Partnership for a Hispanic Diabetes Prevention Program

NCT01564797 | Completed

• 1 other identifier: IR6194
• Study Type: interventional
• Target: 430
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of the study are to investigate

1. 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. 2.the effects of the intervention vs control on consumption of fresh fruit and vegetables
3. 3.the effects of the intervention vs control on levels of physical activity

Conditions

Diabetes; Pre-diabetes

Keywords

Diabetes; haemoglobin A1C; Hispanic; Behavioural Intervention

Outcome Measures

Primary Outcomes (3)

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

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

  Baseline, 3 months

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

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

  Baseline, 3 months

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

  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.

  Baseline, 3 months

Secondary Outcomes (1)

• Effect of the intervention on changes in knowledge and attitudes about diabetes

  Baseline, 3 months

Study Arms (2)

Education Intervention

ACTIVE COMPARATOR

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

Behavioral: Home Health Party

Control Arm

NO INTERVENTION

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

Interventions

Home Health Party BEHAVIORAL

An education-based lay health educator-led intervention designed to educate Hispanic participants with elevated HA1c levels about diabetes, treatment of diabetes, and diet and lifestyle changes.

Education Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Related Publications (1)

• Duggan C, Carosso E, Mariscal N, Islas I, Ibarra G, Holte S, Copeland W, Linde S, Thompson B. Diabetes prevention in Hispanics: report from a randomized controlled trial. Prev Chronic Dis. 2014 Feb 27;11:E28. doi: 10.5888/pcd11.130119.

  PMID: 24576395 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Beti Thompson, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 28, 2012
• Study Start: July 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 6, 2015

Record last verified: 2015-03