Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

Study Overview
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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.

Official Title
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Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

Conditions
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Diet, Healthy, Inactivity, Physical, Obesity

Intervention / Treatment
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* Behavioral: Lifestyle change


Participation Criteria
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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 (based on self report): Age less than 18 years Lower than 5th grade reading level

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evidence based home visiting with lifestyle modules<br>Three lifestyle change modules will be discussed with clients: healthy eating, activity, and tracking diet and weight | Behavioral: Lifestyle change<br>* Three modules target healthy eating, activity, and weight control behaviors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived acceptability of treatment score | Questionnaire | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in life's essential 8 total score | Questionnaire | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home visiting, obesity, pregnancy, postpartum, cardiovascular health