- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01402557
Telehealth for Weight Maintenance of African-American Women ("Exercise Your Faith")
Telehealth for Weight Maintenance of African-American Women
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Rates of obesity in the United States have increased dramatically over the past four decades. Although research studies have demonstrated that weight loss is achievable through lifestyle modifications, the maintenance of weight reduction beyond six months remains a challenge.
This study will examine the feasibility of a telehealth program for weight maintenance. Telehealth is the delivery of health related services to promote healthy behaviors through the innovative use of technology, without the need for travel. The telehealth program will be accessible at home through Internet-enabled television sets. The telehealth program includes three components: (1) weekly video programs that discuss problem solving and relapse prevention strategies and include motivational stories; (2) regularly updated video exercise programs; and (3) online communication with other study participants and an exercise and nutrition specialist.
A randomized controlled trial will determine the feasibility and acceptability of the weight maintenance telehealth program. The study participants will be African-American women, as they have a higher prevalence of obesity with a disproportionate risk of related chronic diseases (e.g., diabetes). Two churches will collaborate with the University of Illinois at Chicago and assist in meeting the social, spiritual, and cultural needs of the participants. One hundred women will be recruited to participate in a one-year trial. The study includes a weight loss phase (Phase 1), and a weight maintenance phase (Phase 2). During Phase 1, all participants will attend a 12-week weight loss program held in the participating churches. Following completion of this program, one church will be assigned to be the intervention group, and the other church will be the comparison group. During Phase 2, participants in the intervention group will receive monthly telephone counseling plus access to the telehealth program, while the comparison group will only receive monthly telephone counseling. The specific aims of the study include: (1) to evaluate the effect of the telehealth program on change in body mass index; and (2) to evaluate the effect of the telehealth program on physical activity and fat, fiber, fruit and vegetable intake.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Self-identification as an African-American or Black woman
- Age 35-65 years
- Body mass index 25-50 kg/m2
- Physician approval to safely exercise if any positive answers on Physical Activity Readiness Questionnaire
- Owns a television
- Has a working telephone line
Exclusion Criteria:
- Plans to move from the Chicago area during the coming year
- Has a household member already in the study
- Uses illicit drugs or drinks more than two alcoholic drinks daily
- Pregnant, nursing, or planning pregnancy
- Participating in an organized weight loss program or using pharmacotherapy for weight loss
- Use an assistive device for ambulation, or cannot participate in exercise classes
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Telephone Support Only
These participants receive telephone support only during the weight maintenance phase.
|
An initial 12-week weight loss program held in churches to ensure adequate participation, competence in performing exercises, and development of social relationships among participants.
All participants attend the church programs prior to the weight maintenance phase.
Following completion of the weight loss program, participants will receive monthly telephone counseling.
|
|
Expérimental: Telehealth
These participants receive telehealth support (with Internet-enabled digital video recorders) during the weight maintenance phase.
These participants also receive telephone support monthly.
|
An initial 12-week weight loss program held in churches to ensure adequate participation, competence in performing exercises, and development of social relationships among participants.
All participants attend the church programs prior to the weight maintenance phase.
Following completion of the weight loss program, participants will receive monthly telephone counseling.
After the weight loss program, women will access the home weight maintenance telehealth program through Internet enabled digital video recorders connected to their television sets.
The telehealth program includes three components: (1) Weekly Video: home access to weekly video programs including problem solving and relapse prevention strategies, as well as motivational stories; (2) Teleexercise: home access to updated video exercise programs; and (3) Electronic Communication: social support through online communication with other participants, and with an exercise and nutrition interventionist.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Indice de masse corporelle
Délai: 12 mois
|
12 mois
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physical activity
Délai: 12 months
|
12 months
|
|
|
Dietary intake
Délai: 12 months
|
Dietary intake includes fat, fiber, fruits and vegetables.
|
12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ben Gerber, MD, MPH, University of Illinois at Chicago
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2006-0836
- R21DK078352 (Subvention/contrat des NIH des États-Unis)
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