Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

Obesity Clinical Trial

Official title:

Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750407
• Other study ID #: CP-ENRICH Pilot
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: August 2023
• Source: California Polytechnic State University-San Luis Obispo
• Contact: Suzanne Phelan
• Phone: 805 756 2087
• Email: Sphelan[@]calpoly.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Obesity

Intervention

Behavioral:
• Lifestyle change
Three modules target healthy eating, activity, and weight control behaviors

Locations

Country	Name	City	State
United States	Miriam Hospital	Providence	Rhode Island
United States	Cal Poly	San Luis Obispo	California

Sponsors (3)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo	Bradley Hospital, The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived acceptability of treatment score	Questionnaire	6 week
Secondary	Change in life's essential 8 total score	Questionnaire	6 weeks