Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.

Condition or disease	Intervention/treatment	Phase
Pre-diabetes; Diabetes; Obesity	Behavioral: Alive-PD; Behavioral: Usual Care	Not Applicable

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	339 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)
Study Start Date :	February 2014
Actual Primary Completion Date :	June 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: participation in Alive-PD; Alive-PD lifestyle intervention with multi-channel delivery	Behavioral: Alive-PD; Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support
Placebo Comparator: Control; Usual care	Behavioral: Usual Care; Placebo Control

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change from baseline in body weight [ Time Frame: at 3 months, 6 months and one year ]
   Mean weight loss and the proportion of subjects who achieve a 5% body weight loss at 3 and 6 months and maintain at 12 months
2. Change from baseline in diabetes risk markers [ Time Frame: at 3 months, 6 months and one year ]
   Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic at 3 and 6 months and maintain at 12 months

Secondary Outcome Measures :

1. Change from baseline in physical activity and dietary factors [ Time Frame: 3 months and 12 months ]
   Extent of change in physical activity and dietary factors as reported in questionnaires

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• at least one measurement in past 2 yrs of fasting plasma glucose of 100-125 mg/dl or impaired glucose tolerance
• at least one measurement of body mass index (BMI) >=27 in the past two years
• age 40-79
• no use of diabetes medications within the past two years
• member of Kaiser Permanente of Northern California (KPNC) for at least 2 years
• live in a 25 mile radius of the KPNC Research Clinic in Oakland, CA

Exclusion Criteria:

• comorbidities that would contraindicate the gradual adoption of light/moderate physical activity, such as a recent cardiovascular event, severe chronic obstructive pulmonary disease, advanced arthritis, or poorly controlled hypertension

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94301

Sponsors and Collaborators

Berkeley Analytics, Inc.

Palo Alto Medical Foundation

Investigators

Principal Investigator:	Gladys Block, PhD	Berkeley Analytics, Inc.

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Block G, Azar KM, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, Dolginsky MS, Hudes ML, Palaniappan LP, Block CH. Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes. J Med Internet Res. 2015 Oct 23;17(10):e240. doi: 10.2196/jmir.4897.

Other Publications:

Block G, Azar KM, Block TJ, Romanelli RJ, Carpenter H, Hopkins D, Palaniappan L, Block CH. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol. JMIR Res Protoc. 2015 Jan 21;4(1):e3. doi: 10.2196/resprot.4046.

Responsible Party:	Gladys Block, Principal Investigator, Berkeley Analytics, Inc.
ClinicalTrials.gov Identifier:	NCT01479062 History of Changes
Other Study ID Numbers:	1R44NR012617-01 ( U.S. NIH Grant/Contract )
First Posted:	November 24, 2011
Last Update Posted:	January 18, 2018
Last Verified:	July 2016

Keywords provided by Gladys Block, Berkeley Analytics, Inc.:

behavior change; pre-diabetes; prevention; diabetes prevention; Hemoglobin A1c; glucose	physical activity; nutrition; email; web; obesity

Additional relevant MeSH terms:

Diabetes Mellitus; Prediabetic State; Glucose Intolerance; Glucose Metabolism Disorders	Metabolic Diseases; Endocrine System Diseases; Hyperglycemia