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- Registre américain des essais cliniques
- Essai clinique NCT01966926
Self-Weighing Instruction Feasibility Study
30 octobre 2019 mis à jour par: University of Minnesota
Scant data have been reported on the effects of weight self-monitoring during weight control.
The purpose of this pilot project was to consider the questions: Is it possible to assign participants to engage in daily weight self-monitoring, and are there differential effects on mood of daily versus weekly weighing?
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This study tested the feasibility of assigning participants to daily or weekly weighing, monitored adherence to weighing instructions, and tracked additional behavioral and psychosocial indicators over a period of six months.
It was hypothesized that there would be no differences in mood or adherence between daily versus weekly weighing conditions.
Knowledge about the benefits of frequent self-weighing may shape public health recommendations for regular weighing as a weight reduction or obesity prevention strategy.
Type d'étude
Interventionnel
Inscription (Réel)
30
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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Minnesota
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Minneapolis, Minnesota, États-Unis, 55454
- University of Minnesota
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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 64 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Body mass index between 25 and 35 kg/m2
Exclusion Criteria:
- Current weight loss program participation
- Chronic health conditions (diabetes, cancer, heart disease, psychiatric disorders requiring medication)
- Current or past eating disorder
- Current pregnancy or pregnant in past year
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: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Daily Weight Tracking
weighing frequency instructions and tips
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Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks
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Expérimental: Weekly Weight Tracking
weighing frequency instructions and tips
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Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Adherence to Weight Tracking Instructions
Délai: 6 months
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Participants were assigned to daily or weekly weight tracking, and were asked to return postcards once a week with weights recorded (7 for daily, 1 for weekly).
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Depression Ratings
Délai: baseline to 6 months
|
Ratings of depressed mood, assessed by the Beck Depression Inventory, were obtained at baseline, three, and six months; the comparison of depression scores between groups and over time from baseline to 3 and 6 months was considered as a secondary outcome and analyzed using repeated measures multivariate analysis of variance (MANOVA).
Scores on the inventory range from 0 to 63, with higher scores indicating greater presence of depressive symptoms.
Scores from 0-10 represent normal mood; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; > 40 = extreme depression.
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baseline to 6 months
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Changes in Anxiety
Délai: baseline to 6 months
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Ratings of anxiety, assessed by the Beck Anxiety Inventory, were assessed at baseline, three, and six months; a comparison of anxiety scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
Possible scores on the scale range from 0-63.
Scores from 0-7 indicate minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.
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baseline to 6 months
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Changes in Body Image
Délai: baseline to 6 months
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Changes in self-reported body image were assessed at baseline, three, and six months using the Appearance subscale of the Multidimensional Body Image Questionnaire.
The subscale has a range of 0 to 42, with higher scores indicating better body image.
A comparison of body image scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
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baseline to 6 months
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Changes in Barriers to Weight Tracking
Délai: baseline to 6 months
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Perceived barriers to self-weighing were assessed at baseline, three, and six months using a scale created for this study.
The scale has a range of 18 to 90, with higher scores indicating greater perceptions of barriers to self-weighing.
A comparison of barriers scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
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baseline to 6 months
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Changes in Perceptions of Weight Tracking
Délai: three to six months
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Perceptions of weight tracking (ease of remembering and understanding, usefulness, awareness, interest, reward value, satisfaction, motivational value) were assessed at three and six months using a scale created for the study.
The scale has a range of 0 to 64, with higher scores indicating greater perceptions of favorability of weight tracking.
A comparison of perceptions scores between groups and over time from 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
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three to six 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: Jennifer A Linde, Ph.D., University of Minnesota
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 octobre 2009
Achèvement primaire (Réel)
1 mai 2010
Achèvement de l'étude (Réel)
1 mai 2010
Dates d'inscription aux études
Première soumission
16 octobre 2013
Première soumission répondant aux critères de contrôle qualité
17 octobre 2013
Première publication (Estimation)
22 octobre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 novembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 octobre 2019
Dernière vérification
1 octobre 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0807S41483
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 .