- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01304615
Foundations for Health (FFH)
3 avril 2018 mis à jour par: Hollie Raynor, The University of Tennessee, Knoxville
Foundations for Health: Combining Culinary Skills Training With a Lifestyle Intervention in Young Overweight Adults at Risk for Type 2 Diabetes
Foundations for Health is a 12-week behavioral weight loss interventions primarily conducted via the internet aimed at helping overweight and obese young adults (ages 18-30) lose weight by increasing physical activity, decreasing the energy density of the diet, and increasing consumption of low energy dense self-made meals by providing culinary training skills.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Young adulthood is recognized as a key time to focus on health promotion/disease prevention, as this time is when young individuals begin to transition to independence and thus are adopting health behaviors that will be carried into later adulthood.
Unfortunately, this time period is often marked by decreases in physical activity and dietary quality.
Working with young adults as they establish their first independent living situation can help set the foundation for behaviors that may aid with lifelong weight management and chronic disease prevention.
Foundations for Health is the first study to examine the effect of a web-based lifestyle modification program in combination with culinary skills or lifestyle skills training sessions on weight loss, dietary intake, and meal preparation behaviors using a reduced energy dense diet in young adults with a family history of diabetes.
Foundations for Health will provide a 12-week weight loss intervention for overweight and obese young adults, aged 18 to 35 years.
Study participants will be randomly assigned to one of two conditions: 1) a web-based behavioral intervention that decreases dietary energy density and increases physical activity; and 2) the same intervention combined with a hands-on culinary skills training program designed to increase food purchasing and meal self-preparation and consumption of meals low in energy density.
The primary aims of this feasibility study are: 1) determine if the web-based plus culinary training condition has a greater increase in food purchasing, meal preparation/cooking behaviors, and intake of self-made meals; and a greater decrease in consumption of "convenience meals" than the web-based condition at 3 months; and 2) determine if the web-based plus culinary training condition has a greater decrease in dietary energy density and percent energy from fat and a greater increase in fruit and vegetable consumption than the web-based condition at 3 months.
Type d'étude
Interventionnel
Inscription (Réel)
10
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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Tennessee
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Knoxville, Tennessee, États-Unis, 37996-1920
- University of Tennessee
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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 à 35 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age between 18 and 35 years old.
- BMI between 25 and 45 kg/m2.
- Have type 2 diabetes or an adult family member, first or second degree relative, with type 2 diabetes.
- Have a cooking and food preparation area, along with cooking utensils, available in their current living situation.
- Consume > 3 restaurant/fast food meals/week.
- Regular and reliable internet access via a computer.
Exclusion Criteria:
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q).20
- Report not being able to walk for two blocks.
- Report major psychiatric diseases or organic brain syndromes.
- Are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months.
- Intend to have bariatric surgery within the time frame of the investigation.
- Intend to move outside of the metropolitan area within the time frame of the investigation.
- Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
- Have percent body fat < 20% for females or < 13% for males.
- Live with an adult who is responsible for food purchasing and/or meal preparation.
- Have purchased a full meal plan from a college dining services program.
- Do not have regular access to transportation (needed for food purchases).
- Do not provide email contact information that is needed for access to web- based program.
- Report consuming > 10 self-made lunches or dinners per week.
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: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Web-Based
Participants will receive a web-based behavioral intervention that decreases dietary energy density and increases physical activity combined with a life skills training program.
Life skills training topics include stress management, coping with change, time management, and thoughts and emotions in weight control.
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Participants will be given goals to help guide their food choices to decrease the energy density of the overall diet.
The goals are to eat 10 or more foods with an ED less than 1.0 and 2 or less foods with an ED of great than 3.0 each day and to reduce portion sizes.
Participants will increase their steps per day by at least 3,000 steps per day above their baseline levels.
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Expérimental: Web-Based plus Culinary Training
Participants will receive a web-based behavioral intervention that decreases dietary energy density and increases physical activity combined with a hands-on culinary skills training program designed to increase food purchasing and meal self-preparation and consumption of meals low in energy density.
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Participants will be given goals to help guide their food choices to decrease the energy density of the overall diet.
The goals are to eat 10 or more foods with an ED less than 1.0 and 2 or less foods with an ED of great than 3.0 each day and to reduce portion sizes.
Participants will increase their steps per day by at least 3,000 steps per day above their baseline levels.
Participants will have the goal of increasing the number of self-prepared meals that they consume to 10 or more lunch and dinner meals each week.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Energy Density (ED) of the Diet
Délai: 3 months
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ED of the diet is will be collected using a 3 day food record and calcuated by determining the mean of the total kcals/gram weight of food consumed for each day.
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3 months
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Body Weight
Délai: 3 months
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3 months
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consumption of Self-made Meals
Délai: 3 months
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In a 3 day food record participants will report all if each meal was self-prepared, with self-prepared being defined as is a meal/food made by you that uses fruits, vegetables, low-fat sauces or herbs, lean meats, or meatless options as the main dish (entrée) of the meal.
The main dish would be the component of the meal that you feel is making the largest contribution to the meal.
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3 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tour de taille
Délai: 3 mois
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3 mois
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Steps per Day
Délai: 3 months
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Measured using the Omron HJ 720 ITC pedometer.
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3 months
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Percent Body fat
Délai: 3 months
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3 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Hollie A. Raynor, Ph.D., University of Tennessee
- Chaise d'étude: Carol Costello, Ph.D., University of Tennessee
- Chaise d'étude: Ann Fairhurst, Ph.D., University of Tennessee
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.
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 février 2011
Achèvement primaire (Réel)
1 décembre 2011
Achèvement de l'étude (Réel)
1 décembre 2011
Dates d'inscription aux études
Première soumission
16 février 2011
Première soumission répondant aux critères de contrôle qualité
24 février 2011
Première publication (Estimation)
25 février 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 avril 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 avril 2018
Dernière vérification
1 avril 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FFH E01-1703-011
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