NCT00790491

Brief Summary

ABSTRACT Although most primary healthcare practitioners recognize the important relationship among nutrition, physical activity and health, few incorporate either dietary or physical activity counseling into routine practice. AUGMENT will employ interactive technology to support effective patient life-style counseling during routine office visits. AUGMENT technology will automate the administration, collection, and analysis of dietary and physical activity questionnaires, and it will guide counseling and present intervention resources and strategies tailored to the patient's unique needs. Using tablet computers, wireless LANs, and inexpensive Internet communications, AUGMENT will have advantages over existing tools: 1.) Lower usage costs (minimal office personal required), 2.) Ability to customize the system, and 3.) Real-time, comprehensive assessment. The AUGMENT system efficiently and relentlessly gathers important healthcare information (such as total fat, type of fat consumption; fruit and vegetable consumption; fiber and micronutrient intake; and energy output). This means patients are less likely to have their preventive needs overlooked by a busy practitioner. The assessment includes questions to determine the amount of effort the patient will commit to improved health. This will enable the physician to effectively guide the patient via targeted recommendations, obtainable goals, and a course of action that is both preventive and prescriptive; and to monitor progress. Patients who receive objective assessments of their healthcare practices and recommendations based on their own unique health history will be more likely to accept and act on the recommendations. The specific aims of the study are to: 1) Incorporate key elements of a previously developed prototype tool into a dietary and physical activity risk assessment system, 2) Create a provider training tool to build proficiency in using AUGMENT for counseling to reduce disease risk. 3\) Validate the AUGMENT dietary and physical activity assessments using dietary recalls and accelerometer data, 4) Complete a process evaluation of the AUGMENT program by using it in interventions managed by six physicians with at least 240 patients, and 5) Survey participating providers and patients to assess acceptability of AUGMENT within a clinical setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 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

Study Start

First participant enrolled

October 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

6.1 years

First QC Date

November 11, 2008

Last Update Submit

November 6, 2013

Conditions

Keywords

reduction in risk of heart disease and diabetes

Outcome Measures

Primary Outcomes (1)

  • Validate the AUGMENT dietary and physical activity assessments using dietary recalls and accelerometer data,

    2 years

Secondary Outcomes (1)

  • Survey participating providers and patients to assess acceptability of AUGMENT within a clinical setting.

    2 years

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL
Behavioral: guidance tool for providers for lifestyle changes

Interventions

automated guidance tool for medical providers involved in patient encounters addressing lifestyle changes. Addresses dietary and physical activity. Seeks to reduce cardiac disease risk.

Lifestyle counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients at Staywell Community Health Center, Waterbury CT

You may not qualify if:

  • terminally ill
  • pregnant women
  • children
  • decisionally impaired / dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greater Waterbury Management Resources and Family Care

Waterbury, Connecticut, 06702, United States

Location

MeSH Terms

Conditions

Heart DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

October 1, 2007

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations