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

Berkeley Analytics, Inc.339 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

339

Conditions

Pre-diabetes Diabetes Obesity

Interventions

Alive-PDBEHAVIORAL

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

Usual CareBEHAVIORAL

Placebo Control

Eligibility

Sex: ALLMin age: 40 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

Palo Alto Medical Foundation Research Institute

Palo Alto, California, United States

Outcomes

Primary Outcomes

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

Time frame: at 3 months, 6 months and one year

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

Time frame: at 3 months, 6 months and one year

Secondary Outcomes

Change from baseline in physical activity and dietary factors

Extent of change in physical activity and dietary factors as reported in questionnaires

Time frame: 3 months and 12 months

Data from ClinicalTrials.gov

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