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

Not Applicable

Completed

• Conditions: Diabetes; Pre-diabetes; Obesity
• Interventions: Behavioral: Alive-PD; Behavioral: Usual Care

• Registration Number: NCT01479062
• Lead Sponsor: Berkeley Analytics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-23
• Study First Posted: 2011-11-24
• Study Start: 2014-02
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
participation in Alive-PD	Alive-PD	Alive-PD lifestyle intervention with multi-channel delivery
Control	Usual Care	Usual care

Primary Outcome Measures

Name	Time	Method
Change from baseline in diabetes risk markers	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
Change from baseline in body weight	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in physical activity and dietary factors	3 months and 12 months	Extent of change in physical activity and dietary factors as reported in questionnaires

Trial Locations

Locations (1)

Palo Alto Medical Foundation Research Institute; 🇺🇸 Palo Alto, California, United States