Lifestyle Improvement Through Food and Exercise (LIFE)Study (LIFE)
8 mai 2017 mis à jour par: Rush University Medical Center
Lifestyle Improvement Through Food and Exercise (LIFE) Study
The primary aim of the LIFE study is to compare low-income African American diabetes patients in a lifestyle intervention group with those in a standard of care control group on change in glycemic control at 12-months.
We hypothesize that, on average, participants in the intervention group will achieve greater glycemic control at 12-months relative to their baseline A1c, than those in the control group.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This project is a randomized controlled trial to test an innovative lifestyle intervention to achieve sustained improvements in glycemic control among low-income African American diabetes patients.
The LIFE (Lifestyle Improvement through Food and Exercise) program is a diabetes self-management program focused on diet and exercise, informed by anthropological research on models of food and health among low-income African-Americans.
Pilot work demonstrated that the LIFE Program is effective in improving glycemic control among low-income African Americans at 6-months.
The main goal of the current study is to determine whether the LIFE Program can achieve sustained improvements in glycemic control for 12 months.
The trial will randomize low-income African American adults with diabetes to a control group, which receives standard diabetes education, or an intervention group, which receives the LIFE Program (28 group meetings with peer support telephone calls) followed by a 6-month maintenance phase (quarterly group sessions with monthly peer support phone calls).
The primary aim of the proposed research is to compare low-income African American diabetes patients receiving the LIFE Program with those in a standard of care control group on change in glycemic control at 12 months.
Our primary hypothesis is that patients in the intervention group will achieve a change in A1c from baseline that is less than patients in the control group.
Secondary aims are to compare low-income African American diabetes patients receiving the LIFE Program with those in a standard of care control group on (a) change in glycemic control at 18 months; (b) change in physical activity and total energy intake at 12 months; (c) change in physical activity and total energy intake at 18 months; and (d) to obtain estimates needed for a subsequent trial, including weight, blood pressure, and diabetes-related hospitalizations.
For secondary aims we hypothesize that a) the intervention group will achieve a mean 18-month change in A1C that is less than the change in the control group; b) at 12 months, a greater proportion of intervention patients will have achieved the activity goal of 150 minutes of moderate activity per week, and the intervention group will achieve a greater reduction from baseline in mean total energy intake than the control group; and c) at 18 months, a greater proportion of intervention patients will have achieved the activity goal of 150 minutes of moderate activity per week, and the intervention group will achieve a greater reduction from baseline in mean total energy intake than the control group.
Type d'étude
Interventionnel
Inscription (Réel)
211
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis
- Cook County Health Clinics
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus (T2DM) and HbA1c > 7%;
- Patients must identify themselves as African American;
- Patients must be patients of Cook County Hospital ambulatory clinics;
- Primary care physician gives clearance for patient to participate in study and engage in moderate level physical activity.
Exclusion Criteria:
- BMI<18.5;
- Patient not on diabetes medication and with a HbA1c reading less than 7%
- End-stage renal disease, stroke with paresis, congestive heart failure (NYHA class 2-4), or other major end-organ complication of diabetes;
- Comorbid conditions limiting probable life span to <4 years (e.g. cancer, AIDS) or indication of end-stage complications of diabetes (kidney dialysis, or transplant, blindness, or lower extremity amputation);
- Receiving treatment for a major psychiatric disorder (i.e. schizophrenia);
- Unable to give informed consent;
- Under the age of 18;
- Has no access to a telephone (Phone contact is a critical component of the intervention).
- Cannot walk 2 blocks without stopping and resting.
- Impaired cognitive function as determined by mini-mental test.
- Lives in the same household as an active LIFE participant.
- Presence of sickle cell trait
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Norme de soins
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Participants receive 2 diabetes education classes taught by a Certified Diabetes Educator.
They also receive diabetes education newsletters every 2 months.
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Expérimental: Intensive education and support
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Group classes for 12 months (weekly for 4 months, biweekly for 4 months, monthly for 4 months), weekly peer supporter telephone calls, and diabetes education newsletters every 2 months.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hemoglobin A1c
Délai: change from baseline to 12 months
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Finger prick on Afinion machine
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change from baseline to 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physical Activity
Délai: change from baseline to 12 months
|
An accelerometer is worn by participants for seven days.
International-Physical Activity Questionnaire is administered at baseline, 6 months, 1 year, and 18 months.
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change from baseline to 12 months
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Total Energy Intake
Délai: change from baseline to 12 months
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24-hour dietary food recalls
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change from baseline to 12 months
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Physical Measures
Délai: change from baseline to 12 months
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Measurements of weight, waist circumference, and blood pressure.
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change from baseline to 12 months
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Medications
Délai: change from baseline to 12 months
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Participants bring all medications to the clinic visit and medication and dosage is recorded.
|
change from baseline to 12 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Elizabeth Lynch, PhD, Rush University Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Lynch EB, Mack L, Avery E, Wang Y, Dawar R, Richardson D, Keim K, Ventrelle J, Appelhans BM, Tahsin B, Fogelfeld L. Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes. J Gen Intern Med. 2019 Jul;34(7):1174-1183. doi: 10.1007/s11606-019-04894-y. Epub 2019 Apr 8.
- Lynch EB, Liebman R, Ventrelle J, Keim K, Appelhans BM, Avery EF, Tahsin B, Li H, Shapera M, Fogelfeld L. Design of the Lifestyle Improvement through Food and Exercise (LIFE) study: a randomized controlled trial of self-management of type 2 diabetes among African American patients from safety net health centers. Contemp Clin Trials. 2014 Nov;39(2):246-55. doi: 10.1016/j.cct.2014.09.003. Epub 2014 Sep 22.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2012
Achèvement primaire (Réel)
25 novembre 2015
Achèvement de l'étude (Réel)
2 décembre 2015
Dates d'inscription aux études
Première soumission
12 juillet 2013
Première soumission répondant aux critères de contrôle qualité
15 juillet 2013
Première publication (Estimation)
17 juillet 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 mai 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mai 2017
Dernière vérification
1 mai 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 1R01DK092271-01 (Subvention/contrat des NIH des États-Unis)
- R01DK092271-01 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .