NCT01233063

Brief Summary

The trial will test whether the Alive email-delivered health behavior program can improve subjects' physical activity, fruits and vegetables and saturated/trans fats and added sugars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
610

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

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

Study Start

First participant enrolled

October 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

1.7 years

First QC Date

October 27, 2010

Last Update Submit

August 28, 2014

Conditions

Cardiovascular DiseaseDiabetesObesityAging

Keywords

behavior changephysical activitynutritionfruits and vegetablessaturated fattrans fatadded sugarsemailwebobesityaging

Outcome Measures

Primary Outcomes (4)

  • Change in physical activity

    Change in physical activity as reported on questionnaire

    3, 6, 9, 12 months

  • Change in Fruits and Vegetables

    Change in fruits and vegetables as reported on questionnaire

    3, 6, 9, 12 months

  • Change in saturated fats

    Change in saturated fat intake as reported on questionnaire

    3, 6, 9, 12 months

  • Change in added sugar

    Change in added sugar as reported on questionnaire

    3, 6, 9, 12 months

Study Arms (3)

Alive2

EXPERIMENTAL

Lifestyle Intervention delivered via email and web

Behavioral: Physical Activity and Diet Intervention via Alive2

Alive2 plus automated phone/print

EXPERIMENTAL

All of Arm 1 components, plus biweekly tailored automated phone coaching plus monthly tailored automated print materials.

Behavioral: Physical Activity and Diet Intervention via Alive2

Control

PLACEBO COMPARATOR

Monthly emailed newsletter on other aspects of wellness, excluding diet and physical activity

Behavioral: Physical Activity and Diet Intervention via Alive2

Interventions

Physical Activity and Diet Intervention via Alive2BEHAVIORAL

Weekly email/web goal-setting intervention to improve physical activity and diet, with and without additional phone and mail support.

Alive2Alive2 plus automated phone/printControl

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 50+
  • currently employed
  • access to email/web

You may not qualify if:

  • angina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berkeley Analytics, Inc.

Berkeley, California, 94704, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Scientific Director

Study Record Dates

First Submitted

October 27, 2010

First Posted

November 3, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 29, 2014

Record last verified: 2014-08

Locations

US(1)