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

Obesity Clinical Trial

Official title:

Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479062
• Other study ID #: 1R44NR012617-01
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: January 16, 2018
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Berkeley Analytics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Glucose Intolerance
• Obesity
• Pre-diabetes
• Prediabetic State

Intervention

Behavioral:
• Alive-PD
Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support
• Usual Care
Placebo Control

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation Research Institute	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Berkeley Analytics, Inc.	Palo Alto Medical Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 Controlle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 3 months, 6 months and one year
Primary	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	at 3 months, 6 months and one year
Secondary	Change from baseline in physical activity and dietary factors	Extent of change in physical activity and dietary factors as reported in questionnaires	3 months and 12 months