Status:
TERMINATED
Type 2 Diabetes Prevention in Community Health Care Settings for at Risk Children and Mothers
Lead Sponsor:
University of Arizona
Conditions:
PreDiabetes
Type 2 Diabetes
Eligibility:
All Genders
8-54 years
Phase:
NA
Brief Summary
The two main questions that this research study will answer: 1. will a 16-week community-based diabetes prevention program for delivery to at-risk mothers and children in a Federally Qualified Health...
Detailed Description
The goal is to implement and evaluate the effects of a 16-week behavioral lifestyle intervention on Type 2 Diabetes (T2D) risk factors delivered by trained staff at a Federally Qualified Health Center...
Eligibility Criteria
Inclusion
- Child:
- 8-12-years-old (if the mother has more than one child in the age range, the oldest child will be invited to participate; other children will be invited to join if the mother wishes it, but will not be measured),
- overweight/obese (≥85th percentile of BMI for age and sex, and ≥2 of the following T2D risk factors: family history of T2D in first or second degree relative; or, identify as a racial/ethnic minority; or, exhibit signs of insulin resistance or conditions associated with insulin resistance, or mother with T2D or GDM during gestation.
- Able to read and speak English, and provide written assent.
- Mother:
- 18-54 years-old,
- BMI ≥ 25 kg/m2 and a risk score ≥5 on the seven-item American Diabetes Association's Diabetes Risk Assessment (84). In addition, women must have prediabetes, determined by an HbA1c value \>5.7% and \<6.5%, or, a self-reported or chart documented history of gestational diabetes mellitus with an HbA1c \<6.5% and/or casual capillary blood glucose \<199 mg/dL.
- Must be willing to participate with their child in all intervention activities and sessions,
- Able to read and speak English or Spanish, and provide informed consent.
Exclusion
- Mother:
- No evidence of prediabetes
- Currently pregnant or planning to become pregnant during the study
- Have any condition or use any medication that could alter glucose metabolism or weight
- Have suffered a heart attack, stroke or transient ischemic attack (TIA) in the past 6 months
- Have uncontrolled hypertension (systolic \>180 mmHg or diastolic \>105 mmHg)
- Received treatment for cancer (excluding surgery alone) within the last 2 years (excluding skin cancer)
- Report chest pain, shortness of breath with minimal activity or at rest or unexplained dizziness or fainting with physical activity,
- Have chronic lung disease, chronic obstructive pulmonary disease, or asthma requiring home oxygen therapy,
- Current use of anti-diabetes medications for the treatment of diagnosed diabetes, are unable to communicate with research staff (including intervention staff),
- Do not have a child within the designated age range (8-12-years-old),
- Unable to speak or read English or Spanish.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2020
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03781102
Start Date
July 1 2019
End Date
March 13 2020
Last Update
August 19 2024
Active Locations (1)
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1
El Rio Community Health Center
Tucson, Arizona, United States, 85701