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Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05750407
Enrollment
15
Registered
2023-03-01
Start date
2023-05-15
Completion date
2024-07-30
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Healthy, Inactivity, Physical, Obesity

Keywords

home visiting, obesity, pregnancy, postpartum, cardiovascular health

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.

Interventions

Three modules target healthy eating, activity, and weight control behaviors

Sponsors

The Miriam Hospital
CollaboratorOTHER
Bradley Hospital
CollaboratorOTHER
California Polytechnic State University-San Luis Obispo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Perceived acceptability of treatment score6 weekQuestionnaire

Secondary

MeasureTime frameDescription
Change in life's essential 8 total score6 weeksQuestionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026