Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

NCT ID: NCT05750407

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2024-07-30

Brief Summary

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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

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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.

Conditions

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Diet, Healthy Inactivity, Physical Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evidence based home visiting with lifestyle modules

Three lifestyle change modules will be discussed with clients: healthy eating, activity, and tracking diet and weight

Group Type EXPERIMENTAL

Lifestyle change

Intervention Type BEHAVIORAL

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

Interventions

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Lifestyle change

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* Age less than 18 years
* Lower than 5th grade reading level
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role collaborator

Bradley Hospital

OTHER

Sponsor Role collaborator

California Polytechnic State University-San Luis Obispo

OTHER

Sponsor Role lead

Responsible Party

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Suzanne Phelan

Professor of Kinesiology & Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cal Poly

San Luis Obispo, California, United States

Site Status

Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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CP-ENRICH Pilot

Identifier Type: -

Identifier Source: org_study_id

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