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

Berkeley Analytics

Status: Completed

Conditions: Diabetes; Pre-diabetes; Obesity

Treatments: Behavioral: Alive-PD; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01479062

1R44NR012617-01

Details and patient eligibility

About

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

Enrollment: 339 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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339 participants in 2 patient groups, including a placebo group

participation in Alive-PD

Experimental group

Description:

Alive-PD lifestyle intervention with multi-channel delivery

Treatment:

Behavioral: Alive-PD

Control

Placebo Comparator group

Description:

Usual care

Treatment:

Behavioral: Usual Care