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Effects of Journaling on Weight Loss

31 janvier 2013 mis à jour par: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
This is a randomized controlled trial with enhanced usual care treatment control. The aim is to determine the effects of journaling and use of resource website on weight loss. There will be two groups of 55 participants each. The intervention condition will be asked to record daily weight, physical activity steps taken and pre-portioned food items and to complete two daily journaling activities. Participants will also receive weekly tracing data, a weekly blog from the principal investigator and have access to a weight control website. The control group will not have access to the tracking, journaling or website for three months. Investigators hypothesize that a website paired with tracking and journaling will be more effective in helping participants lose weight.

Aperçu de l'étude

Description détaillée

Participants will call study line given on recruitment materials and be screened over the phone.

Baseline visit:

Individuals who meet the screening criteria will be invited to a one-hour training session about the website and diet plan book. During the training, a coordinator will review the consent form with the participants and ask if they have any questions. The coordinator will take consented individuals' height, weight and blood pressure measurements. Participants will be given a pedometer to use during physical activities and a meal replacement book to use as a resource.

After baseline visit:

All participants will complete surveys online (Demographics, Three-Factor Eating Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical Activity Questionnaire) and be randomized into one of two groups. The intervention group will be asked to record their weight, physical activity steps, pre-portioned food items and journal entries on a daily basis. The control group will be sent an email informing them they will have access to the tracking, journals and website in three months.

Intervention Group:

Participants will receive daily emails with links to record their weight, physical activity steps and pre-portioned food items; participants will also complete a journaling response to two writing prompts. The emails will contain links to the website to be used as a resource. Every week, participants will enter whether they have an appointment with primary care provider in the next week. Participants will also receive weekly blogs from the principal investigator; participants can opt out of receiving the blog emails at any time. Coordinators will review the database weekly. If a participant has lost ten pounds, they will be emailed to call their doctor since weight loss can affect blood pressure and medication needs. If a participant has an upcoming primary care provider appointment, they will be emailed to print out their tracking graphs (weight, steps taken, meal replacements). Coordinators will also monitor journal responses; coordinators will contact participants who wrote useful entries to ask if the participant's responses can be shared with other participants. Shared posts will be anonymous; only the age of the individual will be given.

Month one and two visits:

Participants from both groups will be asked to come to Hershey Medical Center to have their height, weight and blood pressure measured.

Month three visit:

Participants from both groups will be asked to come to Hershey Medical Center to have their height, weight and blood pressure measured. Prior to their visit, participants will be asked to complete a series of surveys online (Three-Factor Eating Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical Activity Questionnaire, Satisfaction). Participants in the control group will be given a booklet containing the writing prompts, tracking and website address to complete on their own if they so choose.

Participants will be asked if they would like to come back for an optional video interview. The interview will consist of six questions about their experience with the study.

Type d'étude

Interventionnel

Inscription (Réel)

100

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

    • Pennsylvania
      • Hershey, Pennsylvania, États-Unis, 17033
        • Penn State Milton S. Hershey Medical Center

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

21 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • 21 to 65 years old
  • Body mass index between 27 and 45
  • E-mail and Internet access
  • Able to read, write, and understand English

Exclusion Criteria:

  • Weight loss of more than 5% of current body weight in previous 6 months
  • Participated in weight loss research in previous 6 months
  • Current use of weight loss medication or program
  • History of or scheduled weight loss surgery
  • Heart, liver, or kidney failure
  • Been told by doctor of heart trouble
  • Frequent pains in heart and chest
  • Often feel faint or have spells of severe dizziness
  • Bone or joint problem that has been or might be aggravated by exercise
  • Physical reason for not following activity program
  • History of sever cognitive impairment or major psychiatric illness
  • Pregnant in previous 6 months, currently or planning to become pregnant in next 3 months
  • Moving in next 6 months

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: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Tracking + Journaling + Website
In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.
Participants will record their daily weight, physical activity steps and meal replacements online
Participants will journal to two online writing prompts: one on positive focus and one on goal setting
Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.
Participants will receive standard care of monthly height, weight and blood pressure measurements. Participants will also receive a pedometer and a diet plan book on pre-portioned items.
Comparateur actif: Enhanced Usual Care
Participants receive standard care
Participants will receive standard care of monthly height, weight and blood pressure measurements. Participants will also receive a pedometer and a diet plan book on pre-portioned items.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Weight
Délai: 3 months
Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Blood Pressure
Délai: 3 months
Blood pressure will be measured by study staff using an automatic blood pressure monitor.
3 months
Height
Délai: 3 months
Height will be measured using a portable stadiometer.
3 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Sociodemographics and tobacco use
Délai: 3 months
Age, gender, race, ethnicity, education, smoking status and other demographics will be measured by self-report
3 months
Three-factor Eating Questionnaire
Délai: 3 months
Questionnaire asks participants about how their dietary restraint in specific circumstances
3 months
Motivation
Délai: 3 months
Questionnaire asks participants to gauge their motivation to lose weight.
3 months
Weight Loss Habits
Délai: 3 months
Questionnaire asks participants how often they use specific habits to lose weight
3 months
Blood Pressure Medication
Délai: 3 months
Blood pressure medication names, doses and frequency measured by self-report
3 months
International Physical Activity Questionnaire
Délai: 3 months
Questionnaire asks participants to estimate the frequency and duration of specific physical activities
3 months
Satisfaction Survey
Délai: 3 months
Questionnaire asks participants about their satisfaction with specific aspects of the study
3 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

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 août 2012

Achèvement primaire (Réel)

1 janvier 2013

Achèvement de l'étude (Réel)

1 janvier 2013

Dates d'inscription aux études

Première soumission

1 août 2012

Première soumission répondant aux critères de contrôle qualité

6 août 2012

Première publication (Estimation)

9 août 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

4 février 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 janvier 2013

Dernière vérification

1 janvier 2013

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 39952EP

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 .

Essais cliniques sur Tracking

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