Partnership for a Hispanic Diabetes Prevention Program

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Diabetes; Pre-diabetes

Treatments: Behavioral: Home Health Party

Study type: Interventional

Funder types: Other

Identifiers

NCT01564797

IR6194

Details and patient eligibility

About

The aims of the study are to investigate

1. the effects of an intervention vs. control on levels of glycosylated haemoglobin (haemoglobin A1c) in Hispanic participants, older than 18 years, who have elevated hA1c at baseline (>6.0%). Glycosylated haemoglobin provides an indication of blood sugar levels over the past 3 months. Elevated hA1c levels are seen in diabetics and pre-diabetics.
2. the effects of the intervention vs control on consumption of fresh fruit and vegetables
3. the effects of the intervention vs control on levels of physical activity

Enrollment: 430 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Aged 18 years and older
• Haemogloblin A1c ≥ 6.5%
• Hispanic Ethnicity

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

Education Intervention

Active Comparator group

Description:

A series of 5 home-based lay health educator-led education sessions (Home Health Parties (HHP)), to educate a Hispanic population about diabetes, management of diabetes, and diet and exercise

Treatment:

Behavioral: Home Health Party

Control Arm

No Intervention group

Description:

A delayed intervention where the intervention was delivered after the hA1c level was measured for the second time (3 months after the baseline measurement)