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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Pre-diabetes Diabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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participation in Alive-PD

Alive-PD lifestyle intervention with multi-channel delivery

Group Type EXPERIMENTAL

Alive-PD

Intervention Type BEHAVIORAL

Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support

Control

Usual care

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Placebo Control

Interventions

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Alive-PD

Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support

Intervention Type BEHAVIORAL

Usual Care

Placebo Control

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No