Type 2 Diabetes Prevention in Community Health Care Settings for at Risk Children and Mothers

Stopped early · Not applicable

Conditions studied: PreDiabetes, Type 2 Diabetes

In brief

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 Center (FQHC) setting show (a) pre- and post-intervention improvements to Type 2 Diabetes risk factors in 60 mother-child dyads; (b) intervention vs. control improvements to T2D risk factors in 30 mother-child dyads; and (c) maintenance effects to changes to Type 2 Diabetes risk factors in 30 mother-child dyads; and 2. based on the acceptability, adoption, relevance to FQHC and participants, feasibility, fidelity, program costs, and factors influencing sustainability of this program, can it be disseminated nationwide to other FQHC's? The investigators hypothesize that participants (a) will show improvements following the intervention to T2D risk factors, (b) in the intervention will show significant improvements to T2D risk factors in versus the controls, and (c) will maintain the benefits beyond the 16-week intervention. The investigators also predict that this program will meet criteria to be disseminated nationwide to other FQHC's.

Key facts

Study ID: NCT03781102
Run by: University of Arizona
People needed: 92
Starts: 2019-07-01
Expected to finish: 2020-03-13
Last updated by the study team: 2024-08-19

Who can join

Age: 8 and older, up to 54. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

El Rio Community Health Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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