- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01660685
Effects of Journaling on Weight Loss
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Pennsylvania
-
Hershey, Pennsylvania, Yhdysvallat, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: 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.
|
Active Comparator: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Weight
Aikaikkuna: 3 months
|
Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
|
3 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Blood Pressure
Aikaikkuna: 3 months
|
Blood pressure will be measured by study staff using an automatic blood pressure monitor.
|
3 months
|
Height
Aikaikkuna: 3 months
|
Height will be measured using a portable stadiometer.
|
3 months
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Sociodemographics and tobacco use
Aikaikkuna: 3 months
|
Age, gender, race, ethnicity, education, smoking status and other demographics will be measured by self-report
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3 months
|
Three-factor Eating Questionnaire
Aikaikkuna: 3 months
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Questionnaire asks participants about how their dietary restraint in specific circumstances
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3 months
|
Motivation
Aikaikkuna: 3 months
|
Questionnaire asks participants to gauge their motivation to lose weight.
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3 months
|
Weight Loss Habits
Aikaikkuna: 3 months
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Questionnaire asks participants how often they use specific habits to lose weight
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3 months
|
Blood Pressure Medication
Aikaikkuna: 3 months
|
Blood pressure medication names, doses and frequency measured by self-report
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3 months
|
International Physical Activity Questionnaire
Aikaikkuna: 3 months
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Questionnaire asks participants to estimate the frequency and duration of specific physical activities
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3 months
|
Satisfaction Survey
Aikaikkuna: 3 months
|
Questionnaire asks participants about their satisfaction with specific aspects of the study
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3 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 39952EP
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