NCT01479062

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
2.2 years until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 18, 2018

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

November 22, 2011

Last Update Submit

January 16, 2018

Conditions

Pre-diabetesDiabetesObesity

Keywords

behavior changepre-diabetespreventiondiabetes preventionHemoglobin A1cglucosephysical activitynutritionemailwebobesity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Change from baseline in physical activity and dietary factors

    3 months and 12 months

Study Arms (2)

participation in Alive-PD

EXPERIMENTAL

Alive-PD lifestyle intervention with multi-channel delivery

Behavioral: Alive-PD

Control

PLACEBO COMPARATOR

Usual care

Behavioral: Usual Care

Interventions

Alive-PDBEHAVIORAL

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

participation in Alive-PD
Usual CareBEHAVIORAL

Placebo Control

Control

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Location

Related Publications (2)

  • Block G, Azar KM, Block TJ, Romanelli RJ, Carpenter H, Hopkins D, Palaniappan L, Block CH. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol. JMIR Res Protoc. 2015 Jan 21;4(1):e3. doi: 10.2196/resprot.4046.

    PMID: 25608692BACKGROUND

  • Block G, Azar KM, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, Dolginsky MS, Hudes ML, Palaniappan LP, Block CH. Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes. J Med Internet Res. 2015 Oct 23;17(10):e240. doi: 10.2196/jmir.4897.

    PMID: 26499966RESULT

MeSH Terms

Conditions

Glucose IntoleranceDiabetes MellitusObesityMotor Activity

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Gladys Block, PhD

    Berkeley Analytics, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 24, 2011

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

January 18, 2018

Record last verified: 2016-07

Locations

US(1)