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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05750407
Other study ID # CP-ENRICH Pilot
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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