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Completed

NCT Number: NCT01479062

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

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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Key information

Conditions

Pre-diabetes Behavior Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alive-PD

Behavioral

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

Usual Care

Behavioral

Placebo Control

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Berkeley Analytics, Inc.

Industry

Collaborators

  • Palo Alto Medical Foundation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2011
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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