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ENRICH for Multiple Health Conditions (Obesity, High Blood Pressure, Body Composition, Diabetes, Healthy Habits and Diet, Sedentary Lifestyle)

N/A
Recruiting
Led By Mandy Allison, MD, MSPH
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment
Awards & highlights

Study Summary

This trial seeks to improve cardiovascular health in pregnant & postpartum mothers & their children using Nurse-Family Partnership and evidence-based program. New materials to promote healthy behaviors & optimal weight, glycemia, lipid, & blood pressure will be tested in a pilot study.

Who is the study for?
This trial is for English or Spanish-speaking women who are pregnant or less than 24 months postpartum, first-time mothers if pregnant (nulliparous) or have only one child if post-partum (primiparous), aged 18 years or older, and enrolled in Nurse-Family Partnership at Denver Health. It excludes those with a bachelor's degree or higher, substance use disorder diagnosis, current homelessness, significant intellectual disability, or non-gestational diabetes.Check my eligibility
What is being tested?
The ENRICH study aims to enhance the Nurse-Family Partnership program by integrating evidence-based strategies to improve cardiovascular health through healthy diet and lifestyle from early pregnancy until two years after giving birth. The pilot will test new materials designed to promote better habits and health outcomes.See study design
What are the potential side effects?
Since this intervention involves educational materials and lifestyle changes rather than medication, typical drug side effects are not expected. However, participants may experience challenges adjusting to new diet and exercise routines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maternal BMI
Secondary outcome measures
A1C
Blood pressure
Diet Quality
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ENRICHed NFPExperimental Treatment1 Intervention
Participants will receive additional heart health-focused materials and guidance in sessions with their nurse home visitor. The nurse will help them choose and work towards behavior goals to support their health. This will include goals for activity, diet, weight, blood pressure, diabetes, smoking, social relationships, sleep, parenting, and getting health care.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,739 Previous Clinical Trials
2,150,105 Total Patients Enrolled
101 Trials studying Obesity
213,709 Patients Enrolled for Obesity
Denver Health and Hospital AuthorityOTHER
101 Previous Clinical Trials
400,357 Total Patients Enrolled
6 Trials studying Obesity
25,137 Patients Enrolled for Obesity
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,841 Previous Clinical Trials
47,814,065 Total Patients Enrolled
252 Trials studying Obesity
206,056 Patients Enrolled for Obesity

Media Library

ENRICH Clinical Trial Eligibility Overview. Trial Name: NCT05798039 — N/A
Obesity Research Study Groups: ENRICHed NFP
Obesity Clinical Trial 2023: ENRICH Highlights & Side Effects. Trial Name: NCT05798039 — N/A
ENRICH 2023 Treatment Timeline for Medical Study. Trial Name: NCT05798039 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for subjects in this medical trial?

"The research being conducted is seeking volunteers, as evidenced on clinicaltrials.gov. It was initially published on June 19th 2023 and has seen the most recent update occur during the 28th of the same month."

Answered by AI

How many subjects are being monitored in this research initiative?

"Affirmative. Clinicaltrials.gov reports that this trial, which was initiated on the 19th of June 2023, is actively accepting patients. 40 individuals need to be enrolled from 1 medical facility."

Answered by AI
~22 spots leftby May 2025