West Virginia WISEWOMAN Pilot Study to Test a Brief Nutri... | NCT00153413

Studies
West Virginia WISEWOMAN Pilot Study to Test a Brief Nutrition Intervention

NCT00153413

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Aug 2, 2024Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Heart Disease
Blood Pressure
Obesity

Interventions

Cookin' Up Health

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U58/CCU322798-01	Other Grant/Funding Number	CDC

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Jul 2003Actual

Completion Date

Dec 2003Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2024

Last Update Posted Date

Aug 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Detailed Description

To test whether a brief, interactive, computer-based nutrition intervention (Cookin' Up Health)impacts various health outcomes

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Receive Cookin' Up Health, a nutrition intervention	Behavioral: Cookin' Up Health

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cookin' Up Health	Behavioral	A brief nutrition intervention designed to improve dietary habits	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Servings of fruits and vegetables	Based on food frequency questionnaire	3 months

Secondary Outcomes

Measure	Description	Time Frame
Ability to read food labels	Knowledge questions	3 months
Readiness to eat 5 fruits and vegetables per day	Based on Prochaska and DeClemente

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NBCCEDP
Aged 40-64
Attends selected rural clinics

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie Will	Centers for Disease Control and Prevention	Study Chair

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34670680	Background	Santos L. The impact of nutrition and lifestyle modification on health. Eur J Intern Med. 2022 Mar;97:18-25. doi: 10.1016/j.ejim.2021.09.020. Epub 2021 Oct 17.

ID	Term
D006331	Heart Diseases
D009765	Obesity

ID	Term
D002318	Cardiovascular Diseases
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics