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Completed

NCT Number: NCT05750407

Feasibility of Cardiovascular Health Intervention Within Evidence-based Home Visiting

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.

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Key information

Conditions

Diet, Healthy Behavior Body Weight Inactivity, Physical Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cal Poly, San Luis Obispo, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle change

Behavioral

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

Primary outcomes

  1. Perceived acceptability of treatment score

    Time frame: 6 week

    Questionnaire

Secondary outcomes

  1. Change in life's essential 8 total score

    Time frame: 6 weeks

    Questionnaire

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Collaborators

  • Bradley Hospital
  • The Miriam Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2023
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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