Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

Not Applicable

Completed

• Conditions: Obesity; Diet, Healthy; Inactivity, Physical
• Interventions: Behavioral: Lifestyle change

• Registration Number: NCT05750407
• Lead Sponsor: California Polytechnic State University-San Luis Obispo

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.

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-01
• Study Start: 2023-05-15
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evidence based home visiting with lifestyle modules	Lifestyle change	Three lifestyle change modules will be discussed with clients: healthy eating, activity, and tracking diet and weight

Primary Outcome Measures

Name	Time	Method
Perceived acceptability of treatment score	6 week	Questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in life's essential 8 total score	6 weeks	Questionnaire

Trial Locations

Locations (2)

Cal Poly; 🇺🇸 San Luis Obispo, California, United States

Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States