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Behavioral Intervention

Virtual Cardiometabolic Health Program for Prediabetes

N/A
Waitlist Available
Led By Yvonne Commodore-Mensah, PhD, MSH, RN
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have at least two of the following chronic conditions: Body-mass index ≥ 25 kg/m2, Self-reported fasting plasma glucose of 95 to 125 mg/d or HbA1c of 5.7-6.5% in the past 6 months, Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg
African immigrants who are aged 25-75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months and 12 months
Awards & highlights

Study Summary

This trial will study the effect of a virtual health program on African immigrants with multiple cardiometabolic risk factors. 60 participants will be recruited and randomly assigned to an intervention or delayed intervention group. The trial will last 6 months, at the end of which the delayed intervention group will receive the intervention.

Who is the study for?
This trial is for African immigrants aged 25-75 with at least two of these: BMI ≥ 25, blood sugar levels indicating prediabetes, or high blood pressure. They should be uninsured or lack healthcare access and belong to one of the study churches. Those with cognitive issues, serious illnesses, non-English speakers, or not in the church group can't join.Check my eligibility
What is being tested?
The Afro-DPP Program aims to improve heart health by monitoring body composition and blood pressure using Bluetooth devices synced to an app. Participants from two churches will either start immediately or after a delay (control group) to test program effectiveness over six months.See study design
What are the potential side effects?
Since this intervention involves lifestyle changes rather than medication, typical drug side effects are not expected. However, participants may experience stress or discomfort related to regular health monitoring and potential lifestyle adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have at least two of the following: BMI ≥ 25, glucose or HbA1c in a specific range, or high blood pressure.
Select...
I am an African immigrant aged between 25 and 75.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in body fat percentage over a 6-month period
Change in body mass index over a 6-month period
Change in body weight over a 6-month period
+5 more
Secondary outcome measures
Change in body fat percentage over a 12-month period
Change in body mass index over a 12-month period
Change in body weight over a 12-month period
+6 more
Other outcome measures
Change in pain severity over the 12-month period
Change in quality of life over the 12-month period

Trial Design

2Treatment groups
Experimental Treatment
Group I: Immediate Intervention GroupExperimental Treatment1 Intervention
Participants in the immediate intervention group will immediately begin 6 months of the adapted DPP lifestyle intervention with a Lifestyle Coach and remote monitoring of blood pressure and body composition. This will be followed by a 6-month observation period where the intervention (Lifestyle Coach) will be withdrawn. In this period, participants will be evaluated for the maintenance of lifestyle changes.
Group II: Delayed Intervention GroupExperimental Treatment1 Intervention
Participants in the delayed intervention group will receive remote monitoring of blood pressure and body composition for the 1st 6 months (without the Lifestyle Coach) and then will receive the adapted DPP lifestyle intervention with a Lifestyle Coach after 6 months.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,816,577 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
575 Previous Clinical Trials
10,355,513 Total Patients Enrolled
Yvonne Commodore-Mensah, PhD, MSH, RNPrincipal InvestigatorJHU School Of Nursing
1 Previous Clinical Trials
600 Total Patients Enrolled

Media Library

The Diabetes Prevention Program (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05144737 — N/A
Type 2 Diabetes Research Study Groups: Immediate Intervention Group, Delayed Intervention Group
Type 2 Diabetes Clinical Trial 2023: The Diabetes Prevention Program Highlights & Side Effects. Trial Name: NCT05144737 — N/A
The Diabetes Prevention Program (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144737 — N/A

Frequently Asked Questions

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

Are participants under the age of eighty-five permitted to join this experiment?

"This clinical trial requires that all patients are at least 25 years of age and not older than 75."

Answered by AI

What primary objectives is this clinical trial trying to fulfill?

"The primary outcome of this trial, evaluated at baseline and again after 1, 3, and 6 months will be the alteration in Body Mass Index. Secondary outcomes to consider over a 12-month period involve changes in body fat percentage (using an Omron BCM-500 scale) as well as alterations in skeletal muscle and visceral fat percentages via the same technological reading device."

Answered by AI

Are applicants still being accepted into this research program?

"Per the clinicaltrials.gov page, this medical study is not currently in need of participants as it was last edited on December 9th 2021. Nonetheless, there are over 3000 other studies that require volunteers at present."

Answered by AI

What demographic is best suited to participate in this medical study?

"This clinical study seeks to enroll 60 African immigrants aged 25-75 with hypertension and BMI of ≥25 kg/m2, a fasting plasma glucose range between 95-125 mg/d or HbA1c 5.7-6.5% in the prior 6 months, as well as systolic BP of at least 140 mmHg or diastolic BP ≥ 90 mmHg who are uninsured or lack access to healthcare services."

Answered by AI

Who else is applying?

What site did they apply to?
Johns Hopkins School of Nursing
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Mar 2024