Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting
Primary Purpose
Diet, Healthy, Inactivity, Physical, Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle change
Sponsored by
About this trial
This is an interventional treatment trial for Diet, Healthy focused on measuring home visiting, obesity, pregnancy, postpartum, cardiovascular health
Eligibility Criteria
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
Sites / Locations
- Cal PolyRecruiting
- Miriam Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evidence based home visiting with lifestyle modules
Arm Description
Three lifestyle change modules will be discussed with clients: healthy eating, activity, and tracking diet and weight
Outcomes
Primary Outcome Measures
Perceived acceptability of treatment score
Questionnaire
Secondary Outcome Measures
Change in life's essential 8 total score
Questionnaire
Full Information
NCT ID
NCT05750407
First Posted
February 20, 2023
Last Updated
August 29, 2023
Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
The Miriam Hospital, Bradley Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05750407
Brief Title
Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting
Official Title
Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
The Miriam Hospital, Bradley Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Healthy, Inactivity, Physical, Obesity
Keywords
home visiting, obesity, pregnancy, postpartum, cardiovascular health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Evidence based home visiting with lifestyle modules
Arm Type
Experimental
Arm Description
Three lifestyle change modules will be discussed with clients: healthy eating, activity, and tracking diet and weight
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle change
Intervention Description
Three modules target healthy eating, activity, and weight control behaviors
Primary Outcome Measure Information:
Title
Perceived acceptability of treatment score
Description
Questionnaire
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Change in life's essential 8 total score
Description
Questionnaire
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Phelan
Phone
805 756 2087
Email
Sphelan@calpoly.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rena Wing
Email
rwing@lifespan.org
Facility Information:
Facility Name
Cal Poly
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Phelan, PhD
Phone
805-756-2087
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rena R Wing, Phd
Phone
401-793-8959
Email
rwing@calpoly.edu
First Name & Middle Initial & Last Name & Degree
Rena R Wing, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting
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