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

Primary Purpose

Pre-diabetes, Diabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alive-PD
Usual Care
Sponsored by
Berkeley Analytics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring behavior change, pre-diabetes, prevention, diabetes prevention, Hemoglobin A1c, glucose, physical activity, nutrition, email, web, obesity

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Palo Alto Medical Foundation Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

participation in Alive-PD

Control

Arm Description

Alive-PD lifestyle intervention with multi-channel delivery

Usual care

Outcomes

Primary Outcome Measures

Change from baseline in body weight
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
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
Extent of change in physical activity and dietary factors as reported in questionnaires

Full Information

First Posted
November 22, 2011
Last Updated
January 16, 2018
Sponsor
Berkeley Analytics, Inc.
Collaborators
Palo Alto Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01479062
Brief Title
Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics
Official Title
Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Berkeley Analytics, Inc.
Collaborators
Palo Alto Medical Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes, Diabetes, Obesity
Keywords
behavior change, pre-diabetes, prevention, diabetes prevention, Hemoglobin A1c, glucose, physical activity, nutrition, email, web, obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
participation in Alive-PD
Arm Type
Experimental
Arm Description
Alive-PD lifestyle intervention with multi-channel delivery
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Alive-PD
Intervention Description
Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Placebo Control
Primary Outcome Measure Information:
Title
Change from baseline in body weight
Description
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
Time Frame
at 3 months, 6 months and one year
Title
Change from baseline in diabetes risk markers
Description
Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic at 3 and 6 months and maintain at 12 months
Time Frame
at 3 months, 6 months and one year
Secondary Outcome Measure Information:
Title
Change from baseline in physical activity and dietary factors
Description
Extent of change in physical activity and dietary factors as reported in questionnaires
Time Frame
3 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gladys Block, PhD
Organizational Affiliation
Berkeley Analytics, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Medical Foundation Research Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25608692
Citation
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.
Results Reference
background
PubMed Identifier
26499966
Citation
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.
Results Reference
result

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

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