data;Data Banks;Data Bases;Databanks;Databases;Dextrose;Diabetes Mellitus;Diet;E-Mail;Effectiveness;Electronic Databank;Electronic Database;Electronic Mail;Elements;Email;Expenditure;Feedback;Focus Groups;Future;Glucose;Goals;Grant;Health Behavior;Internet;Intervention;Intervention Strategies;Investigators;Ketosis-Resistant Diabetes Mellitus;Life Style;Lifestyle;Mody;Maturity-Onset Diabetes Mellitus;Measures;Medical Care Costs;Methods;Modification;Niddm;Non-Insulin Dependent Diabetes;Non-Insulin-Dependent Diabetes Mellitus;Noninsulin Dependent Diabetes Mellitus;Nurse Practitioners;Participant;Patients;Persons;Phase;Phase 3 Clinical Trials;Phase Iii Clinical Trials;Phone;Physical Activity;Physicians;Prediabetes;Prediabetes Syndrome;Prediabetic State;Prevention Program;Printing;Process;Randomized;Randomized Controlled Trials;Recommendation;Recruitment Activity;Reporting;Research;Research Personnel;Researchers;Sbir;Sbirs (R43/44);Sampling;Services;Slow-Onset Diabetes Mellitus;Small Business Innovation Research;Small Business Innovation Research Grant;Social Network;Solutions;Stable Diabetes Mellitus;T2 Dm;T2d;T2dm;Task Forces;Telephone;Testing;Time;Type 2 Diabetes Mellitus;Type 2 Diabetes;Type Ii Diabetes Mellitus;Type Ii Diabetes;United States Centers For Disease Control;United States Centers For Disease Control And Prevention;Www;Weight;Weight Change;Weight Gain;Weight Increase;Weight Loss;Weight Reduction;Weight Maintenance Regimen;Weights And Measures;Wellness Program;Adult Human (21+);Adult Onset Diabetes;Adulthood;Base;Behavior Change;Body Weight Gain;Body Weight Increase;Body Weight Loss;Cardiovascular Disease Risk;Cardiovascular Disorder Risk;Clinical Data Repository;Commercialization;Compare Effectiveness;Computerized;Cost;Cost Effectiveness;Data Repository;Diabetes;Diabetes Education;Diabetes Prevention Program;Diabetic;Effective Intervention;Glycemic Control;Improved;Interventional Strategy;Ketosis Resistant Diabetes;Life Style Intervention;Lifestyle Intervention;Maturity Onset Diabetes;Member;Phase 3 Trial;Phase Iii Protocol;Phase Iii Trial;Pre-Clinical Study;Pre-Clinical Trial;Pre-Diabetes;Preclinical Study;Preclinical Trial;Prevent;Preventing;Programs;Randomisation;Randomization;Randomized Controlled Study;Randomized Trial;Randomly Assigned;Recruit;Reinforcer;Standard Care;Standard Of Care;Standard Treatment;Syndrome X;Tool;Treatment As Usual;Type 2 Dm;Type Ii Dm;Usual Care;Web;Weight Control;World Wide Web;Wt Gain;Wt-Loss

Significance: Almost 30% of U.S. adults have pre-diabetes. Without weight loss and changes in physical activity and diet, more than 50% of them will eventually develop type 2 diabetes (T2DM), with its increased risk of cardiovascular disease and many other complications. The Diabetes Prevention Program (DPP) proved that lifestyle changes involving weight loss, increased physical activity and dietary changes can delay or prevent the onset of T2DM in pre-diabetics. However, intensive interventions like DPP are expensive (DPP: $1,399/person) and demanding of both patient and professional time. As a result, despite the critical need to prevent progression to T2DM, prevention programs have not been embodied in effective, low-cost, real-world interventions that can assist millions of pre-diabetics. Objectives: The overall goal of this fast-track proposal is to produce a commercializable product aimed at changing physical activity, diet and weight loss behaviors of pre-diabetics. The specific aims are to 1) Adapt an existing successful email/Internet wellness program to focus on prediabetics;2) Conduct a randomized trial of effectiveness in changing weight, glucose and physical activity in pre-diabetics;3) Provide data on cost and participation, for commercialization and future phase 3 trials. Methods: ""Alive"" is an email-delivered intervention to improve physical activity and diet, developed through an R01 to Kaiser Permanente. In a randomized controlled trial, Alive significantly improved all of its target behaviors. The latest version, through an SBIR grant, has added automated tailored print and phone counseling, social networking and a substantial emphasis on weight control. Alive will now be modified to focus on pre-diabetes and the behaviors required for its effective control. The modified program will be delivered over I year through 3 channels (email/internet, phone, print), and will use computerized algorithms to deliver highly individualized weekly goal-setting and motivational support. In the clinical trial, pre-diabetics will be identified through the Kaiser Permanente member database. At clinic visits at baseline, 3 and 12 months, weight and measures of glycemic control will be obtained. Subjects will be randomly assigned to the modified program, Alive-PD, or a control condition representing usual care of pre-diabetics. There is statistical power to detect a clinically meaningful difference between the two groups in weight loss and glycemic control (A1c). Effectiveness, proportion reached, participation and cost will be reported. Impact: A low-cost program such as this could reach thousands or millions of prediabetics with a behavior- change intervention, at a fraction of the cost of in-person or group approaches. If proven effective at improving weight loss and glycemic control in a randomized trial, it could become an important component of the standard of care for prediabetics as a stand-alone service, as a complement to pre-diabetes education classes, and as an important reinforcer of physician and nurse practitioner recommendations.