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

Study Overview
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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.

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

Conditions
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Obesity, Pre-diabetes, Diabetes

Intervention / Treatment
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* Behavioral: Alive-PD
* Behavioral: Usual Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participation in Alive-PD<br>Alive-PD lifestyle intervention with multi-channel delivery | Behavioral: Alive-PD<br>* Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support<br>|
| Placebo Comparator: Control<br>Usual care | Behavioral: Usual Care<br>* Placebo Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavior change, pre-diabetes, prevention, diabetes prevention, Hemoglobin A1c, glucose, physical activity, nutrition, email, web, obesity