Clinical trial NCT01660685: Effects of Journaling on Weight Loss
Official title: Effects of Journaling on Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Keywords: Weight loss
Web-based
Journaling
Body Mass Index between 27 and 45
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: 3 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: 3 months
measure: Height
timeFrame: 3 months
Other outcomes:
measure: Sociodemographics and tobacco use
timeFrame: 3 months
measure: Three-factor Eating Questionnaire
timeFrame: 3 months
measure: Motivation
timeFrame: 3 months
measure: Weight Loss Habits
timeFrame: 3 months
measure: Blood Pressure Medication
timeFrame: 3 months
measure: International Physical Activity Questionnaire
timeFrame: 3 months
measure: Satisfaction Survey
timeFrame: 3 months
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Christopher Sciamanna, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: