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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Palo Alto Medical Foundation

Information provided by (Responsible Party):

Gladys Block, Berkeley Analytics, Inc.

ClinicalTrials.gov Identifier:

NCT01479062

First received: November 22, 2011

Last updated: February 5, 2015

Last verified: February 2015

History of Changes

Purpose

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

Condition	Intervention
Pre-diabetes Diabetes Obesity	Behavioral: Alive-PD Behavioral: Usual Care


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)

Resource links provided by NLM:

MedlinePlus related topics: Health Checkup Prediabetes

U.S. FDA Resources

Further study details as provided by Berkeley Analytics, Inc.:

Primary Outcome Measures:

Change from baseline in body weight [ Time Frame: at 3 months, 6 months and one year ] [ Designated as safety issue: No ]
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
Change from baseline in diabetes risk markers [ Time Frame: at 3 months, 6 months and one year ] [ Designated as safety issue: No ]
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:

Change from baseline in physical activity and dietary factors [ Time Frame: 3 months and 12 months ] [ Designated as safety issue: No ]
Extent of change in physical activity and dietary factors as reported in questionnaires


Estimated Enrollment:	268
Study Start Date:	February 2014
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	40 Years to 79 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479062

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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Gladys Block, Principal Investigator, Berkeley Analytics, Inc.
ClinicalTrials.gov Identifier:	NCT01479062 History of Changes
Other Study ID Numbers:	1R44NR012617-01
Study First Received:	November 22, 2011
Last Updated:	February 5, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016

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