CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 331 enrolled
Drug / intervention
Standard Lifestyle Advice +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01435603
NCT01435603N/ACompleted
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Community Translation of a Lifestyle Intervention to Improve Health in Diabetes

Northwestern University·interventional·Posted Sep 16, 2011·Updated Apr 27, 2018

In Brief

A clinical study evaluating Standard Lifestyle Advice and Advice Plus Lifestyle Intervention for Diabetes Mellitus and 10 related conditions. Completed, enrolled 331 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Hyperglycemia, Obesity, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Overnutrition, Nutrition Disorders, Overweight, Body Weight, Signs and Symptoms
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2011
Enrollment StartAug 1, 2011
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 14.8 years ago

Interventions

Standard Lifestyle Advicebehavioral

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.

Advice Plus Lifestyle Interventionbehavioral

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.