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Clinical Trials/NCT05750407
NCT05750407
Completed
N/A

Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

California Polytechnic State University-San Luis Obispo2 sites in 1 country15 target enrollmentMay 15, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diet, Healthy
Sponsor
California Polytechnic State University-San Luis Obispo
Enrollment
15
Locations
2
Primary Endpoint
Perceived acceptability of treatment score
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this pilot study is to examine the feasibility and acceptability of brief lifestyle intervention modules designed to promote healthy eating, activity, and weight control for pregnant and postpartum clients receiving care as part of evidence-based home visiting.

Detailed Description

The purpose of this pilot study is to examine the feasibility and acceptability of brief lifestyle intervention modules designed to promote healthy eating, activity, and weight control behaviors for pregnant and postpartum clients receiving care as part of evidence-based home visiting. A 6 week, pre-post test of evidence-based home visiting (usual care) plus three lifestyle intervention modules (eating, activity, tracking) will be conducted at two sites (California and Rhode Island). Three, 10 minute intervention modules will target healthy eating, activity, and self-monitoring of weight and diet. Pregnant and postpartum clients (N =20) in home visiting programs will be recruited over 2 months and evaluated at baseline and after 6 weeks. Home visitors will participate in one training session and deliver the intervention content during three visits over 6 weeks. Quantitative data from will inform feasibility of lifestyle intervention within evidence-based home visiting. Findings will inform the cardiovascular health intervention and study protocol for a full scale trial.

Registry
clinicaltrials.gov
Start Date
May 15, 2023
End Date
July 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
California Polytechnic State University-San Luis Obispo
Responsible Party
Principal Investigator
Principal Investigator

Suzanne Phelan

Professor of Kinesiology & Public Health

California Polytechnic State University-San Luis Obispo

Eligibility Criteria

Inclusion Criteria

  • self-reported current participation in a home visiting program
  • self-reported currently pregnant or postpartum less than or equal to 6 weeks
  • English or Spanish speaking
  • Exclusion Criteria (based on self report):
  • Age less than 18 years
  • Lower than 5th grade reading level

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Perceived acceptability of treatment score

Time Frame: 6 week

Questionnaire

Secondary Outcomes

  • Change in life's essential 8 total score(6 weeks)

Study Sites (2)

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