NCT01435603

Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study

Community Translation of a Lifestyle Intervention to Improve Health in Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare ways of giving advice and providing support to improve diet and physical activity in adult primary care patients with elevated body mass index and dysglycemia.

Detailed description

This is a randomized comparative effectiveness trial to evaluate the health and economic effects of a community-based intensive lifestyle intervention for adult primary care patients with elevated body mass index and dysglycemia (either type 2 diabetes or pre-diabetes). The study will use qualitative and quantitative methods to assess reach, effectiveness, costs, adoption, implementation, and maintenance of a clinical-community partnership to offer intensive lifestyle intervention resources to eligible adult primary care patients.

Conditions

• Diabetes Mellitus
• Hyperglycemia
• Obesity
• Glucose Metabolism Disorders
• Metabolic Diseases
• Endocrine System Diseases
• Overnutrition
• Nutrition Disorders
• Overweight
• Body Weight
• Signs and Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Standard Lifestyle Advice	Standard clinical education is offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits and are provided with clinical recommendations for lifestyle and cardiovascular risk factor management. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
BEHAVIORAL	Advice Plus Lifestyle Intervention	Standard clinical education offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits for lifestyle and cardiovascular risk factor management. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.

Timeline

• Start date: 2011-08-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2011-09-16
• Last updated: 2018-04-27
• Results posted: 2018-04-27

Locations

2 sites across 1 country: United States