Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

August 19, 2024 updated by: Suzanne Phelan, California Polytechnic State University-San Luis Obispo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 93407
        • Cal Poly
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evidence based home visiting with lifestyle modules
Three lifestyle change modules will be discussed with clients: healthy eating, activity, and tracking diet and weight
Behavioral: Lifestyle change
Three modules target healthy eating, activity, and weight control behaviors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived acceptability of treatment score
Time Frame: 6 week
Questionnaire
6 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in life's essential 8 total score
Time Frame: 6 weeks
Questionnaire
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Polytechnic State University-San Luis Obispo

Collaborators

The Miriam Hospital
Bradley Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-ENRICH Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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