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Effects of Journaling on Weight Loss

31 januari 2013 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Pennsylvania
      • Hershey, Pennsylvania, Verenigde Staten, 17033
        • Penn State Milton S. Hershey Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Weight
Tijdsspanne: 3 months
Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood Pressure
Tijdsspanne: 3 months
Blood pressure will be measured by study staff using an automatic blood pressure monitor.
3 months
Height
Tijdsspanne: 3 months
Height will be measured using a portable stadiometer.
3 months

Andere uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2012

Primaire voltooiing (Werkelijk)

1 januari 2013

Studie voltooiing (Werkelijk)

1 januari 2013

Studieregistratiedata

Eerst ingediend

1 augustus 2012

Eerst ingediend dat voldeed aan de QC-criteria

6 augustus 2012

Eerst geplaatst (Schatting)

9 augustus 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

4 februari 2013

Laatste update ingediend die voldeed aan QC-criteria

31 januari 2013

Laatst geverifieerd

1 januari 2013

Meer informatie

Termen gerelateerd aan deze studie

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