No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
360 (estimated)
Sponsor
University of Missouri, Kansas City · Other
Who this trial is looking for
This trial is looking for Black or African American adults who are overweight and have prediabetes or other related conditions. Participants will join a program focused on diet, exercise, and weight loss to help prevent diabetes.
Are You a Good Fit for This Trial?
You may be able to join if
I am Black or African American
I am overweight
I have been diagnosed with prediabetes or related condition
You may not be able to join if
I have been diagnosed with diabetes
I am currently pregnant or planning a pregnancy within the next year
I do not speak English fluently
I am currently in a weight loss program
I have a medical condition causing drastic weight loss
I had bariatric surgery in the last year
I cannot walk one block without assistance or stopping due to pain
I have had heart failure
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
African Americans (AAs) have rates of diabetes mellitus (DM) twice that of Whites and are disproportionately affected by leading risk factors for DM - obesity and low-income. A critical strategy in the battle against DM is the Diabetes Prevention Program (DPP), an evidence-based intervention that significantly delays or prevents Type 2 diabetes through the promotion of diet change, exercise and mo…
African Americans (AAs) have rates of diabetes mellitus (DM) twice that of Whites and are disproportionately affected by leading risk factors for DM - obesity and low-income. A critical strategy in the battle against DM is the Diabetes Prevention Program (DPP), an evidence-based intervention that significantly delays or prevents Type 2 diabetes through the promotion of diet change, exercise and modest weight loss. However, weight loss from the DPP among AAs is about half that of White participants, and suboptimal AA attendance is a critical contributor. The investigators propose to conduct a study that will address social determinants (SD) that challenge DPP attendance with underserved African Americans from a safety net hospital. The investigators will examine DPP attendance and weight loss with participants randomized to 3 groups: standard DPP, a culturally-tailored DPP to address acceptability, and a culturally-tailored DPP enhanced to address socioeconomic-related barriers to DPP participation. This novel study is the first to tailor the DPP to address SD cultural and socioeconomic barriers that limit DPP attendance and reduce its effectiveness on outcomes. The proposed multidimensional, SD tailored DPP has great potential to be a feasible and scalable model to reduce DM risks among urban, African Americans and ultimately reduce DM disparities.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Black/African American
* Overweight (\[BMI\> 24); and
* Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test
Exclusion Criteria:
* Diagnosed with diabetes
* Pregnant
* Not fluent in English
* Currently pregnant, p…
Inclusion Criteria:
* Black/African American
* Overweight (\[BMI\> 24); and
* Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test
Exclusion Criteria:
* Diagnosed with diabetes
* Pregnant
* Not fluent in English
* Currently pregnant, planning a pregnancy in the next year, currently breastfeeding or have given birth in the last 6 months
* Currently participating in a weight loss program
* Currently have a medical condition that causes drastic weight loss
* Bariatric weight loss surgery in last year
* Cannot walk a 1-block distance without assistance and without stopping due to pain, tightness, or pressure in the chest
* Had heart failure
* Not willing to use a fitness tracker, wi-fi scale, and the internet
* Not available in the evening one day each week to participate in a class
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