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Clinical Trials/NCT01564797
NCT01564797CompletedNot Applicable

Partnership for a Hispanic Diabetes Prevention Program

Fred Hutchinson Cancer Center0 sites430 target enrollmentStarted: July 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
430
Primary Endpoint
Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants

Time Frame: Baseline, 3 months

Test the efficacy of an intervention to educate diabetics and pre-diabetics about the management of diabetes as assessed by decreases in hemoglobin A1c;

Effect of the intervention on consumption of fresh fruit and vegetables in diabetics and pre-diabetic participants

Time Frame: Baseline, 3 months

Test the efficacy of an intervention to increase the consumption of healthy diets as assessed by increases in fruit and vegetable consumption

Effect of the intervention on physical activity levels in diabetics and pre-diabetic participants

Time Frame: Baseline, 3 months

Test the efficacy of an intervention to increase physical activity as assessed by increases in the times per week engaged in strenuous or moderate activity.

Secondary Outcomes

  • Effect of the intervention on changes in knowledge and attitudes about diabetes(Baseline, 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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