Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics
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ClinicalTrials.gov Identifier: NCT01479062 |
Recruitment Status
:
Completed
First Posted
: November 24, 2011
Last Update Posted
: January 18, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pre-diabetes Diabetes Obesity | Behavioral: Alive-PD Behavioral: Usual Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 339 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD) |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | December 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: participation in Alive-PD
Alive-PD lifestyle intervention with multi-channel delivery
|
Behavioral: Alive-PD
Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support
|
Placebo Comparator: Control
Usual care
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Behavioral: Usual Care
Placebo Control
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- Change from baseline in body weight [ Time Frame: 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
- Change from baseline in diabetes risk markers [ Time Frame: 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 physical activity and dietary factors [ Time Frame: 3 months and 12 months ]Extent of change in physical activity and dietary factors as reported in questionnaires

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Ages Eligible for Study: | 40 Years to 79 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479062
United States, California | |
Palo Alto Medical Foundation Research Institute | |
Palo Alto, California, United States, 94301 |
Principal Investigator: | Gladys Block, PhD | Berkeley Analytics, Inc. |
Publications of Results:
Other Publications:
Responsible Party: | Gladys Block, Principal Investigator, Berkeley Analytics, Inc. |
ClinicalTrials.gov Identifier: | NCT01479062 History of Changes |
Other Study ID Numbers: |
1R44NR012617-01 ( U.S. NIH Grant/Contract ) |
First Posted: | November 24, 2011 Key Record Dates |
Last Update Posted: | January 18, 2018 |
Last Verified: | July 2016 |
Keywords provided by Gladys Block, Berkeley Analytics, Inc.:
behavior change pre-diabetes prevention diabetes prevention Hemoglobin A1c glucose |
physical activity nutrition web obesity |
Additional relevant MeSH terms:
Diabetes Mellitus Prediabetic State Glucose Intolerance Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperglycemia |